A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06668584
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myeloid Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Olutasidenib — DRUG
    Given by mouth

Study Details

The goal of this clinical research study is to learn about the safety and tolerability of giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance therapy after they receive a stem cell transplant.

Key Dates

Start date
Dec 31, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Olutasidenib Maintenance Therapy
    Starting 30-120 days post-stem cell infusion, patients receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study. Additionally, patients may undergo bone marrow aspiration and biopsy, ECHO/MUGA scan and chest x-ray at screening.

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
Jeremy Ramdial, MD
[email protected]
713-745-0146
Jeremy Ramdial, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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