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Allogeneic (Allo) Stem Cell Transplantation (SCT) for Acute Myeloid Leukemia (AML) in First Complete Remission (CR1) with a Reduced Intensity Conditioning (RIC) of Fludarabine (Flu), 2 Day Busulfan (Bu2) and Horse ATG (hATG): The UMass Experience

Track: Poster Abstracts
Wednesday, February 26, 2014, 6:45 PM-7:45 PM
Longhorn Hall E (Exhibit Level 1) (Gaylord Texan)
Rajneesh Nath, MD , Hematology/Oncology, Section BMT, UMass Memorial Medical Center, Worcester, MA
Jan Cerny, MD, PhD , Division of Hematology/Oncology, University of Massachusetts, Worcester, MA
Muthalagu Ramanathan, MD , Hematology/Oncology Section BMT, UMASS Memorial University Campus, Worcester, MA
Glen Raffel, MD, PhD , Hematology/Oncology Section BMT, UMass Medical Center, Worcester, MA
Mridula George, MD , Department of Medicine, UMass Medical Center, Worcester, MA
Zeina Al-Mansour, MD , Hematology/Oncology, UMass Memorial Medical Center, Worcester, MA
Laura Petrillo-Deluca, PAC , Hematology/Oncology, UMass Memorial Medical Center, Worcester, MA
Tzafra Martin, PAC , Hematology/Oncology Section BMT, UMass Memorial Medical Center, Worcester, MA
Zankar Desai , Stem Cell Laboratory, University of Massachusetts Medical Center, Worcester, MA
Jayde Bednarik, PharmD , Pharmacy, UMass Memorial Medical Center, Worcester, MA
Aimee Kroll-Desrosiers, MS , University of Massachussets, Worcester, MA
Alan Rosmarin, MD , Hematology/Oncology, UMass Memorial, Worcester, MA
Background: AML patients are frequently consolidated with Allo-SCT in CR1. There is no consensus about the regimen intensity (RIC versus ablative) in this setting.

Methods: We retrospectively analyzed the outcomes of all AML patients in CR1 who underwent Allo-SCT with RIC regimen (Flu-Bu2-hATG) at UMass since 2010.

Results: 18 patients (12 males; 6 females) with a median age of 67.5 (range 24-83) years were identified. Twelve (66%) had prior MDS or poor prognostic cytogenetics. Induction chemotherapy consisted of High dose Ara-C (HIDAC)/Anthracycline (n=17) and Decitabine (n=1). Five patients required reinduction to achieve a CR. Fourteen (78%) received post CR therapy: HIDAC (n=5), HIDAC/Hypomethylating agent (n=3) and Hypomethylating agent alone (n=6). Seven (39%) patients had inadequate recovery of counts (CRi). Median time from diagnosis to SCT was 130.5 (range 33 -384) days. Median Hematopoietic (H) SCT comorbidity index (CI) was 2.5 range (1- 9). SCT donors were sibling (n=2) and unrelated (n=16). Seventeen (94%) patients were 8/8 HLA match and one (6%) was 7/8 HLA match. Stem cell source was peripheral blood (n=17) and G-CSF primed marrow (n=1). RIC dosing was Bu (3.2 mg/kg day x 2), Flu (30mg/m2 x 6) and hATG (20mg/kg x 3). Graft versus Host Disease (GvHD) prophylaxis was calcineurin inhibitor/mycophenolate-mofetil (MMF) (n=16) and Sirolimus/MMF (n=2).

Median CD34 cells infused were 5 x 10e6/kg range (2.5-6). All patients engrafted with a median time to neutrophil engraftment of 15 days (range 10-22) and a median time to platelet engraftment of 15 days (range 0-21). Non relapse mortality at 100 days was 5.9%. Cumulative incidence of grade 2-4 acute GvHD was 39%. For patients alive beyond 6 months the cumulative incidence of chronic gvhd was 64%. Kaplan Meier estimate of 2 year overall (OS) and progression free survival (PFS) was 80.5 % (95% CI 50.6-93.3%) and 69.9 % (95% CI 36.7-88.0%) The median follow-up for the survivors was 509 (59-1288) days. No patient with HSC-CI < 5 died while all 3 patients with HSCT-CI > 6 expired (p < .001). Presence of chronic gvhd was associated with a better PFS (100% versus 32.1%) (p< .02) and a tendency for better OS (100% versus 57.1%) (p= .06) indicating a preservation of graft versus leukemia effect with this regimen.

Conclusion: Flu-Bu2-hATG RIC regimen has low early mortality and improved PFS and OS for AML patients undergoing Allo-SCT in CR1. The regimen should be evaluated in a prospective clinical trial.

Disclosures:
R. Nath, Celgene, Advisory Board: Advisory Board and Honoraria

J. Cerny, Incyte Inc., advisory board: Advisory Board and Honoraria
Spectrum Pharmaceutical Inc., advisory board: Advisory Board and Honoraria

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