Hem/Onc/BMT Open and Enrolling Clinical Trials

Transcription

1 Hem/Onc/BMT Open and Enrolling Clinical Trials PROTOCOL ID DISEASE PROTOCOL TITLE PI ELIGIBILITY CRITERIA Pfizer Apixaban DVT Apixaban B , A Randomized, Open-Label, Active Controlled, Safety and Extrapolated Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event Sarah H. O'Brien, MD Children 2 to <18 years of age at the time of consent (Age Groups 1 and 2) Ovarian Tissue Freezing for Fertility Preservation All Cancer Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis or Treatment Regimen: A Study by the National Physicians Cooperative of the Oncofertility Consortium at Nationwide Children's Hospital Nicholas Yeager, MD Female, less than or equal to 30 years old who are post-menarche ADVL1622 Refractory Sarcoma, Wilms & Other Rare Tumors Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors Patients must be 2 and 30 years of age at the time of study entry for all strata except upper age limit of 18 years of age for MTC, RCC and HCC ATARA201 Cell Therapy ATARA EBV-CTL-201, Multicenter Expanded Access Protocol of ATA129 for Subjects with Epstein-Barr Virus Associated Viremia or Malignancies for Whom there are No Appropriate Alternative Therapies Rolla Abu-Arja, MD CHOP HAdV Adenovirus CHOP HAdV: Outcomes of Human Adenovirus (HAdV) Infection and Disease in Pediatric Allogeneic Stem Cell Transplant Recipients: A Prospective Multicenter Observational Cohort Monica Ardura, MD Age less than 18 years of age at the time of transplant J1403 Medulloblastoma Pilot Study of a Surgery and Chemotherapy-Only Approach in the Upfront Therapy of Children with WNT Positive Standard Risk Medulloblastoma Mohamed Children at least 3 years of age and less than or equal to 18 years of age at diagnosis To enroll a patient or to speak with a clinical research staff member, please contact: Melinda Triplet, RN Melinda.Triplet@NationwideChildrens.org (614) Amy Yekisa Amy.Yekisa@NationwideChildrens.org (614)

2 ML39356 Hemophilia A An Open-Label, Multicenter, Expanded Access Program for Emicizumab in Patients with Hemophilia A with Inhibitors Amy Dunn, MD Patients (adults and adolescents 12 years old) with hemophilia A with inhibitors against FVIII and who continue to have bleeds of any severity, despite treatment with currently available FDAapproved therapies PNOC003 A pilot trial testing the clinical benefit of using molecular profiling to determine an individualized treatment plan in children and young adults with newly diagnosed DIPG Age 25 years IGM Comprehensive Heme-Onc Profiling All Cancer Institute for Genomic Medicine Comprehensive Profiling for Cancer and Blood Disorders Catherine Cottrell, MD Minor and adult subjects are eligible A1521 A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway Mutant Acute Lymphoblastic Leukemia Age > 1 year and 21 years at time of leukemia diagnosis CMX Adenovirus An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease Hemalatha Geetharani Rangarajan, MD Male or female, aged 2 months and older A05B1 A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens Patient must be less than 31 years of age at the time of initial diagnosis of A08B1 Classification of Newly Diagnosed Acute Lymphoblastic Leukemia () Patient must be < 31 years of age at diagnosis of acute leukemia A0932 Treatment of Patients with Newly Diagnosed Standard Risk B=Lymphoblastic Leukemia (B-) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy) *Patient must be enrolled on A08B1 prior to enrollment Patients must be > 365 days and < 10 years of age (for B- patients); Patients must be >365 days and years of age (for B-LLy patients) A1131 A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-) Testing Clofarabine (IND# 73789, NSC# ) in the Very High Risk Stratum *Patient must be enrolled on A08B1 prior to enrollment Patients must be > 365 days and < 31 years of age A1231 A Phase III Randomized Trial Investigating Bortezomib (NSC# ; IND# 58443) on a Modified Augmented BFM (AMFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-) and T-Lymphoblastic Lymphoma (T-LLy) *Patient must be enrolled on A08B1 prior to enrollment All patients must be > 1 and < 31 years of age A1331 Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-) Patients 1 year and < 31 years of age at the time of relapse will be eligible ACCL1033 A Comprehensive Approach to Improve Medication Adherence in Pediatric Diagnosis of at 1 year and 21 years of age, in first remission. Enrollment on a COG therapeutic study for is not required ACCL1333/CV A Phase III Randomized, Open Label, Multi-center Study of Safety and Efficacy of Apixaban for Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in Children Newly Diagnosed Acute Lymphoblastic Leukemia () or Lymphoma (T or B cell) Treated with Pegylated (PEG) L-Asparaginase Children aged 2 to < 18 years of age

3 Amgen (Onyx) Phase 1b Study of Carfilzomib in Combination with Induction Chemotherapy in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia Susan I. Vear, MD 21 years at time of initial diagnosis AND > 1 year at time of study treatment initiation APEC14B1 All Cancer The Project: Every child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Subjects must be 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating NCTN) therapeutic study, for whom there is a higher upper age limit T Temsirolimus, NHL T A Phase I Trial of Temsirolimus (CCI-779, Pfizer, Inc.) in Combination with Etoposide and Cyclophosphamide in Children with Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma Robyn M. Dennis, MD AAML1031 AML A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib (IND# ; NSC# , NSC# ) for Patients with High Allelic Ratio FLT3/ITD Patients must be less than 30 years of age at the time of study enrollment AAML1522 AML A Phase 2, Multicenter, Single-arm, Open-label Study to Evaluate the Activity, Safety and Pharmacokinetics of Lenalidomide (Revlimid ) in Pediatric Subjects from 1 to 18 Years of Age with Relapsed or Refractory Acute Myeloid Leukemia 1 to 18 years AAML1531 AML Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome Children with Down syndrome > 90 days and < 4 years of age at diagnosis of AML or Myelodysplastic Syndrome (MDS) AflacLL1401 AML Dasatinib in Combination with Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia Guinipero Patients must be 1 and 21 years of age. AAML1331 APL A Phase III Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide and All-Trans Retinoic Acid Patient must be 12 months and < 22 years of age at first diagnosis of APL PIDTC 6903 CGD Analysis of Patients Treated for Chronic Granulomatous Disease Since January 1, 1995 Rolla F. Abu-Arja, MD PNOC007 H3.3K27M Specific Peptide Vaccine Combined with poly-iclc for the Treatment of newly diagnosed HLA-A2+ H3.3K27M Positive Diffuse Intrinsic Pontine Glioma (DIPG) as well as other newly diagnosed HLA-A2+ H3.3K27M Positive Gliomas A02B3 A Children's Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimen No specific age requirement A0332 Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medullablastoma/PNET Patients Age greater than or equal to 3 and less than 22 years at the time of diagnosis A0831 Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years Patients must be greater than 12 months of age and less than 21 years of age at the time of study enrollment

4 Head Start 4 Newly Diagnosed Children (Less Thank 10 Years Old) with Medulloblastoma and Other Central Nervous System Primitive Neuro-ectodermal Tumors: Clinical and Molecular Risk-Tailored Intensive Compressed Induction Chemotherapy Followed by Consolidation with either Single Cycle (Low Risk Patients) To either Single-Cycle or To Three Tandem Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue Jonathan L. Finlay, MB Children less than 10 years of age at the time of definitive confirmatory eligible histologic or cytological diagnosis of eligible tumor within the brain or spinal cord, who have not previously received either irradiation or chemotherapy (except corticosteroids) will be eligible for study entry LGG-1403 Untreated LGG A Phase III Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults with Previously Untreated Low Grade Glioma Diana S. Osorio, MD Patients must be less than 21 years of age at study entry NYU-S Epigenetic/Molecular Profiling of Brain Tumors Diana S. Osorio, MD All Ages PNOC-001 Phase II Study of Everolimus for Recurrent or Progressive Low-Grade Gliomas in Children (CC# ) Age 3 and 21 years PNOC-002 Safety, Phase 0, and Pilot Efficacy Study of vemurafenib, an oral inhibitor of BRAFV600E, in Children and Young Adults with Recurrent/Refractory BRAFV600E- or BRAF Ins T mutant Brain Tumors Patients 25 years of age will be eligible for the expansion cohort J1403/NA_ Pilot Study of a Surgery and Chemotherapy-Only Approach in the Upfront Therapy of Children with WNT Positive Standard Risk Medulloblastoma Children at least 3 years of age and less than or equal to 18 years of age at diagnosis MCC17319/TCC Sunshine Diagnosed or at Risk for Cancer Personalized Medicine: Pediatric Total Cancer Care Protocol Bhuvana A. Setty, MD <18 years of age at diagnosis AAML08B1 DS Biology Study of Transient Myeloproliferative Disorder (TMD) in Children with Downs Syndrome (DS) Patients 1 year and < 31 years of age at the time of relapse will be eligible AEWS07B1 EWS A COG Study for Collecting and Banking Ewing Sarcoma Specimens No specific age requirement AEWS1221 EWS Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# , IND# ) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma Patients 50 years of age at enrollment AGCT1531 GCT A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors Low Risk Stratum: Patients must be < 50 years of age at enrollment. Standard Risk 1: Patient must be < 11 years of age at enrollment. Standard Risk 2: Patients must be 11 and < 25 years of age at enrollment GemPox GCT A Phase II Clinical Trial of Induction Chemotherapy With Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Followed By a Single Cycle of Marrow-Ablative Chemotherapy and Autologous Hematopoietic Progenitor Cell Rescue (AuHPCR) For Patients With Recurrent or Progressive Central Nervous System Germ Cell Tumors Jonathan L. Finlay, MB No age limit Biogen PUPS A Hemophilia An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rfviiifc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A Amy L. Dunn, MD Male, age < 6 years at the time of informed consent

5 Biogen PUPS B Hemophilia An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rfixfc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B Amy L. Dunn, MD Male, age <18 years at the time of informed consent My Life Our Future Hemophilia My Life Our Future: A Hemophilia Genotyping Initiative Data and Sample Research Repository Amy L. Dunn, MD WAPPS Hemophilia WAPPS- Hemo (Web Accessible Population Pharmacokinetics Service - Hemophilia) Protocol Phase 2: Testing and Validation Amy L. Dunn, MD AHEP0731 HEP Treatment of Children with All Stages of Hepatoblastoma with Temsirolimus (IND#122782, NSC#683864) Added to High Risk Stratum Treatment Patients must be 21 years of age at the time of diagnosis AHOD1331 HOD A Randomized Phase III Study of Brentuximab Vedotin (SGN-35, IND #117117) for Newly Diagnosed High- Risk Classical Hodgkins Lymphoma (chl) in Children and Adolescents Ages > 2 - < 19 years JAZZ- Defibrotide A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant Bajwa Patient must be above the age of 1 month as of the start date of study treatment 10-CBA A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications Pediatric and adult patients of any age 13-TLEC Natural History and Biology of Long-Term Late Effects Following Hematopoietic Cell Transplant for Childhood Hematopoietic Cell Transplant for Childhood Hematologic Malignancies Age less than 22 years at admission for HCT. There is no lower limit on age HOST Defense Repository Host Defense Program Hematopoietic Cell Transplant Data Repository Any pediatric patient undergoing autologous or allogeneic hematopoietic cell transplantation NMDP/Data Collection Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries Any recipient of an unrelated or related donor or autologous HC transplant or any recipient of cellular therapy in a CIBMTR center NMDP/Sample Repository Protocol for a Research Sample Repository for Allogeneic Hematopoietic Cell Transplantation and Marrow Toxic Injuries No specific age requirement Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients Monica I. Ardura, DO 3-17 years of age ATTB Allogeneic Hematopoietic Stem Cell Transplant Tissue Bank (ATTB) PBMTCJ13161 PBMTCJ13161, A Pediatric Blood and Marrow Transplant Consortium (PBMTC) multi-center Phase II Pilot Trial of Myeloablative Conditioning and Transplantation of Partially HLA-mismatched T cell replete Bone Marrow with post-transplantation cyclophosphamide for Children and Young Adults with Hematologic Malignancies Patient age 0.5 to 25 years

6 PBMTC SUP1601 Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients with Suspected Lower Respiratory Tract Infection Rajinder P. Bajwa, MD Patients will be 21 years of age with a history of HCT Abatacept Abatacept for Graft Versus Host Disease Prophylaxis after Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease: a Sickle Transplant Alliance for Research Trial Hemalatha Geetharani Rangarajan, MD Patients between the ages of 3 and years Adenovirus immune constitution study Impact of T and NK cell immune reconstitution on human Adenovirus (HAdV) infection in pediatric patients with allogeneic hematopoietic stem cell transplantation () Eunkyung Song, MD Patients from 6 months to 18 years old who receive an allogenic at NCH Leukemia ONE Leukemia, Lymphoma Procurement of Bone Marrow and Peripheral Blood for Patients Potentially Going To Be Enrolled in Leukemia/Lymphoma Research Studies Robyn M. Dennis, MD Age: infant to 31 years ALTE11C1 Lymphoma Longitudinal Assessment of Ovarian Reserve in Adolescents with Lymphoma Patients must be < 30 years of age HMB Registry Menorrhagia Adolescents Presenting to Young Women s Hematology Clinics with Heavy Menstrual Bleeding: A Prospective Cohort Study and Research Registry Sarah H. O'Brien, MD ABTR01B1 Multiple A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors Patients < 30 are eligible for enrollment ACCRN07 Multiple Protocol for the Enrollment of the Official COG Registry, The Childhood Cancer Research Network (CCRN) Participants 0 through 21 years of age are eligible; irrespective of eligibility for other COG studies ALTE05N1 Multiple Umbrella Long-Term Follow-Up Protocol No specific age requirement ALTE07C1 Multiple Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer No specific age requirement Community Counts Multiple Bleeding Disorders Community Counts Surveillance study Amy L. Dunn, MD MDS Registry Myelodysplactic Syndrome, Bone Marrow Failure Disorders Pediatric Myelodysplastic Syndrome and Bone Marrow Failure Disorder Patient Registry and Tissue Repository Melissa J. Rose, DO Ages >1 month to 35 years with MDS, MPD or inherited BMF disorders ANBL00B1 NBL Neuroblastoma Classification Biology Studies No specific age requirement ANBL1232 NBL Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma *Patient must be enrolled on ANBL00B1 prior to enrollment < 12 months of age at diagnosis with INRG Stage L1 or < 18 months of age at diagnosis with INRG Stage L2 or Stage Ms neuroblastoma/ ganglioneuroblastoma MIBG NBL A Phase II Study of 131I-Metaiodobenzylguanidine (131I - MIBG) Therapy for Patients with MIBG Avid Tumors Patients must be between 12 months and 65 years at the time of study enrollment

7 NMTRC014 NBL NMTT - Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO) Keri A. Streby, MD years of age and classified as high risk by the criteria used by COG or SIOPEN at the time of diagnosis Nephrotic Syndrome Nephrotic Syndrome Thrombin Generation in Nephrotic Syndrome Bryce A. Kerlin, MD ANHL04B1 NHL Rare and Cutaneous Non-Hodgkins Lymphoma Registry Age years HSV-1716 Non- Solid Tumor A Phase I Dose Escalation Study of Intraturmoral or Intravenous Herpes Simplex Virus-1 Mutant HSV1716 in Patients with Refractory Non-Central Nervous System (Non-) Solid Tumors Timothy P. Cripe, MD, PhD Subjects must be 7 years and 30 years of age at the time of being administered the first cycle of HSV1716 (Day 0) TVEC Non- Solid Tumor A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects with Advanced Non Central Nervous SystemTumors That are Amenable to Direct Injection Keri A. Streby, MD Subjects aged 0 to < 18 years at the time of informed consent/assent AOST06B1 OST A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens There are no age limitations AOST1321 OST Phase 2 Study of Denosumab (IND# , NSC# ), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma Patients must be equal to or greater than 11 years of age but less than 50 years of age at the time of enrollment AOST1421 OST A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC# , IND# 4308) in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma Patients must be less than 30 years of age at enrollment Early Lymphocyte Recovery in Patients with Osteosarcoma OST Investigation of Early Lymphocyte Recovery in Patients with Osteosarcoma Nicholas D. Yeager, MD AREN03B2 REN Renal Tumors Classification, Biology, and Banking Study Patients must be < 30 years old at the time of diagnosis. MCC18613 Sarcoma Phase II Study of nab-paclitaxel in Combination with Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults Bhuvana A. Setty, MD Age >12 and 30 years PIDTC 6901 SCID Disorders A Prospective Natural History Study of Diagnosis, Treatment and Outcomes of Children with SCID Disorders Rolla F. Abu-Arja, MD < 2 years of age SCN Registry SCN Sever Chronic Neutropenia International Registry Protocol Melissa J. Rose, DO Age greater than three months B Sickle Cell A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Rivipansel (GMI-11070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects with Sickle Cell Disease Anthony D. Villella, MD 6 years of age BOLD Sickle Cell Biomarkers of Sickle Cell Lung Disease Benjamin T. Kopp, MD SCD patients < 19 years old of all genotypes D9902 Soft Tissue Sarcoma A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol Patients must be 50 years of age at time of enrollment

8 MCC16962/VIT in Solid Tumors (Sunshine) Solid Tumor, Malignancy A Phase I Trial of Dose Escalation of Metformin in Combination with Vincristine, Irinotecan, and Temozolomide in Children with Relapsed or Refractory Solid Tumors Bhuvana A. Setty, MD Patients must be > 1 year of age and 18 years of age at time of initiation of protocol therapy ADVL1621 Solid Tumor, Lymphoma A Phase I/II Study of Pembrolizumab (MK-3475) in Children with advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma Be between 6 months and less than 18 years of age on day of signing informed consent/assent ARST1321 Solid Tumors Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# , IND# ) Patients must be 2 years at the time of the biopsy that established the diagnosis of NRSTS will be eligible. BSA> 0.5m2 NCHB001 Solid Tumors NCH Solid Tumor Biology Study: Collection and Banking of Fresh Tumor and Serum Specimens for Research Purposes Bhuvana A. Setty, MD No specific age requirement GAIN Solid Tumors Multicenter Cohort Study To Evaluate Outcomes after Receipt of Targeted Therapy Matched to an Individualized Cancer Therapy (icat) Recommendations in Children and Young Adults with Recurrent, Refractory, or High Risk Solid Tumors: The icat2, GAIN Consortium Study Susan I. Vear, MD Age 30 years at time of initial qualifying solid tumor diagnosis ADVL1322 Solid Tumors A Phase II Study of Pazopanib (GW786034, NSC# in Children, Adolescents and Young Adults with Refractory Solid Tumors Patients must be at least 1 year and less than or equal to 18 years of age at the time of study entry KidsDott Thrombosis Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children (the "Kids-DOTT" Trial) Sarah H. O'Brien, MD Children (birth to <21 years of age) with radiologically-confirmed acute venous thrombosis in the past 30 days Rivaroxaban Thrombosis Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age and body weight adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism Riten Kumar, MD 6 to <12 years of age Rivaroxaban (Phase I) Thrombosis Single-dose study of oral rivaroxaban dry powder suspension formulation in children treated for thrombosis Riten Kumar, MD Children with body weight 3 kg to <12 kg Apixaban B Thrombosis A Randomized, Open-Label, Active Controlled, Safety and Extrapolated Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event Sarah H. O'Brien, MD Age 12 to <18 PIDTC 6904 Wiskott-Aldrich Syndrome Analysis of Patients Treated for Wiskott-Aldrich Syndrome Since January 1, 1990 Rolla F. Abu-Arja, MD