Trial Design and Oversight

The Chinese Children’s Cancer Group study ALL-2015 (CCCG-ALL-2015) is a prospective, multi-institutional clinical trial involving 20 major hospitals and medical centers. The trial protocol is available in Supplement 1, and the statistical design is described in the eMethods and the eAppendix in Supplement 2. The study was approved by the ethics committee of each participating institution. Written informed consent was obtained from the parents, guardians, or patients, as appropriate. The conduct of the protocol included a central review of minimal residual disease (MRD), periodic internal and on-site monitoring, and external auditing to ensure protocol compliance and appropriate data management. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

Eligible patients were children aged 0 to 18 years with a confirmed diagnosis of ALL. All patients received MRD-directed, risk-stratified treatment, modified from the St Jude Children’s Research Hospital Total XV and XVI studies^19,20 and the Shanghai Children’s Medical Center ALL-2005 trial.²¹ CCCG-ALL-2015 consists of 2 open-label, randomized studies. One, which is still under way, tests the efficacy and toxic effects of prolonged pulse therapy with dexamethasone and vincristine sulfate, for which patients with Philadelphia chromosome–positive ALL were not eligible. The other randomized study, which is the subject of this report, compared the efficacy and toxic effects of imatinib vs dasatinib treatment in patients with the t(9;22)(q34:q11.2) translocation detected by conventional cytogenetics, fluorescence in situ hybridization, or BCR (OMIM 151410)–ABL1 fusion identified by reverse transcription polymerase chain reaction analysis. Patients, physicians, and the research staff were not aware of the trial results at any phase of the trial.