A Phase III Multicenter, Randomized Trial Comparing Tacrolimus/Sirolimus/Methotrexate Versus Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma
- Because no one knows which of the study options is best, participants will be
"randomized" into one of the two possible groups for GVHD prophylaxis: 1) a
sirolimus-containing regimen (tacrolimus, sirolimus and methotrexate) or 2) a
sirolimus-free regimen (tacrolimus and methotrexate or cyclosporine and mycophenolate
mofetil).
- Participants will receive a reduced intensity conditioning regimen. This is done to
prepare the body for transplantation. This will consist of a combination of drugs
(either fludarabine and busulfan or fludarabine, cyclophosphamide and low-dose total
body irradiation). The purpose of these drugs is to weaken the immune system and lower
the chance of the body rejecting the donated stem cells.
- Participants will also receive the GVHD prophylaxis regimen that they have been
randomized to. These drugs will lower the chance of rejecting the donor cells and
lower the chance of developing GVHD.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the 2-year rate of overall survival of patients with lymphoma undergoing RIC SCT between those receiving Tacrolimus/Sirolimus/Methotrexate and those receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil
2 years
No
Philippe Armand, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
United States: Institutional Review Board
09-073
NCT00928018
June 2009
November 2014
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |