Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

• 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 more than one chemotherapy drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for acute lymphoblastic leukemia.

PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.

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

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Prednisone; Thioguanine; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of B-cell precursor acute lymphoblastic leukemia

• Registered on POG-9900 Classification Study

• Registered within 7 days of documenting complete response after induction on day 29 or, if 2 more weeks of induction are required, no later than day 49

• Classified as high risk:

• No simultaneous trisomy 4 and 10

• No TEL-AML1 gene

• Meets criteria for 1 of the following:

• Any age with WBC > 100,000/mm^3

• CNS and bone marrow evaluations required for those patients with WBC > 100,000/mm^3 who are within 24 months of initial diagnosis

• Age over 12 (boys) or 16 (girls)

• If younger, WBC must be 1 of the following:

• Greater than 80,000/mm^3 (for boys age 8 or girls age 12)

• Greater than 60,000/mm^3 (for boys age 9 or girls age 13)

• Greater than 40,000/mm^3 (for boys age 10 or girls age 14)

• Greater than 20,000/mm^3 (for boys age 11 or girls age 15)

• At least one of the following:

• CNS 3 disease (CSF WBC at least 5/microliter with blasts present)

• Testicular leukemia

• MLL gene rearrangements

PATIENT CHARACTERISTICS:

Age:

• 1 to 21

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• See Disease Characteristics