RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ziftomenib with standard treatments: FLAG-IDA, low-dose cytarabine, or gilteritinib. It looks at safety, side effects, and how well the treatments fight acute myeloid leukemia (AML), a blood cancer. It is for people whose AML has come back or has not responded to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have AML that has come back or has not responded to treatment.
  • Have an NPM1 gene change or a KMT2A gene rearrangement.
  • For the study group called cA-3 only, have a FLT3 gene change.
  • Be able to care for yourself and be up and about at least half of your waking hours (ECOG score of 2 or less).
  • Have liver and kidney function that meets the study’s rules.
  • Have heart pumping strength above the study’s required level.
  • You or your legal representative must understand the study and give written consent before screening.
  • Agree to use birth control as required by the study.

Who can't join

  • Have acute promyelocytic leukemia or chronic myeloid leukemia in its blast phase, which are other types of leukemia.
  • Have active leukemia in the brain or spinal cord.
  • Have an active infection that is not controlled, or another uncontrolled illness, including certain heart diseases.
  • Have a heart rhythm test result called QTcF above 480 milliseconds.
  • Have had cancer treatment, including an experimental treatment, within 14 days or within 5 drug half-lives before the first study dose. A half-life is the time it takes the body to clear half of a drug.
  • Have had major surgery within 4 weeks before the first study dose.
  • Have not recovered enough from a blood stem cell transplant, or have active graft-versus-host disease (donor cells attacking your body), or take drugs to treat it by lowering immune activity.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 ≤ 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.

Study sites (38)

AZ

CA

CO

CT

GA

IA

IL

KS

MA

MI

MO

NC

NE

NJ

NY

OH

OK

PA

SC

TN

TX

VA

VT

WA

WI