RECRUITING

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

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Conditions

AMLAML With Mutated NPM1Hematologic MalignancyKMT2ArNPM1 MutationMLL RearrangementLeukemiaAcute Myeloid LeukemiaLeukemia, MyeloidLeukemia, Myeloid, AcuteAcute LeukemiaNeoplasms by Histologic Type

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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

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.

Official Title

Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

Quick Facts

Study Start:2024-02-22
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06001788

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. * Has been diagnosed with relapsed/refractory AML.
  2. * Has a documented NPM1 mutation or KMT2A rearrangement.
  3. * Has a documented FLT3 mutation (cohort A-3 only).
  4. * Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
  5. * Has adequate hepatic and renal function as defined per protocol.
  6. * Has an ejection fraction above a protocol defined limit.
  7. * Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
  8. * Has agreed to use contraception as defined per protocol.
  1. * Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
  2. * Has clinically active central nervous system leukemia.
  3. * Has an active and uncontrolled infection.
  4. * Has a mean corrected QT interval (QTcF) \> 480ms.
  5. * Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
  6. * Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \<14 days or within 5 drug half-lives prior to the first dose of study intervention.
  7. * Has had major surgery within 4 weeks prior to the first dose of study intervention.
  8. * Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
  9. * Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD.
  10. * Participant is pregnant or lactating.

Contacts and Locations

Study Contact

Clinical Operations
CONTACT
858 500 8800
KO-MEN-008@kuraoncology.com

Principal Investigator

Clinical Development
STUDY_DIRECTOR
Kura Oncology

Study Locations (Sites)

Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
UCLA Health - Bowyer Oncology Center
Los Angeles, California, 90095
United States
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06511
United States
The University of Kansas
Kansas City, Kansas, 66160
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Cancer Institute
Detroit, Michigan, 48202
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
United States
Stony Brook Cancer Center
Stony Brook, New York, 11794
United States
Atrium Health Levine Cancer Center
Charlotte, North Carolina, 60201
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Prisma Health
Greenville, South Carolina, 29615
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Kura Oncology, Inc.

  • Clinical Development, STUDY_DIRECTOR, Kura Oncology

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 Date2024-02-22
Study Completion Date2027-08

Study Record Updates

Study Start Date2024-02-22
Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

  • AML
  • AML With Mutated NPM1
  • Hematologic Malignancy
  • KMT2Ar
  • NPM1 Mutation
  • MLL Rearrangement
  • Leukemia
  • Acute Myeloid Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Acute Leukemia
  • Neoplasms by Histologic Type