COG-AALL0434: Intensified Methotrexate Nelarabine (Compound 506U78; IND# 52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic
Brief description of study
Main Clinical Objectives: 1. To determine, through randomization, the relative safety and efficacy of the addition of Nelarabine (Compound 506U78) to augmented BFM therapy (Regimen C, CCG-1961). 2. To determine the relative safety and efficacy of high dose methotrexate (5 g/m2) with leucovorin rescue compared to escalating methotrexate without leucovorin rescue plus Pegaspargase (Capizzi I) delivered during Interim Maintenance. 3. To gain preliminary data on the use of Nelarabine in patients with High Risk T-cell lymphoblastic lymphoma and its effect on long-term survival.
Clinical Study Identifier: 07-169
ClinicalTrials.gov Identifier: NCT07-169
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