Clinical Trials Directory

Trials / Completed

CompletedNCT00014235

Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic Malignancies

Nonmyeloablative PBSC Allografting From HLA Matched Related Donors Using Fludarabine and/or Low Dose TBI With Disease-Risk Based Immunosuppression

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
160 (estimated)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
74 Years
Healthy volunteers
Not accepted

Summary

This clinical trial studies fludarabine phosphate and total-body radiation followed by donor peripheral blood stem cell transplant and immunosuppression in treating patients with hematologic malignancies. 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 fludarabine phosphate, cyclosporine, and mycophenolate mofetil before transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the rate of grade III/IV graft-versus-host disease (GVHD) in patients treated with low-dose total body irradiation (TBI), fludarabine (fludarabine phosphate), PBSC infusion and immunosuppression with mycophenolate mofetil and a disease risk-based cyclosporine taper. II. To estimate the risk of graft rejection, GVHD, disease response, non-relapse mortality and the incidence and severity of infectious complications using this treatment strategy. OUTLINE: Patients are assigned to 1 of 2 treatment groups. ARM I (indolent disease): CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: Patients undergo donor peripheral blood stem cell transplantation (PBSCT) on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) or IV every 8-12 hours on days -3 to 56 with a taper to day 180 and mycophenolate mofetil PO BID or IV every 8-12 hours on days 0 to 27. ARM II (aggressive disease): CONDITIONING REGIMEN: Patients receive fludarabine phosphate and undergo TBI as in Arm I. TRANSPLANTATION: Patients undergo donor PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID or IV every 8-12 hours on days -3 to 56 with a taper to day 70 and mycophenolate mofetil as in Arm I. After completion of study treatment, patients are followed up for 5 years.

Conditions

Interventions

TypeNameDescription
DRUGfludarabine phosphateGiven IV
RADIATIONtotal-body irradiationUndergo TBI
PROCEDUREperipheral blood stem cell transplantationUndergo PBSCT
PROCEDUREallogeneic hematopoietic stem cell transplantationUndergo PBSCT
DRUGcyclosporineGiven PO or IV
DRUGmycophenolate mofetilGiven IV or PO
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2000-12-01
Primary completion
2005-02-01
First posted
2003-01-27
Last updated
2020-01-21

Locations

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

Source: ClinicalTrials.gov record NCT00014235. Inclusion in this directory is not an endorsement.