Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Graft-Versus-Host DiseaseHematological Malignancies
Interventions
DRUG

Mycophenolate mofetil

Tablets. For HLA-identical sibling donors:15 mg/kg t.i.d from day 0 to day 28. For alternative donor: 15 mg/kg, from day 0 to day 42.

DRUG

Sirolimus

Tablets. 6 mg loading dose on day -3, followed by (1)-2 mg daily to a target trough level of 5 to 10 ng/mL. Full doses will be given until day 100 (sibling recipients) or 180 (alternative donor recipients). Doses will then be progressively tapered to be definitely discontinued by day 180 (sibling donors) or 365 (alternative donor recipients) in the absence of GVHD.

Trial Locations (13)

1000

Jules Bordet Institute, Brussels

1020

Queen Fabiola Children's University Hospital, Brussels

1090

AZ VUB Jette, Brussels

1200

Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Brussels

2060

Ziekenhuis Netwerk Antwerpen (ZNA), Antwerp

2650

University Hospital, Antwerp, Edegem

3000

University Hospital, Gasthuisberg, Leuven

4000

CHU Sart Tilman, Liège

5530

Cliniques Universitaires de Mont-Godinne, Yvoir

7100

Jolimont Hospital Haine Saint Paul, Haine St-Paul

8000

AZ Sint-Jan AV, Bruges

8800

H.-Hart Hospital Roeselare-Menen, Roeselare

9000

UZ Gent, Ghent

Sponsors
All Listed Sponsors
collaborator

AZ Sint-Jan AV

OTHER

collaborator

Ziekenhuis Netwerk Antwerpen (ZNA)

OTHER

collaborator

Jules Bordet Institute

OTHER

collaborator

University Hospital, Gasthuisberg

OTHER

collaborator

AZ-VUB

OTHER

collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

collaborator

University Hospital, Antwerp

OTHER

collaborator

Cliniques Universitaires de Mont-Godinne

UNKNOWN

collaborator

Hospital de Jolimont

UNKNOWN

collaborator

University Hospital, Ghent

OTHER

collaborator

AZ Delta

OTHER

lead

University of Liege

OTHER