PhI Ven/Aza Comb.w/ Ziftomenib or Cytarabine/Daunorubicin Comb.w/ Ziftomenib for Tx of Pts w/ AML

UCI Specialty Area: Cancer

Principal Investigator: Kiran Naqvi

Official Title: Phase I Study of Venetoclax/Azacitidine or Venetoclax in Combination with Ziftomenib (KO-539) or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination with Ziftomenib for the Treatment of Patients with Acute Myeloid Leukemia

A Study On:

Myeloid and Monocytic Leukemia

Study Description

This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.

Eligibility

-You will sign this informed consent.

-Review of your study eligibility.

-Your chromosomal abnormalities and deoxyribonucleic acid (DNA) information of your leukemia cells will be assessed. In addition, your leukemia cells will be tested for the presence of the NPM1 mutation and/or KMT2A rearrangement along with FLT3 or other mutations.

-You will be asked about your medical and surgical history, disease history, bleeding and family history, and dependence on blood products such as red blood cells or platelets, and prior or current medications. Review any signs or symptoms you may be having (e.g., cough, pain, etc.).

-Your demographic information will be collected (e.g., age, sex, race, etc.).

-A physical exam. In addition, your height / weight, vital signs (pulse, temperature, respiratory rate), and blood pressure will be recorded.

-You will be asked how you are able to perform normal daily activities (an Eastern Cooperative Oncology Group [ECOG] Performance Status assessment).

-A 12-lead electrocardiogram (ECG) will be collected in triplicate (or 3 times) (within 5 minutes of each other). This test measures the electrical activity of your heart.

-A heart ultrasound/scan will be ordered by your study doctor.

-Blood (approximately 4-5 tablespoons or 67 mL) will be collected to determine how your body is functioning, including routine blood chemistries, blood counts, and cardiac markers (heart). Blood clotting factors and inflammatory markers will be collected to evaluate your overall health and organ functions (e.g., liver, heart, kidneys, pancreas), to better understand how ziftomenib works and to determine whether there are specific markers (often called biomarkers) in your blood that could potentially help indicate how your cancer may respond to the study drug. Women who can become pregnant will have a blood (serum) pregnancy test to make sure they are not pregnant.

-Urine (approximately 4 tablespoons or 60 mL) will be collected to determine how your body is functioning.

-You will receive medications to help prevent TLS.

-Review of all the medicines that you are taking, procedures performed, and any symptoms or side effects that you may be having and your dependence on blood products such as red blood cells or platelets.

A female nurse attentively holds a tablet, ready to assist with patient care and medical information.

Interested in Participating in this Trial?

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
researcher listed above will be available to answer your questions.

You are being asked to participate in a clinical research potential participant database to identify
potential clinical research studies you may be eligible for. Participation in this database is voluntary.
You may choose to skip any question. You may refuse to participate or discontinue your involvement
at any time without penalty or loss of benefits. You are free to withdraw from this database at any
time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.

Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.

There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

There are no alternative procedures available. The only alternative is not to participate in this study.

There is no compensation for your participation in this database.

There is no cost to you for participation in this database.

All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.

Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.

The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form

Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.

What is an IRB?