AALL1631: International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Ph+ ALL Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones

Brief description of study

The goal of this trial is to reduce treatmentrelated morbidity and mortality without adversely impacting disease free survival (DFS) in Standard Risk (SR) patients, who comprise approximately 80-85% of all pediatric Ph+ ALL patients. The proposed AALL1631 trial will test whether favorable outcomes may be achieved when imatinib is combined with a less intensive chemotherapy backbone in pediatric Ph+ ALL patients defined as SR based on MRD measurements early in treatment. We plan to randomly compare the two cytotoxic backbones using a non-inferiority design in order to detect whether there is a lack of significant decrement in DFS with the less intensive chemotherapy regimen. The randomized trial design will also allow us to directly compare toxicities associated with the two regimens.


Clinical Study Identifier: s19-00723
ClinicalTrials.gov Identifier: NCT03007147
Principal Investigator: Sharon L Gardner.


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