Phase III Study of Induction With Prednisone, Vincristine, Asparaginase, and Methotrexate, Consolidation With Prednisone, Vincristine, and Methotrexate, and Maintenance With Mercaptopurine, Methotrexate, Prednisone, and Vincristine in Children With Lesser Risk Acute Lymphocytic Leukemia Study: An ALinC #16 Study.

This trial on the cancer.gov site.

Published results.

Treatment for good risk (or lesser risk) B-precursor ALL, no L3 morphology (FAB), defined as:

• no CNS involvement, defined as:
  • less than 5 WBC/microliter in the cerebral spinal fluid or no leukemic blasts on cytospin if WBC is 5/microliter or greater
• no testicular involvement
• no chromosomal translocation t(1;19), t(4;11), or t(9;22)
• age 1 through 9 years
• WBC less than 50,000/mm3 and EITHER
  • Presence of simultaneous trisomwy 4 and 10 OR
  • DNA Index (St. Jude's) greater than 1.16 (if cytogenetics (uninformative)

Date initiated, # of patients:

Protocol Chair:

Specific Aims:

Confirm the treatment results achieved with the least intensive arm of protocol ALinC #14 (POG-8602) in children with lesser risk non-T, non-B acute lymphocytic leukemia.

POG 9201

• 4 Weeks Induction
  • 3-Drug Combination Systemic Chemotherapy plus 3-Drug Intrathecal Therapy
    • prednisone, 1-28 day
    • vincristine, IV days 1, 8, 15, 22
    • asparaginase, IM, days 2, 5, 8, 12, 15, 19
    • TIT (triple intraethical of methotrexate, ara C, hydrocortisone), days 1, 8, 15, 22
• 20 weeks consolidation, weeks 5-24
  • 2-Drug combination systemic chemotherapy (methotrexate and 6-MP) with pulses of another 2-drug combination (prednisone and vincristine) with TITs throughout
    • ID (intermediate dose) methotrexate as IV push with leucovorin rescue over 24 hours weeks 7, 10, 13, 16, 19, 22
    • 6-MP oral, daily, weeks 5-25.
    • prednisone, oral, for 7 days weeks 8, 17, 25.
    • vincristine, IV push, days 1 and 8 of weeks 8, 17, and 25.
    • TIT, weeks 7, 10, 13, 16, 19, 22, 25
• 106 weeks maintenance, weeks 25-130
  • 2-drug combination systemic chemotherapy (6-MP and methotrexate) with 2-drug combination systemic chemotherapy pulses (prednisone and vincristine) plus TIT
    • methotrexate IM (leg shot) once weekly beginning week 25 and continuing to week 130 (half dose is given when TIT is given the same week)
    • 6-MP oral, daily, weeks 25-130. (Dose is increased by 50% week over the first 24 weeks of treatment.)
    • prednisone, oral, for 7 days weeks 41, 57, 73, 89, 105.
    • vincristine, IV, days 1 and 8, weeks 41, 57, 73, 89, 105.
    • TIT, weeks 37, 49, 61, 73, 85, 97, 109