Refractory Leukemia Clinical Trial
Official title:
Study for Safety and Efficacy Evaluation of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (R/R Ph + ALL）
This is an open-label, multicenter, phase 1b study, which is designed to explore the safety, efficacy and PK of olverembatinib, a third-generation tyrosine kinase inhibitor (TKI) marketed in China, in combination with APG-2575 in treating R/R Ph+ALL children, and to preliminarily establish the recommended dose of olverembatinib and APG-2575 for children based on the above results.
Eligible patients will receive a 6-week core treatment after screening, including a 2-week olverembatinib monotherapy and a 4-week combination therapy with olverembatinib, APG-2575 and dexamethasone, and based on the remission of leukemia after 2, 4, and 6 weeks of treatment, these patients will either continue olverembatinib alone/in combination with APG-2575 and dexamethasone as maintenance therapy or switch to other anti-tumor therapy. Toxicities of this study will be graded according to NCI CTCAT (Version 5.0). The investigator will interrupt, reduce or discontinue the dose of the investigational drug according to the correlation and grade of toxicities. The study drug can be resumed when the drug related toxicities resolve to grade 1 or below. ;
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