Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML
ConditionMyeloid Leukemia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
Patients who are receiving any other investigational agents used for the treatment of other cancers.
Patients who have progressed on asciminib and/or a combination of intensive chemotherapy plus venetoclax. Patients with prior treatment with a hypomethylating agent and venetoclax will be eligible.
Active grade III-V cardiac failure as defined by the New York Heart Association Criteria.
Myocardial infarction, unstable angina, or stroke within 3 months prior to signing informed consent.
Trial design
Treatments tested in this trial
- Fludarabine
- Cytarabine
- Idarubicin
- Filgrastim
- Venetoclax
- Asciminib
- Blinatumomab
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov