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New treatment option 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 medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia (aml).
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
- Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells.
- 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
- Key The following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted:
- 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.
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.
- History of other active concurrent malignancies prior to study entry except:
- 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
See the full eligibility criteria
- Key The following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted:
- 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. A male with a female partner of childbearing...
- NONINTENSIVE THERAPY STUDY ONLY (VEN+AZA):
- Documented NPM1-m.
- Patients considered ineligible for Intensive Therapy defined by the following:
- i. Age ≥75, OR
- ii. Age \<75 with an ECOG performance status of 2 or cardiac, renal, or hepatic impairment per protocol criteria.
- INTENSIVE THERAPY STUDY ONLY (7+3):
- 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). Lack of access to an FLT3 inhibitor is not considered...
- 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.
- History of other active concurrent malignancies prior to study entry except:
- 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's taking place
- 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
- Lexington, Kentucky, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- New Brunswick, New Jersey, United States
- Albuquerque, New Mexico, United States
- Buffalo, New York, United States
+ 53 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 - 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?
Study sites include 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 67 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.