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Tests treatment safety and results for Acute Myeloid Leukemia
Official title A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
ClinicalTrials.gov ID: NCT05735184
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.
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 certain genetic alterations. This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations.
- 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
- Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
- Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate liver, renal, and cardiac function according to protocol defined criteria
- A female of childbearing potential must agree to use adequate contraception as well as a double barrier method from the time of screening through 180...
You likely can't join if
- Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia
- Known history of BCR-ABL alteration
- Advanced malignant hepatic tumor
- Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery
- Active central nervous system (CNS) involvement by AML.
- Clinical signs/symptoms of leukostasis or WBC \> 25,000 / microliter. Hydroxyurea and/or leukapheresis and/or up to 2 doses of cytarabine if used per...
See the full eligibility criteria
- Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
- Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate liver, renal, and cardiac function according to protocol defined criteria
- A female of childbearing potential must agree to use adequate contraception as well as a double barrier method from the time of screening through 180 days following the last dose of study intervention. A male of...
- Female patients of childbearing potential who receive quizartinib in Arm C should use a highly effective method of contraception during quizartinib treatment and for 7 months after the last dose Key
- Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia
- Known history of BCR-ABL alteration
- Advanced malignant hepatic tumor
- Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery
- Active central nervous system (CNS) involvement by AML.
- Clinical signs/symptoms of leukostasis or WBC \> 25,000 / microliter. Hydroxyurea and/or leukapheresis and/or up to 2 doses of cytarabine if used per institutional SOC for control of leukocytosis are permitted to meet...
- Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia
- Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
- For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and/or leukapheresis and/or up to 2 doses of cytarabine per institutional standards to control leukocytosis, or prior treatment...
- For relapsed/refractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \< 14 days prior to the first dose of ziftomenib or within 5 drug...
- Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol
- Mean QT interval corrected for heart rate by Fredericia's formula (QTcF)
- Arm A and Arm B: \>480 ms on triplicate ECGs
- Arm C: \>450 ms on triplicate ECGs
- Uncontrolled infection
- Women who are pregnant or lactating
- An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing
- Patients who have active GVHD requiring \>0.5 mg/kg prednisone or any new or increase in immunosuppressants in the prior 2 weeks for GVHD treatment
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Maywood, Illinois, United States
- Iowa City, Iowa, United States
- Fairway, Kansas, United States
- Louisville, Kentucky, United States
- Jefferson, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
+ 19 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 Phoenix, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States and 33 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.