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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07604233
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Nov 30, 2026
Status verified
Jun 2026
Primary completion
Jun 3, 2031
Completion
Jun 3, 2033

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with FLAG-Ida + Venetoclax + Asciminib
  • Experimental: Treatment with FLAG-Ida + Venetoclax + Asciminib + Blinatumomab

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
Fadi Haddad, MD
[email protected]
346-234-4135
Fadi Haddad, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UT MD Anderson· Houston, TX

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