RECRUITING

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

Description

This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.

Conditions

Acute Myeloid LeukemiaMixed Lineage Acute LeukemiaMixed Lineage Leukemia Gene MutationMixed Phenotype Acute LeukemiaRefractory AMLAML with Mutated NPM1Acute Myeloid Leukemia RecurrentAcute Myeloid Leukemia, in RelapseNPM1 MutationKMT2ArMyeloid Sarcoma
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Related Conditions:

Acute Myeloid LeukemiaMixed Lineage Acute LeukemiaMixed Lineage Leukemia Gene MutationMixed Phenotype Acute LeukemiaRefractory AMLAML with Mutated NPM1Acute Myeloid Leukemia RecurrentAcute Myeloid Leukemia, in RelapseNPM1 MutationKMT2ArMyeloid Sarcoma

Study Overview

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Study Details

Study overview

This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.

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

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

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

La Jolla

Moores UC San Diego Cancer Center, La Jolla, California, United States, 92093

Los Angeles

USC University of Southern California / Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Los Angeles

UCLA - Bowyer Oncology Center, Los Angeles, California, United States, 90095

Orange

UCI Health Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868

Aurora

UC Health Blood Disorders and Cell Therapies Center - Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

New Haven

Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut, United States, 06510

Chicago

Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States, 60611

Fairway

The University of Kansas Cancer Center, Fairway, Kansas, United States, 66205

Louisville

Norton Cancer Institute - St. Matthews, Louisville, Kentucky, United States, 40207

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
  • * 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 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 adequate contraception from the time of screening through 90 days following the last dose of study intervention
  • * Diagnosis of either acute promyelocytic leukemia or blast chronic myelomonocytic leukemia
  • * Known history of BCR-ABL alteration
  • * Advanced malignant hepatic tumor \[for patients receiving ven/aza combination\]
  • * 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 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 to control leukocytosis, prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia, or non-HMA therapy for prior myelodysplastic syndrome
  • * 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 corrected QT interval corrected for heart rate by Fredericia's formula (QTcF) \>480 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kura Oncology, Inc.,

Study Record Dates

2027-05