Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Children With Acute Lymphoblastic Leukemia

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

Summary

This phase II trial is studying how well combination chemotherapy with or without donor peripheral stem cell transplant works in treating children with acute lymphoblastic leukemia. Giving combination chemotherapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Asparaginase; Cyclophosphamide; Cyclosporine; Cyclosporins; Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Etoposide phosphate; Ifosfamide; Imatinib Mesylate; Leucovorin; Levoleucovorin; Mercaptopurine; Methotrexate; Pegaspargase; Vincristine

Criteria

Inclusion Criteria:

• Diagnosis of acute lymphoblastic leukemia

• Received prior front-line therapy on a Pediatric Oncology Group (POG),Children's Cancer Group (CCG), or Central Oncology Group (COG) study

• Received induction therapy comprising vincristine, asparaginase, prednisone/dexamethasone, and daunorubicin as in CCG, POG, or COG protocols

• M1 or M2 bone marrow status after front-line induction therapy and presenting with at least 1of the following:

• Philadelphia chromosome positive (Ph+) with t(9;22)(q34;q11) by cytogenetics or fluorescence in situ hybridization

• bcr-abl fusion transcript by reverse transcription polymerase chain reaction

• Hypodiploid with less than 44 chromosomes and/or DNA index less than0.81

• MLL translocation (11q23) by cytogenetics and a slow early response (SER) to induction therapy, defined as at least 5% blasts at day 15 of induction and/or at least .1% minimal residual disease (MRD) after induction therapy

• Failed to achieve remission after front-line induction therapy

• M3 bone marrow status (greater than 25% blasts) after induction therapy

• M2 bone marrow status (5-25% blasts) or at least 1% MRD after induction therapy and M2 or M3or at least 1% MRD after consolidation therapy (CCG studies) or extended induction therapy (POG or COG studies)

• See Disease Characteristics

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• See Disease Characteristics

• See Disease Characteristics

• No concurrent prophylactic cranial radiotherapy