Phase I Trial of Parathyroid Hormone to Facilitate Stem Cell Mobilization
|
|
- Alberta Jones
- 5 years ago
- Views:
Transcription
1 Biology of Blood and Marrow Transplantation 13: (2007) 2007 American Society for Blood and Marrow Transplantation /07/ $32.00/0 doi: /j.bbmt Phase I Trial of Parathyroid Hormone to Facilitate Stem Cell Mobilization Karen K. Ballen, 1 Elizabeth J. Shpall, 4 David Avigan, 3 Beow Y. Yeap, 1 David C. Fisher, 2 Kathleen McDermott, 2 Bimalangshu R. Dey, 1 Eyal Attar, 1 Steven McAfee, 1 Marina Konopleva, 4 Joseph H. Antin, 2 Thomas R. Spitzer 1 1 Hematology/Oncology Division, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; 2 Division of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts; 3 Division of Hematologic Malignancies, Beth Israel Deaconess Medical Center, Boston, Massachusetts; and 4 M.D. Anderson Cancer Center, Houston, Texas Correspondence and reprint requests: Karen Ballen, M.D., Division of Hematology/Oncology, Massachusetts General Hospital, Zero Emerson Place, Suite 118, Room 134, Boston, MA ( kballen@partners.org). Received December 13, 2006; accepted March 16, 2007 ABSTRACT Autologous stem cell transplantation is a curative procedure for many patients with lymphomas, and has been shown to improve survival in patients with multiple myeloma. Approximately 20% of patients are unable to mobilize sufficient hematopoietic stem cells to proceed safely to autologous stem cell transplantation. Parathyroid hormone (PTH) affects osteoblasts and the stem cell niche, and has been shown to improve survival when given posttransplant in a mouse competitive transplant model. In this Phase I study, 20 subjects who had 1 or 2 unsuccessful stem cell mobilization attempts, received PTH in escalating doses of 40 g, 60 g, 80 g, and 100 g for 14 days. On days of treatment, subjects received filgrastim 10 g/kg. The PTH was tolerated well and there was no dose-limiting toxicity. Forty-seven percent of subjects who had failed 1 prior mobilization attempt met the mobilization criteria of >5 CD34 cells/ L in the peripheral blood. Forty percent of subjects who failed to reach adequate CD34 cell counts in 2 prior mobilization attempts met the mobilization criteria. PTH was well tolerated at doses up to 100 g in human cancer patients. The efficacy of PTH for mobilization of hematopoietic stem cells will need to be tested in a larger Phase II study American Society for Blood and Marrow Transplantation KEY WORDS Parathyroid hormone Mobilization Stem cells INTRODUCTION Chemotherapy followed by growth factor administration has become a standard strategy for mobilization of peripheral blood stem cells (PBSCs) in preparation for autologous stem cell transplantation [1,2]. Regardless of the mobilization strategy, approximately 10%-20% of patients fail to collect an adequate number of stem cells to ensure engraftment [3,4]. Predictive factors for poor mobilization have been studied and include age 70 years, 12 months of prior therapy, and platelet count /L prior to mobilization [4]. Poor mobilization of PBSCs has also been associated with worse transplant outcomes in lymphoma patients [5]. Studies in mouse models have been undertaken to try to understand the stem cell niche, and thereby increase stem cell numbers. Osteoblasts are a regulatory component of the hematopoietic stem cell niche and can be targeted as a means to increase stem cell numbers [6,7]. Osteoblasts produce hematopoietic growth factors and are activated by parathyroid hormone (PTH) or the locally produced, PTH-related protein (PTH-rP), through the PTH/PTHrP receptor (PPR) [8,9]. The Notch signaling pathway regulates cell fate in a wide variety of systems including hematopoietic self-renewal [10]. Furthermore, the Notch ligand Jagged 1 is expressed by marrow stromal cells and murine osteoblasts, and is increased with PPR activation [6]. It is one of several potential molecular mechanisms by which osteoblast stimulation may alter stem cell numbers [11,12]. Using either a genetic model where the PPR was constitutively active in osteoblasts or a pharmacologic 838
2 Parathyroid Hormone and Stem Cell Mobilization 839 model where PTH(1-34) was used to activate PPR, the Scadden laboratory has demonstrated a 2-fold increase in hematopoietic stem cells in murine bone marrow. This resulted in increased ability to engraft irradiated recipient animals when either bone marrow or granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood was used as a stem cell source. In addition, treatment of animals with PTH(1-34) following transplantation with a limiting number of stem cells markedly improved animal survival and bone marrow cellularity [6]. These data suggest that using PTH to alter activity of the stem cell microenvironment may improve either the yield of stem cells derived from treated donors or the efficiency of engraftment in treated recipients. We hypothesized that similar activities may exist in humans and that PTH may provide a novel means of changing stem cell number and function in settings of clinical importance. The trial detailed here is our first attempt to test the safety of this approach in the context of stem cell donors with cancer who have failed prior efforts at stem cell mobilization. We performed a Phase I study of PTH at 4 different dose levels, given with filgrastim, to patients with hematologic malignancies who required a second or third mobilization regimen. PATIENTS AND METHODS Patients Patients aged 18 to 75 years with relapsed or refractory Hodgkin s disease or non-hodgkin s lymphoma, multiple myeloma, or acute myelogenous leukemia (AML) in second or subsequent remission or in first remission with high risk cytogenetics were eligible for this study. Patients were eligible to participate if they did not reach adequate CD34 cell counts in 1 or 2 prior mobilization attempts, defined as 5 CD34 cells/ L in the blood or CD 34 cells/kg after 4 apheresis collections. Patients with serum calcium 10.5 mg/dl or a phosphate level 1.6 mg/dl were excluded. Patients also had to be eligible for transplantation including ECOG performance status of 0, 1, or 2, creatinine 2.0, bilirubin 2.0, ejection fraction 45%, and DLCO 50% predicted. All subjects signed an informed consent form approved by the Institutional Review Boards of either M.D. Anderson Cancer Center or Dana Farber/Harvard Cancer Center. Treatment Plan Treatment with PTH began within 21 days of determination that inadequate CD34 cells were obtained in the prior mobilization regimen. All subjects received human PTH(1-34) (teriparatide) given as a subcutaneous injection for days 1-14 of the study or until the completion of apheresis. PTH was supplied in multidose pens; subjects were taught the appropriate use, and medication was given at home or in the outpatient clinic, at the following dose levels: 40 g, 60 g, 80 g, and 100 g a day. Three subjects were treated at each dose level, in ascending order, with an additional 3 subjects to be added for any dose limiting toxicity. Subjects treated with more than 40 g a day had a daily dose escalation; for example, subjects treated at the 100 g dose received 40 g on day 1, 60 g on day 2, 80 g on day 3, and then 100 g on days All subjects received filgrastim 10 g/kg daily on days of the study or until the completion of apheresis. Definitions of Toxicity and Response Calcium levels, phosphate level, ionized calcium, albumin, blood counts, and vital signs were monitored thrice weekly. On the first day of their maximal PTH dose, subjects were monitored 4 hours after the PTH dose as well. Dose-limiting toxicity was defined as any of the following: serum calcium level 11.5 mg/dl, an ionized calcium level 1.5 mm, systolic blood pressure 80 mmhg, phosphate 1.0 mg/dl. Mobilization was defined as a peripheral CD34 cell count of 5 cells/ L on day 14 of the study. Subjects who met the mobilization criteria proceeded to stem cell collection and, if adequate numbers of stem cells were collected, autologous stem cell transplant. Subjects who did not meet the mobilization criteria were treated off study. Statistics Time to neutrophil or platelet engraftment was measured from day 0 of autologous stem cell transplant and was estimated by the Kaplan-Meier method. One subject was censored at day 0 for platelet engraftment as he did not nadir /L as a result of transfusion to maintain a platelet count /L because of concomitant anticoagulation therapy. RESULTS Patient Characteristics Patient characteristics are outlined in Table 1. Twenty subjects were enrolled on this study. The median age was 57 years with a range of years. Thirty-five percent of subjects were male. The majority of subjects (85%) had lymphoma. Fifteen subjects had undergone 1 prior mobilization attempt and 5 subjects had undergone 2 prior mobilization attempts. Eight subjects had received filgrastim mobilization alone, and 12 subjects had received chemotherapy plus filgrastim as their prestudy mobilization regimen. Prior mobilizations regimens included filgrastim alone, cyclophosphamide/filgrastim, rituximab/cyclophospha-
3 840 K. K. Ballen et al. Table 1. Patient Characteristics Number of Patients Institution Dana-Farber/Brigham & Women s 7 (35%) Massachusetts General Hospital 6 (30%) MD Anderson Cancer Center 4 (20%) Beth Israel Deaconess 3 (15%) Age, years Median 57 Range Sex Male 7 (35%) Female 13 (65%) Diagnosis Non-Hodgkin s lymphoma 12 (60%) Hodgkin s disease 6 (30%) Multiple myeloma 2 (10%) Mobilization prior attempts 1 15 (75%) 2 5 (25%) mide/filgrastim, rituximab/ifosfamide/carboplatin/etoposide/filgrastim, and AMD3100/filgrastim. Eastern Cooperative Oncology Group Performance Status was 0 for 13 subjects and 1 for 7 subjects. Toxicity and Dose Escalation There was no dose-limiting toxicity at any of the 4 doses. Three subjects each were treated at the dose levels of 40 g, 60 g, and 80 g. One subject in the initial 100 g cohort was admitted overnight with fever and rigors, and therefore an additional 3 subjects were added at this dose level. This side effect did not occur again. Per protocol, an additional 5 subjects (for a total of 11) were enrolled at the highest dose. There was no hypercalcemia (calcium 11.5 mg/dl) at any dose level. The maximum calcium level was 11.3 mg/dl and the maximum ionized calcium level was 1.5 mm. Side effects experienced included 6 grade 3 toxicities as listed in Table 2. The pre- and 4-hour post-pth injection calcium levels are outlined in Table 3. Mobilization Nine of the 20 subjects met the mobilization criteria of 5 CD34 cells/ Londay 14 of treatment. The patients and their mobilizations results are displayed in Table 4. The median peripheral blood Table 2. Toxicities Related to PTH Grade 3 Events Number of Subjects Headache 2 Muscle pain 1 Back pain 1 Fatigue 1 Hypothermia 1 Table 3. Calcium Levels before and after Parathyroid Hormone Injection CD34 count on day 14 was 3.3 cells/ L, with a range of 0-20 cells/ L. Seven of 15 subjects (47%) who had 1 prior unsuccessful mobilization attempt met the mobilization criteria. Subjects who had previously received 2 unsuccessful mobilization regimens did not fare worse; 2 of 5 subjects (40%) met the mobilization criteria. There did not appear to be an increased mobilization efficiency at higher doses. Subjects who did not achieve 5 CD34 cells/ l were treated off study. Nine subjects went onto apheresis and required a median of 2 collections (range: 1-5) to collect a median of CD34 cells/kg (range: ). Three subjects collected over 2 million CD34 cells/kg. However, of the 9 subjects evaluable for apheresis collections, 2 subjects had access problems that limited success of apheresis and 1 patient s physician elected to terminate collections prior to completion because of a low initial stem cell yield. Parameters of Bone Activity Osteocalcin and alkaline phosphatase (alk phos) levels were not required as part of the protocol; however, pre- and posttreatment alk phos levels were available on 8 subjects. The median pre treatment alk phos was 137 U/L, with a range of The median posttreatment alk phos was 195 U/L, with a range of Five of these 8 patients met the mobilization criteria of 5 CD34 cells/ l onday 14 of treatment. Four of these patients had an increase in alk phos after PTH treatment ranging from 45 to 184 U/L, and 1 patient had a decrease in alk phos of 76 U/L. Transplantation Data Maximum Calcium (mg/dl) Maximum Ionized Calcium (mm) Preinjection Hours Postinjection Six subjects proceeded to autologous stem cell transplant using PTH stimulated stem cell collections. In 1 subject insufficient CD34 cells were collected and 1 subject had an allogeneic transplant. Subjects received a variety of conditioning regimens as appropriate for their disease. The median number of red blood cell transfusions prior to engraftment was 4 (range: 1-6) and the median number of platelet transfusions was 4 (range: 2-4). The median days to neutrophil engraftment, defined as an absolute neutrophil count cells/l was 11 days (range: 8-12 days). The median days to platelet engraftment, defined as a platelet count cells/l unsupported, was 19 days, with a range of days. One
4 Parathyroid Hormone and Stem Cell Mobilization 841 Table 4. Mobilization Characteristics Patient Number Age Disease Number of Prior Mobilizations PTH Dose Peripheral Blood CD34 Count on Day Hodgkin s 1 40 g Lymphoma 1 40 g Hodgkin s 1 40 g Hodgkin s 1 60 g Lymphoma 2 60 g Lymphoma 1 60 g Hodgkin s 1 80 g Lymphoma 2 80 g Hodgkin s 1 80 g Lymphoma g Lymphoma g Lymphoma g Lymphoma g Myeloma g Myeloma g Lymphoma g Lymphoma g Hodgkin s g Lymphoma g Lymphoma g 4.1 subject was transfused with platelets to maintain a platelet count greater than cells/l because of concomitant anticoagulation therapy. All 6 of these patients are alive without evidence of disease, with a median follow up of 22 months (range: months). DISCUSSION In this phase I trial, we demonstrated that PTH could be administered safely to subjects as part of a mobilization strategy prior to autologous stem cell transplantation. We undertook these trials because in approximately 20% of patients who are candidates for autologous stem cell transplant, insufficient cells can be collected to ensure rapid engraftment. The optimal strategy to provide a suitable stem cell product for these patients is unclear. Options include remobilization with growth factors with or without chemotherapy, bone marrow harvesting, proceeding to autologous stem cell transplantation with a low stem cell dose, or allogeneic transplantation. Investigational agents, such as AMD3100, which inhibits the binding of stromal derived growth factor-1 (SDF-1) or CXCL12 to its receptor CXCR-4 are now in advanced clinical trials [13,14]. Studies of stem cell biology in mouse models led to the discovery that the osteoblast is a component of the regulatory stem cell niche, and that altering osteoblast activity by PPR stimulation could affect hematopoietic stem cell number and function [15]. This was apparent in settings relevant for clinical transplantation including stem cell harvesting and stem cell engraftment. These findings suggested that manipulation of the stem cell niche could be a strategy for improving transplantation outcomes. Work by Jung and colleagues [16] suggested that PTH increases stromal derived factor-1 (SDF-1) expression in the bone marrow, potentially contributing to homing. However, whether mouse models could predict human outcomes in this setting was unknown, and conversion of the dose of hormone used in the mouse to the human is complex with PTH because of the very different sensitivity of rodents to PTH. What was known from the mouse and could be anticipated in humans, is that stimulation of osteoblasts was likely to take a prolonged interval prior to an appreciable effect on the slowly cycling stem cells. In the mouse model this interval was shown to be 28 days [6]. However, we were concerned that a prolonged interval of PTH stimulation would require modifying a standard approach to patients failing a prior mobilization and extend the time prior to their receiving potentially curative intensive chemotherapy. We therefore chose to restrict the interval of PTH dosing to 14 days, thereby not subjecting the patient participants to a delay in their chemotherapy, yet collecting important safety data, but likely compromising our ability to detect a biologic effect on stem cell number. The doses chosen for study were based on prior studies of PTH as an anabolic agent to enhance bone mineral density and reduce the risk of fracture [17,18]. Large-scale osteoporosis studies in men and postmenopausal women have used doses of g daily of PTH(1-34) [19,20]. Side effects have included headaches, joint pain, muscle aches, and fatigue. Twelve percent of women had an elevated calcium level; in 2% of women on long-term treatment the
5 842 K. K. Ballen et al. level was above 11.2 mg/dl. In mouse studies, PTH(1-34) was shown to have a dose-related effect on stem cell number [21]. Therefore, we performed a dose escalation study, exceeding doses typically used in treatment of osteoporosis by 5-fold. We found that doses of PTH up to 100 g/day were tolerated well. There was no dose-limiting toxicity and no serious hypercalcemia. Mild headache and fever occurred in only 2 patients. No patient stopped PTH because of toxicity. This may result from the vigorous prior treatment of these patients potentially compromising their osteoclast function or simply from the short-term nature of the trial. We would conclude, however, that the dose of 100 g might be safely used for at least short intervals in further investigation of stem cell effects in patients with hematologic malignancies. Peripheral blood CD34 cell concentration predicts the CD34 yield in the leukapheresis product, and is used here as a marker of mobilization [22]. Itis difficult to determine whether PTH administration enhanced CD34 cell collection, because other strategies may result in similar outcomes and there was no comparator group. For instance, filgrastim alone can be used as a second mobilization strategy. In 1 study, 48% of patients obtained sufficient cells ( CD34 cells/kg) to proceed to autologous stem cell transplant [23]. Filgrastim and sargramostim have also been used together as a second mobilization strategy, with 50% of patients reaching the target goal of 3 million CD34 cells/kg from the first and second mobilization sessions [24]. A retrospective review compared PBSC harvesting to bone marrow harvesting in patients who had failed to have 1 adequate stem cell mobilzation [25]. Fifty-one percent of patients collected CD 34 cells/kg from the second mobilization. In our study, the mobilization rate was 47% for second mobilizations and 40% for third mobilizations, comparable to the reported literature. However, the study was not powered nor designed to address efficacy. All the patients that proceeded to transplant with PTH stimulated stem cells engrafted with a median day to absolute neutrophil count (ANC) of 500 of 11 days, similar to engraftment reported in the literature after transplant with G-CSF stimulated stem cells [26]. There were no relapses in this group of heavily pretreated patients, and all patients are alive and disease-free posttransplant. This observation in a limited number of patients is intriguing, as unpublished data suggests that rats treated with daily PTH for 2 years had a dose-related decrease in the development of spontaneous leukemia. Further studies to address activity of PTH on stem cells will require longer treatment intervals to test whether it can enhance stem cell harvests. An alternative approach, however, would be to test whether PTH can improve the efficiency of stem cell engraftment in recipients. A logical application using this approach is umbilical cord blood transplantation. The success rate of adult cord blood transplantation has been limited by the low cell dose [27]. Strategies such as double cord blood transplantation have been undertaken to increase the cell dose, but time to cell count recovery is still prolonged, and infection, presumably from poor immune reconstitution, remains the primary cause of death [28,29]. A future study will evaluate PTH at the dose established here, 100 g a day, for 4 weeks following double cord blood transplantation. ACKNOWLEDGMENTS The authors acknowledge the contributions of Dr. Gregor Adams, Dr. Henry Kronenberg, Dr. Robert Neer, and Dr. David Scadden for their helpful discussions and comments. This work was supported by the Cheryl Chagnon Lymphoma Research Foundation, the Leukemia and Lymphoma Society, the Burroughs Wellcome Foundation, and the National Heart, Lung, and Blood Institute of the National Institutes of Health (U54 HL081030). REFERENCES 1. Narayanasami U, Konteti R, Morelli J, et al. Randomized trial of filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells for rescue in autologous transplantation. Blood. 2001;98: Koc O, Gerson SC, Cooper BW, et al. Rapid hematopoietic recovery after co-infusion of autologous-blood stem cells and culture-expanded marrow mesenchymal stem cells in advanced breast cancer patients receiving high dose chemotherapy. J Clin Oncol. 2000;18: Carlo-Stella C, Di Nicola M, Milani R, et al. Use of granulocyte colony-stimulating factor (rhg-csf) for the mobilization and collection of CD34 cells in poor mobilizers. Blood. 2004; 104: Morris CL, Siegel E, Barlogie B, et al. Mobilization of CD34 cells in elderly patients ( 70 years old) with multiple myeloma: influence of age, prior therapy, platelet count, and mobilization regimen. Br J Hematother. 2003;120: Gordan LN, Sugrue MW, Lynch JW, et al. Poor mobilization of peripheral blood stem cells is a risk factor for worse outcome in lymphoma patients undergoing autologous stem cell transplantation. Leukemia Lymphoma. 2003;44: Calvi LM, Adams GB, Welbrecht KW, et al. Osteoblastic cells regulate the hematopoietic stem cell niche. Nature. 2003;425: Zhang J, Niu C, Huang H, et al. Identification of the haematopoietic stem cell niche and control of the niche size. Nature. 2003;425: Taichman RS, Reilly MJ, Emerson SG. Human osteoblasts support human hematopoietic progenitor cells in vitro bone marrow cultures. Blood. 1996;87:
6 Parathyroid Hormone and Stem Cell Mobilization Taichman RS, Emerson SJ. Human osteoblasts support the production of granulocyte colony-stimulating factor. J Exp Med. 1994;179: Karanu FN, Murdoch B, Gallacher C, et al. The notch ligand Jagged-1 represents a novel growth factor of human hematopoietic stem cells. J Exp Med. 2000;192: Taichman RS. Blood and bone: two tissues whose fates are intertwined to create the hematopoietic stem-cell niche. Blood. 2005;105: Zhu J, Zhang Y, Joe GJ, et al. NF-Ya activates multiple hematopoietic stem cell (HSC) regulatory genes and promotes HSC self-renewal. Proc Natl Acad Sci. 2005;102: Devine SM, Flomenberg N, Vesole DH, et al. Rapid mobilization of CD34 cells following administration of the CXCR4 antagonist AMD 3100 to patients with multiple myeloma and non Hodgkin s lymphoma. J Clin Oncol. 2004;22: Liles WC, Broxmeyer HE, Rodger E, et al. Mobilization of hematopoietic progenitor cells in healthy volunteers by AMD 3100, a CXCR4 antagonist. Blood. 2003;102: Stier S, Chen T, Dombkowski D, et al. Notch 1 activation increases hematopoietic stem cell self-renewal in vivo and favors lymphoid over myeloid lineage outcome. Blood. 2002;99: Jung Y, Wang J, Schneider A, et al. Regulation of SDF-1 (CXCL12) production by osteoblasts; a possible mechanism for stem cell homing. Bone. 2006;38: Finkelstein JS, Klibanski A, Arnold AL, et al. Prevention of estrogen deficiency-related bone loss with human parathyroid hormone: a randomized controlled trial. JAMA. 1988;280: Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001; 344: Finkelstein JS, Hayes A, Hunzelman L, et al. The effect of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med. 2003;349: Black DM, Greensplan SL, Ensrud KE, et al. The effects of parathyroid hormone and alendronate alone or in combination with postmenopausal osteoporosis. N Engl J Med. 2003;349: Adams GB, Martin RP, Alley IR, et al. Therapeutic targeting of a stem cell niche. Nat Biotechnol. 2007;25: Fu P, Bagai PK, Meyerson H, et al. Pre-mobilization therapy blood CD34 cell count predicts the likelihood of successful hematopoietic stem cell mobilization. Bone Marrow Transplant. 2006;38: Weaver CH, Tauer K, Zhen B, et al. Second attempts at mobilization of peripheral blood stem cells in patients with initial low CD34 cell yields. J Hematother. 1998;7: Bashey A, Corringham S, Gilpin E, et al. Simultaneous administration of G-CSF and GM-CSF for re-mobilization in patients with inadequate progenitor cell collections for autologous transplantation. Cytotherapy. 2000;2: Goterris R, Hernadez-Bolida JC, Teruel A, et al. Impact of different strategies of second-line stem cell harvest on the outcome of autologous transplantation in poor peripheral blood stem cell mobilizers. Bone Marrow Transplant. 2005; 36: Parkins MD, Bahlis N, Brown C, et al. Overnight storage of autologous stem cell apheresis products before cryopreservation does not adversely impact early or long-term engraftment following transplantation. Bone Marrow Transplant. 2006;38: Ballen KK. New trends in umbilical cord blood transplantation Blood. 2005;105: Barker JN, Weisdorf DF, DeFor TE. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood. 2003;102: Ballen KK, Spitzer TR, Yeap B, et al. Double unrelated reduced intensity umbilical cord blood transplantation in adults. Biol Blood Marrow Transplant. 2007;13:82-89.
Phase II Trial of Parathyroid Hormone after Double Umbilical Cord Blood Transplantation
Phase II Trial of Parathyroid Hormone after Double Umbilical Cord Blood Transplantation Karen Ballen, 1 Adam M. Mendizabal, 2 Corey Cutler, 3 Ioannis Politikos, 4 Katarzyna Jamieson, 5 Elizabeth J. Shpall,
More information& 2007 Nature Publishing Group All rights reserved /07 $
(7), 437 441 & 7 Nature Publishing Group All rights reserved 268-3369/7 $. www.nature.com/bmt ORIGINAL ARTICLE Patients mobilizing large numbers of CD34 þ cells ( super mobilizers ) have improved survival
More informationStem Cell Mobilization Protocols: Filgrastim vs. Mozobil
White Paper September 2016 Stem Cell Mobilization Protocols: Filgrastim vs. Mozobil Lily C. Trajman, Ph.D. Introduction Hematopoietic stem cells (HSCs) are primitive cells capable of both self renewal
More informationDepartment of Pharmacy, Georgia Health Sciences University, Augusta, GA, USA 3
Oncology Volume 2012, Article ID 931071, 5 pages doi:10.1155/2012/931071 Research Article Plerixafor Salvage Is Safe and Effective in Hard-to-Mobilize Patients Undergoing Chemotherapy and Filgrastim-Based
More informationBone Marrow Transplantation and the Potential Role of Iomab-B
Bone Marrow Transplantation and the Potential Role of Iomab-B Hillard M. Lazarus, MD, FACP Professor of Medicine, Director of Novel Cell Therapy Case Western Reserve University 1 Hematopoietic Cell Transplantation
More informationPlerixafor (Mozobil Ò ) Alone to Mobilize Hematopoietic Stem Cells from Multiple Myeloma Patients for Autologous Transplantation
BRIEF ARTICLES Plerixafor (Mozobil Ò ) Alone to Mobilize Hematopoietic Stem Cells from Multiple Myeloma Patients for Autologous Transplantation Neal Flomenberg, 1 Raymond L. Comenzo, 2 Karin Badel, 3 Gary
More informationStony Brook University Hospital, Stony Brook, NY 2. TaiGen Biotechnology Co., Ltd, Taipei, Taiwan
A Phase 2, Open-label Study to Evaluate the Safety and Hematopoietic Stem Cell Mobilization of TG- 0054 (burixafor) Alone or in Combination with G- CSF in Patients with Multiple Myeloma, Non- Hodgkin s
More informationTransplantation - Challenges for the future. Dr Gordon Cook S t James s Institute of Oncology, Leeds Teaching Hospitals Trust
Transplantation - Challenges for the future Dr Gordon Cook S t James s Institute of Oncology, Leeds Teaching Hospitals Trust Bone Marrow Transplantation Timeline, 1957-2006 Appelbaum F. N Engl J Med 2007;357:1472-1475
More informationIntroduction to Hematopoietic Stem Cell Transplantation
Faculty Disclosures Introduction to Hematopoietic Stem Cell Transplantation Nothing to disclose Jeanne McCarthy-Kaiser, PharmD, BCOP Clinical Pharmacist, Autologous Stem Cell Transplant/Long- Term Follow-Up
More informationDr.PSRK.Sastry MD, ECMO
Peripheral blood stem cell transplantation (Haematopoietic stem cell transplantation) Dr.PSRK.Sastry MD, ECMO Consultant, Medical Oncology Kokilaben Dhirubhai Ambani Hospital Normal hematopoiesis Historical
More informationNew Evidence reports on presentations given at EHA/ICML Bendamustine in the Treatment of Lymphoproliferative Disorders
New Evidence reports on presentations given at EHA/ICML 2011 Bendamustine in the Treatment of Lymphoproliferative Disorders Report on EHA/ICML 2011 presentations Efficacy and safety of bendamustine plus
More informationClinical Policy: Donor Lymphocyte Infusion
Clinical Policy: Reference Number: PA.CP.MP.101 Effective Date: 01/18 Last Review Date: 11/16 Coding Implications Revision Log This policy describes the medical necessity requirements for a donor lymphocyte
More informationLeukine. Leukine (sargramostim) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Leukine Page: 1 of 6 Last Review Date: November 30, 2018 Leukine Description Leukine (sargramostim)
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 16 December 2009
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 16 December 2009 MOZOBIL 20 mg/ml, solution for injection Box containing 1 vial (CIP: 397 153-7) Applicant: GENZYME
More information5/9/2018. Bone marrow failure diseases (aplastic anemia) can be cured by providing a source of new marrow
5/9/2018 or Stem Cell Harvest Where we are now, and What s Coming AA MDS International Foundation Indianapolis IN Luke Akard MD May 19, 2018 Infusion Transplant Conditioning Treatment 2-7 days STEM CELL
More informationLeukine. Leukine (sargramostim) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.08 Subject: Leukine Page: 1 of 5 Last Review Date: September 15, 2017 Leukine Description Leukine
More informationHematopoietic Growth Factors Colony Stimulating Factors. Erythropoietin (Epoetin alfa). Granulocyte-macrophage colonystimulating factor (G-CSF).
Hematopoietic Growth Factors Colony Stimulating Factors. Erythropoietin (Epoetin alfa). Granulocyte colony-stimulating factor(g-csf). Granulocyte-macrophage colonystimulating factor (G-CSF). Interleukin-11
More informationTRANSPARENCY COMMITTEE. The legally binding text is the original French version OPINION. 21 June 2006
TRANSPARENCY COMMITTEE The legally binding text is the original French version OPINION 21 June 2006 Granocyte 13 (13.4 million IU/1 ml), powder and solvent in prefilled syringe for solution for injection
More informationFor peripheral blood stem cell (PBSC) mobilization prior to and during leukapheresis in cancer patients preparing to undergo bone marrow ablation
Last Review: 4/2010 NON-FORMULARY Clinical Guideline Neupogen (filgrastim; G-CSF), Neulasta (peg-filgrastim; G-CSF), Neumega (oprelvekin; rh-il-11), Leukine (sargramostim; GM-CSF) Indications Neupogen
More informationCD34+ Cells: A Comparison of Stem and Progenitor Cells in Cord Blood, Peripheral Blood, and the Bone Marrow
White Paper September 2016 CD34+ Cells: A Comparison of Stem and Progenitor Cells in Cord Blood, Peripheral Blood, and the Bone Marrow Lily C. Trajman, PhD Introduction: Hematopoietic Stem Cells (HSCs)
More informationSponsor: Sanofi Drug substance(s): GZ316455
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor: Sanofi Drug substance(s):
More informationReduced-Intensity Conditioning Stem Cell Transplantation: Comparison of Double Umbilical Cord Blood and Unrelated Donor Grafts
Reduced-Intensity Conditioning Stem Cell Transplantation: Comparison of Double Umbilical Cord Blood and Unrelated Donor Grafts Yi-Bin Chen, 1 Julie Aldridge, 2 Haesook T. Kim, 2 Karen K. Ballen, 1 Corey
More informationCord Blood Stem Cell Banking and Transplantation
Cord Blood Stem Cell Banking and Transplantation JOHN W. ADAMSON New York Blood Center, New York, New York, USA Key Words. Cord blood Stem cells Cord blood banking Cord blood transplantation. Cord blood.stern
More informationAETNA BETTER HEALTH Non-Formulary Prior Authorization guideline for Colony Stimulating Factor (CSF)
AETNA BETTER HEALTH Non-Formulary Prior Authorization guideline for Colony Stimulating Factor (CSF) Colony Stimulating Factor (CSF) Neupogen (filgrastim; G-CSF), Neulasta (peg-filgrastim; G-CSF); Neulasa
More informationDonor Lymphocyte Infusion for Malignancies Treated with an Allogeneic Hematopoietic Stem-Cell Transplant
Last Review Status/Date: September 2014 Page: 1 of 8 Malignancies Treated with an Allogeneic Description Donor lymphocyte infusion (DLI), also called donor leukocyte or buffy-coat infusion is a type of
More informationAETNA BETTER HEALTH Non-Formulary Prior Authorization guideline for Colony Stimulating Factor (CSF)
AETNA BETTER HEALTH Non-Formulary Prior Authorization guideline for Colony Stimulating Factor (CSF) Colony Stimulating Factor (CSF) Neupogen (filgrastim; G-CSF), Neulasta (peg-filgrastim; G-CSF); Neulasa
More informationAllogeneic Stem Cell Transplantation with Peripheral Blood Stem Cells Mobilized by Pegylated G-CSF
Biology of Blood and Marrow Transplantation 12:63-67 (26) 26 American Society for Blood and Marrow Transplantation 183-8791/6/126-2$32./ doi:1.116/j.bbmt.26.3.1 Allogeneic Stem Cell Transplantation with
More information2. Is therapy prescribed by, or in consultation with, a hematologist and/or oncologist?
Pharmacy Prior Authorization AETA BETTER HEALTH EW JERSE (MEDICAID) Colony Stimulating Factors (Medicaid) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review
More informationBL-8040: BEST-IN-CLASS CXCR4 ANTAGONIST FOR TREATMENT OF ONCOLOGICAL MALIGNANCIES. Overview and Mechanism of Action Dr.
BL-8040: BEST-IN-CLASS CXCR4 ANTAGONIST FOR TREATMENT OF ONCOLOGICAL MALIGNANCIES Overview and Mechanism of Action Dr. Leah Klapper, CSO 88 BL-8040: Novel CXCR4 Antagonist For Hematological Cancers Indications:
More informationHematopoietic stem cell mobilization and collection. Koen Theunissen Hematologie Jessa Ziekenhuis Hasselt Limburgs Oncologisch Centrum
Hematopoietic stem cell mobilization and collection Koen Theunissen Hematologie Jessa Ziekenhuis Hasselt Limburgs Oncologisch Centrum Transplants Transplant Activity in the U.S. 1980-2010 14,000 12,000
More informationBMTCN REVIEW COURSE PRE-TRANSPLANT CARE
BMTCN REVIEW COURSE PRE-TRANSPLANT CARE Jennifer Shamai MS, RN, AOCNS, BMTCN Professional Practice Leader Department of Clinical Practice And Professional Education Click How to edit the Master Experts
More informationBC Cancer Protocol Summary for Therapy of Acute Myeloid Leukemia Using azacitidine and SORAfenib
BC Cancer Protocol Summary for Therapy of Acute Myeloid Leukemia Using azacitidine and SORAfenib Protocol Code Tumour Group Contact Physician ULKAMLAS Leukemia/BMT Dr. Donna Hogge ELIGIBILITY: Acute myeloid
More informationUMBILICAL CORD BLOOD STEM CELLS EXPANDED IN THE PRESENCE OF NICOTINAMIDE (NICORD) PROVIDE LONG TERM MULITI-LINEAGE ENGRAFTMENT
UMBILICAL CORD BLOOD STEM CELLS EXPANDED IN THE PRESENCE OF NICOTINAMIDE (NICORD) PROVIDE LONG TERM MULITI-LINEAGE ENGRAFTMENT Mitchell E. Horwitz, MD Duke University Medical Center Duke Cancer Institute
More informationInduction Therapy & Stem Cell Transplantation for Myeloma
Induction Therapy & Stem Cell Transplantation for Myeloma William Bensinger, MD Professor of Medicine, Division of Oncology University of Washington School of Medicine Director, Autologous Stem Cell Transplant
More information"Chemotherapy based stem cell mobilization: pro and con"
"Chemotherapy based stem cell mobilization: pro and con" Mohamad MOHTY Clinical Hematology and Cellular Therapy Dpt. Sorbonne Université Hôpital Saint Antoine Paris, France Disclosures Sponsorship or research
More informationReference: NHS England 1602
Clinical Commissioning Policy Proposition: Clofarabine for refractory or relapsed acute myeloid leukaemia (AML) as a bridge to stem cell transplantation Reference: NHS England 1602 First published: TBC
More informationGranix. Granix (tbo-filgrastim) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.10.16 Subject: Granix 1 of 7 Last Review Date: September 18, 2015 Granix Description Granix (tbo-filgrastim)
More information3.1 Clinical safety of chimeric or humanized anti-cd25 (ch/anti-cd25)
3 Results 3.1 Clinical safety of chimeric or humanized anti-cd25 (ch/anti-cd25) Five infusions of monoclonal IL-2 receptor antibody (anti-cd25) were planned according to protocol between day 0 and day
More informationMyelodysplasia/Myeloproliferative Neoplasms (MDS/MPN) Post-HCT Data
Instructions for Myelodysplasia/Myeloproliferative Neoplasms (MDS/MPN) Post-HCT Data (Form 2114) This section of the CIBMTR Forms Instruction Manual is intended to be a resource for completing the Myelodysplasia/Myeloproliferative
More informationGranix. Granix (tbo-filgrastim) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.16 Subject: Granix 1 of 7 Last Review Date: December 2, 2016 Granix Description Granix (tbo-filgrastim)
More informationWAA/SFH Joint Congress
WAA/SFH Joint Congress Paris, 27 29 April 2016 Mobilization of HSC: History, evolution & impact Pitié-Sâlpétrière Hospital-Paris- France University Hospital of Paris-VI Nabih AZAR MD Key areas covered
More informationLeukine. Leukine (sargramostim) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.10.08 Subject: Leukine Page: 1 of 6 Last Review Date: March 13, 2014 Leukine Description Leukine (sargramostim)
More informationOne Day BMT Course by Thai Society of Hematology. Management of Graft Failure and Relapsed Diseases
One Day BMT Course by Thai Society of Hematology Management of Graft Failure and Relapsed Diseases Piya Rujkijyanont, MD Division of Hematology-Oncology Department of Pediatrics Phramongkutklao Hospital
More information2/4/14. Plerixafor. Learning Objective
Efficacy of late Hematopoietic Stem Cell Mobilization 35-40 hours after administration of Vikas Bhushan, MD Attending Physician, Stem Cell Transplantation, Medical City Hospital Dallas, TX Cyclam Rings
More informationGranix. Granix (tbo-filgrastim) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.10.16 Section: Prescription Drugs Effective Date: April 1, 2014 Subject: Granix 1 of 7 Last Review Date:
More informationThis was a multicenter study conducted at 11 sites in the United States and 11 sites in Europe.
Protocol CAM211: A Phase II Study of Campath-1H (CAMPATH ) in Patients with B- Cell Chronic Lymphocytic Leukemia who have Received an Alkylating Agent and Failed Fludarabine Therapy These results are supplied
More informationSTEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA
STEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan.
More informationAutologous peripheral blood stem cells (PBSC)
998; 83-6 9-3-25 9:27 Pagina 489 Haematologica 998; 83:489-495 original paper C D 3 4 + cell dose and CD33 subsets: collection and engraftment kinetics in autologous peripheral blood stem cells tra n s
More informationHLA-DR-matched Parental Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients with High-risk Acute Leukemia
BRIEF COMMUNICATION HLA-DR-matched Parental Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients with High-risk Acute Leukemia Shang-Ju Wu, Ming Yao,* Jih-Luh Tang, Bo-Sheng Ko, Hwei-Fang
More informationAbstract 861. Stein AS, Topp MS, Kantarjian H, Gökbuget N, Bargou R, Litzow M, Rambaldi A, Ribera J-M, Zhang A, Zimmerman Z, Forman SJ
Treatment with Anti-CD19 BiTE Blinatumomab in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL) Post-Allogeneic Hematopoietic Stem Cell Transplantation Abstract
More informationTrends in Hematopoietic Cell Transplantation. AAMAC Patient Education Day Oct 2014
Trends in Hematopoietic Cell Transplantation AAMAC Patient Education Day Oct 2014 Objectives Review the principles behind allogeneic stem cell transplantation Outline the process of transplant, some of
More informationCLINICAL RESEARCH. KEY WORDS: Autologous peripheral blood stem cell transplantation, Cell dose, Platelet recovery, Plerixafor
CLINICAL RESEARCH Transplanted CD34 1 Cell Dose Is Associated with Long-Term Platelet Count Recovery following Autologous Peripheral Blood Stem Cell Transplant in Patients with Non-Hodgkin Lymphoma or
More informationCorporate Medical Policy
White Blood Cell Growth Factors Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: white_blood_cell_growth_factors 9/2016 4/2017 4/2018 6/2017 Description of
More informationDonatore HLA identico di anni o MUD giovane?
Donatore HLA identico di 60-70 anni o MUD giovane? Stella Santarone Dipartimento di Ematologia, Medicina Trasfusionale e Biotecnologie Pescara AGENDA 1. Stem Cell Donation: fatalities and severe events
More informationProtocol. Hematopoietic Stem-Cell Transplantation for Primary Amyloidosis
Protocol Hematopoietic Stem-Cell Transplantation for Primary Amyloidosis (80142) Medical Benefit Effective Date: 04/01/13 Next Review Date: 07/15 Preauthorization Yes Review Dates: 04/07, 05/08, 01/10,
More informationPharmacy Prior Authorization
Pharmacy Prior Authorization MERC CARE (MEDICAID) Colony Stimulating Factors (Medicaid) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign
More informationSTEM CELL COLLECTION IN MOBILIZATION FAILURE
STEM CELL COLLECTION IN MOBILIZATION FAILURE FEVZI ALTUNTAŞ Yıldırım Beyazıt Medical School, Ankara Oncology Hospital Department of Hematology and Bone Marrow Transplantation Unit OUTLINE Introduction
More informationReduced-intensity Conditioning Transplantation
Reduced-intensity Conditioning Transplantation Current Role and Future Prospect He Huang M.D., Ph.D. Bone Marrow Transplantation Center The First Affiliated Hospital Zhejiang University School of Medicine,
More informationNiCord Single Unit Expanded Umbilical Cord Blood Transplantation: Results of Phase I/II Trials
NiCord Single Unit Expanded Umbilical Cord Blood Transplantation: Results of Phase I/II Trials Mitchell E. Horwitz, MD Duke University Medical Center Duke Cancer Institute Adult Umbilical Cord Blood Transplantation
More informationNeupogen (Filgrastim)/Neulasta (Pegfilgrastim)
Policy Number Reimbursement Policy NEU12182013RP Approved By UnitedHealthcare Medicare Reimbursement Policy Committee Current Approval Date 12/18/2013 IMPORTANT NOTE ABOUT THIS REIMBURSEMENT POLICY This
More informationHaplo vs Cord vs URD Debate
3rd Annual ASBMT Regional Conference for NPs, PAs and Fellows Haplo vs Cord vs URD Debate Claudio G. Brunstein Associate Professor University of Minnesota Medical School Take home message Finding a donor
More informationSummary of Changes Page BMT CTN 1205 Protocol Amendment #4 (Version 5.0) Dated July 22, 2016
Page 1 of 8 Date: July 22, 2016 Summary of Changes Page BMT CTN 1205 Protocol #4 Dated July 22, 2016 The following changes, and the rationale for the changes, were made to the attached protocol in this
More informationSequential Dose-Dense Adjuvant Therapy With Doxorubicin, Paclitaxel, and Cyclophosphamide
Sequential Dose-Dense Adjuvant Therapy With Doxorubicin, Paclitaxel, and Cyclophosphamide Review Article [1] April 01, 1997 By Clifford A. Hudis, MD [2] The recognition of paclitaxel's (Taxol's) activity
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Sargramostim (Leukine) Reference Number: CP.PHAR.295 Effective Date: 10.01.18 Last Review Date: 07.13.18 Line of Business: Oregon Health Plan Coding Implications Revision Log See Important
More informationHematopoietic Stem Cells, Stem Cell Processing, and Transplantation
Hematopoietic Stem Cells, Stem Cell Processing, and Joseph (Yossi) Schwartz, M irector, Hemotherapy and Stem Cell Processing Facility Bone Marrow Can Cure: Leukemia Lymphoma Multiple Myeloma Genetic iseases:
More informationSummary of Changes BMT CTN 1101 Version 7.0 to 8.0 Dated: January 18, Original text: Changed to: Rationale
BMT CTN 1101 RIC ducb vs. Haplo Page 1 of 10 Date: January 20, 2017 Summary of Changes BMT CTN 1101 Version 7.0 to 8.0 Dated: January 18, 2017 A Multi-Center, Phase III, Randomized Trial of Reduced Intensity(RIC)
More informationGranix. Granix (tbo-filgrastim) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.16 Subject: Granix 1 of 6 Last Review Date: September 15, 2017 Granix Description Granix (tbo-filgrastim)
More informationPlerixafor: mechanism of action
Plerixafor and GCSF in patients with lymphoma and multiple myeloma previously failing mobilization with G- CSF +/- chemotherapy for autologous hematopoietic stem cell mobilization: The Austrian experience
More informationCitation for published version (APA): Hovenga, S. (2007). Clinical and biological aspects of Multiple Myeloma s.n.
University of Groningen Clinical and biological aspects of Multiple Myeloma Hovenga, Sjoerd IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from
More informationDisclosures. Membership of Advisory Committees: Research Support/ PI: Celgene Corporation Millennium Pharmaceuticals Johnson & Johnson
Randomized, Open-Label Phase 1/2 Study of Pomalidomide Alone or in Combination With Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma Who Have Received Prior Treatment That
More informationMozobil (Plerixafor Injection) AHM
Mozobil (Plerixafor Injection) AHM Clinical Indications Mozobil (Plerixafor Injection) in combination with granulocyte-colony stimulating factor (G-CSF) is considered medically necessary to mobilize hematopoietic
More informationKEY WORDS Stem cell mobilization AMD3100 GCSF CD34 hematopoiesis NOD/SCID transplantation
Biology of Blood and Marrow Transplantation 13:398-411 (2007) 2007 American Society for Blood and Marrow Transplantation 1083-8791/07/1304-0001$32.00/0 doi:10.1016/j.bbmt.2006.12.445 Human Progenitor Cells
More informationA Phase 1 Trial of Lenalidomide (REVLIMID ) With Bortezomib (VELCADE ) in Relapsed and Refractory Multiple Myeloma
A Phase 1 Trial of Lenalidomide (REVLIMID ) With Bortezomib (VELCADE ) in Relapsed and Refractory Multiple Myeloma P.G. Richardson, 1 R. Schlossman, 1 N. Munshi, 1 D. Avigan, 2 S. Jagannath, 3 M. Alsina,
More informationStem Cell Transplantation for Severe Aplastic Anemia
Number of Transplants 10/24/2011 Stem Cell Transplantation for Severe Aplastic Anemia Claudio Anasetti, MD Professor of Oncology and Medicine Chair, Blood and Marrow Transplant Dpt Moffitt Cancer Center
More informationCXCR4 inhibitor plerixafor and G-CSF allow for an effective peripheral blood stem cell collection in patients who failed previous mobilization attempt
CXCR4 inhibitor plerixafor and G-CSF allow for an effective peripheral blood stem cell collection in patients who failed previous mobilization attempt Grzegorz Wladyslaw Basak 1 *, Elzbieta Urbanowska
More informationSickle Cell Diseasechronic. curable disease? Objectives. Why would a family ask about cure for SCD?
Sickle Cell Diseasechronic illness or curable disease? Gregory M.T. Guilcher MD, FRCPC, FAAP Objectives To review the general principles of hematopoietic stem cell transplantation (HSCT), including risks
More informationMedical Policy Title: HDC Progenitor Cell ARBenefits Approval: 02/08/2012
Medical Policy Title: HDC Progenitor Cell ARBenefits Approval: 02/08/2012 Support AL Amyloidosis (Light Chain Amyloidosis) Effective Date: 01/01/2013 Document: ARB0413:01 Revision Date: 10/24/2012 Code(s):
More informationR-GDP: Rituximab, Gemcitabine, Dexamethasone &Cisplatin
: Rituximab, &Cisplatin INDICATION Relapsed or refractory Hodgkin and non-hodgkin lymphoma. Omit Rituximab for patients with Hodgkin Lymphoma. TREATMENT INTENT Palliative or curative depending on context.
More informationIdelalisib treatment is associated with improved cytopenias in patients with relapsed/refractory inhl and CLL
Idelalisib treatment is associated with improved cytopenias in patients with relapsed/refractory inhl and CLL Susan M O Brien, Andrew J Davies, Ian W Flinn, Ajay K Gopal, Thomas J Kipps, Gilles A Salles,
More informationLCD for Sargramostim (GM-CSF, Leukine ) (L29275)
LCD for Sargramostim (GM-CSF, Leukine ) (L29275) Contractor Information Contractor Name First Coast Service Options, Inc. Contractor Number 09102 Contractor Type MAC - Part B LCD ID Number L29275 LCD Information
More informationBack to the Future: The Resurgence of Bone Marrow??
Back to the Future: The Resurgence of Bone Marrow?? Thomas Spitzer, MD Director. Bone Marrow Transplant Program Massachusetts General Hospital Professor of Medicine, Harvard Medical School Bone Marrow
More informationStem Cells And The Future of Regenerative Medicine. Dipnarine Maharaj, M. D., FACP
Stem Cells And The Future of Regenerative Medicine Dipnarine Maharaj, M. D., FACP The following potential conflict of interest relationships are germane to my presentation. Employment: South Florida Bone
More informationThe National Marrow Donor Program. Graft Sources for Hematopoietic Cell Transplantation. Simon Bostic, URD Transplant Recipient
1988 199 1992 1994 1996 1998 2 22 24 26 28 21 212 214 216 218 Adult Donors Cord Blood Units The National Donor Program Graft Sources for Hematopoietic Cell Transplantation Dennis L. Confer, MD Chief Medical
More informationActinium Pharmaceuticals Highlights Analysis of Pivotal Iomab-B Phase 3 SIERRA Trial Presented in Oral Session at ASH Annual Meeting
December 4, 2018 Actinium Pharmaceuticals Highlights Analysis of Pivotal Iomab-B Phase 3 SIERRA Trial Presented in Oral Session at ASH Annual Meeting - Key highlights include near universal engraftment
More informationRituximab, and autologous stem cell collection rate after induction therapy with Bortezomib-Rituximab. 4 Not yet recruiting
1 Recruiting A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Conditions: Waldenstrom's ; Waldenstrom Macroglobulinaemia Intervention: Biological: Ofatumumab Sponsor: GlaxoSmithKline Number
More informationClinical Policy: Sargramostim (Leukine) Reference Number: CP.PHAR.295
Clinical Policy: (Leukine) Reference Number: CP.PHAR.295 Effective Date: 12/16 Last Review Date: 10/16 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory
More informationLenograstim-mobilized peripheral blood progenitor cells in volunteer donors: an open label randomized split dose escalating study
(2) 25, 371 376 2 Macmillan Publishers Ltd All rights reserved 268 3369/ $15. www.nature.com/bmt Lenograstim-mobilized peripheral blood progenitor cells in volunteer donors: an open label randomized split
More informationClinical Policy: Donor Lymphocyte Infusion Reference Number: CP.MP.101 Last Review Date: 11/17
Clinical Policy: Reference Number: CP.MP.101 Last Review Date: 11/17 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description
More informationMeeting Report. From December 8 to 11, 2012 at Atlanta, GA, U.S.A
Meeting Report Affiliation Department of Transfusion Medicine and Cell Therapy Name Hisayuki Yao Name of the meeting Period and venue Type of your presentation Title of your presentation The 54 th Annual
More informationImmature Reticulocyte Fraction in Guiding Stem Cell Harvest in Autologous Peripheral Blood Stem Cell Transplant
Malaysian Journal Immature of Medicine Reticulocyte and Health Fraction Sciences in (ISSN Guiding 1675-8544); Stem Cell Harvest Vol. 10 (1) in Autologous Jan 2014: 1-6 Peripheral Blood Stem Cell Transplant
More informationR-GDP: Rituximab, Gemcitabine, Dexamethasone &Cisplatin
: Rituximab, Gemcitabine, Dexamethasone &Cisplatin INDICATION Relapsed or refractory Hodgkin and non-hodgkin lymphoma. Omit Rituximab for patients with Hodgkin Lymphoma or high grade T cell non-hodgkin
More informationUICC EML Review 2014
UICC EML Review 2014 Granulocyte Stimulating Agents (G- CSF) Supplemental Document Many antineoplastic agents are cytotoxic to the bone marrow and prevent the development of granulocytes necessary to fight
More informationHematopoietic Stem Cell Therapy
Hematopoietic Stem Cell Therapy Grace Totoe, MBChB, SBB CME August 2012 Accra-Ghana Hematopoietic Stem Cells Cells capable of self renewal and differentiation into all blood cell lineages Objectives Historical
More informationDonor work up, follow up and ethical issues
Donor work up, follow up and ethical issues Hans Hägglund MD. PhD. Associate Professor Hematology Center, Karolinska University Hospital, Stockholm, Sweden Outline The donor has been identified as a match
More informationDr Claire Burney, Lymphoma Clinical Fellow, Bristol Haematology and Oncology Centre, UK
EMBT LWP 2017-R-05 Research Protocol: Outcomes of patients treated with Ibrutinib post autologous stem cell transplant for mantle cell lymphoma. A retrospective analysis of the LWP-EBMT registry. Principle
More informationCorporate Medical Policy
Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: hematopoietic_stem-cell_ transplantation_for_primary_amyloidosis 2/2001 11/2018 11/2019 11/2018 Description
More informationCase-Control Study: ABO-Incompatible Plasma Causing Hepatic Veno-Occlusive Disease in HSCT
Case-Control Study: ABO-Incompatible Plasma Causing Hepatic Veno-Occlusive Disease in HSCT Erin Meyer, DO, MPH Assistant Medical Director of Blood, Tissue, and Apheresis Services Children s Healthcare
More informationstem cell yield with the majority of patients requiring 1 day of apheresis. Autologous hematopoietic SCT (auto-hsct)
Hematology Reports 2016; volume 8:6319 The high effect of chemomobilization with high-dose etopside + granulocyte-colony stimulating factor in autologous hematopoietic peripheral blood stem cell transplantation:
More informationUnderstanding the role of ex vivo T cell depletion
Prevention of graftversus-host disease (GVHD) Understanding the role of ex vivo T cell depletion Information for patients undergoing allogeneic stem cell transplantation in AML and their families 2 This
More informationHematopoetic Stem Cell Therapies in TURKIYE
Hematopoetic Stem Cell Therapies in TURKIYE World Location of transplant centers participating in CIBMTR (2010) Dr. Mustafa ÇETİN Mustafa CETIN, M.D. Erciyes University Medical Faculty Kayseri-TURKIYE
More information