Recruiting

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

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: December 16, 2025

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: December 16, 2025

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

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.

Age ≥ 18 years.

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.

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

Show More Criteria

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).

The effects of the study drug on the developing human fetus or transmission through breast feeding are unknown. Therefore, nursing women and women with a positive urine pregnancy test and excluded. Additionally, women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP who are not willing to maintain adequate contraception are excluded. a. WOCBP includes all female participants between the onset of menses (as early as 8 years of age) to 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). iv. History of bilateral tubal ligation or another surgical sterilization procedure. b. Approved methods of birth control are as follows: hormonal contraception (i.e. birth control pills, injection, transdermal patch, vaginal ring, hormonal implant), intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post-vasectomy, double barrier methods (e.g. condom in combination with spermicide). Abstinence for the duration of the trial and drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. c. Adequate contraception must be maintained from initiation of the study drug until 90 days after the last dose of the study drug.

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

Show More Criteria

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 StatesSee the location

Recruiting

One Study Center