Phase III Comparison of Intensification with Intravenous MP plus Intermediate-Dose Intravenous MTX vs Low-Dose Oral MTX Following Induction with PRED/VCR/ASP in Children with Low-Risk ALL.

This trial on the cancer.gov site.

low-risk ALL, as defined by:

• age 1 to 10, no CNS disease, and WBC less than 10,000, or
• age 3 to 5, no CNS disease, and WBC 10,000-99,000
  
  or: without CNS disease and with a DNA index (St. Jude Reference Laboratory) greater than 1.16, with prognostic group B defined as:
  Age 11 or more, or
  WBC 10,000-99,000 and age 1-2 or 6-10, or
  WBC 100,000 or more, or
  CNS involvement
  

(more details on cancer.gov site)

Date initiated, # of patients: (revised 1992, used 1996)

POG 9005

• 4 Weeks Induction

????

• 24 weeks intensive continuation
  • 2-Drug combination systemic chemotherapy (methotrexate and 6-MP) with TITs throughout
    • weeks 1, 3, 5, 7, 9, 11, and so on to week 23
      • methotrexate IV, intermediate dose, with leucovorin rescue
      • 6-MP, IV

      (these are given on a two-day inpatient schedule)

    • weeks 2, 4, 6, 8, and so on to week 24
      • methotrexate IM
      • 6-MP, oral
    • weeks 1, 2, 3, 7, 13, 19, 25
      • TITs (methotrexate, hydrocortisone, ara C)
• 105 weeks continuation
  • two drug combination systemic chemotherapy (methotrexate and 6-MP) with TITs throughout
    • Methotrexate, IM, weekly
    • 6-MP, oral, daily
    • TIT, week 25, 37, 49, 61, 73, 85, 97, 109, 121

not given, but in 9201: pulses of another 2-drug combination (prednisone and vincristine)