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New drug cocktail aims to tackle tough leukemia

NCT ID NCT05735184

Disease control Sponsor: Kura Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called ziftomenib alongside standard treatments for acute myeloid leukemia (AML) in people with specific gene mutations. About 420 participants with newly diagnosed or relapsed AML will be assigned to one of three treatment arms. The main goals are to check safety and see if the combination helps achieve remission.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ziftomenib (investigational drug) combined with standard AML drugs (venetoclax, azacitidine, cytarabine, daunorubicin, quizartinib)
What this could lead to
If successful, this could point toward a new treatment option for acute myeloid leukemia patients with certain genetic changes.
What could go wrong
This is an early Phase 1 trial, so safety and dosing are still being tested. It may not work as hoped, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML * Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Adequate liver, renal, and cardiac function according to protocol defined criteria * A female of childbearing potential must agree to use adequate contraception as well as a double barrier method from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or use a double barrier method of contraception from the time of screening through 180 days following the last dose of study intervention * Female patients of childbearing potential who receive quizartinib in Arm C should use a highly effective method of contraception during quizartinib treatment and for 7 months after the last dose Key Exclusion Criteria: * Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia * Known history of BCR-ABL alteration * Advanced malignant hepatic tumor * Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery * Active central nervous system (CNS) involvement by AML. * Clinical signs/symptoms of leukostasis or WBC \> 25,000 / microliter. Hydroxyurea and/or leukapheresis and/or up to 2 doses of cytarabine if used per institutional SOC for control of leukocytosis are permitted to meet this criterion * Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia * Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection * For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and/or leukapheresis and/or up to 2 doses of cytarabine per institutional standards to control leukocytosis, or prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia * For relapsed/refractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \< 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug * Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol * Mean QT interval corrected for heart rate by Fredericia's formula (QTcF) * Arm A and Arm B: \>480 ms on triplicate ECGs * Arm C: \>450 ms on triplicate ECGs * Uncontrolled infection * Women who are pregnant or lactating * An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing * Patients who have active GVHD requiring \>0.5 mg/kg prednisone or any new or increase in immunosuppressants in the prior 2 weeks for GVHD treatment

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with mutated NPM1 acute myeloid leukemia, MLL gene rearrangement early-onset generalized dystonia hematopoietic and lymphoid system neoplasm leukemia myeloid sarcoma refractory hematologic cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Acute myeloid leukemia recurrent Acute myeloid leukemia, in relapse AML with mutated NPM1 KMT2AR Mixed lineage leukemia gene mutation Myeloid sarcoma NPM1 mutation Nucleophosmin 1-mutated acute myeloid leukemia Refractory AML

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    44 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Cleveland Clinic Taussig Cancer Institute

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Duke Blood Cancer Center

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Emory Healthcare - The Emory Clinic

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Georgia Cancer Center at Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Johns Hopkins School of Medicine

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 60153, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Phoenix

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin Cancer Center

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Moores UC San Diego Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • Mount Sinai - Ruttenberg Treatment Center

    RECRUITING

    New York, New York, 10029, United States

  • New York - Presbyterian / Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

  • Norton Cancer Institute - St. Matthews

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • OU Health Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Ochsner MD Anderson Cancer Center

    RECRUITING

    Jefferson, Louisiana, 70121, United States

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • Rutgers Cancer Institute

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South Austin

    RECRUITING

    Austin, Texas, 78704, United States

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • The James Cancer Hospital and Solove Research Institute

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Kansas Medical Center Research Institute

    RECRUITING

    Fairway, Kansas, 66205, United States

  • TriStar Bone Marrow Transplant

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • UC Irvine Health Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • UCLA - Bowyer Oncology Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UMass Chan Medical School

    RECRUITING

    Worcester, Massachusetts, 01655, United States

    Contact Email: •••••@•••••

  • USC / Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT Southwestern - Simmons Cancer Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospitals & Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kentucky Markey Cancer Center

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Michigan Comprehensive Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Wisconsin Hospital and Clinics

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Yale Cancer Center and Smilow Cancer Hospital

    RECRUITING

    New Haven, Connecticut, 06510, United States

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Other studies related to the condition(s) this trial covers.