POG 9605

an ALinC #16 study

Phase III Randomized Study of Delayed Intensification With Twice Weekly Oral Methotrexate (MTX) Versus Standard Weekly Intramuscular MTX and of Twice Daily Versus Standard Daily Mercaptopurine (MP) During Delayed Intensification and Continuation Therapy in Children With Standard Risk Acute Lymphocytic Leukemia: An ALinC #16 Study.

This trial on the cancer.gov site.

Treatment for standard risk pre-B and B-cell ALL, risk defined as:

And one of the following groups of characteristics:

note: this means that DNA index greater than 1.16 and trisomies 4 and 10 are good, older kids with them can go on the standard risk along with the younger kids that do not have them. They also override WBC greater than 50,000.

Objectives

Determine whether the addition of delayed intensification therapy with divided dose oral methotrexate (MTX) improves event free survival in children with newly diagnosed standard risk acute lymphoblastic leukemia.

Compare the effect of delivering oral mercaptopurine (MP) on a twice daily vs once daily schedule during delayed intensification and continuation therapy on event free survival of these patients.

Date initiated, # of patients: 905 patients over 2.7 years; is current 12/97, started??

Protocol Chair: Beverly Ann Bell, 404-727-4451

Specific Aims:

Also:

4 arms of treatment:

POG 9605

 


Notes:

"Trisomies 4 and 10" means that the leukemic cells have 3 copies each (instead of the usual 2) of the chromosomes numbers 4 and 10 (normally there are 23 pairs of chromosomes = 46 total). For more information on this, see the journal Blood, 1992, Jun 15;79 (12):3316-3324 "Trisomy of leukemic cell chromosomes 4 and 10 identifies children with B-progenitor cell acute lymphoblastic leukemia with a very low risk of treatment failure: a Pediatric Oncology Group study." Harris MB, Shuster JJ, Carroll A, Look AT, Borowitz MJ, Crist WM, Nitschke R, Pullen J, Steuber CP, Land VJ.

DNA index greater than 1.16 is "hyperploidy", meaning there are more than 46 chromosomes in the leukemic clones, which is considered a good prognostic indicator.

Comments:

No anthracyclines! No cytoxin! Even the low risk CCG protocols use these.

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Last Updated 4/06

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