Hodgkin Lymphoma Clinical Trial
Official title:
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
This trial is comparing whether using a drug called sirolimus for graft versus host disease (GVHD) prevention can decrease the chance of the participant's lymphoma relapsing after transplantation, compared to using a standard GVHD prevention regimen without sirolimus. Since mTOR inhibitors have anti-lymphoma activity, their use after transplantation may lead to a decreased risk of relapse and hence better transplantation outcome.
- 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.
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