Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring adult acute lymphoblastic leukemia in remission, childhood acute lymphoblastic leukemia in remission
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of acute lymphoblastic leukemia (ALL) Adult patients must meet 1 of the following criteria: Age 50 to 75 with high-risk ALL in complete remission (CR) (less than 5% blasts by morphology on bone marrow aspirate and absence of peripheral blasts) or ALL in second CR (CR2) or greater Age 18 to 50 with high-risk ALL in first CR (CR1) and either ineligible for conventional allogeneic transplantation (based on general medical condition) or refused conventional transplantation High-risk adult ALL in CR1 includes patients meeting 1 or more of the following criteria: Age 30 and over Non-T-cell phenotype Cytogenetic abnormalities including t(9;22), t(4;11), trisomy 8, or monosomy 7 Failure to achieve CR after 4 weeks of induction chemotherapy Age 18 to 50 with ALL in CR2 or greater and ineligible for conventional allogeneic transplantation based on general medical condition Age 18 to 50 with high-risk ALL in CR2 or greater and refused conventional allogeneic transplantation Pediatric patients must meet 1 of the following criteria: Under age 18 with high-risk ALL in CR1 and ineligible for conventional allogeneic transplantation based on general medical condition High-risk pediatric ALL in CR1 includes patients meeting 1 or more of the following criteria: Cytogenetic abnormalities t(9;22) with WBC at least 25,000/mm3 at diagnosis t(4;11) in patients under age 1 or age 10 and over Hypodiploidy (no more than 45 chromosomes) Failure to achieve CR after 4 weeks of induction chemotherapy Persistent peripheral blasts after 1 week of induction chemotherapy Under age 18 with CR2 or greater and ineligible for conventional allogeneic transplantation based on general medical condition Age 12 and under allowed if approved by the principle investigator No active CNS disease Availability of a sibling donor (excluding an identical twin) HLA genotypically identical for at least 1 haplotype HLA-A, -B, -C, -DRB1, and -DQB1 genotypically or phenotypically identical PATIENT CHARACTERISTICS: Age: See Disease Characteristics 75 and under Performance status: Karnofsky 50-100% (adults) Lansky 40-100% (children) Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: No fulminant liver failure No alcoholic hepatitis No history of bleeding esophageal varices No grade II or greater hepatic encephalopathy No hepatic synthetic dysfunction evidenced by prolongation of PT with INR greater than 2.5 No intractable ascites related to portal hypertension No bacterial or fungal liver abscess No chronic viral hepatitis with bilirubin greater than 5 mg/dL No biliary obstruction with bilirubin greater than 5 mg/dL No concurrent symptomatic biliary disease Renal: Not specified Cardiovascular: Cardiac ejection fraction at least 30% Pulmonary: No requirement for supplementary continuous oxygen Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception during and for 1 year after study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent posttransplantation growth factors during mycophenolate mofetil administration Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Sites / Locations
- Cancer Institute at Oregon Health and Science University
- Fred Hutchinson Cancer Research Center
- Universitaet Leipzig