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Randomized Trial of Busulfan or Total Body Irradiation Conditioning Regimens for Children With Acute Lymphoblastic Leukemia

Phase 3
21 Years
Open (Enrolling)

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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

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:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Nancy Bunin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital of Philadelphia


United States: Federal Government

Study ID:




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



Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
University of Chicago Cancer Research CenterChicago, Illinois  60637
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Tulane University School of MedicineNew Orleans, Louisiana  70112
Children's Mercy HospitalKansas City, Missouri  64108
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Washington University Medical CenterSaint Louis, Missouri  63105
Palmetto Richland Memorial HospitalColumbia, South Carolina  29203
Children's Hospital and Health CenterSan Diego, California  92123-4282
Louisiana State University School of MedicineNew Orleans, Louisiana  70112-2822
South Texas Cancer InstituteSan Antonio, Texas  78229