Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective for treating infants with acute lymphoblastic leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed acute lymphoblastic leukemia.

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

Details

• Lead Sponsor: Dutch Childhood Oncology Group
• Treatments: 6-Mercaptopurine; Asparaginase; Cytarabine; Mercaptopurine; Methotrexate; Prednisolone; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute lymphoblastic leukemia (ALL)

• Newly diagnosed

• Morphological verification by cytochemistry and immunophenotyping

• CNS or testicular leukemia at diagnosis allowed

• Trisomy 21 allowed

PATIENT CHARACTERISTICS:

Age:

• 365 days or less

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for leukemia

Endocrine therapy:

• At least 4 weeks since prior systemic corticosteroids

• Prior inhaled steroids allowed

Radiotherapy:

• No prior radiotherapy for leukemia

Surgery:

• Not specified