Clinical Trials Directory

Trials / Completed

CompletedNCT00105001

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

A Randomized Phase II Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor G-CSF Mobilized Peripheral Blood Mononuclear Cell (G-PBMC) Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies A Multi-Center Trial

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
210 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body-irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving MMF and tacrolimus with or without sirolimus after transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To determine which of 3 GVHD prophylaxis regimens results in reduction of acute grades II-IV GVHD to =\< 40%. SECONDARY OBJECTIVES: I. Reduce the incidence of non-relapse mortality from infections and GVHD before day 200 to =\< 15%. II. Reduce the utilization of high-dose corticosteroids compared to protocols 1463, 1641, and 1668. III. Compare survival and progression-free survival to that achieved under protocols 1463, 1641, and 1668. OUTLINE: CONDITIONING: All patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -4 to -2 and undergo total-body irradiation on day 0. TRANSPLANTATION: All patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive tacrolimus IV or orally (PO) every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. ARM II: Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. ARM III: Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. After completion of study treatment, patients are followed up at 6 months and then every year thereafter.

Conditions

Interventions

TypeNameDescription
DRUGFludarabine PhosphateGiven IV
RADIATIONTotal-Body IrradiationUndergo total-body irradiation
PROCEDUREPeripheral Blood Stem Cell TransplantationUndergo allogeneic peripheral blood stem cell transplantation
PROCEDUREAllogeneic Hematopoietic Stem Cell TransplantationUndergo allogeneic peripheral blood stem cell transplantation
DRUGTacrolimusGiven IV or PO
DRUGMycophenolate MofetilGiven PO
DRUGSirolimusGiven PO

Timeline

Start date
2004-11-01
Primary completion
2011-05-01
Completion
2015-05-08
First posted
2005-03-04
Last updated
2019-10-30
Results posted
2015-09-15

Locations

11 sites across 3 countries: United States, Denmark, Germany

Source: ClinicalTrials.gov record NCT00105001. Inclusion in this directory is not an endorsement.