Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07304011
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given IV or SC
  • Olutasidenib — DRUG
    Given PO

Study Details

This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.

Key Dates

Start date
Dec 17, 2025
Status verified
Mar 2026
Primary completion
Jan 1, 2031
Completion
Jan 1, 2032

Study Design

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

Arms

  • Experimental: Treatment (olutasidenib, azacitidine)
    Patients receive olutasidenib PO BID on days 1-28 of each cycle and azacitidine IV or SC for seven days of each cycle as per schedule determined by investigator. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy and blood sample collection throughout the study.

Primary Outcome Measure

Treatment failure [ Time Frame: At 12 months from complete response (CR)/complete remission with incomplete count recovery (CRi) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Selina Laqui
[email protected]
916-734-0565
Brian Jonas, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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