Trial studying safety and effects for AML
Official title Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06001788
What this study is testing
What is Ziftomenib?
Ziftomenib is an investigational oral medicine being studied for patients with relapsed or refractory acute myeloid leukemia.
Also referred to as KO-539.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and well tolerated ziftomenib is when used with FLAG‑IDA, low‑dose cytarabine, or gilteritinib, and whether it shows any anti‑leukemia activity.
- Who it's for
- Adults with relapsed or refractory acute myeloid leukemia who have already tried other treatments.
- What's involved
- Participants will receive ziftomenib together with one of the standard drug regimens and will have regular blood tests, scans, and clinic visits to monitor safety and response.
- Time commitment
- The study lasts several months, with frequent clinic visits and blood draws as scheduled by the research team.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Maywood, Illinois, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Hackensack, New Jersey, United States
- Buffalo, New York, United States
- Lake Success, New York, United States
- New York, New York, United States
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States and 34 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.