A Phase II Study to Assess the Efficacy of Maraviroc, a CCR5-Antagonist in Prophylaxis of Graft-Versus-Host Disease in Patients With Hematologic Malignancies Undergoing Reduced-Intensity Allogeneic Stem-Cell Transplantation From Unrelated Donors
To estimate the cumulative incidence of grade 2-4 acute GVHD by day 180 with the addition of
maraviroc to a standard prophylaxis regimen in patients with hematologic malignancies
undergoing reduced intensity allogeneic stem-cell transplantation (RIC SCT) from unrelated
1. To assess the toxicity of a prolonged administration of maraviroc in patients
undergoing RIC SCT.
2. To estimate the rates of severe (grade 3-4) acute GVHD by day 100 and 180, grade 2-4
acute GVHD by day 100, organ-specific acute GVHD, chronic GVHD, relapse, infections,
non-relapse mortality, use of immunosuppressive therapies and 1-year survival in
patients treated with maraviroc after RIC SCT.
3. To assess the effect of treatment with maraviroc on immune recovery, engraftment and
donor T-cell chimerism in peripheral blood and in target organs.
4. To assess the effect of donor and recipient CCR5 genotype on the incidence of acute
GVHD in patients receiving maraviroc as part of a GVHD prophylaxis regimen.
OUTLINE: Patients receive a standard conditioning regimen with fludarabine and busulfan
followed by a peripheral blood stem cell infusion from an unrelated donor, standard GVHD
prophylaxis and standard antiviral and antifungal prophylaxis. In addition, all patients
receive maraviroc from day -3 to d+ 90.
Patients are followed for 1 year after the stem-cell infusion.
Primary Purpose: Treatment
Number of Serious Adverse Events
The cumulative incidence of grade 2-4 acute GVHD by day 180 after the stem-cell infusion
Ran Reshef, MD
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|