Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07411586
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ziftomenib — DRUG
    Given by mouth
  • Olutasidenib — DRUG
    Given by mouth

Study Details

The goal of Phase 1 is to find the recommended dose of ziftomenib and olutasidenib in patients with relapsed/refractory AML that has a mutation in the NPM1 and IDH1 genes. The goal of Phase 1b is to learn if the recommended dose of ziftomenib and olutasidenib found in Phase 1 can help to control the disease. The safety and effects of this combination will also be studied in both parts.

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Jan 14, 2027
Completion
Jan 14, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Escalation and Phase 1b Expansion: Treatment with Ziftomenib + Olutasidenib
    Adult participants with relapsed/refractory NPM1m/ IDH1m AML will be enrolled. Treatment will consist of 28-day cycles of ziftomenib and olutasidenib given concomitantly. All participants will receive olutasidenib 150 mg orally twice daily (total 300 mg dose per day).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Courtney DiNardo, MD
[email protected]
713-794-1141
Courtney DiNardo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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