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Brief Title: Azacytidine and Lymphocytes in Relapse of AML or MDS After Allogeneic Stem Cell Transplantation.
Official Title: Sequential Administration of 5-azacytidine (AZA) and Donor Lymphocyte Infusion (DLI) for Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) in Relapse After Allogeneic Stem Cell Transplantation.
Study ID: NCT02017457
Brief Summary: The present project is a multicenter, phase II trial which aims at evaluating if the administration of azacytidine (Vidaza®) combined to donor lymphocyte infusion (DLI) could improve the response rate to DLI in the population of patients with relapsed acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic hematopoietic stem cell transplantation.
Detailed Description: This is a prospective, multicenter, non-randomized phase II study. The aims at evaluating if the administration of azacytidine (Vidaza®) combined to donor lymphocyte infusion (DLI) could improve the response rate to DLI in the population of patients with relapsed acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic hematopoietic stem cell transplantation. Because the investigators focus our interest on relapsed MDS and low marrow blast count relapsed AML, the investigators postulate that one cycle at higher doses of azacytidine given at 100 mg/m² during 5 days is enough to induce temporary disease control, as suggested by the predictive value of the immediate response rate after the first cycle described in the study of Czibere et al. Starting with cycle 2, the investigators propose to administer DLI along with azacytidine to optimise the immunomodulatory effect. Because these immunomodulatory effects have been described at low dose, the investigators postulate that 35 mg/m² given during 5 days is enough to harness a graft-versus-leukemia effect and induce durable remissions without exacerbating GvHD. DLI will be given every other cycle following an escalated-dose regimen. The investigators have estimated a sample size of 50 patients to be recruited during 4 years with a 2-year follow-up and a 3-year long-term follow-up. The whole study will be completed within 9 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ziekenhuis Netwerk Antwerpen, Antwerpen, , Belgium
AZ Sint-Jan Brugge, Brugge, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Hopital de Jolimont, Haine-St-Paul, , Belgium
Universitair Ziekenhuis Brussel, Jette, , Belgium
Universitair Ziekenhuis Leuven, Leuven, , Belgium
CHU Liège, Liège, , Belgium
Hartziekenhuis Roeselare Menen, Roeselare, , Belgium
Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert, , Belgium
CHU Mont-Godinne, Yvoir, , Belgium
Name: Xavier Poiré, MD
Affiliation: Cliniques universitaires Saint-Luc
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos Graux, MD, PhD
Affiliation: Cliniques Universitaires Mont-Godinne
Role: PRINCIPAL_INVESTIGATOR