Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
- Conditions
- Multiple Myeloma and Plasma Cell NeoplasmLeukemiaMyelodysplastic SyndromesLymphomaMyelodysplastic/Myeloproliferative Diseases
- Registration Number
- NCT00044954
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Rocky Mountain Cancer Centers - Denver Midtown
🇺🇸Denver, Colorado, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Kansas City Cancer Centers - Central
🇺🇸Kansas City, Missouri, United States
Blood and Marrow Transplant Group of Georgia
🇺🇸Atlanta, Georgia, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Texas Transplant Institute
🇺🇸San Antonio, Texas, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States