Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07032727

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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-15

68

Participants Needed

1

Research Sites

194 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

R

Rigel Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of relapsed or refractory acute myeloid leukemia (including biphenotypic or bilineage leukemia with a myeloid component) OR high-risk myelodysplastic syndrome, myeloproliferative neoplasm, or MDS/MPN with at least 10% blasts
  • Documented mutation in the IDH1 gene
  • Documented co-signaling mutation in one or more of the following genes: KRAS, NRAS, PTPN11, CBL, NF1, FLT3-ITD, FLT3-TKD, KIT, JAK2, MPL, CALR, CSF3R
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Adequate kidney function with estimated GFR of 30 or higher
  • Adequate liver function with direct bilirubin 2 times or less the upper limit of normal and AST and ALT 3 times or less the upper limit of normal, except up to 5 times allowed for Gilbert's disease or leukemic involvement
  • At least 14 days or five half-lives since prior treatment for cytotoxic or non-cytotoxic therapy
  • Oral hydroxyurea and/or cytarabine allowed before and during first two cycles for rapid disease
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Prior treatment with olutasidenib
  • Diagnosis of acute promyelocytic leukemia with t(15;17) translocation
  • Uncontrolled significant medical conditions or life-threatening infections
  • Uncontrolled psychiatric illness limiting study compliance
  • New York Heart Association functional class III or IV heart failure
  • Active graft-versus-host disease post stem cell transplant, except controlled skin GVHD after discussion with investigator
  • Active uncontrolled central nervous system leukemia
  • Severe gastrointestinal or metabolic conditions affecting oral drug absorption
  • Active hepatitis B, hepatitis C, or HIV infections unless viral load is undetectable
  • White blood cell count greater than 25 x 10^9/L unless treated with hydroxyurea or cytarabine
  • Nursing women or positive pregnancy test
  • Women of child-bearing potential and men sexually active with such partners unwilling to use adequate contraception
  • History of allergic reaction to venetoclax, gilteritinib, ruxolitinib, cladribine, or cytarabine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

Loading map...

Research Team

C

Courtney DiNardo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

5

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here