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Acute Myeloid LeukemiaPhase 1NCT07130695

Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation

A Phase 1 study testing Olutasidenib Investigational Agent Administration in people with Acute Myeloid Leukemia, run by Virginia Commonwealth University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Treatment with olutasidenib for isocitrate dehydrogenase 1 (IDH1) mutant acute myeloid leukemia (AML) after completion of traditional intensive induction/consolidation is likely to be safe, tolerable, and may provide clinical benefit in terms of maintenance of remission and perhaps improvement in survival. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Olutasidenib Investigational Agent Administration
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
2 Feb 2026to 31 Oct 2030
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed non-acute promyelocytic isocitrate dehydrogenase (1 IDH1) mutant acute myeloid leukemia (AML). IDH1 mutation may be identified by NGS or PCR based methods and identified at time of diagnosis or any other time point prior to enrollment.
  • Completed induction and/or consolidation intended as per treating physician to reach complete response (CR),complete response with partial hematologic recovery (CRh), or complete response with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) at time of study enrollment Patients must be within 90 days of their last cycle of upfront therapy.
  • Age ≥18 years
  • Calculated creatinine clearance (by Cockroft-Gault) ≥30 mL/min
  • Total bilirubin ≤2 × upper limit of normal (ULN) Note: patients with Gilbert's syndrome may be included if total bilirubin is ≤3 × ULN and direct bilirubin is ≤2 × ULN
  • Serum aspartate aminotransferase/ alanine aminotransferase (AST/ALT) ≤3 × ULN
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  • Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2 or KPS >50%
  • Able to take oral medications
  • Women of childbearing potential must consent to effective contraception during study treatment and at least 6 months following the last dose. Effective methods of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double- barrier methods. (ie, combination of male condom with either cap, diaphragm or sponge with spermicide)
  • Male participants who are sexually active with a woman of childbearing potential and who have not had vasectomies must be willing to use a barrier method of contraception and refrain from sperm donation from initial study drug until 90 days after last dose of study drug.

Who cannot join

  • History of hypersensitivity or allergic reaction to olutasidenib or its components
  • Corrected Q-T interval (QTc) (Fredericia calculation) > 450 ms (after corrective action is taken)
  • History of Torsades de Pointes
  • Any gastrointestinal condition thought by the treating investigator to impair oral absorption of medication
  • Stem cell transplant eligible and planned within 60 days of study start date in the opinion of the treating investigator
  • Uncontrolled intercurrent illness or infection (those with controlled human immunodeficiency virus (HIV), hepatitis, or other chronic infections are eligible)
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  • Female participants who are pregnant or intend to donate eggs during the study or for 6 months after receiving their last dose of study drug
  • Nursing women, women of childbearing potential with positive pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. (Appropriate method(s) of contraception include oral or injectable hormonal birth control, IUD, and double-barrier methods)
  • Male participants who intend to donate sperm during the course of this study or for 3 months after last dose
  • Participants receiving, or are expected to require during the study, any concomitant medications that may interfere with efficacy, metabolism, or safety of the investigational agent, including drugs known to cause QT prolongation. for which drug interactions with olutasidenib would be prohibitory
  • Concurrent chemotherapy for non-AML malignancy that is expected to interfere with the efficacy, metabolism, or safety of the agent under investigation
  • Received non-intensive upfront therapy including hypomethylating agents (HMA) /Venetoclax based
  • Currently receiving other targeted therapies or AML directed therapies, including but not limited to other IDH1 or IDH2 inhibitors, FMS-like tyrosine kinase 3 (FLT3) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors, menin inhibitors
  • Other investigational agents in another clinical trial within 4 weeks prior to enrollment
  • Systemic corticosteroids above physiologic replacement doses (10mg/day prednisone or equivalent), unless used to tread IDH differentiation syndrome or as part of a pre-specified protocol exception
  • Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk or limit the participant's adherence with study requirements

About this study

Official title: Olutasidenib Single Agent as Maintenance Therapy in IDH1mut AML After Induction and Consolidation

Treatment with olutasidenib for isocitrate dehydrogenase 1 (IDH1) mutant acute myeloid leukemia (AML) after completion of traditional intensive induction/consolidation is likely to be safe, tolerable, and may provide clinical benefit in terms of maintenance of remission and perhaps improvement in survival.

Read the detailed description

Up to 15 participants will receive treatment with olutasidenib 150 mg by mouth twice daily for up to 2 years. Participants will be regularly monitored for toxicities, adverse events, quality of life (QOL), and disease status. Once off treatment, participants will continue to be followed for a maximum of 2 years from date of enrollment for survival endpoints

Being tested
Olutasidenib Investigational Agent Administration
Keywords
Acute Myeloid Leukemia
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olutasidenib Investigational Agent AdministrationDrug

    Twice daily olutasidenib maintenance therapy

Study groups in NCT07130695
Study groupRoleWhat they receive
Olutasidenib Investigational Agent AdministrationExperimental150 mg by mouth twice daily.
Receives: Drug: Olutasidenib Investigational Agent Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the feasibility of olutasidenib after upfront acute myeloid leukemia (AML) therapy with intensive induction and/or consolidation in IDH1 mutant AML.

    Feasibility defined as the number of participants with 75% protocol treatment compliance for a duration of at least 4 cycles (to include protocol defined dose delays), or until disease relapse or allogeneic hematopoietic stem cell transplant (alloHCT).

    Measured: Up to 2 years

  2. Assess the tolerability of olutasidenib after upfront AML therapy with intensive induction and/or consolidation in IDH1 mutant AML

    Incidence of grade ≥4 adverse events (AEs) attributable to study drug for duration of treatment on study

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Measure progression free survival

    Progression free survival (PFS), defined as the time from the date of the first dose of study treatment to the date of relapse or death

    Measured: Up to 2 years following end of treatment

  2. Estimate overall survival (OS)

    Overall survival defined as the time from the date of diagnosis to the date of death.

    Measured: Up to 2 years following end of treatment

  3. Assess mean residual disease (MRD) negativity rates by both PCR based and flow cytometric methodologies

    MRD status by multi-parameter flow cytometry at 10-5 sensitivity, by PCR based IDH1 sequencing assay, or by both methods of detection.

    Measured: Baseline, Cycle 3 Day 15, and End of Treatment (Each cycle is 28 days)

  4. Estimate rates of ability to proceed with transplant given maintenance opportunities.

    Incidence of study patients receiving allogeneic hematopoietic stem cell transplant (alloHCT) within 2 years of initiating olutasidenib maintenance therapy.

    Measured: Up to 2 years

  5. Characterize quality of life (QOL) metrics by SF 36

    Health-related quality of life (HRQOL) metrics as assessed by Short Form (SF-36), a 36-item, patient-reported survey that assesses health-related quality of life. This survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The RAND-36 Health Survey is scored by first recoding the answers to a 0-100 scale, with higher scores indicating better health. (https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html)

    Measured: Cycle 1Day 1, Cycle 2 Day 1, Cycle 4 day 1, and End of Treatment (EOT) (Each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start2 Feb 2026
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2030 (estimated)

Why it stopped: Budgetary constraints

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07130695
Sponsor's protocol ID
MCC-25-22096
Status last verified
Oct 2026
First submitted
7 Aug 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There are no current plans to share individual patient data (IPD).

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Olutasidenib Investigational Agent Administration in people with Acute Myeloid Leukemia, run by Virginia Commonwealth University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the feasibility of olutasidenib after upfront acute myeloid leukemia (AML) therapy with intensive induction and/or consolidation in IDH1 mutant AML. (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07130695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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