Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL
- Conditions
- LeukemiaLymphoma
- Registration Number
- NCT00041288
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may prevent this from happening.
PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
- Detailed Description
OBJECTIVES:
* Compare the 1-year overall survival rate of patients with relapsed low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with fludarabine and total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic peripheral blood stem cell transplantation and donor lymphocyte infusions.
* Compare the toxic effects of these regimens in these patients.
* Compare the incidence and severity of acute and chronic graft-versus-host disease in patients treated with these regimens.
* Compare the 1-year treatment-related mortality and infectious complications in patients treated with these regimens.
* Compare the efficacy of these treatment regimens, in terms of 1-year disease-free survival, of these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease, age (less than 55 vs over 55), and participating transplantation center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral mycophenolate mofetil twice daily on days 0-28.
* Arm II: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on days -3 to -2. Patients undergo PBSCT on day 0. Patients receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and tacrolimus IV continuously and then orally on days -2 to 90 followed by a taper on days 90-150.
At approximately day 180, patients with persistent disease, evidence of T-cell chimerism, and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months.
Quality of life is assessed at baseline, 1 month, every 3 months for 1 year, and then every 6 months for 1 year.
Patients are followed at 1 month, every 3 months for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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 (23)
Blood and Marrow Transplant Group of Georgia
🇺🇸Atlanta, Georgia, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Missouri Kansas City School of Medicine
🇺🇸Kansas City, Missouri, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Delaware Clinical & Laboratory Physicians
🇺🇸Newark, Delaware, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Oregon Cancer Institute
🇺🇸Portland, Oregon, United States
Texas Transplant Institute
🇺🇸San Antonio, Texas, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Hopital du Saint-Sacrament, Quebec
🇨🇦Quebec City, Quebec, Canada
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Toronto
🇨🇦Toronto, Ontario, Canada