A G E N D A CIBMTR WORKING COMMITTEE FOR ACUTE LEUKEMIA Salt Lake City, UT Thursday, February 22 nd, 2018, 12:15 2:45 pm

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1 Not for publication or presentation A G E N D A CIBMTR WORKING COMMITTEE FOR ACUTE LEUKEMIA Salt Lake City, UT Thursday, February 22 nd, 2018, 12:15 2:45 pm Co-Chair: Co-Chair: Scientific Director: Assistant Scientific Director: Statistical Director: Statistician: Marcos de Lima, MD, University Hospitals Case Medical Center, Cleveland, OH; Telephone: ; marcos.delima@uhhospitals.org Brenda Sandmaier, MD, Fred Hutchinson Cancer Research Center, Seattle, WA; Telephone: ; bsandmai@fredhutch.org Daniel J. Weisdorf, MD, University of Minnesota Medical Center, Minneapolis, MN; Telephone: ; weisd001@umn.edu Wael Saber, MD, MS, CIBMTR Statistical Center, Milwaukee, WI; Telephone: ; wsaber@mcw.edu Mei-Jie Zhang, PhD, CIBMTR Statistical Center, Milwaukee, WI; Telephone: ; meijie@mcw.edu Hai-Lin Wang, MPH, CIBMTR Statistical Center, Milwaukee, WI; Telephone: ; hwang@mcw.edu 1. Introduction a. Minutes and Overview Plan from February 2017 meeting (Attachment 1) b. Introduction of incoming co-chair: Mark Litzow, MD; Mayo Clinic; litzow.mark@mayo.edu c. Instruction for sign-in and voting 2. Accrual summary (Attachment 2) 3. Presentations, published or submitted papers a. LK13-02 Lazaryan A, Dolan M, Zhang MJ, Wang HL, Bachanova V, de Lima M, Sandmaier BM, Saber W, Weisdorf D. Prognostic significance of cytogenetic abnormalities in patients with Philadelphianegative ALL undergoing allogeneic hematopoietic stem cel transplantation in complete remission. Presentation at ASH meeting in Atlanta, GA, December b. LK13-04 Segal E, Martens M, Wang HL, Brazauskas R, Weisdorf DJ, Sandmaier BM, Khoury HJ, de Lima M and Saber W (2017), Comparing outcomes of matched related donor and matched unrelated donor hematopoietic cell transplants in adults with B-Cell acute lymphoblastic leukemia. Cancer. doi: /cncr c. LK14-01 Bejanyan N, Zhang MJ, Wang HL, Lazaryan A, de Lima M, Marks DI, Sandmaier BM, Bachanova V, Rowe JM, Tallman MS, Kebriaei P, Kharfan-Dabaja M, Gale RP, Lazarus HM, Ustun C, Copelan E, Hamilton BK, Schiller G, Hogan W, Hashmi S, Seftel M, Kanakry CG, Olsson RF, Martino R, Saber W, Khoury J, Weisdorf DJ. Pretransplant consolidation is not beneficial for adults with ALL undergoing myeloablative allogeneic transplantation. Accepted by Biol Blood and Marrow Transplant. 1

2 Not for publication or presentation d. LK15-02 Yeshurun M, Weisdorf DJ, Zhang MJ, Wang HL, Flowers ME, de Lima M, Rowe JM, Sandmaier BM, Tallman MS, Verneris MR, Bachanova V. Graft-vs-leukemia effect in acute lymphoblastic leukemia: mild acute graft-vs-host disease protects against relapse and improves survival after allogeneic transplantation. Presentation at ASH meeting in Atlanta, GA, December e. LK15-04 Kebriaei P, Anasetti C, Zhang MJ, Wang HL, Aldoss I, de lima M, Khoury HJ, Sandmaier BM, Horowitz MM, Artz A, Bejanyan N, Ciurea S, Lazarus HM, Gale RP, Litzow M, Bredeson C, Seftel MD, Pulsipher MA, Boelens JJ, Alvarnas J, Champlin R, Forman S, Pullarkat V, Weisdorf DJ, Marks DI. Intravenous Busulfan compared to total body irradiation pre-transplant conditioning for adults with acute lymphoblastic leukemia. Biol Blood Marrow Transplant [Epub ahead of print] 4. Studies in progress (Attachment 3) a. LK13-02 Prognostic significance of cytogenetic abnormalities in patients with Philadelphia - negative acute lymphoblastic leukemia undergoing allogeneic hematopoietic stem cell transplantation in complete remission (A Lazaryan/ V Bachanova/ D Weisdorf) Manuscript preparation b. LK15-01 AlloHCT vs. other consolidation therapies per Alliance and SWOG/ECOG protocols in older AML in CR1 (A Artz / C Ustun) Analysis c. LK15-02 Impact of GVHD on outcome after allogeneic hematopoietic cell transplantation for acute lymphocytic leukemia (M Yeshurun/J Rowe/ M Tallman/ V Bachanova) Manuscript preparation d. LK16-01 Reduced Intensity Conditioning (RIC) regimens for Acute Myeloid Leukemia (AML): A comparison of Busulfan (B) and Melphlan (M) based regimens from the CIBMTR database (Rajneesh Nath/ Zheng Zhou/ Jan Cerny) Protocol development e. LK16-02 DRI-guided Choice of Conditioning Intensity for Allogeneic Hematopoietic Cell Transplantation in Adults with Acute Myeloid Leukemia and Myelodysplastic Syndromes (Nelli Bejanyan/ Erica Warlick/ Claudio Brunstein/ Daniel Weisdorf) Protocol development f. LK16-03 Allogeneic transplantation to treat therapy related acute myeloid leukemia and myelodysplastic syndromes (Natalie Callander/ Leland Metheny/ Marcos De Lima/ Aric Hall) Protocol development g. LK16-04 Comparing outcomes between HLA-haploidentical and matched sibling allogeneic transplants in patients with acute myeloid leukemia (Rizwan Romee/ Armin Rashidi/ Mehdi Hamadani/ Wael Saber) Protocol development h. LK17-01 Outcomes of acute myeloid leukemia patients who undergo allogeneic transplant stratified by depth of clinical response (Mary-Elizabeth Percival/ Brenda Sandmaier/ Eli Estey) Protocol development i. LK17-02 Outcomes for AlloHCT in adult MLL-rearranged AML (K Menghrajani/ M Tallman) Protocol development j. LK17-03 Impact of post-hct TKI on Ph+ ALL (Z DeFilipp/ YB Chen) Protocol development 5. Future/proposed studies a. PROP Outcomes of allohct of AML patients who achieved complete remission after one or more cycles of induction chemotherapy vs. patients with primary refractory AML (Michael Boyiadzis / Marcos de Lima) (Attachment 4) b. PROP Impact of Maintenance Therapy after Allogeneic Hematopoietic Cell Transplant (HCT) on Outcomes in Acute Myeloid Leukemia (Masumi Ueda/ Marcos de Lima) (Attachment 5) c. PROP Identifying an ideal conditioning regimen for the elderly with AML (Saurabh Chhabra/ Gemlyn George) (Attachment 6) d. PROP Prognostic Impact of the new European LeukemiaNet (ELN) Genetic Risk Stratification Categories in Predicting Outcomes for Adults with Acute Myeloid Leukemia 2

3 Not for publication or presentation undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Antonio Martin Jimenez/ Trent Peng Wang/ Marcos De Lima/ Krishna Komanduri) (Attachment 7) e. PROP Syngeneic stem cell transplant for hematologic malignancies (Usama Gergis) (Attachment 8) f. PROP / Comparison of outcomes of haploidentical hematopoietic cell transplantation (HCT) with matched-related donor or matched-unrelated donor allogeneic HCT for adults with Ph-negative acute lymphoblastic leukemia (Matthew Wieduwilt/ Leland Metheny/ Marcos de Lima) (Attachment 9) Proposed studies; not accepted for consideration at this time a. PROP day survival and risk of developing acute graft versus host disease (agvhd) in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) after allogeneic stem cell transplant: blinatumomab vs chemotherapy remission induction b. PROP The influence of donor source, cytogenetics and molecular markers on outcomes after a second hematopoietic cell transplant for patients with relapsed leukemia and MDS c. PROP Outcomes of older adults with acute myeloid leukemia who received hypomethylating agents followed by hematopoietic stem cell transplantation d. PROP Impact of conditioning regimen FLuMel vs CyTbi on outcomes of ALL patients years old e. PROP Second Unrelated Allograft for Relapsed/Refractory Acute Leukemia after First Unrelated Allogeneic Stem Cell Transplantation: The Role of using the Original vs an Alternate Unrelated Donor f. PROP Transplant Outcomes in Patients with MLL (KMT2A) rearranged B-cell acute lymphoblastic leukemia (ALL), stratified by type of MLL (KMT2A) rearrangement: Analysis of the Center for International Bone and Marrow Transplant Research (CIBMTR) g. PROP Reduced Intensity versus Nonmyeloablative Conditioning for Patients Aged 65 and Older h. PROP Transplant outcomes for patients with T- and Natural Killer (NK)-cell large granular lymphocyte (LGL) leukemia i. PROP The impact of minimal residual disease by flow cytometry at the time transplantation on post-transplant outcomes in acute myeloid leukemia patients with complete remission j. PROP Development of a pre-transplant risk score for patients undergoing allogeneic HCT for acute myeloid leukemia k. PROP Autologous versus Allogeneic Hematopoietic Stem Cell Transplantation in Acute Leukemia Patients 60 Years and Older l. PROP Induction chemotherapy vs. hypomethylating agent therapy for older AML patients undergoing allogeneic hematopoietic stem cell transplantation 6. Other business 3

4 Not for publication or presentation Attachment 1 MINUTES AND OVERVIEW PLAN CIBMTR WORKING COMMITTEE FOR ACUTE LEUKEMIA Orlando, FL Thursday, February 23 rd, 2017, 12:15 2:15 pm Co-Chair: Co-Chair: Co-Chair: Scientific Director: Assistant Scientific Director: Statistical Director: Statistician: Marcos de Lima, MD, University Hospitals Case Medical Center, Cleveland, OH; Telephone: ; marcos.delima@uhhospitals.org H Jean Khoury, MD, Winship Cancer Institute of Emory University, Atlanta, GA; Telephone: ; hkhoury@emory.edu Brenda Sandmaier, MD, Fred Hutchinson Cancer Research Center, Seattle, WA; Telephone: ; bsandmai@fredhutch.org Daniel J. Weisdorf, MD, University of Minnesota Medical Center, Minneapolis, MN; Telephone: ; weisd001@umn.edu Wael Saber, MD, MS, CIBMTR Statistical Center, Milwaukee, WI; Telephone: ; wsaber@mcw.edu Mei-Jie Zhang, PhD, CIBMTR Statistical Center, Milwaukee, WI; Telephone: ; meijie@mcw.edu Hai-Lin Wang, MPH, CIBMTR Statistical Center, Milwaukee, WI; Telephone: ; hwang@mcw.edu 1. Introduction The CIBMTR Acute Leukemia Working Committee was called to order at 12:15 pm on Thursday, February 23rd, 2017, by Dr. H. Jean Khoury. The chairs, scientific director and statisticians were presented. Kwang-Woo Ahn filled in for Mei-Jie Zhang, who could not attend tandem meeting. Attendees were asked to have their name badges scanned for attendance purposes and to maintain committee membership, and to fill out the Working Committee evaluations and voting sheets for proposals. The meeting was limited to presentation and discussion of proposals. Dr. Khoury briefly introduced the committee s accomplishments for the past year and progress of ongoing studies. Each proposal presentation was limited to 5 minutes to allow for adequate time for discussion (5 minutes). The minutes of the February 2016 meeting were approved without modifications. 2. Accrual summary Due to the full agenda, the accrual summary of registration and research cases between 1995 and 2016 were not presented to the committee, but were available as part of the Working Committee attachments. 3. Presentations, published or submitted papers Due to the full agenda, the 2016 presentations and published papers were mentioned, but not presented. Five papers were published, one submitted, and two ASH presentations were given during the past year. a. LK12-02 Deol A, Sengsayadeth S, Ahn HW, Wang HL, Aljurf M, Antin JH, Bornhauser M, Cahn JY, Camitta B, Chen YB, Cutler CS, Gale RP, Ganguly S, Hamadani M, Inamoto Y, Jagasia M, Kamble R, Koreth J, Lazarus HM, Liesveld J, Litzow MR, Marks DI, Nishihori T, Olsson RF, Reshef R, Rowe JM, Saad AA, Sabloff M, Schouten HC, Shea TC, Soiffer RJ, Uy GL, Waller EK, Wiernik PH, Wirk B, 4

5 Not for publication or presentation Attachment 1 Woolfrey AE, Bunjes D, Devine S, de Lima M, Sandmaier BM, Weisdorf DJ, Khoury HJ, Saber W. (2016) Does FLT3 mutation impact survival after hematopoietic stem cell transplantation for acute myeloid leukemia? A Center for International Blood and Marrow Transplant Research (CIBMTR) analysis. Cancer, 2016 Oct; 122(19): b. LK13-01 Rosko AE, Wang HL, de Lima M, Sandmaier B, Khoury HJ, Artz A, Brammer J, Bredeson C, Farag S, Kharfan Dabaja M, Lazarus HM, Marks DI, Martino Bufarull R, McGuirk J, Mohty M, Nishihori T, Nivison-Smith I, Rashidi A, Ringden O, Seftel M, Weisdorf D, Bachanova V, Saber W. (2016). Reduced intensity conditioned allograft yields favorable survival for older adults with B cell acute lymphoblastic leukemia. American Journal of Hematology, 2017 Jan; 92(1): c. LK13-03 Munker R, Brazauskas R, Wang HL, de Lima M, Khoury HJ, Gale RP, Maziarz RT, Sandmaier BM, Weisdorf D, Saber W. Allogeneic Hematopoietic Cell Transplantation for Patients with Mixed Phenotype Acute Leukemia. Biology of Blood and Marrow Transplantation, 2016 Jun 30; 22(6): d. LK14-03 Ganzel C, Mathews V, Alimoghaddam K, Ghavamzadeh A, Kuk D, Devlin S, Wang HL, Zhang M-J, Weisdorf D, Douer D, Rowe JM, Estev J, Nagler A, Mohty M, Tallman MS. Autologous Transplant remains the Preferred Therapy for Relapsed APL in CR2. Bone Marrow Transplantation, 2016 Sep; 51(9): e. LK14-02 Michelis FV, Gupta V, Zhang MJ, Wang HL, Aljurf M, Bacher U, Beitinjaneh A, Chen YB, DeFilipp Z, Gale RP, Kebriaei P, Kharfan-Dabaja M, Lazarus HM, Nishihori T, Olsson RF, Oran B, Rashidi A, Rizzieri DA, Tallman MS, de Lima M, Khoury HJ, Sandmaier BM, Weisdorf DJ, Saber W. Cytogenetic risk determines outcomes following allogeneic transplantation in older patients with acute myeloid leukemia in second complete remission: A CIBMTR cohort analysis. Cancer, f. LK15-05 Ustun C, Giannotti F, Zhang MJ, Wang HL, Brunstein C, Labopin M, Rocha V, de Lima M, Baron F, Sandmaier BM, Eapen M, Gluckman E, Nagler A, Weisdorf DJ, Ruggeri A. Outcomes of UCB transplantation are comparable in FLT3+ AML: results of CIBMTR, EuroCord and EBMT collaboration. Leukemia, g. SC15-05 Weisdorf D, Millard HR, Horowitz MM, Hyare P, Champlin R, Ho V, Mielcarek M, Rezvani A, Stockerl-Goldstein K, Khoury HJ, De Lima M, Saber W, Sandmaier B, Zhang MJ, Eapen M. Allogeneic Transplantation for Advanced AML: The Value of Complete Remission. Cancer, Studies in progress The progress of the ongoing studies during the past year was not presented in order to provide more time for the new proposals presentation and discussion. A summary of the progress was provided as an attachment to the committee members. a. LK13-02 Prognostic significance of cytogenetic abnormalities in patients with Philadelphia - negative acute lymphoblastic leukemia undergoing allogeneic hematopoietic stem cell transplantation in complete remission (A Lazaryan/V Bachanova/D Weisdorf) Analysis b. LK14-01 Effect of post-remission consolidation chemotherapy prior to allogeneic transplantation for acute lymphocytic leukemia in first complete remission (N Bejanyan/A Lazaryan/D Weisdorf) Manuscript preparation c. LK15-01 AlloHCT vs. other consolidation therapies per Alliance and SWOG/ECOG protocols in older AML in CR1 (A Artz / C Ustun) Data file preparation d. LK15-02 Impact of GVHD on outcome after allogeneic hematopoietic cell transplantation for acute lymphocytic leukemia (M Yeshurun/J Rowe/M Tallman/V Bachanova) Analysis e. LK15-03 Comparison of outcomes of older adolescents and young adults with Philadelphiachromosome/BCR-ABL1-negative acute lymphoblastic leukemia receiving post-remission consolidation chemotherapy with pediatric-inspired chemotherapy on CALGB or 5

6 Not for publication or presentation Attachment 1 myeloablative allogeneic hematopoietic cell transplantation (M Wieduwilt/W Stock) Data file preparation f. LK15-04 Outcome of hematopoietic stem cell transplantation using total body irradiation-based versus chemotherapy-based full intensity conditioning regimens for adults with acute lymphoblastic leukemia (P Kebriaei/I Aldoss/V Pullarkat/C Anasetti/D Marks) Manuscript preparation g. LK16-01 Reduced Intensity Conditioning (RIC) regimens for Acute Myeloid Leukemia (AML): A comparison of Busulfan (B) and Melphalan (M) based regimens from the CIBMTR database (Zartash Gul/ Gulrayz Ahmed/ Muhammed Khan/ Gerhard Hilderbrandt/ Hassan Alkhateeb/ Moussab Damlaj/ Miranal Patnaik/ Rajneesh Nath/ Zheng Zhou/ Jan Cerny) Protocol development h. LK16-02 DRI-guided Choice of Conditioning Intensity for Allogeneic Hematopoietic Cell Transplantation in Adults with Acute Myeloid Leukemia and Myelodysplastic Syndromes (Nelli Bejanyan/ Erica Warlick/ Claudio Brunstein/ Daniel Weisdorf) Protocol development i. LK16-03 Allogeneic transplantation to treat therapy related acute myeloid leukemia and myelodysplastic syndromes (Natalie Callander/ Leland Metheny/ Marcos De Lima / Aric Hall) Protocol development j. LK16-04 Comparing outcomes between HLA-haploidentical and matched sibling allogeneic transplants in patients with acute myeloid leukemia (Rizwan Romee/ Armin Rashidi/ Mehdi Hamadani/ Wael Saber) Protocol development k. LK17-01 Outcomes of acute myeloid leukemia patients who undergo allogeneic transplant stratified by depth of clinical response (Mary-Elizabeth Percival / Brenda Sandmaier / Eli Estey) Protocol received 5. Future/proposed studies Drs. Sandmaier and de Lima led this session. a. PROP / / Impact of Maintenance Therapy after Allogeneic Hematopoietic Cell Transplant (HCT) on Outcomes in Acute Myeloid Leukemia (AML) (Masumi Ueda, Tania Jain, Jeanne Palmer, Lisa Sproat, Amer Assal, Sergio Giralt, Marcos de Lima) Dr. Ueda presented this proposal. There are 410 adult patients who underwent first allo-hct for AML between with any type of post-hct maintenance therapy. Comments were received about restricting to specific HMA vs. looking at any maintenance therapy and it was suggested that we further review crosstabs between patients in CR1 vs. conditioning intensity vs. type of maintenance therapy received. b. PROP Fludarabine/busulfan versus fludarabine/melphalan conditioning in patients with acute lymphoblastic leukemia (Yasuyuki Arai) Dr. Arai presented this proposal. There are 124 vs. 201 adult patients who underwent first allo-hct for ALL with Flu+Bu vs. Flu+Mel reduced intensity conditioning between Comments were received regarding the time span and method of Busulfan administration and question was raised regarding the intention of picking these 2 specific regimens. c. PROP Hypomethylating agents prior to allogeneic hematopoietic cell transplant in AML: a retrospective matched cohort analysis of disease free survival and overall survival (Zachary Crees, Geoffrey Uy, John DiPersio) Dr. Crees presented this proposal. There are 160 adult patients who underwent first BM/PB graft allo-hct for AML in CR1 between with pre-hct hypomethylating agents. Comments were received about the lack of TP53 mutation data; time of therapy duration to HCT; proportion of patients with secondary AML and the intrinsic selection bias of not considering patients who didn t proceed to HCT. d. PROP / / The Influence of Donor Source, Cytogenetics, and Molecular 6

7 Not for publication or presentation Attachment 1 Markers on Outcomes after a Second Hematopoietic Cell Transplant for Patients with Relapsed Leukemia and MDS (Marcos de Lima, Leland Metheny, Kalyan Nadiminti, Margarida Silverman, Eric Huselton, Mark Schroeder) Dr. Huselton presented this proposal. There are 850 adult patients who underwent 2 nd allo-hct for persistent/relapsed Leukemia/MDS between Comments were received about time from 1 st HCT to relapse; further selecting the subset of AML cases as AML are the majority of this population; potential influence of donor selection by the severity of disease and timing; and how recent changes in therapy might also affect outcome. e. PROP Allogeneic Hematopoietic Transplant Outcomes in Adult Patients with MLLrearranged Acute Myeloid Leukemia (Martin Tallman, Kamal Menghrajani) Dr. Menghrajani presented this proposal. There are 443 adult patients who underwent first allo- HCT for MLL rearranged AML in CR1 or beyond between Comments were received about the lack of ability to identify subtypes of MLL arrangement from current CIBMTR forms which might require review of original cytogenetic reports from centers. f. PROP Optimizing Allogeneic Hematopoietic Cell Transplant Outcomes in Acute Myeloid Leukemia Using Next Generation Sequencing (Betty Hamilton, Navneet Majhail, Jaroslaw Maciejewski, Aziz Nazha) Dr. Hamilton presented this proposal. There are 2530 patients with pre-hct blood (but no marrow) samples available who underwent first BM/PB graft allo-hct for AML between Comments were received regarding the type of samples available for this study. CIBMTR would provide recipient blood samples at time of pre-hct, but tumor samples are more of interest and also sample pairs from diagnosis and pre-hct would be desirable for the proposed study. g. PROP / Sorafenib use with allogeneic stem cell transplant for FLT3 mutation positive acute myeloid leukemia (Benjamin Tomlinson, Marcos de Lima, Yi-Bin Chen) Dr. Tomlinson presented this proposal. There are 436 adult patients who underwent first allo-hct for FLT3-ITD mutated AML between , among whom 44 received only pre-hct Sorafenib, 44 received only post-hct Sorafenib and 19 received both pre/post HCT Sorafenib. Comments were received about separating pre vs. post HCT Sorafenib given and looking at other molecular marker profiles. Also it was suggested that cases receiving other FLT3 inhibitors be excluded so the study population could further decrease. h. PROP Impact of post-transplant maintenance therapy with BCR-ABL tyrosine kinase inhibitors on outcomes of Philadelphia chromosome-positive acute lymphoblastic leukemia (Zack DeFilipp, Yi-Bin Chen) Dr. DeFilipp presented this proposal. There are 383 vs. 282 adult patients who underwent first allo- HCT for Ph+ ALL between with vs. without post-hct TKI as maintenance therapy. Comments were received about the variation of practice of administering TKI at different centers; potential comparison with non-hct cases; limited or no data on the duration of post-hct therapy. Proposed studies; not accepted for consideration at this time These proposals were not discussed during the meeting. Dr. Sandmaier made comments about committee s busy portfolio and encouraged attendees to submit ideas again if not accepted at this time. a. PROP Impact of FLT3 mutation on post-transplant outcomes of patients with AML who are not in remission at the time of hematopoietic stem cell transplant (Divaya Bhutani, Abhinav Deol) b. PROP Clinical Outcomes of Patients with a History of Prior Autologous Transplant Undergoing a Second Allogeneic Transplant for Therapy Related AML/MDS c. PROP Evaluation of allogeneic hematpoietic cell transplantation outcomes and prognostic factors in acute megakaryoblastic leukemia: a CIBMTR analysis 7

8 Not for publication or presentation Attachment 1 d. PROP Impact of time from diagnosis to hematopoietic cell transplantation on outcomes in acute myeloid leukemia in first complete remission e. PROP Allogeneic transplant versus no allogeneic transplant in adult patients with MRD negative Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in first complete remission (CR1) f. PROP Evaluating Primary Refractory Acute Myeloid Leukemia; the effects of Disease Characteristics and Outcomes of Allogeneic Stem Cell Transplantation g. PROP Comparing Autologous versus Allogeneic Stem Cell Transplantation for Blastic Plasmacytoid Dendritic Cell Neoplasm h. PROP Outcomes of allo-hct of AML patients who achieved complete remission after two or more cycles of induction chemotherapy versus patients with primary refractory AML undergoing allo-hct i. PROP Outcome of allogeneic hematopoietic stem cell transplantation for adolescent and young adults with relapsed Acute Lymphoblastic Leukemia following frontline therapy with an asparaginase-containing regimen j. PROP Comparison of melphalan-based reduced intensity conditioning with myeloablative conditioning for acute myeloid leukemia and myelodysplastic syndrome k. PROP A Retrospective Study of Allogeneic Stem Cell Transplantation Comparing Conditioning Chemotherapy Intensity of Regimen Containing Myeloablative Busulfan versus Reduced Intensity Melphalan in Patients with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) l. PROP Survival of patients with acute lymphoblastic leukemia (ALL) relapsing after first allogeneic hematopoietic cell transplantation: Prognostic factors and impact of post-relapse therapies m. PROP Predictive model for progression free survival in patients with acute myeloid leukemia receiving allogeneic stem cell transplantation n. PROP Survival of patients with ALL relapsing after allogeneic transplantation o. PROP The role of haploidentical allogeneic HCT in FLT-3 ITD positive acute myelogenous leukemia p. PROP Comparison of outcomes of allogeneic hematopoietic cell transplantation (HCT) in secondary acute myeloid leukemia (AML) with prior solid tumor history or antecedent hematologic condition q. PROP The impact of pretransplant diabetes on posttransplant outcomes in patients with acute myeloid leukemia 6. Other business After the new proposals were presented, each participant in the meeting had the opportunity to rate each proposal using paper ballots. Based on the voting results, current scientific merit, available number or relevant cases and the impact of the study on the field, the following studies will move forward as the committee s research portfolio for the upcoming year: PROP Allogeneic Hematopoietic Transplant Outcomes in Adult Patients with MLL-rearranged Acute Myeloid Leukemia (Martin Tallman, Kamal Menghrajani) PROP Impact of post-transplant maintenance therapy with BCR-ABL tyrosine kinase inhibitors on outcomes of Philadelphia chromosome-positive acute lymphoblastic leukemia (Zack DeFilipp, Yi-Bin Chen) 8

9 Not for publication or presentation Attachment 1 Working Committee Overview Plan for a. LK13-02 Prognostic significance of cytogenetic abnormalities in patients with Philadelphia - negative acute lymphoblastic leukemia undergoing allogeneic hematopoietic stem cell transplantation in complete remission. Analysis is in progress and we plan to submit paper by June (Total hour: 110; Allocated for the fiscal year: 110) b. LK14-01 Effect of post-remission consolidation chemotherapy prior to allogeneic transplantation for acute lymphocytic leukemia in first complete remission. Manuscript preparation is underway and we plan to publish paper by June (Total hour: 10; Allocated for the fiscal year: 10) c. LK15-01 AlloHCT vs. other consolidation therapies per Alliance and SWOG/ECOG protocols in older AML in CR1. Data file preparation is in progress with collaborative group (Alliance, SWOG, ECOG) and we plan to move to analysis by June 2017 and submit paper by June (Total hour: 100; Allocated for the fiscal year: 100) d. LK15-02 Impact of GVHD on outcome after allogeneic hematopoietic cell transplantation for acute lymphocytic leukemia. Analysis is underway. We plan to move to manuscript preparation by June 2017 and submit paper by June (Total hour: 110; Allocated for the fiscal year: 110) e. LK15-03 Comparison of outcomes of older adolescents and young adults with Philadelphiachromosome/BCR-ABL1-negative acute lymphoblastic leukemia receiving post-remission consolidation chemotherapy with pediatric-inspired chemotherapy on CALGB or myeloablative allogeneic hematopoietic cell transplantation. Data file preparation is underway and we plan to have data file ready for analysis by June 2017 and finalize analysis for manuscript preparation by June (Total hour: 250; Allocated for the fiscal year: 180) f. LK15-04 Outcome of hematopoietic stem cell transplantation using total body irradiation-based versus chemotherapy-based full intensity conditioning regimens for adults with acute lymphoblastic leukemia. Manuscript preparation is underway and we plan to submit paper by June (Total hour: 30; Allocated for the fiscal year: 30) g. LK16-01 Reduced Intensity Conditioning (RIC) regimens for Acute Myeloid Leukemia (AML): A comparison of Busulfan (B) and Melphlan (M) based regimens from the CIBMTR database. Protocol development is underway and we plan to move to data file preparation by June 2017 and finalize analysis for manuscript preparation by June (Total hour: 310; Allocated for the fiscal year: 240) h. LK16-02 DRI-guided Choice of Conditioning Intensity for Allogeneic Hematopoietic Cell Transplantation in Adults with Acute Myeloid Leukemia and Myelodysplastic Syndromes. Protocol development is underway and we plan to move to data file preparation by June 2017 and have data file ready for analysis by June (Total hour: 310; Allocated for the fiscal year: 160) i. LK16-03 Allogeneic transplantation to treat therapy related acute myeloid leukemia and myelodysplastic syndromes. Protocol development is underway and we plan to move to data file preparation by June 2017 and finalize analysis for manuscript preparation by June (Total hour: 280; Allocated for the fiscal year: 210) 9

10 Not for publication or presentation Attachment 1 j. LK16-04 Comparing outcomes between HLA-haploidentical and matched sibling allogeneic transplants in patients with acute myeloid leukemia. Protocol development is underway and we plan to move to analysis by June 2017 and submit paper by June (Total hour: 280; Allocated for the fiscal year: 280) k. LK17-01 Outcomes of acute myeloid leukemia patients who undergo allogeneic transplant stratified by depth of clinical response. We anticipate developing the study protocol after July 2017 and move to data file preparation and analysis by June (Total hour: 310; Allocated for the fiscal year: 60) Oversight Assignments for Working Committee Leadership (March 2017) Daniel Weisdorf Wael Saber Marcos de Lima Brenda Sandmaier H Jean Khoury LK13-02: Prognostic significance of cytogenetic abnormalities in patients with Philadelphia negative acute lymphoblastic leukemia undergoing allogeneic hematopoietic stem cell transplantation in complete remission LK15-01: Comparison of Allogeneic Hematopoietic Cell Transplantation with Other Consolidation Therapies Per Alliance/SWOG/ECOG Protocols in Older ( 60 years) AML Patients in First Complete Remission. LK15-03: Comparison of outcomes of older adolescents and young adults with Philadelphia-chromosome/BCR-ABL1-negative acute lymphoblastic leukemia receiving post-remission consolidation chemotherapy with pediatric-inspired chemotherapy on CALGB or myeloablative allogeneic hematopoietic cell transplantation. LK15-04: Comparison of total body irradiation (TBI)-based with intravenous (i.v.) busulfan (Bu) containing chemotherapy-only myeloablative transplant conditioning regimens in adult patients with acute lymphoblastic leukemia. LK17-02: Allogeneic Hematopoietic Transplant Outcomes in Adult Patients with MLL-rearranged Acute Myeloid Leukemia LK16-03: Allogeneic transplantation to treat therapy related acute myeloid leukemia and myelodysplastic syndromes. LK16-04: Comparing outcomes between HLA-haploidentical and matched sibling allogeneic transplants in patients with acute myeloid leukemia. LK15-02: Impact of GVHD on outcome after allogeneic hematopoietic cell transplantation for acute lymphocytic leukemia. LK16-02: DRI-guided choice of conditioning intensity for allogeneic hematopoietic cell transplantation in adults with acute myeloid leukemia and myelodysplastic syndromes. LK16-01: Reduced intensity conditioning regimens for acute myeloid leukemia: A comparison of busulfan and melphalan based regimens from the CIBMTR database. LK17-01: Outcomes of acute myeloid leukemia patients who undergo allogeneic transplant stratified by depth of clinical response LK14-01: Effect of post-remission consolidation chemotherapy prior to allogeneic transplantation for acute lymphocytic leukemia in first complete 10

11 Not for publication or presentation Attachment 1 remission. LK14-02: Prognostic factors in patients 60 years undergoing allogeneic hematopoietic cell transplantation for acute myeloid leukemia in first and second complete remission. LK17-03: Impact of post-transplant maintenance therapy with BCR-ABL tyrosine kinase inhibitors on outcomes of Philadelphia chromosome-positive acute lymphoblastic leukemia 11

12 Not for publication or presentation Attachment 2 Accrual Summary for the Acute Leukemia Working Committee Characteristics of recipients of first allogeneic transplants for AML and ALL reported a to the CIBMTR between 1995 and 2017 Variable AML ALL Number of patients Number of centers Age in decades < (9) 2570 (24) (10) 2556 (24) (12) 1908 (18) (14) 1420 (13) (19) 1209 (11) (21) 779 (7) (14) 298 (3) (2) 9 (<1) Median (range) 44 (<1-72) 21 (<1-65) Gender Male (53) 6570 (61) Female 9972 (47) 4178 (39) Missing 1 (<1) 1 (<1) HCT-CI (12) 1314 (12) (6) 479 (4) (5) 368 (3) (16) 865 (8) N/A, earlier than (58) 7449 (69) Missing 637 (3) 274 (3) Disease status prior to HCT Primary induction failure 2784 (13) 366 (3) CR (48) 4478 (42) CR (21) 3665 (34) CR3 405 (2) 929 (9) Relapse 3237 (15) 1301 (12) Missing 66 (<1) 10 (<1) Time from diagnosis to HCT Median (range) 6 (<1-73) 11 (<1-137) <6 months 9940 (47) 3035 (28) 6-12 months 5157 (24) 2506 (23) >12 months 6058 (29) 5204 (48) Missing 19 (<1) 4 (<1) 12

13 Not for publication or presentation Attachment 2 Variable AML ALL Conditioning regimen intensity Myeloablative (72) 9711 (90) RIC 3610 (17) 509 (5) NMA 1536 (7) 279 (3) TBD 497 (2) 166 (2) Missing 181 (<1) 84 (<1) Graft type Bone marrow 6958 (33) 4958 (46) Peripheral blood (55) 3882 (36) Umbilical cord blood 2568 (12) 1898 (18) Missing 11 (<1) 11 (<1) Type of donor HLA-identical sibling 6767 (32) 3067 (29) Identical twin 87 (<1) 61 (<1) Other relative 1172 (6) 600 (6) Unrelated (48) 4937 (46) Cord blood 2568 (12) 1898 (18) Missing 428 (2) 186 (2) Year of HCT (8) 1306 (12) (7) 1135 (11) (7) 1068 (10) (9) 1101 (10) (10) 1117 (10) (12) 1249 (12) (12) 1074 (10) (10) 638 (6) (4) 430 (4) (10) 815 (8) 2015-current b 2225 (11) 816 (8) Median follow-up of survivors (range), months 73 (1-268) 82 (1-265) a Patients have available comprehensive research form (CRF) and consented for research b Cases continue to be reported in this interval 13

14 Not for publication or presentation Attachment 2 Accrual Summary for Acute Leukemia Working Committee Characteristics of recipients of first autologous transplants for AML and ALL reported a to the CIBMTR between 1995 and 2017 Variable AML ALL Number of patients Number of centers Age in decades <10 61 (6) 16 (10) (7) 25 (16) (13) 38 (24) (17) 19 (12) (19) 28 (18) (22) 23 (15) (16) 8 (5) 70 8 (<1) 0 Median (range) 44 (<1-70) 30 (1-66) Gender Male 504 (51) 99 (63) Female 485 (49) 58 (37) HCT-CI 0 54 (5) 3 (2) 1 20 (2) 2 (1) 2 13 (1) 4 (3) (4) 2 (1) N/A, earlier than (87) 146 (93) Missing 2 (<1) 0 Disease status prior to HCT Primary induction failure 10 (1) 2 (1) CR1 638 (65) 100 (64) CR2 258 (26) 44 (28) CR3 14 (1) 6 (4) Relapse 66 (7) 5 (3) Missing 3 (<1) 0 Time from diagnosis to HCT Median (range) 7 (0-82) 9 (2-133) <6 months 413 (42) 23 (15) 6-12 months 265 (27) 73 (46) >12 months 311 (31) 61 (39) Graft type Bone marrow 171 (17) 25 (16) 14

15 Not for publication or presentation Attachment 2 Variable AML ALL Peripheral blood 818 (83) 132 (84) Year of HCT (27) 55 (35) (22) 45 (29) (11) 16 (10) (9) 12 (8) (7) 5 (3) (9) 9 (6) (11) 10 (6) (2) 1 (<1) (<1) (2) 3 (2) 2015-current b 9 (<1) 1 (<1) Median follow-up of survivors (range), months 101 (1-265) 145 (2-266) a Patients have available comprehensive research form and consented for research b Cases continue to be reported in this interval 15

16 Not for publication or presentation Attachment 3 TO: FROM: RE: Acute Leukemia Working Committee Members Daniel J. Weisdorf, MD; Scientific Director and Wael Saber, MD, MS; Assistant Scientific Director for the Acute Leukemia Working Committee Studies in Progress Summary LK13-02: Prognostic significance of cytogenetic abnormalities in patients with Philadelphia-negative ALL undergoing allogeneic Hematopoietic Stem Cell Transplantation in complete remission (A Lazaryan/ V Bachanova) The purpose of this study is: (1) To develop allo-hct specific cytogenetic classification of Ph-negative ALL for prognostication of relapse and survival outcomes following allo-hct. (2) To validate within the CIBMTR database the prognostic significance of existing cytogenetic classifications of Ph-negative ALL in the context of the allo-hct. (3) To compare the performance of both CIBMTR-based and existing classifications of Ph-negative ALL treated with allo-hct. Manuscript preparation is underway. The goal of the study is to have the manuscript submitted by June LK15-01: Comparison of Allogeneic Hematopoietic Cell Transplantation (AlloHCT) with Other Consolidation Therapies Per Alliance and SWOG/ECOG Protocols in Older ( 60 years) AML Patients in First Complete Remission (CR1) (A Artz / C Ustun) The purpose of this study is: (1) To compare DFS and TRM between allohct and non-allohct consolidations. (2) To find the frequency of acute and chronic graft-versus-host disease (GVHD) in the allohct cohort (3) To identify patient or disease characteristics (age, cytogenetic risk group, etc.) which preferentially benefit patients receiving allohct vs. non-allohct consolidation therapy. Analysis is underway. The goal of the study is to have the manuscript submitted by June LK15-02: Impact of GVHD on outcome after allogeneic hematopoietic cell transplantation for acute lymphocytic leukemia (M Yeshurun/ J Rowe/ M Tallman/ V Bachanova) The purpose of this study is: (1) Identify any differential GVHD-associated GVL influences after allohct for ALL, using either myeloablative or reduced intensity conditioning regimens. (2) Study the impact of acute and chronic GVHD and its extent on relapse, NRM, DFS and OS rates after allohct for ALL. Manuscript preparation is underway. The goal of the study is to have the manuscript submitted by June LK15-03: Comparison of outcomes of older adolescents and young adults with Philadelphiachromosome/BCR-ABL1-negative acute lymphoblastic leukemia receiving post-remission consolidation chemotherapy with pediatric-inspired chemotherapy on CALGB or myeloablative allogeneic hematopoietic cell transplantation (M Wieduwilt/ W Stock) The purpose of this study is: (1) To compare overall survival, relapse-free survival, relapse, and non-relapse mortality between older adolescent and young adults aged years with Ph/BCR-ABL1-negative acute lymphoblastic 16

17 Not for publication or presentation Attachment 3 leukemia in first complete remission receiving consolidation therapy with pediatric-inspired chemotherapy on CALGB to myeloablative allogeneic hematopoietic cell transplantation. (2) To compare outcomes of CALGB to allogeneic HCT using fully matched related or unrelated donors in patients who attained CR1 in <8 weeks. (3) To compare outcomes of obese and non-obese ALL patients between cohorts (4) To compare CNS relapse rates in the two cohorts. (5) To determine patient and disease factors influencing outcomes of consolidation with pediatricinspired chemotherapy versus allogeneic hematopoietic cell transplantation. Study is deferred until CALGB data is available. LK16-01: Reduced Intensity Conditioning (RIC) regimens for Acute Myeloid Leukemia (AML): A comparison of Busulfan (B) and Melphlan (M) based regimens from the CIBMTR database (Z Gul/ G Ahmed/ M Khan/ G Hilderbrandt/ H Alkhateeb/ M Damlaj/ M Patnaik/ R Nath/ Z Zhou/ J Cerny). The purpose of this study is: (1) To compare the treatment related toxicity of M based and B based RIC regimens in terms of nonrelapse mortality and incidence and severity of acute and chronic GVHD. (2) To compare hematologic recovery, engraftment kinetics, incidence of relapse, progression free survival and overall survival between the two regimens. Protocol development is underway. The goal of the study is to finalize data analysis by June LK16-02: DRI-guided Choice of Conditioning Intensity for Allogeneic Hematopoietic Cell Transplantation in Adults with Acute Myeloid Leukemia and Myelodysplastic Syndromes (N Bejanyan/ E Warlick/ C Brunstein/ D Weisdorf). The purpose of this study is: (1) To study the effect of conditioning intensity on overall survival (OS) of adult allograft recipients with AML and MDS based on DRI assignment. (2) To study neutrophil recovery, platelet recovery, acute and chronic GVHD, treatment-related mortality (TRM), malignancy relapse and leukemia-free survival (LFS). Protocol development is underway. The goal is to finalize the protocol and start data file preparation by June LK16-03: Allogeneic transplantation to treat therapy related acute myeloid leukemia and myelodysplastic syndromes (N Callander/ L Metheny/ M De Lima / A Hall). The purpose of this study is: (1) To evaluate overall survival of adult allogeneic HCT patients with therapy related AML and MDS (t- AML and t-mds). (2) To assess day-30 mortality, day-100 mortality, leukemia-free-survival (LFS), treatment- related mortality (TRM), non-relapse mortality (NRM), relapse rate (REL), acute and chronic GVHD (3) To evaluate overall survival of adult allogeneic HCT patients with t-aml/ t-mds secondary to autologous transplant. (4) To assess the effect of preparative regimen intensity on outcomes. (5) To identify patient, disease and transplant related prognostic factors for outcome after allogeneic hematopoietic stem cell transplantation. Protocol development is underway. The goal of the study is to finish data file preparation and start analysis by June

18 Not for publication or presentation Attachment 3 LK16-04: Comparing outcomes between HLA-haploidentical and matched sibling allogeneic transplants in patients with acute myeloid leukemia (R Romee/ A Rashidi/ M Hamadani/ W Saber). The purpose of this study is: (1) To compare post-transplantation outcomes in patients with AML undergoing T-replete matched sibling allo-hct versus T-replete haploidentical related donor allo-hct (with PT-CY) including: neutrophil and platelet recovery, acute and chronic GVHD, non-relapse mortality, relapse, Leukemia-free survival and overall survival. Data file preparation is underway. The goal of the study is to finalize data analysis by June LK17-01: Outcomes of acute myeloid leukemia patients who undergo allogeneic transplant stratified by depth of clinical response (M Percival / B Sandmaier / E Estey). The purpose of this study is: (1) To compare overall survival in AML patients undergoing HCT in CR1 who have CR vs. a response less than complete remission. (2) To evaluate event-free survival and treatment-related mortality in AML patients undergoing HCT in CR1 who have CR vs. a response less than complete remission. Protocol development is underway. The goal is to finalize the protocol and start data file preparation by June LK17-02: Allogeneic Hematopoietic Transplant Outcomes in Adult Patients with MLL-rearranged Acute Myeloid Leukemia (K Menghrajani/ M Tallman). The purpose of this study is: (1) Retrospectively evaluate the overall survival, leukemia-free survival, relapse incidence, and nonrelapse mortality of adult AML patients with MLL-rearranged acute myeloid leukemia who underwent an allogeneic bone marrow transplant at or beyond CR1. (2) Evaluate whether or not the type of MLL rearrangement (e.g.11q- or any balanced 11q23 abnormality) allows for stratification of the above outcomes. (3) Understand how outcomes differ for patients who undergo allogeneic transplant for MLL-rearranged leukemia as compared to AML with other intermediate- or adverse-risk features. Protocol development is underway. The goal is to finalize the protocol and start data file preparation by June LK17-03: Impact of post-transplant maintenance therapy with BCR-ABL tyrosine kinase inhibitors on outcomes of Philadelphia chromosome-positive acute lymphoblastic leukemia (Z DeFilipp/ Y Chen). The purpose of this study is: (1) Describe DFS (at 1- and 3-years post-transplant) of patients with Ph+ ALL undergoing allogeneic HCT in CR1 who received maintenance TKI therapy and compare to controls (no maintenance therapy). (2) Compare the OS (at 1- and 3-years post-transplant) between the same two groups (maintenance versus no maintenance). Protocol development is underway. The goal is to finalize the protocol and start data file preparation by June

19 Not for publication or presentation Attachment 4 Proposal: Title: Outcomes of allo-hct of AML patients who achieved complete remission after one or more cycles of induction chemotherapy versus patients with primary refractory AML Michael Boyiadzis, MD, MHSc, boyiadzism@upmc.edu, University of Pittsburgh, UPMC Hillman Cancer Center Marcos de Lima, MD, Marcos.deLima@UHhospitals.org, Case Western Reserve University, University Hospitals Seidman Cancer Center Hypothesis: We hypothesize that the use of multiple cycles of induction chemotherapy to achieve first Complete remission (CR) is a surrogate marker of disease refractoriness which negatively impacts survival following allo-hct. We hypothesize that AML patients who achieve CR after multiple cycles of induction chemotherapy do not do better than patients with primary refractory AML who undergo allo- HCT. Specific aims: To compare overall survival of patients who underwent allo-hct in first CR who required 1 cycle of induction chemotherapy versus patients with AML in CR1 who required two or more cycles of induction chemotherapy, versus patients with primary refractory AML (defined as persistent leukemia after 2 or more cycles) who underwent allo-hct using myeloablative conditioning To determine the CR rate in patients with primary refractory leukemia who underwent allo-hct To determine disease-free survival and treatment-related mortality for subsets of patients Scientific impact: The number of cycles of induction chemotherapy in AML is associated with significant mortality, and may be a surrogate maker of AML resistance. In addition, medical complications associated with multiple cycles of induction chemotherapy may make patients ineligible for allo-hct despite having achieved CR. Outcomes of patients who required multiple cycles of induction chemotherapy to achieve CR followed by allo-hct have not been extensively investigated. Furthermore, comparisons of the outcomes of these patients to AML patients with primary refractory leukemia have not been studied. If the study demonstrates worse outcomes for AML patients who received multiple cycles of induction chemotherapy to achieve CR and proceeded to allo-hct compared to AML patients with primary refractory leukemia, then there will be a significant shift in clinical practice. AML patients with persistent leukemia after 2 cycles of induction chemotherapy should be referred for allo-hct evaluation, sparing them from the associated complications and treatment-related mortality of additional induction chemotherapy. Scientific justification: The goal of induction chemotherapy in AML is to achieve complete remission with restoration of normal bone marrow. Attainment of CR is an important first goal in the treatment of AML, as this is associated with improved survival 1. Patients who do not achieve CR after induction chemotherapy have a poor prognosis. Primary refractory leukemia, as defined by not achieving CR after 2 cycles of intensive 19

20 Not for publication or presentation Attachment 4 chemotherapy, occurs in 10-30% of newly diagnosed AML patients 2. With no standard therapy, decisions regarding therapy for patients with primary refractory AML remain challenging. Patients may receive a third or fourth cycle of induction chemotherapy with the goal of achieving CR and then proceeding to allo-hct 3. However, additional cycles of induction chemotherapy are associated with significantly high treatment-related mortality and morbidity and may result in complications that cause patients to be at high risk for post-transplant complications. Another approach for patients with persistent leukemia is to proceed to allo-hct using a myeloablative conditioning regimen The goal of this approach is dual; to reduce the leukemia burden using myeloablative conditioning and to provide graft-versus-leukemia effect Duval M et al 4 reported outcomes and a predictive score for AML patients who underwent allo-hct with persistent leukemia after a myeloablative regimen reported to the CIBMTR. The overall survival rate at 3 years was 19% for AML patients. The objective of the proposed study is to compare outcomes of patients with primary refractory leukemia who underwent allo-hct to AML patients who received one or more induction chemotherapy cycles in order to achieve CR and then proceeded to allo-hct. The results of this study will provide guidance to physicians and patients for a commonly encountered clinical challenge; to proceed to myeloablative allo-hct for patients with primary refractory leukemia or to continue with further induction chemotherapy in an attempt to induce complete remission. Patient eligibility population: Age: > 18 years Year of transplant: (the number of induction cycles of therapy for AML have been reported to CIBMTR since 2008) Disease and disease status: Newly diagnosed AML patients who received induction chemotherapy (1 or more cycles) and achieved CR. Newly diagnosed AML patients who received at least 2 cycles of induction chemotherapy and had persistent leukemia. Graft and donor type: First myeloablative or reduced intensity allogeneic bone marrow or peripheral blood transplantation performed; HLA identical sibling, well matched/partially matched unrelated/mismatched unrelated Transplant regimen: ablative or reduced intensity Data requirements: Variables proposed in the study are included in the data collection forms, including the AML form. In the AML form, items 93 and 122 collect the first and second line of induction therapy and items 97 and 126 collect the number of cycles and the specifics for each chemotherapy course (98-111, ). Information on more than 2 lines of therapy is also captured. The following variables will be required from the CIBMTR Research Database: age at transplantation, donor and recipient sex, Karnofsky or Lansky performance score at allo-hct, disease status at allo-hct (CR or persistent leukemia), number of induction cycles prior to HCT, number of consolidation cycles, pre-hct extramedullary leukemia, prior MDS, cytogenetics for AML, prior fungal infection, conditioning regimen, donor-recipient sex and sex match, donor-recipient HLA match, donor-recipient cytomegalovirus (CMV) status, graft type, GVHD prophylaxis, and year of transplantation. 20