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โ† Trials
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Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

RecruitingPhase 1Ages 18 Years - anyAllKura Oncology, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * Has been diagnosed with relapsed/refractory AML. * Has a documented NPM1 mutation or KMT2A rearrangement. * Has a documented FLT3 mutation (cA-3 only). * Has an Eastern Cooperative Oncology Group (ECOG) Performance status โ‰ค 2. * Has adequate hepatic and renal function as defined per protocol. * Has an ejection fraction above a protocol defined limit. * Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure. * Has agreed to use contraception as defined per protocol. Key Exclusion Criteria: * Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia. * Has clinically active central nervous system leukemia. * Has an active and uncontrolled infection. * Has a mean corrected QT interval (QTcF) \> 480ms. * Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease. * 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. * Has had major surgery within 4 weeks prior to the first dose of study intervention. * Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria. * Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD * Participant is pregnant or lactating.
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What it tests

  • Ziftomenib
  • Fludarabine
  • Idarubicin
  • Cytarabine
  • Gilteritinib
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Where

45 sites
Banner MD Anderson Cancer Center
Gilbert, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
UCLA Health - Bowyer Oncology Center
Los Angeles, United States
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, United States
University of California San Francisco
San Francisco, United States
Colorado Blood Cancer Institute
Denver, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, United States
Emory Healthcare - The Emory Clinic
Atlanta, United States

โ€ฆand 37 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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