Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations
NCT07032727 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2026-04-15
Summary
To learn about the safety and tolerability of study drug combinations in patients with relapsed/refractory, IDH1-mutated myeloid malignancies with a co-signaling mutation.
Conditions
- Targeted Therapy
- IDH1-Mutated Malignancies
- Mutations
Interventions
- DRUG
-
Olutasidenib
Given by po
- DRUG
-
Cladribine (CLAD)
Given by IV
- DRUG
-
Given by po
- DRUG
-
Gilteritinib
Given by po
- DRUG
-
Given by po
- DRUG
-
Given SQ
Sponsors & Collaborators
-
Rigel Pharmaceuticals
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Courtney DiNardo, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-12
- Primary Completion
- 2027-06-01
- Completion
- 2029-06-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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