Hormone Therapy Plus Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

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

Summary

RATIONALE: Hormone therapy may stop the growth of cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more cancer cells. It is not yet known which hormone therapy and chemotherapy regimen is most effective for acute lymphoblastic leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of different steroid therapy and chemotherapy regimens in treating children who have acute lymphoblastic leukemia.

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

Details

• Lead Sponsor: Medical Research Council
• Treatments: 6-Mercaptopurine; Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Pegaspargase; Prednisolone; Thioguanine; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed acute lymphoblastic leukemia (ALL)

• No B-ALL (Burkitt-like, t(8;14), L3 morphology, SMIg positive)

• Meets criteria for one of the following risk groups:

• Standard risk

• 1 to 9 years old

• Highest WBC less than 50,000/mm^3

• BCR-ABL negative

• Not hypodiploid

• No MLL gene rearrangements if 12 to 24 months old

• Intermediate risk

• Over 10 years old AND/OR

• WBC greater than 50,000/mm^3

• BCR-ABL negative

• Not hypodiploid

• No MLL gene rearrangement if 12 to 24 months old

• High risk, defined by at least 1 of the following:

• Slow early response with regimen A or B

• BCR-ABL positive

• Hypodiploid

• MLL gene rearrangement and 12 to 24 months old

PATIENT CHARACTERISTICS:

Age:

• 1 to 18

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Previous treatment with HR1 regimens allowed