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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Fludarabine
Drug
Given by IV
Cytarabine
Drug
Given by IV
Idarubicin
Drug
Given by IV
Filgrastim
Drug
Given by injection
Venetoclax
Drug
Given by orally
Asciminib
Drug
Given orally
Blinatumomab
Drug
Given by IV

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Treatment with FLAG-Ida + Venetoclax + AsciminibExperimental treatment 6 interventions

Group B: Treatment with FLAG-Ida + Venetoclax + Asciminib + BlinatumomabExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0

Time frame

Through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: