RECRUITING

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

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Conditions

Acute Myeloid LeukemiaMixed Lineage Leukemia Gene MutationRefractory AMLAML With Mutated NPM1Acute Myeloid Leukemia RecurrentAcute Myeloid Leukemia, in RelapseNPM1 MutationKMT2ArMyeloid SarcomaNucleophosmin 1-mutated Acute Myeloid LeukemiaLeukemiaMyeloidAMLHematological malignancyKMT2ANPM1MeninAcute LeukemiaNewly diagnosed AMLUntreated AMLvenetoclaxcytarabinedaunorubicinKMT2A-rquizartinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-18
Study Completion:2030-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05735184

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
  2. * 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
  3. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  4. * Adequate liver, renal, and cardiac function according to protocol defined criteria
  5. * 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
  6. * 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
  1. * Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia
  2. * Known history of BCR-ABL alteration
  3. * Advanced malignant hepatic tumor
  4. * Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery
  5. * Active central nervous system (CNS) involvement by AML.
  6. * 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
  7. * Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia
  8. * Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
  9. * 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
  10. * 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
  11. * Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol
  12. * Mean QT interval corrected for heart rate by Fredericia's formula (QTcF)
  13. * Arm A and Arm B: \>480 ms on triplicate ECGs
  14. * Arm C: \>450 ms on triplicate ECGs
  15. * Uncontrolled infection
  16. * Women who are pregnant or lactating
  17. * An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing
  18. * 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

Contacts and Locations

Study Contact

Clinical Operations
CONTACT
617-588-3755
KO-MEN-007@kuraoncology.com

Study Locations (Sites)

Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
United States
Moores UC San Diego Cancer Center
La Jolla, California, 92093
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
UCLA - Bowyer Oncology Center
Los Angeles, California, 90095
United States
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
UC Health Blood Disorders and Cell Therapies Center - Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Yale Cancer Center and Smilow Cancer Hospital
New Haven, Connecticut, 06510
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Emory Healthcare - The Emory Clinic
Atlanta, Georgia, 30308
United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
The University of Kansas Medical Center Research Institute
Fairway, Kansas, 66205
United States
University of Kentucky Markey Cancer Center
Louisville, Kentucky, 40202
United States
Norton Cancer Institute - St. Matthews
Louisville, Kentucky, 40207
United States
Ochsner MD Anderson Cancer Center
Jefferson, Louisiana, 70121
United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
UMass Chan Medical School
Worcester, Massachusetts, 01655
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08903
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
United States
New York - Presbyterian / Weill Cornell Medicine
New York, New York, 10021
United States
Mount Sinai - Ruttenberg Treatment Center
New York, New York, 10029
United States
Columbia University Medical Center
New York, New York, 10032
United States
Stony Brook University Hospital
Stony Brook, New York, 11794
United States
Duke Blood Cancer Center
Durham, North Carolina, 27705
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195
United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
United States
Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South Austin
Austin, Texas, 78704
United States
UT Southwestern - Simmons Cancer Center
Dallas, Texas, 75235
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2023-07-18
Study Completion Date2030-04

Study Record Updates

Study Start Date2023-07-18
Study Completion Date2030-04

Terms related to this study

Keywords Provided by Researchers

  • Leukemia
  • Myeloid
  • AML
  • Hematological malignancy
  • KMT2A
  • NPM1
  • Menin
  • Acute Leukemia
  • Newly diagnosed AML
  • Untreated AML
  • venetoclax
  • cytarabine
  • daunorubicin
  • KMT2A-r
  • NPM1 mutation
  • Refractory AML
  • Acute Myeloid Leukemia, in Relapse
  • quizartinib

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • Mixed Lineage Leukemia Gene Mutation
  • Refractory AML
  • AML With Mutated NPM1
  • Acute Myeloid Leukemia Recurrent
  • Acute Myeloid Leukemia, in Relapse
  • NPM1 Mutation
  • KMT2Ar
  • Myeloid Sarcoma
  • Nucleophosmin 1-mutated Acute Myeloid Leukemia