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Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML

NCT07604233 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Myeloid Leukemia

Interventions

DRUG

Fludarabine

Given by IV

DRUG

Cytarabine

Given by IV

DRUG

Idarubicin

Given by IV

DRUG

Filgrastim

Given by injection

DRUG

Venetoclax

Given by orally

DRUG

Asciminib

Given orally

DRUG

Blinatumomab

Given by IV

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Fadi Haddad, MD · UT MD Anderson

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2031-06-03
Completion
2033-06-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604233 on ClinicalTrials.gov