Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

Full Title: Phase III Partially Randomized Study of Risk-Adapted Chemotherapy in Pediatric Patients With Newly Diagnosed Standard-Risk B-Precursor 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.

This trial on the site. (Excellent summary.)

This trial is designed to determine if maintenance therapy for AR patients is best at an oral dosing of methotrexate is best at 40 mg/m2/week or 20 mg/m2/week, and if vincristine/dexamethasone pulses can be dropped from once a month to once every 3 months.

LR patients are treated with either a P9904-based regimen of 6 courses of intermediate dose IV methotrexate (no cyclophosphamide or anthracyclines) OR an out-patient regimen similar to that of the AR patients with reduced vincristine sulfate/dexamethasone pulses at 12-week intervals during maintenance.

Provides a separate treatment arm for standard risk Down syndrome patients. This is not outlined below, please see the site.

This trial is for treatment of newly diagnosed standard risk ALL patients. "Standard risk" is by NCI definitions, meaning as below. Since any child who is 10 years or older is NCI-HR (high risk), this trial is only for patients under the age of 10. Since at the trial's activation date the new trial for high risk patients is not yet open, patients who begin on this plan but are determined to be high risk at the end of induction will go to COG1131.)

NCI definitions of standard risk (NCI-SR) or high risk (NCI-HR):

Classification of newly diagnosed leukemia

Definitive risk assignment comes after day 29:

T-cell and infant ALL are treated on separate trials. Downs Syndrome patients go to a specific arm. (I am not including this DS arm here.)

CNS 2 patients are in average risk subset. CNS 3 goes to HR protocol.

The description of this trial on the NCI ( website is excellent, better than the summary below. I strongly recommend you visit that site via this link: site.

Induction, 35 days

This induction therapy is essentially the same as that of CCG 1991. (Same induction for low-, average-, and high-risk arms. DS patients are treated separately.)

All patients receive:

Day 8: peripheral blood sample taken for MRD sample taken (PB-MRD)

Day 29: bone marrow sample taken for MRD sample taken (BM-MRD)

AR (average risk) patients and LR patients randomized to arm LR-C

Consolidation (28 days), begins Day 36

Interim Maintenance (56 das)

Delayed Intensification (56 days)

Interim maintenance II (56 days)

Maintenance has 4 arms: A, B, C, D

arm A:

arm B:

arm C:

arm D:

LR patients randomized to arm LR-M

Arm I

Consolidation (19 weeks), begins Day 36

Maintenance (16 week cycles for 2 1/2 years from date of dx for both boys and girls)

Arm II (this is the same as for AR patients, up to maintenance)

Consolidation (4 weeks), begins Day 36

Interim maintenance

delayed intensifictaion

interim maintenance



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Last Updated 4/06

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