Clinical Trials Directory

Trials / Completed

CompletedNCT01251575

Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant

A Phase II Study to Assess Immunosuppression With Sirolimus Combined With Cyclosporine (CSP) and Mycophenolate Mofetil (MMF) for Prevention of Acute GVHD After Non-Myeloablative HLA Class I or II Mismatched Donor Hematopoietic Cell Transplantation- A Multi-Center Trial

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

Summary

This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant 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 together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether the incidence of acute GVHD grades II-IV can be reduced to less than the historical rate of 70% with the triple-immunosuppressant combination of cyclosporine (CSP)/mycophenolate mofetil (MMF) with sirolimus in human leukocyte antigens (HLA) class I or class II mismatched related or unrelated donor hematopoietic cell transplantation (HCT) using nonmyeloablative conditioning. The evaluation will be carried out separately among class I and class II mismatched patients. SECONDARY OBJECTIVES: I. To evaluate the incidence of non-relapse mortality before day 100. II. To evaluate the incidences of grades III-IV acute GVHD. OUTLINE: CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -4 to -2. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation. IMMUNOSUPPRESSION: Patients receive sirolimus orally (PO) once daily (QD) on days -3 to 180 with taper to day 365; cyclosporine PO twice daily (BID) on days -3 to 150 with taper to day 180; and mycophenolate mofetil PO thrice daily (TID) on days 0-30 and then BID to day 100 with taper to day 150. After completion of study treatment, patients are followed up at 6 months and every year thereafter.

Conditions

Interventions

TypeNameDescription
PROCEDUREAllogeneic Hematopoietic Stem Cell TransplantationUndergo allogeneic peripheral blood stem cell transplant
DRUGCyclosporineGiven PO or IV
DRUGFludarabine PhosphateGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGMycophenolate MofetilGiven PO
PROCEDUREPeripheral Blood Stem Cell TransplantationUndergo allogeneic peripheral blood stem cell transplant
DRUGSirolimusGiven PO
RADIATIONTotal-Body IrradiationUndergo total-body irradiation

Timeline

Start date
2010-12-01
Primary completion
2018-11-23
Completion
2019-02-11
First posted
2010-12-02
Last updated
2019-12-09
Results posted
2019-12-09

Locations

5 sites across 2 countries: United States, Denmark

Source: ClinicalTrials.gov record NCT01251575. Inclusion in this directory is not an endorsement.