Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib

NCT06445959 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-20

No results posted yet for this study

Summary

To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.

Conditions

  • Mutant IDH1 Inhibitor Olutasidenib

Interventions

DRUG

Olutasidenib

Given by PO

DRUG

Venetoclax

Given by PO

DRUG

Decitabine

Given by IV

DRUG

Decitabine/cedazuridine

Given by PO

Sponsors & Collaborators

  • Rigel Pharmaceuticals,Inc.

    collaborator UNKNOWN
  • 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
2024-08-29
Primary Completion
2027-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06445959 on ClinicalTrials.gov