M.D. Anderson Cancer Center
The goal of Phase 1b is to establish the safety of asciminib in combination with FLAG-Ida and venetoclax in patients with CML-MBP, CML-LBP, and Ph+ AML. The goal of Phase 2 is to learn if asciminib in combination with FLAG-Ida and venetoclax can help to control the disease.
Primary Objectives: Phase 1: To establish the safety of asciminib in combination with FLAG-Ida and venetoclax. Phase 2: To evaluate the efficacy and toxicity of asciminib in combination with FLAG-Ida and venetoclax. Primary Endpoints: Phase 1: Incidence of dose limiting toxicities (DLTs) during the first cycle of study treatment. Phase 2: Rate of complete response and rate of adverse events. Secondary Objectives: To assess the rates of conversion to CML-CP with this combination. To assess the cytogenetic and molecular response rates with this combination. To assess the survival outcomes…
Inclusion Criteria: * Age 18 to 70 years. Because no dosing or adverse event data are currently available on the use of the combination of FLAG-Ida with venetoclax and asciminib in patients \<18 years of age, children are excluded from this study. * Newly diagnosed or relapsed/refractory: * BCR::ABL1-rearranged CML in myeloid BP or Philadelphia chromosomepositive or BCR::ABL1-rearranged AML as defined by the WHO 2022 criteria23 * BCR::ABL1-rearranged CML in lymphoid BP. * ECOG performance status ≤ 2. * Adequate liver, cardiac, renal and pancreatic function as defined by the following cri…
Given by IV
Given by IV
Given by IV
Given by injection
Given by orally
Given orally
Given by IV
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