Clinical trial for Acute Myeloid Leukemia (AML)
Official title Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
ClinicalTrials.gov ID: NCT07007312
What this study is testing
What is Ziftomenib?
Ziftomenib is an investigational oral medicine being studied for the treatment of acute myeloid leukemia (AML). It is designed to target the menin pathway in cancer cells.
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 see if adding ziftomenib to usual AML therapy helps patients with certain genetic changes. It will compare the drug to a placebo to find out the benefits and risks.
- Who it's for
- Patients who have not yet received AML treatment and have either an NPM1 mutation or a KMT2A rearrangement.
- What's involved
- Participants will receive standard AML drugs plus either ziftomenib or a placebo. The treatment plan varies: older or medically unfit patients get venetoclax and azacitidine with the study drug or placebo, while fitter patients get a multi‑phase regimen of cytarabine, daunorubicin, and the study drug or placebo during induction, consolidation, and maintenance.
- Time commitment
- The study lasts about 12 months, with regular clinic visits, blood tests, and monitoring throughout the treatment phases.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Age ≥18 years at time of signing the informed consent form.
- Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Adequate liver and kidney function according to protocol requirements.
- A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of...
You likely can't join if
- Prior therapy for AML (except hydroxyurea or leukapheresis for WBC control).
- Diagnosis of acute promyelocytic leukemia (APL), blast phase chronic myeloid leukemia, or isolated myeloid sarcoma.
- Known history of BCR-ABL mutation.
- Basal cell skin cancer or localized squamous cell cancer of the skin
- Previous malignancy confined and locally resected (or treated with other modalities) with curative intent
- Prostate or breast cancer receiving adjuvant hormonal therapy.
See the full eligibility criteria
- Age ≥18 years at time of signing the informed consent form.
- Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Adequate liver and kidney function according to protocol requirements.
- 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.
- Documented NPM1-m.
- i. Age ≥75, OR
- ii. Age \<75 with an ECOG performance status of 2 or cardiac, renal, or hepatic impairment per protocol criteria.
- Documented NPM1-m or KMT2A-r (KMT2A-r patients with a partial tandem duplication are not eligible).
- Documented FLT3 wild-type or ITD ratio \<0.05 OR ineligible to receive FLT3-targeted therapy (medically ineligible or mutation in which FLT3 inhibition is not SOC).
- Ejection fraction of ≥50%.
- Fit for Intensive Therapy per Investigator opinion. Key
- Prior therapy for AML (except hydroxyurea or leukapheresis for WBC control).
- Diagnosis of acute promyelocytic leukemia (APL), blast phase chronic myeloid leukemia, or isolated myeloid sarcoma.
- Known history of BCR-ABL mutation.
- Basal cell skin cancer or localized squamous cell cancer of the skin
- Previous malignancy confined and locally resected (or treated with other modalities) with curative intent
- Prostate or breast cancer receiving adjuvant hormonal therapy.
- Active central nervous system (CNS) involvement by AML.
- Clinical signs/symptoms of leukostasis or white blood cells (WBC) \>25×10\^9/L prior to start of ziftomenib/placebo. Note: Hydroxyurea and/or leukapheresis are permitted to meet this criterion.
- Known uncontrolled HIV infection or known active hepatitis B virus, hepatitis C virus infection, or other uncontrolled infection.
- Uncontrolled intercurrent illness including but not limited to, cardiac illness as defined in the protocol.
- Women who are pregnant or lactating.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Clovis, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Iowa City, Iowa, United States
- Fairway, Kansas, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Saint Paul, Minnesota, United States
+ 103 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; Clovis, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; Aurora, Colorado, United States and 117 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.