Recruiting

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

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Study AimThis 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, 2025Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf 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).

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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).
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.

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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

Given by po

Given by IV

Given SQ
Group II
Experimental
Treatment with Olutasidenib + Cladribine + Cytarabine + Venetoclax

Given by po

Given by IV

Given by po

Given SQ
Group III
Experimental
Treatment with Olutasidenib + Gilteritnib

Given by po

Given by po
Group IV
Experimental
Treatment with Olutasidenib + Gilteritnib + Venetoclax

Given by po

Given by po

Given by po
Group 5
Experimental
Treatment with Olutasidenib + Ruxolitinib

Given by po

Given by po
Study Objectives
Primary Objectives

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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 CenterHouston, United StatesSee the location
Recruiting
One Study Center
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