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Bone Marrow Transplant. 2019 May 14. doi: 10.1038/s41409-019-0536-y. [Epub ahead of print]

Prospective phase II study of prophylactic low-dose azacitidine and donor lymphocyte infusions following allogeneic hematopoietic stem cell transplantation for high-risk acute myeloid leukemia and myelodysplastic syndrome.

Author information

1
Hematology Department, Nantes University Hospital, Nantes, France. thierry.guillaume@chu-nantes.fr.
2
Cancer Research Center Nantes-Angers, INSERM U1232, Nantes, France. thierry.guillaume@chu-nantes.fr.
3
Hematology Department, AP-HP, Saint-Antoine Hospital, Paris, France.
4
INSERM UMR 938 and Pierre et Marie Curie University, Paris, France.
5
Bone Marrow Transplantation Unit, Lille University Hospital, Lille, France.
6
Hematology and Cell Therapy Department, Bordeaux University Hospital, Pessac, France.
7
Hematology Department, Institut Universitaire du Cancer Toulouse - Oncopole, Toulouse, France.
8
Hematology Department, Nantes University Hospital, Nantes, France.
9
Cancer Research Center Nantes-Angers, INSERM U1232, Nantes, France.
10
Lille Inflammation Research Center, INSERM U995, University of Lille, Nantes, France.

Abstract

Thirty patients, with high-risk acute myeloid leukemia (AML, n = 20) or myelodysplastic syndrome (MDS, n = 10), were enrolled in a phase II trial entailing prophylactic post-transplant azacitidine (AZA) plus escalated doses of donor lymphocyte infusion (DLI). The median number of AZA cycles was 5 (1-12) with 10 patients (33%) completing the 12 projected cycles. DLI were performed in 17 patients: 5 received one DLI, 2 received 2 DLI and 8 received 3 infusions. AZA was well tolerated, but discontinued in 20 patients primarily due to graft-versus-host disease (GvHD) and relapse. The cumulative incidence (CI) of grade 1-3 acute GvHD was 31.5% and the chronic GvHD CI was 53% at 2 years. At a median follow-up of 49 months (27-63), 18 patients are alive. The overall and disease-free survivals are 65.5% (CI 95% = 48.2-82.8) at 2 years. Cause of death was mainly relapse for 9 patients. The median time to relapse was 7 months (2.5-58) and the cumulative incidence of relapse at 2 years was 27.6% (CI 95% = 12.8-44.6). These results confirm that AZA is well tolerated as a prophylactic treatment to reduce the risk of post-transplantation relapse and compared favorably to those of patients who receive no post-transplant maintenance.

KEYWORDS:

azacitidine; donor lymphocyte infusion; relapse prevention

PMID:
31089280
DOI:
10.1038/s41409-019-0536-y

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