NCT07032727

Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives 1. To determine the safety and tolerability of olutasidenib in combination with cladribine + LDAC ± venetoclax (Arm 1), gilteritinib ± venetoclax (Arm 2), and ruxolitinib (Arm 3) for patients with relapsed/refractory IDH1-mutated myeloid malignancies with a co-signaling mutation. 2. To quantify the composite complete remission rate (CRc; CR + CRh + CRi) in patients with relapsed/refractory IDH1-mutated myeloid malignancies with a co-signaling mutation treated with olutasidenib in combination with cladribine + LDAC ± venetoclax (Arm 1), gilteritinib ± venetoclax (Arm 2), and ruxolitinib (Arm3). Secondary Objectives 1. To determine overall survival (OS), event free survival (EFS), and duration of response (DOR) with olutasidenib in combination with a co-targeting chemotherapeutic agent. 2. To determine the overall response rate (ORR; CR + CRh + CRi + MLFS + PR) of olutasidenib in combination with a co-targeting chemotherapeutic agent. 3. To evaluate occurrence of measurable residual disease (MRD) negative status by multiparameter flow cytometry and molecular evaluation by polymerase chain reaction (PCR) and next generation sequencing (NGS)-based assays (e.g. IDH1 and FLT3 if applicable). 4. To characterize the pharmacokinetic (PK) profiles of olutasidenib and venetoclax in plasma samples.

Conditions

• Targeted Therapy
• IDH1-Mutated Malignancies
• Mutations

Interventions

Type	Name	Description
DRUG	Olutasidenib	Given by po
DRUG	Cladribine (CLAD)	Given by IV
DRUG	Venetoclax	Given by po
DRUG	Gilteritinib	Given by po
DRUG	Ruxolitinib	Given by po
DRUG	Cytarabine	Given SQ

Timeline

• Start date: 2025-09-12
• Primary completion: 2027-06-01
• Completion: 2029-06-01
• First posted: 2025-06-24
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study