Clinical Trials Directory

Trials / Completed

CompletedNCT00044954

Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Low Dose Total-Body Irradiation And Fludarabine Followed By HLA Matched Allogeneic Stem Cell Transplantation For Hematologic Malgnancies - A Multi-Center Study

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
—
Sponsor
University of Texas Southwestern Medical Center · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.

Detailed description

OBJECTIVES: * Determine the response rate and duration of response in patients with low-risk hematologic malignancies treated with low-dose total-body irradiation (TBI) and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a slow immunosuppression taper and donor leukocyte infusions (DLI). * Determine the response rate and duration of response in patients with high-risk hematologic malignancies treated with low-dose TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression taper and DLI. * Determine the incidence and extent of graft-versus-host disease, regimen-related toxicity, and engraftment in patients treated with these regimens. * Assess the quality of life of patients treated with these regimens. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups (high-risk vs low-risk hematologic malignancy). The high-risk group includes acute myelogenous leukemia, myelodysplastic syndromes, accelerated phase chronic myelogenous leukemia (CML), second chronic phase CML, and non-Hodgkin's lymphoma. The low-risk group includes Hodgkin's lymphoma, first chronic phase CML, multiple myeloma, and chronic lymphocytic leukemia. Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation. Patients also receive oral mycophenolate mofetil on days 0-28. High-risk patients receive oral cyclosporine twice daily on days -2 to day 60. Patients with persistent disease, T-cell chimerism, and no graft-vs-host disease (GVHD) on day 90 receive up to 3 doses of donor leukocyte infusion (DLI) over the next 4 months. Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150. Patients with persistent disease, T-cell chimerism, and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months. Quality of life is assessed at baseline and at 1, 3, 6, 9, 12, 18, and 24 months. Patients are followed at 1, 3, 6, 9, and 12 months and then annually for 2 years. PROJECTED ACCRUAL: A total of 120 patients (60 per group) will be accrued for this study.

Conditions

Interventions

TypeNameDescription
BIOLOGICALtherapeutic allogeneic lymphocytes
DRUGcyclosporine
DRUGfludarabine phosphate
DRUGmycophenolate mofetil
PROCEDUREallogeneic bone marrow transplantation
PROCEDUREperipheral blood stem cell transplantation
RADIATIONradiation therapy

Timeline

Start date
1999-11-01
Primary completion
2006-11-01
Completion
2006-11-01
First posted
2003-01-27
Last updated
2019-09-17

Locations

14 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00044954. Inclusion in this directory is not an endorsement.