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

March 11, 2026 updated by: Kura Oncology, Inc.

Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.

This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.

The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic - Phoenix
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
    • California
      • La Jolla, California, United States, 92093
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
      • Los Angeles, California, United States, 90095
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health Chao Family Comprehensive Cancer Center
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
      • Denver, Colorado, United States, 80218
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center and Smilow Cancer Hospital
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgia Cancer Center at Augusta University
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
        • Contact:
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • S. Tsai
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Medical Center Research Institute
        • Contact:
    • Kentucky
    • Louisiana
      • Jefferson, Louisiana, United States, 70121
        • Recruiting
        • Ochsner MD Anderson Cancer Center
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins School of Medicine
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
      • New Brunswick, New Jersey, United States, 08903
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Roswell Park Comprehensive Cancer Center
        • Contact:
      • New York, New York, United States, 10032
      • New York, New York, United States, 10021
        • Recruiting
        • New York - Presbyterian / Weill Cornell Medicine
        • Contact:
      • New York, New York, United States, 10029
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Durham, North Carolina, United States, 27705
    • Ohio
      • Cleveland, Ohio, United States, 44106
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Taussig Cancer Institute
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The James Cancer Hospital and Solove Research Institute
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • TriStar Bone Marrow Transplant
        • Contact:
          • Ask Sarah
          • Phone Number: 844-482-4812
    • Texas
      • Austin, Texas, United States, 78704
        • Recruiting
        • Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South Austin
        • Contact:
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin Cancer Center
        • Contact:
          • Medical College of WI Cancer Center Clinical Trials Office
          • Phone Number: 414-805-8900
          • Email: cccto@mcw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation: Ziftomenib with Venetoclax and Azacitidine in R/R NPM1-m (A-1)
Ziftomenib with Venetoclax and Azacitidine in relapsed/refractory NPM1-m AML patients who have failed at least one prior line of therapy
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Venetoclax
Oral Administration
Other Names:
  • Venclexta
  • Venclyxto
Drug: Azacitidine
Subcutaneous or Intravenous Administration
Other Names:
  • Vidaza
  • Azadine
Experimental: Dose Validation/Expansion: Ziftomenib with Venetoclax and Azacitidine in R/R NPM1-m (A-1)
Ziftomenib with Venetoclax and Azacitidine in relapsed/refractory NPM1-m AML patients who have failed at least one prior line of therapy
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Venetoclax
Oral Administration
Other Names:
  • Venclexta
  • Venclyxto
Drug: Azacitidine
Subcutaneous or Intravenous Administration
Other Names:
  • Vidaza
  • Azadine
Experimental: Dose Escalation: Ziftomenib with 7+3 in 1L NPM1-m/FLT3 wildtype (A-2)
Ziftomenib with 7+3 in newly diagnosed NPM1-m AML patients who are candidates for intensive chemotherapy and must be FLT3 wildtype or ITD ratio <0.05
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Daunorubicin
Intravenous Administration
Other Names:
  • Cerubidine
  • daunomycin
Drug: Cytarabine
Intravenous Administration
Other Names:
  • Cytosar-U
  • Tarabine PFS
  • cytosine arabinoside (ara-C)
Experimental: Dose Validation/Expansion: Ziftomenib with 7+3 in 1L NPM1-m/FLT3 wildtype (A-2)
Ziftomenib with 7+3 in newly diagnosed NPM1-m AML patients who are candidates for intensive chemotherapy and must be FLT3 wildtype or ITD ratio <0.05
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Daunorubicin
Intravenous Administration
Other Names:
  • Cerubidine
  • daunomycin
Drug: Cytarabine
Intravenous Administration
Other Names:
  • Cytosar-U
  • Tarabine PFS
  • cytosine arabinoside (ara-C)
Experimental: Dose Validation/Expansion: Ziftomenib with Venetoclax in R/R NPM1-m (A-3)
Ziftomenib with Venetoclax in relapsed/refractory NPM1-m AML patients who have failed at least one prior line of therapy
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Venetoclax
Oral Administration
Other Names:
  • Venclexta
  • Venclyxto
Experimental: Dose Validation/Expansion: Ziftomenib with Venetoclax and Azacitidine in 1L NPM1-m (A-4)
Ziftomenib with Venetoclax and Azacitidine in newly diagnosed NPM1-m AML patients
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Venetoclax
Oral Administration
Other Names:
  • Venclexta
  • Venclyxto
Drug: Azacitidine
Subcutaneous or Intravenous Administration
Other Names:
  • Vidaza
  • Azadine
Experimental: Dose Escalation: Ziftomenib with Venetoclax and Azacitidine in R/R KMT2A-r (B-1)
Ziftomenib with Venetoclax and Azacitidine in relapsed/refractory KMT2A-r AML patients who have failed at least one prior line of therapy
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Venetoclax
Oral Administration
Other Names:
  • Venclexta
  • Venclyxto
Drug: Azacitidine
Subcutaneous or Intravenous Administration
Other Names:
  • Vidaza
  • Azadine
Experimental: Dose Validation/Expansion: Ziftomenib with Venetoclax and Azacitidine in R/R KMT2A-r (B-1)
Ziftomenib with Venetoclax and Azacitidine in relapsed/refractory KMT2A-r AML patients who have failed at least one prior line of therapy
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Venetoclax
Oral Administration
Other Names:
  • Venclexta
  • Venclyxto
Drug: Azacitidine
Subcutaneous or Intravenous Administration
Other Names:
  • Vidaza
  • Azadine
Experimental: Dose Escalation: Ziftomenib with 7+3 in 1L KMT2A-r (B-2)
Ziftomenib with 7+3 in newly diagnosed KMT2A-r AML patients who are candidates for intensive chemotherapy
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Daunorubicin
Intravenous Administration
Other Names:
  • Cerubidine
  • daunomycin
Drug: Cytarabine
Intravenous Administration
Other Names:
  • Cytosar-U
  • Tarabine PFS
  • cytosine arabinoside (ara-C)
Experimental: Dose Validation/Expansion: Ziftomenib with 7+3 in 1L KMT2A-r (B-2)
Ziftomenib with 7+3 in newly diagnosed KMT2A-r AML patients who are candidates for intensive therapy
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Daunorubicin
Intravenous Administration
Other Names:
  • Cerubidine
  • daunomycin
Drug: Cytarabine
Intravenous Administration
Other Names:
  • Cytosar-U
  • Tarabine PFS
  • cytosine arabinoside (ara-C)
Experimental: Dose Validation/Expansion: Ziftomenib with Venetoclax + Azacitidine in 1L KMT2A-r (B-3)
Ziftomenib with Venetoclax and Azacitidine in newly diagnosed KMT2A-r AML patients
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Venetoclax
Oral Administration
Other Names:
  • Venclexta
  • Venclyxto
Drug: Azacitidine
Subcutaneous or Intravenous Administration
Other Names:
  • Vidaza
  • Azadine
Experimental: Dose Escalation: Ziftomenib with 7+3+quizartinib in 1L NPM1-m/FLT3-ITD+ AML patients (C-1)
Ziftomenib with 7+3 and quizartinib in newly diagnosed NPM1-m and FLT3-ITD+ (with allelic ratio ≥0.05) AML patients who are candidates for IC and eligible to receive FLT3-targeted therapy
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Daunorubicin
Intravenous Administration
Other Names:
  • Cerubidine
  • daunomycin
Drug: Cytarabine
Intravenous Administration
Other Names:
  • Cytosar-U
  • Tarabine PFS
  • cytosine arabinoside (ara-C)
Drug: Quizartinib
Oral Administration
Other Names:
  • Vanflyta
Experimental: Dose Validation/Expansion: Ziftomenib with 7+3+quizartinib in 1L NPM1-m/FLT3-ITD+ AML patients (C-1)
Ziftomenib with 7+3 and quizartinib in newly diagnosed NPM1-m and FLT3-ITD+ (with allelic ratio ≥0.05) AML patients who are candidates for IC and eligible to receive FLT3-targeted therapy
Drug: Ziftomenib
Oral Administration
Other Names:
  • KO-539
Drug: Daunorubicin
Intravenous Administration
Other Names:
  • Cerubidine
  • daunomycin
Drug: Cytarabine
Intravenous Administration
Other Names:
  • Cytosar-U
  • Tarabine PFS
  • cytosine arabinoside (ara-C)
Drug: Quizartinib
Oral Administration
Other Names:
  • Vanflyta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of dose limiting toxicities (DLTs) per dose level (Part 1a only)
Time Frame: During the first 28 days of ziftomenib in combination with SOC backbone treatment (1 cycle)
Assessed by the NCI-CTCAE v5.0
During the first 28 days of ziftomenib in combination with SOC backbone treatment (1 cycle)
Descriptive statistics of adverse events
Time Frame: From Cycle 1 Day 1 up to and including 28 days following the end of 36 months of treatment
Assessed by the NCI-CTCAE v5.0
From Cycle 1 Day 1 up to and including 28 days following the end of 36 months of treatment
Complete remission (CR) rate
Time Frame: Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first
Assessed by the ELN 2022 criteria
Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Complete Remission (CRc)
Time Frame: Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first
Assessed by the ELN 2022 criteria
Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first
Morphologic leukemia-free state (MLFS) rate
Time Frame: Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever comes first
Assessed by the ELN 2022 criteria
Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever comes first
Measurable residual disease (MRD)
Time Frame: Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first
Assessed by multiparameter flow cytometry (MFC) and/or molecular analysis (NGS, PCR)
Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first
Median OS
Time Frame: From Cycle 1 Day 1 to date of death from any cause, assessed up to 36 months of treatment
To assess overall survival of ziftomenib
From Cycle 1 Day 1 to date of death from any cause, assessed up to 36 months of treatment
Proportion of patients alive
Time Frame: From Cycle 1 Day 1 until death from any cause, assessed up to 1 year following start of treatment
To assess proportion of patients alive at 1 year following start of treatment with ziftomenib
From Cycle 1 Day 1 until death from any cause, assessed up to 1 year following start of treatment
Median EFS
Time Frame: From Cycle 1 Day 1 to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months of treatment
To assess median event free survival
From Cycle 1 Day 1 to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months of treatment
EFS
Time Frame: From Cycle 1 Day 1 to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 1 year following start of treatment
To assess event free survival at 1 year
From Cycle 1 Day 1 to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 1 year following start of treatment
Median DOR
Time Frame: From time of first remission to relapse or death, whichever occurs first, assessed up to 36 months from start of treatment
To assess median duration of remission
From time of first remission to relapse or death, whichever occurs first, assessed up to 36 months from start of treatment
Proportion of patients who undergo HSCT
Time Frame: From Cycle 1 Day 1 until date of HSCT, assessed up to 36 months of treatment
To assess proportion of patients who undergo hematopoietic stem cell transplant
From Cycle 1 Day 1 until date of HSCT, assessed up to 36 months of treatment
TI
Time Frame: From 28 days prior to Cycle 1 Day 1 up to and including 28 days following the end of 36 months of treatment
To assess rate of transfusion independence
From 28 days prior to Cycle 1 Day 1 up to and including 28 days following the end of 36 months of treatment
Cmax
Time Frame: Cycle 1; each cycle is 28 days
Maximum plasma concentration (Cmax) of ziftomenib and metabolites
Cycle 1; each cycle is 28 days
Tmax
Time Frame: Cycle 1; each cycle is 28 days
Time to maximum plasma concentration (Tmax) of ziftomenib and metabolites
Cycle 1; each cycle is 28 days
AUC0-last
Time Frame: Cycle 1; each cycle is 28 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last) of ziftomenib and metabolites
Cycle 1; each cycle is 28 days
AUCtau
Time Frame: Cycle 1; each cycle is 28 days
Area under the concentration-time curve over a dosing interval (AUCtau) of ziftomenib
Cycle 1; each cycle is 28 days
Accumulation ratio of ziftomenib and metabolites
Time Frame: Cycle 1; each cycle is 28 days
To assess accumulation ratio of ziftomenib and metabolites
Cycle 1; each cycle is 28 days
Cmax of venetoclax
Time Frame: Cycle 1; each cycle is 28 days
Maximum plasma concentration (Cmax) of venetoclax
Cycle 1; each cycle is 28 days
Tmax of venetoclax
Time Frame: Cycle 1; each cycle is 28 days
Time to maximum plasma concentration (Tmax) of venetoclax
Cycle 1; each cycle is 28 days
AUC0-last of venetoclax
Time Frame: Cycle 1; each cycle is 28 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last) of venetoclax
Cycle 1; each cycle is 28 days
AUCtau of venetoclax
Time Frame: Cycle 1; each cycle is 28 days
Area under the concentration-time curve over a dosing interval (AUCtau) of venetoclax
Cycle 1; each cycle is 28 days
Cmax of quizartinib
Time Frame: Cycle 1; each cycle is 28 days
Maximum plasma concentration (Cmax) of quizartinib
Cycle 1; each cycle is 28 days
Tmax of quizartinib
Time Frame: Cycle 1; each cycle is 28 days
Time to maximum plasma concentration (Tmax) of quizartinib
Cycle 1; each cycle is 28 days
AUC0-last of quizartinib
Time Frame: Cycle 1; each cycle is 28 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last) of quizartinib
Cycle 1; each cycle is 28 days
AUCtau of quizartinib
Time Frame: Cycle 1; each cycle is 28 days
Area under the concentration-time curve over a dosing interval (AUCtau) of quizartinib
Cycle 1; each cycle is 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kura Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KO-MEN-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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