POG 9906

Phase III Randomized Study of Multidrug Intensive Antimetabolite Therapy in Children With Newly Diagnosed High Risk Acute Lymphoblastic Leukemia.

Note: this outline was patched together from the NCI online protocol and input from parents of kids with ALL. It is summarized here for our convenience, so that we can quickly compare our protocols. We do not guarantee the accuracy of this outline - it is not an official document. You can contact your child's oncologist and ask for the complete protocol document if you are interested in the details of your child's protocol.

POG 9906 NCI PDQ (takes you to the cancer.gov site)


Treatment for high risk ALL, ages 1 to 21, defined as presenting features of:

must not have:

has one of the following:

Must not be very high risk:

Very High Risk is defined by one of the following, taking precedence over all other considerations:

M2 means the marrow has between 5% and 25% leukemic blasts.
M3 means there are more than 25% leukemic blasts.
M1 means less than 5% blasts and is the usual definition of a "remission"
marrow.

These Very High Risk, will be entered on a separate combined POG/CCG (COG) trial evaluating new chemotherapy and marrow transplant strategies.

Objectives

Lay translation: BFM is Berlin Frankfurt Muenster, and refers to the 1976/79 trial of acute lymphoblastic leukemia (ALL) in children which produced impressive disease-free survival rates with a protocol that began with 8 weeks of intensive therapy, followed by 8 weeks of maintenance therapy, and then another 6 weeks of intensive treatment (delayed intensification). "ALinc" is the code for POG protocols, 14 was 1986-1991. POG traditionally favored an "anti-metabolite" therapy (e.g., methotrexate) without the delayed intensification. CCG protocols traditionally follow BFM therapy.

Protocol Outline

This is a randomized study. Patients are stratified by CNS or testicular disease (yes vs no).

All patients receive induction therapy as per POG 9900. (weeks 1-5)

Induction

4-drug induction (vinc, asp, pred, daun) (please double check this outline on the COG or the cancer.gov site)

Consolidation (weeks 6-14)

Patients with M1 bone marrow proceed to consolidation therapy (below).

Patients achieving M2 bone marrow on day 29 receive oral prednisone three times daily on days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and asparaginase IM on days 29, 32, 36, and 39.

If bone marrow is M3 on day 29 or M2 on day 43, then patient is off study.

Patients then proceed to interim maintenance and delayed intensification on weeks 15-46. Courses repeat every 16 weeks.

Maintenance I and II (weeks 15-22 and 31-38): Patients receive:

Delayed Intensification (weeks 23-36 and 39-42): Patients receive:

Delayed Intensification-Reconsolidation (weeks 27-30 and 43-46): Patients receive:

Patients then proceed to continuation therapy on weeks 47-130. This consists of:

Patients with CNS 3 disease undergo whole brain radiotherapy (omit or discontinue mercaptopurine and IT methotrexate) on day 1. Testicular radiotherapy also begins on day 1.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

A total of 260 patients will be accrued for this study within 3.1 years.with this clinical trial should be consulted before using this protocol.

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Last Updated 4/06

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