Azacytidine and Lymphocytes in Relapse of AML or MDS After Allogeneic Stem Cell Transplantation.

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

November 30, 2019

Study Completion Date

November 30, 2019

Conditions
Acute Myelogenous LeukemiaMyelodysplastic Syndrome
Interventions
BIOLOGICAL

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"

DRUG

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."

Trial Locations (12)

1000

Institut Jules Bordet, Brussels

1090

Universitair Ziekenhuis Brussel, Jette

1200

Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

2060

Ziekenhuis Netwerk Antwerpen, Antwerp

2650

Universitair Ziekenhuis Antwerpen, Edegem

3000

Universitair Ziekenhuis Leuven, Leuven

4000

CHU Liège, Liège

5530

CHU Mont-Godinne, Yvoir

7100

Hopital de Jolimont, Haine-St-Paul

8000

AZ Sint-Jan Brugge, Bruges

8800

Hartziekenhuis Roeselare Menen, Roeselare

9000

Universitair Ziekenhuis Gent, Ghent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Belgian Hematological Society

OTHER

lead

Carlos Graux, MD, PhD

OTHER