COG-AALL00P2

Phase II Pilot Study of Modified Multiagent Berlin-Frankfurt-Muenster-86 Chemotherapy With or Without Nelarabine in Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia.

or, Combination Chemotherapy in Treating Patients With Newly Diagnosed 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 cancer.gov site.


AALL00P2

This is a Phase II trial for T-cell ALL only. Phase II means that it is trying a new drug or drugs, and that said drug has already been tried in a Phase I trial to determine dosing. Phase II trials try the drug on more patients. This particular trial is for compound 506U78, also called Nelarabine, a precursor for Ara G (see a discussion of this drug in my Sea to Ara C article). Nelarabine has shown particular efficiacy against T-cell leukemias.

Previous trials using a BFM approach found that early prednisone reponse of T-cell patients has prognostic significance: a good response indicates a favorable EFS and a poor response indicates an unfavorable EFS. Thus, the trial singles out poor prednisone responders and puts them on the Nelarabine trial, while the good prednisone responders are given a standard of care protocol.

Prednisone Response Pre-Induction

All patients receive:

Good prednisone responders proceed to induction on regimen A. Poor prednisone responders proceed to induction on regimen C. Good response to prednisone means less than 1000 blasts per microliter of blood.

Regimen A (good prednisone responders)

Induction (weeks 1-5)

If bone marrow is M1, week 6 of induction therapy begins on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues. Those patients with minimal residual disease (MRD) on day 36 proceed to regimen B.

Induction (weeks 6-9)

Consolidation (weeks 10-19)

Reinduction (weeks 20-29)

Beginning on day 169 or when blood counts recover:

Maintenance (weeks 30-101)

Treatment repeats every 8 weeks for 9 courses.


Regimen B (patients with MRD on day 36 of regimen A)

(good prednisone responders who then show a slowish response to treatment)

Induction (weeks 1-9) (same as regimen A)

Consolidation (weeks 10-19)

Reinduction (weeks 20-29)

Beginning on day 169 or when blood counts recover:

Maintenance (weeks 30-101)

Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.


Regimen C (poor prednisone responders)

Induction (weeks 1-5)

Induction (weeks 1-5)

If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.

Induction (weeks 6-9) (same as regimen A)

Consolidation (weeks 10-19) (same as regimen A)

Reinduction (weeks 20-29) (same as regimen B)

Maintenance (weeks 30-101) (same as regimen B)

Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.


Regimen D

Induction (weeks 1-5)

If bone marrow is M1, week 6 of induction therapy begins on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.

Induction (weeks 6-9)

Patients who are poor responders to prednisone in induction therapy proceed to regimen F. Patients who are good responders to prednisone but have MRD after induction therapy proceed to regimen E. Patients who are good responders to prednisone and have no MRD after induction therapy continue therapy on regimen D.

Consolidation (weeks 10-19)

Patients must have M1 marrow to proceed.

Reinduction (weeks 20-29)

Patients less than 13 years old receive dexamethasone 3 times daily on days 140-161.

Patients greater than or equal to 13 years old receive oral dexamethasone on days 140-146 and 155-161.

Maintenance (weeks 30-61)

Treatment repeats every 8 weeks for 4 courses.

Maintenance (weeks 62-101)

Treatment repeats every 8 weeks for 5 courses.


Regimen E (good responders to induction prednisone but with MRD) (effective 5/2004):

Regimen F (poor responders to induction prednisone) (effective 5/2004):


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Last Updated 4/06

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