Tacrolimus/Sirolimus/Methotrexate vs Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma

Completed · Phase 3

Conditions studied: Non-hodgkin Lymphoma, Hodgkin Lymphoma

In brief

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.

Key facts

Study ID: NCT00928018
Run by: Dana-Farber Cancer Institute
People needed: 139
Starts: 2009-06-01
Expected to finish: 2014-11-01
Last updated by the study team: 2019-02-01

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients will be eligible if their primary indication for transplantation is among the following: Indolent B-cell non-Hodgkin lymphoma (NHL); Aggressive B-Cell NHL; T-cell NHL; or Hodgkin Lymphoma.
Patients must have one of the following combinations of disease status and disease histology at the time of enrollment: 1) Patients may be transplanted as part of first-line therapy if they have one of the following histologies: CLL with adverse cytogenetics, MCL or, T-cell NHL. 2) Patients may be transplanted as part of treatment for relapsed or refractory disease without a prior autologous transplantation of they have one of the following histologies: Indolent NHL (including CLL/SLL), MCL or T-cell NHL. 3) Patients may be transplanted as part of treatment for disease that has relapsed or progressed after autologous transplantation if they have any of the histologies listed above. Patients may also be enrolled without a prior autologous transplantation if they have a contraindication to autologous transplantation, in the opinion of the treating clinician. 4) There is no minimal or maximal time interval from the patient's last anti-lymphoma therapy and the time of transplantation.
18-72 years of age
Matched related or matched unrelated donor
Donor willing to donate peripheral blood stem cells and meeting institutional criteria for stem cell donation. The donor must be medically eligible to donate stem cells according to individual transplant center criteria.

You may not qualify if…

Patients with Burkitt lymphoma or DLBCL with a c-myc rearrangement
Karnofsky performance status of less than 70% at the time of registration
Prior allogeneic stem cell transplantation (note that prior autologous stem cell transplantation is allowed)
Uncontrolled infection
Serum creatinine 2.0mg/dl or greater
Total bilirubin 2.0mg/dl or greater (unless related to hemolysis or Gilbert's syndrome)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times or greater than the institutional upper limit of normal
Left ventricular ejection fraction < 30%
Cholesterol > 500mg/dl or triglycerides > 500 mg/dl despite appropriate treatment
Seropositivity for HIV
Pregnancy or breast-feeding (effective contraception must be used during therapy and for at least 6 months after the end of immunosuppressive agents)
Prior history of allergy to sirolimus, tacrolimus, cyclosporine, methotrexate or MMF
Concomitant treatment with another investigational drug (unless cleared by study chair)

Where it is running

Emory University Hospital — Atlanta, Georgia, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
University of Minnesota — Minneapolis, Minnesota, United States
Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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