Phase Ib/II of the Combination of Fludarabine, Cytarabine, Idarubicin, G-CSF (FLAG-Ida) With Venetoclax and Asciminib in Patients With Advanced Phase Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
M.D. Anderson Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugFludarabine
Given by IV
- DrugCytarabine
Given by IV
- DrugIdarubicin
Given by IV
- DrugFilgrastim
Given by injection
- DrugVenetoclax
Given by orally
- DrugAsciminib
Given orally
- DrugBlinatumomab
Given by IV
Location
- UT MD AndersonHouston, Texas