Olutasidenib Single Agent as Maintenance Therapy in IDH1mut AML After Induction and Consolidation

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

Treatment with olutasidenib for isocitrate dehydrogenase 1 (IDH1) mutant acute myeloid leukemia (AML) after completion of traditional intensive induction/consolidation is likely to be safe, tolerable, and may provide clinical benefit in terms of maintenance of remission and perhaps improvement in survival.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Histologically or cytologically confirmed non-acute promyelocytic isocitrate dehydrogenase (1 IDH1) mutant acute myeloid leukemia (AML). IDH1 mutation may be identified by NGS or PCR based methods and identified at time of diagnosis or any other time point prior to enrollment.

• Completed induction and/or consolidation intended as per treating physician to reach complete response (CR),complete response with partial hematologic recovery (CRh), or complete response with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) at time of study enrollment Patients must be within 90 days of their last cycle of upfront therapy.

• Age ≥18 years

• Calculated creatinine clearance (by Cockroft-Gault) ≥30 mL/min

• Total bilirubin ≤2 × upper limit of normal (ULN) Note: patients with Gilbert's syndrome may be included if total bilirubin is ≤3 × ULN and direct bilirubin is ≤2 × ULN

• Serum aspartate aminotransferase/ alanine aminotransferase (AST/ALT) ≤3 × ULN

• Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2 or KPS \>50%

• Able to take oral medications

• Women of childbearing potential must consent to effective contraception during study treatment and at least 6 months following the last dose. Effective methods of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double- barrier methods. (ie, combination of male condom with either cap, diaphragm or sponge with spermicide)

• Male participants who are sexually active with a woman of childbearing potential and who have not had vasectomies must be willing to use a barrier method of contraception and refrain from sperm donation from initial study drug until 90 days after last dose of study drug.

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Massey IIT Research Operations
masseyepd@vcu.edu
804-628-6430
Time Frame
Start Date: 2026-02-02
Estimated Completion Date: 2030-10-31
Participants
Target number of participants: 15
Treatments
Experimental: Olutasidenib Investigational Agent Administration
150 mg by mouth twice daily.
Related Therapeutic Areas
Sponsors
Leads: Virginia Commonwealth University
Collaborators: Rigel Pharmaceuticals

This content was sourced from clinicaltrials.gov