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Back|NCT05735184Recruiting
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

Phase
Phase 1
Sponsor
Kura Oncology, Inc.
Enrollment
420
Timeline
Jul 2023 → Apr 2030
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
  • 2Those 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
  • 3Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • 4Adequate liver, renal, and cardiac function according to protocol defined criteria
  • 5A 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
  • 6Female 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

Exclusion Criteria

  • 1Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia
  • 2Known history of BCR-ABL alteration
  • 3Advanced malignant hepatic tumor
  • 4Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery
  • 5Active central nervous system (CNS) involvement by AML.
  • 6Clinical 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
  • 7Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia
  • 8Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
  • 9For 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
  • 10For 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
  • 11Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol
  • 12Mean QT interval corrected for heart rate by Fredericia's formula (QTcF)
  • 13Arm A and Arm B: \>480 ms on triplicate ECGs
  • 14Arm C: \>450 ms on triplicate ECGs
  • 15Uncontrolled infection
  • 16Women who are pregnant or lactating
  • 17An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing
  • 18Patients 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

Locations

44 sites participating in this study

Emory Healthcare - The Emory Clinic

Atlanta, Georgia 30308

Recruiting

Gigi Stoneback

gissela.blanco.stoneback@emory.edu

Mayo Clinic - Phoenix

Phoenix, Arizona 85054

Recruiting

Clinical Trials Referral Office

855-776-0015

Moores UC San Diego Cancer Center

La Jolla, California 92093

Recruiting

Krisma Montalvo

k1montalvo@health.ucsd.edu
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →