Risk-Adjusted Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

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

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. A donor stem cell transplant may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving combination chemotherapy before the transplant helps stop the growth of cancer cells and stop the patient's immune system from rejecting the donor's stem cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is studying different risk-adjusted combination chemotherapy regimens in treating young patients with acute lymphoblastic leukemia.

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

Details

• Lead Sponsor: University Hospital, Motol
• Treatments: 6-Mercaptopurine; Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Etoposide; Ifosfamide; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Prednisone; Thioguanine; Vincristine; Vindesine

Criteria

DISEASE CHARACTERISTICS:

• Cytologically proven acute lymphoblastic leukemia (ALL)

• No relapse of a previously unrecognized ALL

• Patients must meet one of the following risk criteria:

• Standard-risk (SR) group meeting all of the following criteria:

• Blasts < 1,000/μL in peripheral blood (PB) on day 8

• Aged 1 to < 6 years

• Initial WBC < 20,000/μL

• M1 (5%) or M2 (≥ 5% to < 25%) blasts in bone marrow on day 15

• M1 marrow on day 33

• Intermediate-risk (IR) group meeting all of the following criteria:

• Aged < 1 or ≥ 6 years and/or WBC ≥ 20,000/μL

• Blasts < 1,000/μL in PB on day 8

• M1 or M2 marrow on day 15

• M3 (≥ 25%) marrow on day 15 OR meets SR criteria but M3 marrow on day 15 and M1 marrow on day 33

• High-risk (HR) group meeting ≥ 1 of the following criteria:

• Meets IR criteria and M3 marrow on day 15 (not SR and M3 on day 15)

• Blasts ≥ 1,000/μL in PB on day 8

• M2 or M3 marrow on day 33

• Translocation t(9;22) [BCR/ABL+] (Philadelphia chromosome-positive) or t(4;11) [MLL/AF4+]

• No secondary ALL

PATIENT CHARACTERISTICS:

• No Down syndrome

• No other major disease that prohibits study treatment (e.g., severe congenital heart disease)

• Not requiring significant therapy modification owing to study therapy-associated complications

• No complications due to other interventions

• No one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm

PRIOR CONCURRENT THERAPY:

• No steroids or cytostatic drugs within four weeks prior to start of study therapy