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Safe Integration of Nelarabine Into Intensive Chemotherapy in Newly Diagnosed T-cell Acute Lymphoblastic Leukemia: Children's Oncology Group Study AALL0434

Safe Integration of Nelarabine Into Intensive Chemotherapy in Newly Diagnosed T-cell Acute Lymphoblastic Leukemia: Children's Oncology Group Study AALL0434

Stuart S Winter, Kimberly P Dunsmore, Meenakshi Devidas, Nancy Eisenberg, Barbara L Asselin, Brent L Wood, Marcia S Leonard Rn, John Murphy, Julie M Gastier-Foster, Andrew J Carroll, Nyla A Heerema, Mignon L Loh, etc.

Pediatr Blood Cancer. 2015 Jul;62(7):1176-83.

PMID: 25755211

Abstract:

Background:
Nelarabine has shown impressive single agent clinical activity in T-cell acute lymphoblastic leukemia (T-ALL), but has been associated with significant neurotoxicities in heavily pre-treated patients. We showed previously that it was safe to add nelarabine to a BFM-86 chemotherapy backbone (AALL00P2). Children's Oncology Group (COG) AALL0434 is a Phase III study designed to test the safety and efficacy of nelarabine when incorporated into a COG augmented BFM-based regimen, which increases exposure to agents with potential neurotoxicity compared to the historical AALL00P2 regimen.
Procedure:
AALL0434 included a safety phase to assess nelarabine toxicity. Patients with high-risk (HR) T-ALL were randomized to receive Capizzi-style escalating methotrexate (MTX) plus pegaspargase or high dose (HD) MTX with/without six five-days courses of nelarabine. We report results from 94 patients who participated in the initial safety phase of the study.
Results:
There were no differences in the incidence of peripheral motor neuropathies, sensory neuropathies or central neurotoxicities among those randomized to the nelarabine (n = 47) and non-nelarabine arms (n = 47).
Conclusions:
The addition of nelarabine to COG-augmented BFM chemotherapy regimen is safe and feasible. The ongoing AALL0434 Efficacy Phase will determine whether the addition of nelarabine treatment improves outcome for patients with T-ALL.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP121032299	Nelarabine		121032-29-9	Price

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