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Olutasidenib with Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies

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Study Aim

This study explores if the drug Olutasidenib, when used with other treatments, is safe and effective for adults with certain types of relapsed or refractory blood cancers (myeloid malignancies) that have a specific genetic change (IDH1-mutation). The study will also assess any side effects.

What is being tested

Olutasidenib

+ Cladribine (CLAD)

+ Cytarabine

Drug
Who is being recruted

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Study ContactCourtney DiNardo, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 12, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to explore the safety and effectiveness of a new treatment combination for people with certain types of blood cancers that have returned or not responded to previous treatments. These cancers have a specific genetic change called an IDH1 mutation, along with other mutations that activate certain cellular pathways. The study evaluates combining a drug called olutasidenib with other treatments, such as cladribine, LDAC, venetoclax, gilteritinib, and ruxolitinib, in patients with these mutations. The goal is to improve remission rates and survival outcomes for these patients, addressing an urgent need for better treatment options. Participants in the study receive the treatment combinations via oral or injection methods, depending on the specific drug regimen. Researchers will closely monitor patients to assess the safety and any side effects of these treatment combinations. The study measures success through various outcomes, including the rate of complete remission, overall survival, and the duration of treatment response. Additionally, the study will look at how well the cancer is reduced to undetectable levels using advanced techniques. This trial is crucial for understanding how these new drug combinations can help people with challenging forms of blood cancer.

Official TitleOlutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations
NCT07032727
Principal SponsorM.D. Anderson Cancer Center
Study ContactCourtney DiNardo, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate
Age ≥ 18 years.

Adequate renal function with estimated GFR ≥ 30 by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).

Adequate hepatic function, defined as direct bilirubin ≤ 2x upper limit of normal (ULN) and AST and ALT ≤ 3x ULN unless the increase is due to Gilbert's disease or leukemic involvement, in which case direct bilirubin, AST, and ALT ≤ 5x ULN will be considered eligible.

Participants must also have a documented co-signaling mutation in one or more of the following: KRAS, NRAS, PTPN11, CBL, NF1, FLT3-ITD, FLT3-TKD, KIT, JAK2, MPL, CALR, CSF3R.

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12 exclusion criteria prevent from participating
Participants who have received prior olutasidenib (Rezlidhiai, previously FT-2102).

Participant has white blood cell count \>25 x 109/L (Note: Hydroxyurea and cytarabine are permitted to mean this criterion).

History of an allergic reaction to venetoclax, gilteritinib, ruxolitinib, cladribine, or cytarabine.

Participants with any uncontrolled psychiatric illness that would limit compliance with study requirements.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treatment with Olutasidenib + Cladribine + Cytarabine

Group II

Experimental
Treatment with Olutasidenib + Cladribine + Cytarabine + Venetoclax

Group III

Experimental
Treatment with Olutasidenib + Gilteritnib

Group IV

Experimental
Treatment with Olutasidenib + Gilteritnib + Venetoclax

Group 5

Experimental
Treatment with Olutasidenib + Ruxolitinib

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

MD Anderson Cancer Center

Houston, United StatesOpen MD Anderson Cancer Center in Google Maps
Recruiting
One Study Center