Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Timothy Pardee
Study ID
NCT07471841
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • IDH1 Mutation
  • Relapsed / Refractory AML

Eligibility Criteria

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

Interventions

  • Olutasidenib — DRUG
    Olutasidenib 150 mg orally twice a day
  • Azacitidine (AZA) — DRUG
    Azacitidine 75 mg/m2 subcutaneously or IV (over 10-40 minutes)

Study Details

This is a prospective, single-arm phase 2 pilot study to assess the response rate of IDH1 mutated relapsed/refractory acute myeloid leukemia (AML) patients who receive olutasidenib after progressing on venetoclax based regimens. Each cycle will last for 28 days. Patients will receive olutasidenib 150 mg orally twice daily Day 1 through Day 28. After 3 cycles of olutasidenib, azacitidine 75 mg/m2 given on Day 1 through Day 7 may be added at the discretion of the treating investigator if the patient has not achieved a complete remission. Subjects with at least a PR after 6 cycles of treatment will continue treatment as previously described. Subjects without at least a partial response (PR) after 6 cycles of treatment will move to long term follow up.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

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

Arms

  • Experimental: Olutasidenib and Azacitidine
    Each cycle will last for 28 days. Patients will receive olutasidenib 150 mg orally twice daily Day 1 through Day 28. After 3 cycles of olutasidenib, azacitidine 75 mg/m2 given on Day 1 through Day 7 may be added at the discretion of the treating investigator if the patient has not achieved a complete remission or for whom loss of response is suspected. Subjects with at least a PR after 6 cycles of treatment will continue treatment.. Subjects without at least a PR after 6 cycles of treatment will move to long term follow up.

Primary Outcome Measure

Composite complete remission rate [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Elizabeth Parke
[email protected]
980-442-2000
Timothy Pardee, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By research site
Atrium Health Wake Forest Baptist Medical Center· Winston-Salem, NC

Related Studies