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

Summary

The present project is a multicenter phase II trail aiming at comparing which of the two postgrafting immunosuppressive regimens proposed in this study will be best suited to prevent graft-versus-host disease (GVDH).

The immunosuppressive regimens will consist of: Tacrolimus plus Mycophenolate Mofetil or Tacrolimus plus Sirolimus. Before grafting patients will undergo a reduced-intensity conditioning with Fludarabine/total body irradiation (TBI) or Fludarabine/Busulfan/anti-thymoglobuline. Following the interim analysis of October 2014, the protocol has been amended to allow inclusion only after Flu-TBI conditioning. The hypothesis is that the Tacrolimus plus Sirolimus regimen will be associated with better progression-free survival due to a lower incidence of relapse/progression.

Conditions

• Graft-Versus-Host Disease
• Hematological 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.

Sponsors & Collaborators

• AZ Sint-Jan AV

  collaborator OTHER

• Ziekenhuis Netwerk Antwerpen (ZNA)

  collaborator OTHER

• Jules Bordet Institute

  collaborator OTHER

• University Hospital, Gasthuisberg

  collaborator OTHER

• AZ-VUB

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Cliniques Universitaires de Mont-Godinne

  collaborator UNKNOWN

• Hospital de Jolimont

  collaborator UNKNOWN

• University Hospital, Ghent

  collaborator OTHER

• AZ Delta

  collaborator OTHER

• University of Liege

  lead OTHER

Principal Investigators

• Frédéric Baron, MD; PhD · University of Liege

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Belgium

Study Locations