Clinical Trials Directory

Trials / Completed

CompletedNCT01231412

Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant

A Randomized Phase III Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies: A Multi-center Trial

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
174 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

This randomized phase III trial studies how well graft-vs-host disease (GVHD) prophylaxis works in treating patients with hematologic malignancies undergoing unrelated donor peripheral blood stem cell transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant (PBSCT) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation (TBI) together with fludarabine phosphate (FLU), cyclosporine (CSP), mycophenolate mofetil (MMF), or sirolimus before transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To compare the effectiveness of 2 GVHD prophylaxis regimens in preventing acute grades II-IV GVHD. SECONDARY OBJECTIVES: I. Compare non-relapse mortality in the 2 arms. II. Compare survival and progression-free survivals in the 2 arms. OUTLINE: Patients are randomized to 1 of 2 treatment arms. All patients receive FLU intravenously (IV) over 30 minutes on days -4 to -2 followed by 2-3 Gy TBI on day 0. ARM 0: Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011 ARM I: Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and MMF PO three times daily (TID) on days 0-29 and then BID on days 30-150 with taper to day 180. ARM II: Patients receive CSP as in Arm I and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 following the TBI. After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

TypeNameDescription
PROCEDUREAllogeneic Hematopoietic Stem Cell TransplantationUndergo allogeneic PBSCT
DRUGCyclosporineGiven PO or IV
DRUGFludarabine PhosphateGiven IV
DRUGMycophenolate MofetilGiven PO
PROCEDUREPeripheral Blood Stem Cell TransplantationUndergo allogeneic PBSCT
DRUGSirolimusGiven PO
RADIATIONTotal-Body IrradiationUndergo TBI

Timeline

Start date
2010-11-01
Primary completion
2016-10-08
Completion
2017-06-30
First posted
2010-11-01
Last updated
2019-10-24
Results posted
2017-12-04

Locations

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

Source: ClinicalTrials.gov record NCT01231412. Inclusion in this directory is not an endorsement.