Not for publication or presentationAttachment 1

A G E N D A

CIBMTR WORKING COMMITTEE FOR ACUTE LEUKEMIA

Orlando, FL

Thursday, February 23rd, 2017, 12:15 – 2:15 pm

Co-Chair: / Marcos de Lima, MD, University Hospitals Case Medical Center, Cleveland, OH; Telephone: 216-286-6869; E-mail:
Co-Chair: / H Jean Khoury, MD, Winship Cancer Institute of Emory University, Atlanta, GA;
Telephone: 404-778-3932; E-mail:
Co-Chair: / Brenda Sandmaier, MD, Fred Hutchinson Cancer Research Center, Seattle, WA; Telephone: 206-667-4961; E-mail:
Scientific Director: / Daniel J. Weisdorf, MD, University of Minnesota Medical Center, Minneapolis, MN; Telephone: 612-624-3101; E-mail:
Assistant Scientific Director: / Wael Saber, MD, MS, CIBMTR Statistical Center, Milwaukee, WI;
Telephone: 414-805-0700; E-mail:
Statistical Director: / Mei-Jie Zhang, PhD, CIBMTR Statistical Center, Milwaukee, WI;
Telephone: 414-456-8375; E-mail:
Statistician: / Hai-Lin Wang, MPH, CIBMTR Statistical Center, Milwaukee, WI;
Telephone: 414-805-0647; E-mail:
1. / Introduction
TheCIBMTRAcuteLeukemiaWorking Committeewascalledto orderat12:15pmon Thursday,February23rd,2017,by Dr. H.Jean Khoury. Thechairs,scientificdirector andstatisticianswerepresented. Kwang-Woo Ahn filled in for Mei-Jie Zhang, who could not attend tandem meeting. Attendeeswereasked tohavetheir namebadgesscannedforattendancepurposes andtomaintaincommitteemembership, andto fill outtheWorking Committeeevaluationsandvoting sheetsforproposals.Themeeting waslimited topresentationanddiscussionofproposals.Dr.Khourybrieflyintroduced thecommittee’saccomplishmentsforthepastyear andprogressofongoingstudies.Eachproposalpresentation waslimitedto5minutestoallowforadequatetimefordiscussion (5minutes).Theminutesof theFebruary2016 meetingwereapprovedwithoutmodifications.
2. / Accrual summary
Dueto the full agenda,theaccrualsummary of registration andresearchcasesbetween1995and 2016werenotpresented to thecommittee,butwereavailable aspartoftheWorkingCommitteeattachments.
3. / Presentations, published or submitted papers
Dueto the full agenda,the2016presentationsandpublished paperswerementioned, butnotpresented.Fivepaperswerepublished,onesubmitted, and twoASH presentations weregivenduring thepastyear.
a. / LK12-02Deol 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, 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):3005-14.
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):42-49.
c. / LK13-03Munker 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):1024-9.
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):1180-3.
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, 2016.
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, 2016.
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, 2017.
4. / Studies in progress
Theprogressof the ongoingstudiesduring thepastyear wasnotpresented inorder to providemoretimeforthenewproposals’ presentation anddiscussion.A summaryoftheprogresswas provided as anattachmentto thecommitteemembers.
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 protocols in older AML in CR1 (A Artz / C Ustun)Data file preparation
d. / LK15-02Impact 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 Philadelphia-chromosome/BCR-ABL1-negative acute lymphoblastic leukemia receiving post-remission consolidation chemotherapy with pediatric-inspired chemotherapy on CALGB 10403 or 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/ MoussabDamlaj/ 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 (NelliBejanyan/ 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. / LK16-04Comparing 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 1510-21/1611-08/1611-70Impact of Maintenance Therapy after Allogeneic Hematopoietic Cell Transplant (HCT) on Outcomes in Acute Myeloid Leukemia (AML) (Masumi Ueda, Tania Jain, Jeanne Palmer, Lisa Sproat, AmerAssal, Sergio Giralt, Marcos de Lima)
Dr. Ueda presented this proposal. There are 410 adult patients who underwent first allo-HCT for AML between 2013-2016 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 1611-33 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 2000-2015. 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 1611-49Hypomethylating 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 2013-2015 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 1611-64/1611-102/1611-152The Influence of Donor Source, Cytogenetics, and Molecular 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 2ndallo-HCT for persistent/relapsed Leukemia/MDS between 2000-2015. Comments were received about time from 1st 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 1611-95 Allogeneic Hematopoietic Transplant Outcomes in Adult Patients with MLL-rearranged 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 2008-2015. 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 1611-100 Optimizing Allogeneic Hematopoietic Cell Transplant Outcomes in Acute Myeloid Leukemia Using Next Generation Sequencing (Betty Hamilton, NavneetMajhail, JaroslawMaciejewski, 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 2008-2015. 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 1611-111/1611-112Sorafenib 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 2013-2016, 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 1611-163 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 2008-2015 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 1609-01 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, AbhinavDeol)
b. / PROP 1610-14 Clinical Outcomes of Patients with a History of Prior Autologous Transplant Undergoing a Second Allogeneic Transplant for Therapy Related AML/MDS
c. / PROP 1611-27 Evaluation of allogeneic hematpoietic cell transplantation outcomes and prognostic factors in acute megakaryoblastic leukemia: a CIBMTR analysis
d. / PROP 1611-39 Impact of time from diagnosis to hematopoietic cell transplantation on outcomes in acute myeloid leukemia in first complete remission
e. / PROP 1611-58 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 1611-66 Evaluating Primary Refractory Acute Myeloid Leukemia; the effects of Disease Characteristics and Outcomes of Allogeneic Stem Cell Transplantation
g. / PROP 1611-99 Comparing Autologous versus Allogeneic Stem Cell Transplantation for BlasticPlasmacytoid Dendritic Cell Neoplasm
h. / PROP 1611-101 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 1611-114 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 1611-118 Comparison of melphalan-based reduced intensity conditioning with myeloablative conditioning for acute myeloid leukemia and myelodysplastic syndrome
k. / PROP 1611-121 A Retrospective Study of Allogeneic Stem Cell Transplantation Comparing Conditioning Chemotherapy Intensity of Regimen Containing MyeloablativeBusulfan versus Reduced Intensity Melphalan in Patients with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
l. / PROP 1611-125 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 1611-132 Predictive model for progression free survival in patients with acute myeloid leukemia receiving allogeneic stem cell transplantation
n. / PROP 1611-135 Survival of patients with ALL relapsing after allogeneic transplantation
o. / PROP 1611-141 The role of haploidentical allogeneic HCT in FLT-3 ITD positive acute myelogenous leukemia
p. / PROP 1611-143 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 1611-161 The impact of pretransplant diabetes on posttransplant outcomes in patients with acute myeloid leukemia
6. / Other business
Afterthenewproposalswerepresented,each participant in themeeting had theopportunitytorateeachproposalusing paperballots. Basedon thevoting results,currentscientificmerit, available number or relevant casesand theimpactof thestudyon thefield,thefollowingstudieswillmoveforward asthe committee’sresearchportfoliofortheupcomingyear:
PROP 1611-95 Allogeneic Hematopoietic Transplant Outcomes in Adult Patients with MLL-rearranged Acute Myeloid Leukemia (Martin Tallman, Kamal Menghrajani)
PROP 1611-163 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)
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 2017.(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 2017. (Total hour: 10; Allocated for the fiscal year: 10)
c. / LK15-01 AlloHCT vs. other consolidation therapies per Alliance and SWOG 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 2018. (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 2018. (Total hour: 110; Allocated for the fiscal year: 110)
e. / 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 10403 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 2018. (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 2017. (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 2018. (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 2018. (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 2018. (Total hour: 280; Allocated for the fiscal year: 210)
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 2018. (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. WeanticipatedevelopingthestudyprotocolafterJuly2017andmovetodatafilepreparationand analysisbyJune2018. (Total hour: 310; Allocated for the fiscal year: 60)

DanielWeisdorfLK13-02:PrognosticsignificanceofcytogeneticabnormalitiesinpatientswithPhiladelphia‐negativeacutelymphoblasticleukemiaundergoingallogeneichematopoieticstemcelltransplantation in completeremission

LK15-01:ComparisonofAllogeneicHematopoieticCellTransplantationwithOtherConsolidationTherapiesPerAllianceProtocolsinOlder(≥60years)AMLPatients in FirstCompleteRemission.

LK15-03:ComparisonofoutcomesofolderadolescentsandyoungadultswithPhiladelphia-chromosome/BCR-ABL1-negativeacutelymphoblasticleukemiareceivingpost-remissionconsolidationchemotherapywithpediatric-inspiredchemotherapyonCALGB10403ormyeloablativeallogeneichematopoieticcelltransplantation.

LK15-04:Comparisonoftotalbodyirradiation(TBI)-basedwithintravenous(i.v.)busulfan(Bu)containingchemotherapy-onlymyeloablativetransplantconditioning regimens in adultpatients with acutelymphoblasticleukemia.

Wael SaberLK17-02:Allogeneic Hematopoietic Transplant Outcomes in Adult Patients with MLL-rearranged Acute Myeloid Leukemia

MarcosdeLimaLK16-03: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.

BrendaSandmaierLK15-02:ImpactofGVHDonoutcomeafterallogeneichematopoieticcelltransplantationforacutelymphocyticleukemia.

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.