50
Participants
Start Date
December 31, 2013
Primary Completion Date
November 30, 2019
Study Completion Date
November 30, 2019
Donor lymphocyte infusion
"On day 1 of cycle 2, 4 and 6 of Azacytidine, patients will be infused with donor lymphocytes (ideally on day 1 but in case of organizational problems, DLI can be administered until day 5) .~* Patients with a sibling donor will receive:~* 5x10exp7 CD3+/kg on day 1 of cycle 2~* 5x10exp7 CD3+/kg on day 1 of cycle 4~* 10x10exp7 CD3+/kg on day 1 of cycle 6~* Patients with an unrelated donor will receive:~* 1x10exp7 CD3+/kg on day 1 of cycle 2~* 5x10exp7 CD3+/kg on day 1 of cycle 4~* 10x10exp7 CD3+/kg on day 1 of cycle 6"
Azacytidine
"* Cycle 1: Subcutaneous administration of 100mg/m2/day for 5 days.~* Cycle 2: Subcutaneous administration of 35mg/m2/day for 5 days. Cycles will be administered every 28 days.~All patients will receive at least 6 cycles of Azacytidine except if progression requests additional disease-related treatment such as hydroxyurea or other chemotherapeutic agents. In such cases, the patient will be excluded from the study and only disease status and survival status will be reported during the 3-year follow-up period. In case of complete remission after cycle 5, 2 additional cycles will be administered after achievement of complete remission.~In case of stable disease or partial response, Azacytidine will be continued until progression.~In case of disease progression after cycle 6, Azacytidine will be stopped."
Institut Jules Bordet, Brussels
Universitair Ziekenhuis Brussel, Jette
Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert
Ziekenhuis Netwerk Antwerpen, Antwerp
Universitair Ziekenhuis Antwerpen, Edegem
Universitair Ziekenhuis Leuven, Leuven
CHU Liège, Liège
CHU Mont-Godinne, Yvoir
Hopital de Jolimont, Haine-St-Paul
AZ Sint-Jan Brugge, Bruges
Hartziekenhuis Roeselare Menen, Roeselare
Universitair Ziekenhuis Gent, Ghent
Collaborators (1)
Celgene Corporation
INDUSTRY
Belgian Hematological Society
OTHER
Carlos Graux, MD, PhD
OTHER