Clinical Trials

Overview

About this study

AALL0232 is a COG group-wide phase III study designed for NCI high risk patients with acute lymphoblastic leukemia (ALL) from 1-30 years of age. Although event free survival and overall survival continue to increase for children with high risk ALL, CNS disease has become an increasing cause of treatment failure. There is evidence that both dexamethasone and high dose methotrexate prevent CNS relapse. To specifically address the relative increase in CNS events this study will test safety and efficacy of these two therapeutic interventions. The study utilizes a 2 x 2 factorial design with an augmented intensity BFM backbone. Patients will be randomized upfront to receive high dose methotrexate (5 gm/m 2 ) versus Capizzi escalating methotrexate during Interim Maintenance I. A second randomization will compare dexamethasone 10 mg/m2 /day for 14 days versus prednisone 60 mg/m2 /day for 28 days during Induction. Based upon an increased rate of osteonecrosis (ON) observed in patients 10+ years of age randomized to receive dexamethasone during Induction, Amendment #5 restricts the Induction steroid randomization to patients 1-9 years of age, with older patients non-randomly assigned to prednisone during Induction therapy. Patients classified as rapid early responders (RER) will receive one Delayed Intensification course and those classified as slow early responders (SER) will receive two Delayed Intensification courses.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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