Randomized Trial of Busulfan or Total Body Irradiation Conditioning Regimens for Children With Acute Lymphoblastic Leukemia
N/A
21 Years
Both
Leukemia
Trial Information
Randomized Trial of Busulfan or Total Body Irradiation Conditioning Regimens for Children With Acute Lymphoblastic Leukemia
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 PCR in patients receiving bulsulfan 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 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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed childhood acute lymphoblastic leukemia
(ALL) in second hematologic remission or greater who have relapsed: On therapy OR Within
one year of discontinuation of therapy OR Greater than 1 year from discontinuation of high
risk intensive therapy (matched sibling donor only) Patients with central nervous system
or testicular relapse: Occurred within 18 months of diagnosis OR Following prophylactic or
therapeutic cranial irradiation T cell disease with isolated CNS or bone marrow relapse at
any time Patients in first remission with greater than 4 weeks to achieve remission or
with high risk features such as: t(4,11) t(9,22) Hypodiploidy Patients under 12 months of
age in first remission with any of the following features at diagnosis: CALLA (CD10)
negative WBC at least 100,000/mm3 Day 14 M2 or M3 bone marrow CNS disease
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: No active hepatitis B or C
Bilirubin no greater than 1.5 times normal ALT or AST less than 2.5 times normal Renal:
Creatinine no greater than 1.5 times normal OR Creatinine clearance at least 65 mL/min
Cardiovascular: Shortening fraction greater than 27% by echocardiogram OR Ejection
fraction greater than 47% by radionuclide angiogram Pulmonary: FEV1/FVC greater than 60%
For uncooperative children: No evidence of dyspnea at rest No exercise intolerance Pulse
oximetry greater than 94% Other: No active infection No occult untreated infection HIV
negative Not eligible for CCG or POG transplant study Donor criteria: Genotypically
matched sibling or phenotypically matched family member (bone marrow or peripheral blood
stem cells may be used) One antigen mismatched related donor Matched or one antigen
mismatched unrelated donor Cord blood (genotypic or phenotypic match or one antigen
mismatch) Matched sibling or phenotypically matched family member peripheral stem cells
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Nancy Bunin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Children's Hospital of Philadelphia
Authority:
United States: Federal Government
Study ID:
CDR0000065440
NCT ID:
NCT00002961
Start Date:
October 1995
Completion Date:
Related Keywords:
- Leukemia
- recurrent childhood acute lymphoblastic leukemia
- childhood acute lymphoblastic leukemia in remission
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
| Washington University Medical Center | Saint Louis, Missouri 63105 |
| Palmetto Richland Memorial Hospital | Columbia, South Carolina 29203 |
| Children's Hospital and Health Center | San Diego, California 92123-4282 |
| Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
| South Texas Cancer Institute | San Antonio, Texas 78229 |
