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A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

Sponsor: Kura Oncology, Inc. · NCT05735184 on ClinicalTrials.gov ↗

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Conditions studied

Acute Myeloid LeukemiaMixed Lineage Leukemia Gene MutationRefractory AMLAML With Mutated NPM1Acute Myeloid Leukemia RecurrentAcute Myeloid Leukemia, in RelapseNPM1 MutationKMT2ArMyeloid SarcomaNucleophosmin 1-mutated Acute Myeloid Leukemia

What it tests

  • Ziftomenibdrug
  • Venetoclaxdrug
  • Azacitidinedrug
  • Daunorubicindrug
  • Cytarabinedrug
  • Quizartinibdrug

Where it's running44 sites

  • Mayo Clinic - Phoenix

    Phoenix, Arizona 85054

    Recruiting now

  • Moores UC San Diego Cancer Center

    La Jolla, California 92093

    Recruiting now

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California 90033

    Recruiting now

  • UCLA - Bowyer Oncology Center

    Los Angeles, California 90095

    Recruiting now

  • UC Irvine Health Chao Family Comprehensive Cancer Center

    Orange, California 92868

    Recruiting now

  • University of Colorado

    Aurora, Colorado 80045

    Recruiting now

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218

    Recruiting now

  • Yale Cancer Center and Smilow Cancer Hospital

    New Haven, Connecticut 06510

    Recruiting now

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224

    Recruiting now

  • Emory Healthcare - The Emory Clinic

    Atlanta, Georgia 30308

    Recruiting now

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia 30912

    Recruiting now

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois 60611

    Recruiting now

  • Loyola University Medical Center

    Maywood, Illinois 60153

    Recruiting now

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242

    Recruiting now

  • The University of Kansas Medical Center Research Institute

    Fairway, Kansas 66205

    Recruiting now

  • University of Kentucky Markey Cancer Center

    Louisville, Kentucky 40202

    Recruiting now

  • Norton Cancer Institute - St. Matthews

    Louisville, Kentucky 40207

    Recruiting now

  • Ochsner MD Anderson Cancer Center

    Jefferson, Louisiana 70121

    Recruiting now

  • Johns Hopkins School of Medicine

    Baltimore, Maryland 21205

    Recruiting now

  • Massachusetts General Hospital

    Boston, Massachusetts 02114

    Recruiting now

  • UMass Chan Medical School

    Worcester, Massachusetts 01655

    Recruiting now

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109

    Recruiting now

  • Karmanos Cancer Institute

    Detroit, Michigan 48201

    Recruiting now

  • University of Minnesota

    Minneapolis, Minnesota 55455

    Recruiting now

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905

    Recruiting now

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601

    Recruiting now

  • Rutgers Cancer Institute

    New Brunswick, New Jersey 08903

    Recruiting now

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203

    Recruiting now

  • New York - Presbyterian / Weill Cornell Medicine

    New York, New York 10021

    Recruiting now

  • Mount Sinai - Ruttenberg Treatment Center

    New York, New York 10029

    Recruiting now

  • Columbia University Medical Center

    New York, New York 10032

    Recruiting now

  • Stony Brook University Hospital

    Stony Brook, New York 11794

    Recruiting now

  • Duke Blood Cancer Center

    Durham, North Carolina 27705

    Recruiting now

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106

    Recruiting now

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohio 44195

    Recruiting now

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio 43210

    Recruiting now

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104

    Recruiting now

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104

    Recruiting now

  • TriStar Bone Marrow Transplant

    Nashville, Tennessee 37203

    Recruiting now

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

    Austin, Texas 78704

    Recruiting now

  • UT Southwestern - Simmons Cancer Center

    Dallas, Texas 75235

    Recruiting now

  • MD Anderson Cancer Center

    Houston, Texas 77030

    Recruiting now

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53792

    Recruiting now

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin 53226

    Recruiting now
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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

Updated 2026-03-13 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.