MINUTES AND OVERVIEW PLAN CIBMTR WORKING COMMITTEE FOR HODGKIN AND NON HODGKIN LYMPHOMA Grapevine, TX Thursday, February 27, 2014, 12:15 pm 2:15 pm

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1 MINUTES AND OVERVIEW PLAN CIBMTR WORKING COMMITTEE FOR HODGKIN AND NON HODGKIN LYMPHOMA Grapevine, TX Thursday, February 27, 2014, 12:15 pm 2:15 pm Co Chair: Co Chair: Co Chair: Statisticians: Scientific Director: Silvia Montoto, MD, St. Bartholomew s Hospital, London, United Kingdom Telephone: ; Fax: ; E mail: s.montoto@qmul.ac.uk David Maloney, MD, PhD, Fred Hutchinson Cancer Research Center, Seattle, WA Telephone: ; Fax: ; E mail: dmaloney@fhcrc.org Sonali Smith, MD, University of Chicago Hospitals, Chicago, IL Telephone: ; Fax: ; E mail: smsmith@medicine.bsd.uchicago.edu Jeanette Carreras, MPH, CIBMTR Statistical Center, Milwaukee, WI Telephone: ; Fax: ; E mail: jcarrera@mcw.edu Mei Jie Zhang, PhD, CIBMTR Statistical Center, Milwaukee, WI Telephone: ; Fax: ; E mail: meijie@mcw.edu Mehdi Hamadani MD, Medical College of Wisconsin, Milwaukee, WI Telephone: ; Fax: ; E mail: mhamadani@mcw.edu 1. Introduction The CIBMTR Hodgkin and Non Hodgkin Lymphoma Working Committee was called to order at 12:16 pm on Thursday, February 27, 2014, by Dr. Silvia Montoto. Working Committee Leadership was introduced and audience was asked to fill out the Working Committee evaluations and voting sheets for proposals. Dr. Mehdi Hamadani introduced Dr. Anna Sureda as the newly appointed Chair for the Hodgkin & Non Hodgkin Lymphoma Working Committee starting March 1, Dr. Montoto was acknowledged for all of her efforts during these past years as Co Chair. Dr. Rodney Sparapani was introduced as the incoming PhD statistician and Dr. Hamadani as the incoming Scientific Director. Dr. Wael Saber was acknowledged for all of his efforts and statistical expertise these past years as Scientific Director. Working Committee goals, expectations and limitations were discussed as well as the CIBMTR guidelines for voting by Dr. David Maloney. The guidelines are based on a scale from 1 to 9; 1= high scientific impact, 9= low scientific impact. These are consistent across all Working Committees. Each proposal was limited to 5 minutes (maximum 3 4 overheads) to allow for adequate time for discussion. Rules of authorship were discussed. Authors must meet the following 3 conditions to assure authorship: 1) substantial and timely contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; 3) final approval of the version to be published. The minutes of the February 2013 meeting were approved. A significant increase in productivity of the Working Committee was reported including 8 published/submitted papers, 3 manuscripts in preparation, 2 presentations at the American Society of Hematology in New Orleans, LA and 1 presentation at the BMT Tandem Meetings in Grapevine, TX.

2 2. Accrual summary Due to the full agenda, the accrual summary of registration and research cases between 2000 and 2013 were not presented to the committee but were available as part of the Working Committee attachments: HLA identical Alternative Donor Autologous Non Hodgkin Lymphoma Registration only Research Hodgkin Lymphoma Registration only Research Presentations, published or submitted papers Due to the full agenda, the 2013 presentations and published papers were mentioned but not presented. LY04 03 Maziarz RT, Wang Z, Zhang MJ, Bolwell BJ, Chen AI, Fenske TS, Freytes CO, Gale RP, Gibson J, Hayes Lattin BM, Holmberg L, Inwards DJ, Isola LM, Khoury HJ, Lewis VA, Maharaj D, Munker R, Phillips GL, Rizzieri DA, Rowlings PA, Saber W, Satwani P, Waller EK, Maloney DG, Montoto S, Laport GG, Vose JM, Lazarus HM, Hari PN. Autologous hematopoietic cell transplantation for non Hodgkin lymphoma with CNS involvment. British Journal of Haematology Sep 1; 162(5): LY06 05 Smith SS, Burns LJ, van Besien K, LeRademacher J, He W, Fenske T, Suzuki R, Hsu JW, Schouten HC, Hale GA, Holmberg LA, Sureda A, Freytes CO, Maziarz RT, Inwards DJ, Gale RP, Gross TG, Cairo MS, Costa LJ, Lazarus HM, Wiernik PH, Maharaj D, Laport GG, Montoto S, Hari PN. Autologous or allogeneic hematopoietic stem cell transplantation for systemic mature T cell non Hodgkin lymphoma. Journal of Clinical Oncology Sep 1; 31(25): LY10 01a Hamadani M, Saber W, Ahn KW, Carreras J, Cairo MS, Fenske TS, Gale RP, Gibson J, Hale GA, Hari PN, Hsu JW, Inwards DJ, Kamble RT, Klein A, Maharaj D, Marks DI, Rizzieri DA, Savani BN, Schouten HC, Waller EK, Wirk B, Laport GG, Montoto S, Maloney DG, Lazarus HM. Impact of pretransplant conditioning regimens on outcomes of allogeneic transplantation for chemotherapy unresponsive diffuse large B cell lymphoma and grade III follicular lymphoma. Biology of Blood & Marrow Transplantation May 1; 19(5): LY10 01b Hamadani M, Saber W, Ahn KW, Carreras J, Cairo MS, Fenske TS, Gale RP, Gibson J, Hale GA, Hari PN, Hsu JW, Inwards DJ, Kamble RT, Klein A, Maharaj D, Marks DI, Rizzieri DA, Savani BN, Schouten HC, Waller EK, Wirk B, Lazarus HM. Allogeneic hematopoietic cell transplantation for chemotherapy unresponsive mantle cell lymphoma: a cohort analysis from the CIBMTR. Biology of Blood & Marrow Transplantation Apr 1; 19(4): LY06 06 Hahn T, McCarthy PL, Carreras J, Zhang MJ, Lazarus HM, Laport GG, Montoto S, Hari PN. Simplified validated prognostic model for progression free survival autologous transplantation for relapsed or refractory Hodgkin lymphoma. In Press, Biology of Blood & Marrow Transplantation.

3 LY08 02 Fenske TS, Zhang MJ, Carreras J, Ayala E, Burns LJ, Cashen A, Costa LC, Freyte CO, Gale RP, Hamadani M, Holmberg LA, Inwards DJ, Lazarus HM, Maziarz RT, Munker R, Perales MA, Rizzieri DA, Schouten HC, Smith SM, Waller EK, Wirk BM, Laport GG, Maloney DG, Montoto S, and Hari PN. Autologous or reduced intensity allogeneic hematopoietic cell transplantation for chemotherapy sensitive mantle cell lymphoma: analysis of transplant timing and modality. In Press, Journal of Clinical Oncology. LY07 02 Lechowicz MJ, Lazarus HM, Carreras J, Laport GG, Cutler CS, Wiernik PH, Hale GA, Maharaj D, Gale RP, Rowlings PA, Freytes CO, Miller AM, Vose JM, Maziarz RT, Montoto S, Maloney DG, Hari PN. Allogeneic hematopoietic cell transplantation for cutaneous T cell lymphoma. Submitted. LY09 01 B Wirk, Fenske TS, Hamadani M, Hu ZH, Akpek G, Aljurf MD, Armand P, Ayala, E, Bachanova V, Bolwell B, Cairo MS, Cashen A, Chn YB, Costa LJ, Farhan S, Freytes CO, Gajewski JL, Gibson J, Hale GA, Holmerg LA, Hsu JW, Inwards DJ, Kamble RT, Maharaj D, Maziarz RT, Munker R, Nath R, Reddy NM, Reeder CB, Rizzieri DA, Sauter CS, Savani BN, Shouten HC, Sureda A, Vose JM, Waller EK, Wiernik PH, Gale RP, Burns LJ, Saber W. Outcomes of hematopoietic cell transplantation for diffuse large B cell lymphoma transformed from follicular lymphoma. Submitted. LY10 02 Veronika Bachanova, Claudio Brunstein, Linda Burns, Tao Wang, Jeanette Carreras, Ginna Laport, Sonali M. Smith, Silvia Montoto, David Maloney and Wael Saber. Alternative Donor Transplantation for Adults with Lymphoma: Comparison of Umbilical Cord Blood versus 8/8 HLA matched Donor (URD) versus 7/8 URD. Oral presentation at the American Society of Hematology in New Orleans, LA, December 2013; Manuscript Preparation. LY12 02/GV11 01 Alvaro Urbano Ispizua, Steve Pavletic, Mary Flowers, Mei Jie Zhang, Jeanette Carreras, Sonali Smith, David Maloney, Silvia Montoto, Corey Cutler, Steve Spellman, Mukta Arora, and Wael Saber. Association of graft vs. host disease with a lower relapse/progression rate after allogeneic hemopoietic stem cell transplantation with reduced intensity conditioning in patients with follicular and mantle cell lymphoma. Presentation at the American Society of Hematology in New Orleans, LA, December 2013; Manuscript Preparation. 4. Studies in progress The studies in progress were not presented in order to provide reasonable time to the new proposals for presentation and discussion. Attendees were asked to review the materials to assess the progress of ongoing studies. These were: LY10 02: Alternative donor transplantation for adults with lymphoma: comparison of umbilical cord blood versus 8/8 HLA matched URD versus 7/8 URD (V Bachanova). We compared outcomes of 1593 non Hodgkin and Hodgkin lymphoma patients who underwent alternative donor HCT from UCB (n=142), 8/8 HLA URD (n=1176) and 7/8 matched URD (n=275) HCT recipients were followed for 25, 57 and 65 months, respectively. In multivariate analysis 7/8 URD had 1.3 fold higher risk of TRM than the 8/8 URD. Acute graft versus host disease risk were higher with URD donors compared to UCB group (8/8 URD HR 1.47 [95% CI ]; p=0.049 and 7/8 URD HCT HR 2.12 [95%CI ]; p<0.001). Manuscript will be submitted soon after the BMT Tandem meetings.

4 LY12 02/GV11 01: Association of graft versus host disease with a lower relapse/progression rate after allogeneic hematopoietic stem cell transplantation with reduced intensity conditioning in patients with follicular and mantle cell lymphoma. A CIBMTR analysis (A Urbano Ispizua/S Pavletic/M Flowers). RIC transplantation is an established platform of immunotherapy for lymphoma due to the graft vs. lymphoma (GVLy) effect. The objective of this study was to determine if GVLy was associated with agvhd or cgvhd in B cell and T cell lymphomas, and to analyze whether this effect differs in myeloablative and RIC transplants. Inclusion criteria were patients older than 18 years undergoing HLA identical sibling or unrelated donor HSCT between 1997 and 2009, with diagnosis of HL, DLBCL, follicular lymphoma (FL), peripheral T NHL, and MCL. Twin transplants, cord blood, and ex vivo T cell depletion cases were excluded. Landmark analysis will be performed and manuscript is underway and will be submitted before July 1 st, LY06 03: Allogeneic hematopoietic cell transplantation for relapsed follicular lymphoma: impact of donor type and prognostic risk score for surviva. (A Sureda). This study compared the outcomes of 702 recipients of allogeneic HCT for FL (198 unrelated and 504 sibling donors) from 171 centers world wide reporting to the CIBMTR or EBMT between 1997 and This study shows that unrelated HCTs are performed later in the treatment course for FL; in higher risk patients; most commonly with reduced intensity conditioning; and in multivariate analysis adjusting for baseline differences between the 2 groups, unrelated HCTs were significantly associated with worse PFS and OS compared to sib HCT. This study was submitted to JCO and based on reviewer s comments and internal discussion inclusion criteria will be modified with different transplant years to pick up a more modern cohort. Data file preparation is underway and a conference call for further collaboration will be scheduled after the BMT Tandem meetings. LY13 01: Autologous transplantation for diffuse large B cell lymphomas patients refractory to, or relapsing early after rituximab containing first line chemo immunotherapies (M Hamadani). Among patients with chemosensitive DLBCL at transplant (CR2, PR1/PR2) that received rituximab containing induction chemoimmunotherapy and either never responded to that first line or subsequently relapsed, we will compare post transplantation outcomes in Early Rituximab Failure (ERF) patients (refractory or relapsed within 1 year since diagnosis) vs. Late Rituximab Failure (LRF) patients (relapsed greater than a year since diagnosis). Abstract is submitted to 2014 Annual Meetings of ASCO and manuscript is underway and will be submitted before July 1 st, LY12 01: Positron Emission Tomography Imaging Prior to AlloHCT for Lymphoma. (V Bachanova). The purpose of this study is to determine the role of positron emission tomography imaging performed prior to start of preparative regimen for allogeneic transplants in predicting the recurrence, lymphoma free survival and overall survival in patients with non Hodgkin lymphoma (NHL, B and T cell) and Hodgkin lymphoma. Patients with PET scan negative/positive who underwent allogeneic transplants from 2008 and 2010 and reported to the CIBMTR will be analyzed. Protocol is in development. LY13 02: Outcome of autologous hematopoietic cell transplantation for children, adolescents, and young adults with relapsed/refractory hodgkin lymphoma (P Satwani). Autologous stem cell transplantation (AutoSCT) has become a standard of care in children, adolescents and young adults (CAYA) with relapsed/refractory Hodgkin Lymphoma (HL). However, due to a small number of patients reported in few retrospective and prospective studies, the risk factors associated with poor outcomes have not been well established. We hypothesize that after receiving AutoSCT, CAYA relapsing with HL within 1 year of original diagnosis, and CAYA with refractory HL, will have

5 significantly poor 2 year overall survival (OS) and disease free survival (DFS) compared to those who relapse after 1 year of original diagnosis. Protocol is in development. LY13 03: Comparison of autologous versus allogeneic hematopoietic cell transplantation after reduced/non myeloablative conditioning for relapsed/refractory patients with follicular lymphoma (E Klyuchnikov). This study intends to compare overall (OS) and progress free survival (PFS) in patients aged 18 years with relapsed/refractory follicular lymphoma (FL) who underwent reducedintensity/non myeloablative allogeneic stem cell transplantation (RIC/NMAC HSCT) versus autologous stem cell transplantation (auto HSCT) as second line approach. Protocol is in development. 5. Future/ Proposed studies PROP Comparison between Total Body Irradiation and non TBI based conditioning regimens for allogeneic hematopoietic cell transplant in patients with diffuse large B cell non Hodgkin s Lymphoma (J Hsu). Dr. Hsu presented the study. This study will determine the effect of TBI in the conditioning regimen in allogeneic HCT for diffuse large B cell non Hodgkin s Lymphoma on efficacy and toxicity outcomes. The amount of TBI may also have a significant effect on outcomes. A CIBMTR analysis of 502 patients with ALL who received a matched sibling allograft in first or second remission using either Cy/TBI or VP16/TBI conditioning found no significant differences in TRM, leukemia free survival, cumulative incidence of relapse, and overall when comparing dose of TBI for patients who were transplanted in CR1. There are also differences in late effects between TBI and non TBI containing conditioning regimens. A recent report by the CIBMTR on late effects in 1718 patients with aplastic anemia who underwent a matched sibling or matched unrelated donor transplant found a greater proportion of late effects in patients exposed to TBI. Because radiation is considered an effective treatment modality for DLBCL, registry analysis will include TBI vs. non TBI containing regimens as a covariate in the analysis. This study will investigate the role of TBI in allogeneic conditioning regimens of patients with DLBCL. There are 465 TBI and 555 non TBI patients with AlloHCT for DLBCL registered to the CIBMTR between The Working Committee suggested dividing myeloablative and RIC/NST since it might have a different outcome effect. PROP Impact of conditioning regimen on outcomes of autologous hematopoietic cell transplantation for relapsed follicular and diffuse large B cell lymphomas (B William) Dr. William presented the study. This study will determine the impact of the conditioning regimen used for autologous HCT for follicular and diffuse large B cell non Hodgkin s Lymphoma on efficacy and toxicity outcomes. There are 43 TBI and 347 non TBI patients with autohct for relapsed/refractory follicular lymphoma reported to the CIBMTR between If accepted, the Committee suggested including Rituximab in the analysis. PROP Transplant Outcomes in Nodular Lymphocyte Predominant Hodgkin Lymphoma (G Akpek) Dr. Akpek presented the study. The study proposed will analyze CIBMTR data to address the working hypothesis that patients with relapsed or primary refractory NLPHL have greater than 50% probability of surviving without progression at 5 years following HCT. The study aims to generate data on standard transplant outcomes after autologous and allogeneic HCT in patients with NLPHL and to identify variables associated with favorable survival outcomes. There are 306 patients with AutoHCT for Hodgkin lymphoma registered to the CIBMTR between The Committee

6 suggested restricting the study to Transformed lymphoma cannot be analyzed since it is not collected on the registration forms. Only 26 of 306 patients have research detailed information. Dr. Montoto mentioned the high percentage (44%) of CR2 prior to transplant status reported. PROP Outcomes of diffuse large B cell lymphoma with skeletal involvement after autologous hematopoietic cell transplantation (B Wirk) Dr. Wirk presented the study. This study aims to analyze the outcomes of autologous hematopoietic cell transplantation for diffuse large B cell lymphoma with or without skeletal involvement. There are 131 bone involvement and 1158 non bone involvement patients with AutoHCT for relapse/refractory DLBCL reported to the CIBMTR between Dr. Wirk suggested including Rituximab in the analysis. Dr. Philip Rollings suggested looking at the PET scan to confirm skeletal involvement. Matched pair analysis was suggested and sites of skeletal involvement would need to be reported. PROP High Dose Therapy and Autologous Transplantation for Intravascular Large B cell Lymphoma (M Hamadani) Dr. Abraham Kanate presented the study. The study aims to describe the outcomes with high dose therapy (HDT) and autologous hematopoietic cell transplantation of intravascular large B cell lymphoma (IVLBCL) and to identify patient, disease, and HCT related characteristics that are associated with post HCT outcomes among patients with IVLBCL. There are 213 registration only and 35 research patients with autohct for IVLBCL reported to the CIBMTR from Study pitfalls: unknown denominator (selection bias), question of best timing cannot be answered, uncertain if analysis will be clinically useful or will it inform practice. Dr. Montoto asked going back to the centers to identify how many patients they have. It was concluded not worth the effort since this special supplemental request will take at least a year. PROP Outcome of Hematopoietic Cell Transplantation in non Hodgkin s Lymphoma patients aged 70 years or older (K Wudhikarn) Dr. Wudhikarn presented the study. There are 3 hypothesis for this study: 1) Hematopoietic cell transplantation (HCT) for Non Hodgkin s Lymphoma (NHL) patients age 70 years or older is an effective treatment strategy; 2) transplant related complications of HCT in NHL patients aged 70 years or older are higher than NHL patients who undergo HCT at a younger age; 3) survival outcomes of HCT in NHL patients aged 70 years or older are inferior to patients in the younger age group of years old. This study aims to describe the characteristics of NHL patients aged 70 years or older who undergo autologous or allogeneic HCT. There are 347 patients between years of age and years of age with allohct in NHL registered to the CIBMTR from There are 3390 patients between years of age and years of age with autohct in NHL registered to the CIBMTR from Committee members mentioned the higher number of autohct patients as compared to allohct. It was suggested to look at comorbidities & Sorror score and look only at 70 years of age vs. rest. PROP Trends in allograft use and survival after reduced intensity/non myeloablative conditioning allogeneic hematopoietic cell transplantation for Hodgkin lymphoma: (V Bachanova) Dr. Bachanova presented the study. This study aims to describe and compare outcomes in Hodgkin lymphoma (HL) patients undergoing a reduced intensity /non myeloablative (RIC/NST) allogeneic cell transplant (allohct) in 3 time periods: ( vs vs ) and to describe changes in utilization of allohct and in 1) patient 2) disease and 3) transplant characteristics,

7 including the treatment with brentuximab, prior to allograft during these 3 time periods. There are 157 patients transplanted between , 140 in and 91 in with allohct in NHL registered to the CIBMTR. Myeloablative conditioning regimen was excluded. Year of transplant cut offs were questioned by the Committee and especially the later years. Committee suggested waiting 1 2 years to increase number of patients to increase scientific interest. It was also suggested to include myeloablative regimens. Suggested to include prior therapy and rituximab prior to transplant. Dr. Timothy Fenske suggested looking and those patients who had an allohct following an autohct. Audience agreed that additional follow up is needed and suggested to distinguish between HLA identical siblings, haplo identical donors and cord blood grafts. PROP Hematopoietic cell transplantation outcomes for relapsed or refractory marginal zone lymphomas (B William) Dr. William presented the study. This study aims to descriptive study to analyze trends in utilization and outcomes of autologous and/or allogeneic HCT in relapsed or refractory marginal zone lymphomas (MZL). We have 151 allohct and 250 autohct patients with MZL registered to the CIBMTR from Committee members suggested describing FLIPI score in the study. Potential collaboration with EBMT on a combined analysis for allogeneic transplant outcomes was discussed. A total of 413 non transplanted MZL were presented from various institutions for collaboration: University Hospitals Case Medical Center (n=99), Cleveland Clinical Foundation (n=218) and University of Nebraska Medical Center (n=96). PROP Hematopoietic Stem Cell Transplantation for Hepatosplenic T cell Lymphoma (M Alghamdi) Dr. Alghamdi presented the study. This study aims to analyze outcomes of hematopoietic cell transplantation (HCT) for hepatosplenic T cell lymphoma. Given the low incidence of HSTCL and the absence of prospective studies with HCT for HSTCL, analysis of cumulative registry data remains the best way to study the safety and efficacy of HCT in this disease. There are 72 allohct and 35 autohct patients for Hepatosplenic T cell Lymphoma registered to the CIBMTR from Working Committee members mentioned a similar ASH abstract with potential patient overlap from the University of Nebraska that was presented in PROP Updated prognostic information for lymphoma survivors beyond 1 year from allogeneic hematopoietic cell transplantation. A landmark CIBMTR analysis (A Lazaryan) Dr. Lazaryan presented the study. This study aims to generate updated individualized prognostic models for outcomes of allograft recipients with lymphoma who survive beyond the 1 st year after allo HCT. There are 621 follicular lymphoma, 196 DLBCL and 114 Hodgkin disease patients who survived more than 1 year post allohct for relapsed/refractory lymphoma reported to the CIBMTR from Committee members suggested to restrict to 1997, eliminate Hodgkin disease and include transformed cases to eliminate older cases. It was suggested to do a landmark analysis of each subsequent year to prognosticate survival. Dr. Patrick Stiff reiterated the importance of this study. Members suggested that performing the calculator is not the primary objective. Primary outcome will be survival and secondary outcomes include non relapse mortality, relapse/progression, disease free survival and acute and chronic GVHD. PROP Evaluation of potential anti lymphoma clinical benefit with sirolimus based graftversus host disease prevention after allogeneic hematopoietic cell transplantation (J Mathews) Dr. Mathews presented the study. The study aims to determine the existence of anti lymphoma effect with sirolimus based GVHD prophylaxis and to discern subtypes of lymphoma in which sirolimus based GVHD prophylaxis might be particularly effective. There are 149 sirolimus based

8 and 1488 no sirolimus based allohct lymphoma patients reported to the CIBMTR from In a retrospective study, Armand et al. compared the outcomes of patients who received sirolimus for GVHD prophylaxis with those patients who received allogeneic HCT with a combination of a calcineurin inhibitor and methotrexate. Overall survival was significantly superior in the sirolimus group and the benefit was restricted to patients undergoing reduced intensity conditioning. Sirolimus was associated with decreased incidence of disease progression. In addition, the effect of sirolimus persisted after adjusting for the occurrence of GVHD. Therefore, the study hypothesizes that the use of sirolimus based GVHD prophylaxis may reduce the incidence of lymphoma progression compared to combination regimens of a calcineurin inhibitor and methotrexate. The Committee suggested a possible matched pair analysis. 149 patients were previously reported by different institutions and uncertain how much can be added to these reports. Dr. Robert Peter Gale reiterated the importance of not using an observational database in these types of studies since we will get the same results as the clinical trial. PROP Outcome of patients with relapsed diffuse large B cell lymphoma treated with allogeneic hematopoietic cell transplantation following a failed autologous HCT (T Fenske) Dr. Tara Graff presented the study. This study aims to 1) determine overall survival (OS), progression free survival (PFS), relapse/progression and treatment related mortality (NRM) at 1 year, 3 years and 5 years in DLBCL patients who underwent an allo HCT following a failed auto HCT; 2) to determine the impact of age on OS, PFS, relapse/progression and NRM at 1 year, 3 years and 5 years, using different age cutoffs (50, 60, or 70 years); 3) to determine the impact of time elapsed from auto HCT to allo HCT on OS, PFS, relapse/progression and NRM at 1 year, 3 years and 5 years, using different time cutoffs (0 6 months, 6 12 months, or >12 months); 4) to determine the impact of performance status (PS), HCT comorbidity index (HCT CI), disease status, and donor type (related vs unrelated) on OS, PFS, relapse/progression and NRM at 1 year, 3 years and 5 years; and 5) to define a specific group of patients (using some combination of age, PS, HCT CI, time from auto HCT and disease status and donor type), for whom allo HCT is a reasonable option. There are 133 allohct after an autohct transplanted for relapsed DLCBL from reported to the CIBMTR. Committee member suggested to perform a matched control of those patients who relapsed after an autohct but did not undergo an allohct and compare outcomes. CIBMTR does not collect treatment for relapse. It was informed that University of Nebraska published this idea with fewer numbers of cases. Nine additional proposals were submitted to the committee but not presented due to the reasons stated below: PROP Comparison of syngeneic with autologous transplant for patients with Hodgkin s lymphoma (K Van Besien). Dropped due to low number {n=23 cases received syngeneic transplant (research and registration) from }. PROP Impact of brentuximab vedotin on outcomes of allogeneic hematopoietic cell transplantation for relapsed or refractory Hodgkin lymphoma (B Wirk). No patients in the allogeneic database received brentuximab from PROP A Comparison of Busulfan/Cyclophosphamide/Etoposide with BCNU/Etoposide/Cytarabine/Melphalan for Patients Undergoing Autologous Stem Cell Transplant for Relapsed Hodgkin s Lymphoma (J Cohen). Overlap with SC10 06.

9 PROP Clinical Outcomes in Patients with HIV related lymphoma undergoing autologous HSCT (H Haddad). Dropped due to low number of patients (n=48 HIV+). PROP Impact of Radioimmunotherapy (RIT) Exposure on Survival after Autologous Stem Cell Transplantation for Diffuse Large B Cell Lymphoma (R Karmali). Dropped due to low number of patients (n=64 RIT exposure). PROP The Impact of Conditioning Regimen Intensity on the Outcomes of Allogeneic Hematopoietic Cell Transplantation for Patients with Lymphoma who have Chemo sensitive Disease (N Ghosh). Overlap with LY PROP The Prognostic Impact of Cytogenetic and Molecular Abnormalities on Autologous Hematopoietic Cell Transplant Outcomes for Patients with Diffuse Large B Cell Lymphoma (B Trottier). Dropped due to no cytogenetic information available for lymphoma. PROP Impact of Post Hematopoietic Cell Transplantation (HCT) Rituximab (R) on Progression Free and Overall Survival in B cell non Hodgkin Lymphoma (B NHL) Patients Undergoing Reduced Intensity Conditioning Allogeneic HCT (C Sauter). Dropped due to low number (31 post transplant Rituximab). PROP Outcomes of hematopoietic cell transplantation in Adult T cell leukemialymphoma (AE Hallack Neto). Dropped due to low number of cases (Registration=103 AlloHCT & 34AutoHCT; Research=61 AlloHCT & 4 AutoHCT). 6. Other business After the new proposals were presented, each participant in the meeting had the opportunity to rate each proposal using paper ballots. Without additional comments, the meeting was adjourned at 2:15 pm.

10 Working Committee Overview Plan for a. LY10 02 Umbilical cord blood versus unrelated donor allogeneic hematopoietic cell transplantation for patients with lymphoma. We anticipate submitting the manuscript for peerreview before July 1, b. LY12 02/GV11 01 Graft vs lymphoma post allogeneic hematopoietic cell transplantation. We anticipate finalizing the landmark analysis and submitting the manuscript for peer review before July 1, c. LY06 03 Allogeneic hematopoietic cell transplantation for relapsed follicular lymphoma: impact of donor type and prognostic risk score for survival. Final dataset from EBMT is expected, no later than June 30, The combined analysis with EBMT is expected to start by July 1, 2014 (pending EBMT collaboration). We anticipate a finalized analysis by July 1, d. LY13 01 Autologous transplantation for diffuse large B cell lymphomas patients refractory or relapsing early after Rituximab containing first line chemoimmunotherapies. We anticipate submitting the manuscript for peer review before July 1, e. LY12 01 Positron Emission Tomography Imaging Prior to AlloHCT for Lymphoma. We anticipate finalizing the data file before July 1, 2014 and submitting the manuscript for peer review before July 1, f. LY13 02 Outcomes of autologous stem cell transplantation for children, adolescents and young adults with relapsed/refractory Hodgkin lymphoma. We anticipate finalizing the data file before July 1, 2014 and submitting the manuscript for peer review before July 1, g. LY13 03 Comparison of autologous versus RIC allogeneic stem cell transplantation for relapsed/refractory patients with follicular lymphoma. We anticipate finalizing the data file before July 1, 2014 and submitting the manuscript for peer review before July 1, h. LY14 01 (PROP ) Updated prognostic information for lymphoma survivors beyond 1 year from allogeneic hematopoietic cell transplantation. A landmark CIBMTR analysis. We anticipate finalizing the protocol before July 1, i. LY14 02 (PROP ) Outcome of patients with relapsed diffuse large B cell lymphoma treated with allogeneic hematopoietic cell transplantation following a failed autologous HCT. We anticipate finalizing the analysis before July 1, 2015.

11 Work Assignments for Working Committee Leadership (March 2014) David Maloney LY12 01: Positron Emission Tomography Imaging Prior to AlloHCT for Lymphoma. LY14 01 (PROP ) Updated prognostic information for lymphoma survivors beyond 1 year from allogeneic hematopoietic cell transplantation. A landmark CIBMTR analysis Sonali Smith LY14 02 (PROP ) Outcome of patients with relapsed diffuse large B cell lymphoma treated with allogeneic hematopoietic cell transplantation following a failed autologous HCT Anna Sureda Wael Saber Mehdi Hamadani LY06 03: Allogeneic hematopoietic cell transplantation for relapsed follicular lymphoma: impact of donor type and prognostic risk score for survival LY10 02: Umbilical cord blood versus unrelated donor allogeneic hematopoietic cell transplantation for patients with lymphoma. LY12 02/GV11 01: Graft vs lymphoma post allogeneic hematopoietic cell transplantation. LY13 01: Autologous transplantation for diffuse large B cell lymphomas patients refractory or relapsing early after Rituximab containing first line chemoimmunotherapies. LY13 02: Outcomes of autologous stem cell transplantation for children, adolescents and young adults with relapsed/refractory Hodgkin lymphoma. LY13 03: Comparison of autologous versus RIC allogeneic stem cell transplantation for relapsed/refractory patients with follicular lymphoma.

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