Chemotherapy With or Without Total-Body Irradiation Prior to Bone Marrow Transplantation in Treating Children With Acute Lymphoblastic Leukemia
- Conditions
- Leukemia
- Interventions
- Procedure: allogeneic bone marrow transplantationRadiation: Total Body IrradiationRadiation: Radiation
- Registration Number
- NCT00002961
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy, radiation therapy, and bone marrow transplantation may kill more cancer cells.
PURPOSE: Randomized phase III trial to compare high-dose chemotherapy with or without total-body irradiation before bone marrow transplantation in treating children with acute lymphoblastic leukemia.
- Detailed Description
OBJECTIVES: I. Compare the efficacy of a busulfan containing conditioning regimen versus a total body irradiation (TBI) containing regimen for children with acute lymphoblastic leukemia (ALL) undergoing allogeneic bone marrow transplantation. II. Compare relapse rate between a chemotherapy only regimen versus a total body irradiation containing regimen for children with ALL. III. Assess and compare the acute and chronic neuropsychological effects of bone marrow transplantation (BMT) in children undergoing BMT with busulfan or TBI conditioning regimens. IV. Assess and compare the cardiac, pulmonary and growth effects of BMT in children undergoing this conditioning regimen. V. Assess the relationship between plasma busulfan levels and relapse and toxicity. VI. Assess and compare minimal residual disease patterns by quantitative polymerase chain reaction (PCR) in patients receiving busulfan or TBI conditioning regimens.
OUTLINE: This is a multicenter, randomized study comparing a chemotherapy only arm, including busulfan, with a TBI containing arm. Arm I patients receive TBI on days -7, -6, and -5 given in 2 fractions daily. Arm II patients receive busulfan every 6 hours on days -8, -7, -6, and -5. Both regimens are followed by etoposide over 4 hours on day -4 and cyclophosphamide intravenously (IV) on days -3 and -2. Marrow infusion begins following a day of rest. Starting on day -1, cyclosporine IV is administered every 12 hours or by continuous infusion and continues until day 50. Methotrexate IV is administered on days 1, 3, and 6
PROJECTED ACCRUAL: A total of 230 patients will be entered into this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Total body irradiation allogeneic bone marrow transplantation Total body irradiation 1200 centigray Total body irradiation Total Body Irradiation Total body irradiation 1200 centigray Total body irradiation Radiation Total body irradiation 1200 centigray Busulfan allogeneic bone marrow transplantation Busulfan 16 doses Busulfan Mesna Busulfan 16 doses Busulfan Radiation Busulfan 16 doses Total body irradiation cyclophosphamide Total body irradiation 1200 centigray Total body irradiation etoposide Total body irradiation 1200 centigray Busulfan cyclophosphamide Busulfan 16 doses Busulfan etoposide Busulfan 16 doses Busulfan cyclosporine Busulfan 16 doses Busulfan methotrexate Busulfan 16 doses Busulfan Busulfan Busulfan 16 doses
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Children's Hospital and Health Center
🇺🇸San Diego, California, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Palmetto Richland Memorial Hospital
🇺🇸Columbia, South Carolina, United States
South Texas Cancer Institute
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Louisiana State University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Washington University Medical Center
🇺🇸Saint Louis, Missouri, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States