Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborators: Medical Research Council; National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Imatinib Mesylate; Leucovorin; Levoleucovorin; Mercaptopurine; Methotrexate; Prednisone; Sargramostim; Thioguanine; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed acute lymphoblastic leukemia (ALL)

• More than 25% lymphoblasts in bone marrow

• Patients with myeloid antigen expression AND unequivocal lymphoid immunophenotype are eligible

• Philadelphia (Ph) chromosome status determined by cytogenetics, fluorescence in situ hybridization (FISH), and/or RNA analysis

• Patients determined to be Ph chromosome negative by cytogenetics, but positive for BCR-ABL by FISH or polymerase chain reaction are considered Ph chromosome positive

• Patients with Ph chromosome-positive disease may be up to age 65

• No myelodysplasia or other antecedent hematologic disorder

• Patients age 50 and under must be HLA typed during induction therapy of study treatment OR provide a written explanation for not undergoing HLA typing

• A and B typing required

• C and DR typing done if feasible

• Allogeneic stem cell transplantation patients must meet the following criteria:

• Appropriate HLA histocompatible donor available

• Ph chromosome-negative patients must have HLA identical sibling

• Ph chromosome-positive patients must have HLA identical, HLA-matched unrelated, or haploidentical related donor

• Postinduction therapy:

• CSF negative for leukemia

• No occult or overt leukemic meningitis

• Documented complete remission

PATIENT CHARACTERISTICS:

Age:

• 15 to 65

Performance status:

• Induction therapy:

• Not specified

• Postinduction therapy:

• 0-1

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Induction therapy:

• Direct bilirubin ≤ 2.0 mg/dL

• Postinduction therapy:

• Direct bilirubin < 2.0 mg/dL

• SGPT or SGOT < 3 times normal

Renal:

• Induction therapy:

• Creatinine < 2 mg/dL

• Postinduction therapy:

• Creatinine ≤ 2 mg/dL

• Creatinine clearance ≥ 60 mL/min

Cardiovascular:

• Induction and postinduction therapy:

• No significant cardiac disease requiring digoxin and/or diuretics

• No major ventricular dysrhythmia requiring medication

• No ischemic heart disease requiring medication

• Postinduction therapy:

• Cardiac ejection fraction ≥ 50% for patients under consideration for transplantation

Pulmonary:

• Induction therapy:

• Not specified

• Postinduction therapy:

• FEV_1 ≥ 60% of predicted for patients under consideration for transplantation

• DLCO ≥ 50% of predicted for patients under consideration for transplantation

Other:

• Induction and postinduction therapy:

• HIV negative

• No concurrent organ damage or other medical problem (e.g., psychiatric disorder or drug abuse) that would preclude study therapy

• Not pregnant

• Postinduction therapy:

• No persistent infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent umbilical cord allogeneic transplantation

Chemotherapy:

• Not specified

Endocrine therapy:

• Prior corticosteroids for ALL allowed

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• Induction and postinduction therapy:

• No other prior therapy for ALL

• Postinduction therapy:

• No concurrent antibiotics