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Nucleoside Analog
Ziftomenib Combinations for Acute Myeloid Leukemia
Phase 1
Recruiting
Research Sponsored by Kura Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year following end of treatment with ziftomenib
Awards & highlights
Study Summary
This trial will test a new combination of drugs to treat leukemia, assessing safety and effectiveness.
Who is the study for?
This trial is for adults with a specific type of leukemia (AML) that's either new or has come back after treatment. They must have certain genetic changes (NPM1 mutation or KMT2A rearrangement), be in decent physical shape, and agree to use birth control. People can't join if they have other active cancers, uncontrolled infections, heart problems, CNS involvement by AML, high white blood cell counts without management options like hydroxyurea or leukapheresis, HIV/Hepatitis B/C infection, or if women are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests the safety and potential effectiveness of Ziftomenib combined with Venetoclax/Azacitidine ('ven/aza'), just Venetoclax ('ven'), or standard chemo ('7+3') in patients with Acute Myeloid Leukemia (AML). It focuses on those who have NPM1 mutations or KMT2A rearrangements.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea/vomiting from chemotherapy drugs like Daunorubicin and Cytarabine; liver issues due to Azacitidine; low blood counts leading to increased infection risk; bleeding complications from Venetoclax.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year following end of treatment with ziftomenib
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year following end of treatment with ziftomenib
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission (CR) rate
Descriptive statistics of adverse events
Rate of dose limiting toxicities (DLTs) per dose level
Secondary outcome measures
AUC0-last
AUC0-last of venetoclax
AUCtau
+15 moreTrial Design
11Treatment groups
Experimental Treatment
Group I: Dose Validation/Expansion: Ziftomenib/Venetoclax/Azacitidine in R/R NPM1-m (A-1)Experimental Treatment3 Interventions
Ziftomenib/Venetoclax/Azacitidine in relapsed/refractory NPM1-m AML patients who have failed at least one prior line of therapy
Group II: Dose Validation/Expansion: Ziftomenib/Venetoclax/Azacitidine in R/R KMT2A-r (B-1)Experimental Treatment3 Interventions
Ziftomenib/Venetoclax/Azacitidine in relapsed/refractory KMT2A-r AML patients who have failed at least one prior line of therapy
Group III: Dose Validation/Expansion: Ziftomenib/Venetoclax/Azacitidine in 1L NPM1-m (A-4)Experimental Treatment3 Interventions
Ziftomenib/Venetoclax/Azacitidine in newly diagnosed NPM1-m AML patients
Group IV: Dose Validation/Expansion: Ziftomenib/Venetoclax/Azacitidine in 1L KMT2A-r (B-3)Experimental Treatment3 Interventions
Ziftomenib/Venetoclax/Azacitidine in newly diagnosed KMT2A-r AML patients
Group V: Dose Validation/Expansion: Ziftomenib/Venetoclax in R/R NPM1-m (A-3)Experimental Treatment2 Interventions
Ziftomenib/Venetoclax in relapsed/refractory NPM1-m AML patients who have failed at least one prior line of therapy
Group VI: Dose Validation/Expansion: Ziftomenib/7+3 in 1L NPM1-m (A-2)Experimental Treatment3 Interventions
Ziftomenib/7+3 in newly diagnosed NPM1-m AML patients who are candidates for intensive chemotherapy and meet the protocol definition of high-risk disease
Group VII: Dose Validation/Expansion: Ziftomenib/7+3 in 1L KMT2A-r (B-2)Experimental Treatment3 Interventions
Ziftomenib/7+3 in newly diagnosed KMT2A-r AML patients who are candidates for intensive chemotherapy
Group VIII: Dose Escalation: Ziftomenib/Venetoclax/Azacitidine in R/R NPM1-m (A-1)Experimental Treatment3 Interventions
Ziftomenib/Venetoclax/Azacitidine in relapsed/refractory NPM1-m AML patients who have failed at least one prior line of therapy
Group IX: Dose Escalation: Ziftomenib/Venetoclax/Azacitidine in R/R KMT2A-r (B-1)Experimental Treatment3 Interventions
Ziftomenib/Venetoclax/Azacitidine in relapsed/refractory KMT2A-r AML patients who have failed at least one prior line of therapy
Group X: Dose Escalation: Ziftomenib/7+3 in 1L NPM1-m (A-2)Experimental Treatment3 Interventions
Ziftomenib/7+3 in newly diagnosed NPM1-m AML patients who are candidates for intensive chemotherapy and meet the protocol definition of high-risk disease
Group XI: Dose Escalation: Ziftomenib/7+3 in 1L KMT2A-r (B-2)Experimental Treatment3 Interventions
Ziftomenib/7+3 in newly diagnosed KMT2A-r AML patients who are candidates for intensive chemotherapy and meet the protocol definition of high-risk disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440
Daunorubicin
2013
Completed Phase 4
~4940
Cytarabine
2016
Completed Phase 3
~3310
Find a Location
Who is running the clinical trial?
Kura Oncology, Inc.Lead Sponsor
15 Previous Clinical Trials
1,310 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known BCR-ABL gene change.I agree to use birth control or abstain from sex as required.I have not received any live vaccines within the last 14 days and won't until my B-cell levels recover.My acute myeloid leukemia (AML) has spread to my brain or spinal cord.I do not have any uncontrolled illnesses like heart disease.I have leukemia and have only had specific treatments before my current diagnosis.I have been diagnosed with a specific type of leukemia.I have an advanced liver cancer and am receiving ven/aza treatment.I have recovered from side effects of treatment, except for hair loss.I do not have active HIV, hepatitis B, or hepatitis C.My liver, kidneys, and heart are working well.I do not have any infections that aren't responding to treatment.I am not pregnant or breastfeeding.I am currently on chemotherapy for an active, worsening cancer.My AML is either new or has returned, and tests show I have an NPM1 mutation or KMT2A rearrangement.I can take care of myself and am up and about more than half of my waking hours.I have symptoms of leukostasis or my white blood cell count is over 25,000.I haven't had cancer treatment or experimental therapy within the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Validation/Expansion: Ziftomenib/7+3 in 1L KMT2A-r (B-2)
- Group 2: Dose Validation/Expansion: Ziftomenib/Venetoclax/Azacitidine in R/R KMT2A-r (B-1)
- Group 3: Dose Validation/Expansion: Ziftomenib/Venetoclax in R/R NPM1-m (A-3)
- Group 4: Dose Escalation: Ziftomenib/7+3 in 1L NPM1-m (A-2)
- Group 5: Dose Validation/Expansion: Ziftomenib/7+3 in 1L NPM1-m (A-2)
- Group 6: Dose Validation/Expansion: Ziftomenib/Venetoclax/Azacitidine in R/R NPM1-m (A-1)
- Group 7: Dose Validation/Expansion: Ziftomenib/Venetoclax/Azacitidine in 1L NPM1-m (A-4)
- Group 8: Dose Validation/Expansion: Ziftomenib/Venetoclax/Azacitidine in 1L KMT2A-r (B-3)
- Group 9: Dose Escalation: Ziftomenib/Venetoclax/Azacitidine in R/R KMT2A-r (B-1)
- Group 10: Dose Escalation: Ziftomenib/7+3 in 1L KMT2A-r (B-2)
- Group 11: Dose Escalation: Ziftomenib/Venetoclax/Azacitidine in R/R NPM1-m (A-1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit of individuals enrolled in this clinical experiment?
"Affirmative. The information on clinicaltrials.gov elucidates that this medical experiment, which was initially made available on July 18th 2023, is actively recruiting for participation. Approximately 212 patients will be recruited from 3 distinct healthcare centres."
Answered by AI
What are the paramount aims of this research project?
"This medical trial's primary objective is to determine the frequency of adverse events over a 28-day period while on ziftomenib and SOC backbone treatment. Secondary outcomes include assessing measurable residual disease through multiparameter flow cytometry, measuring patient survival rate after one year, as well as determining how many patients undergo hematopoietic stem cell transplantation."
Answered by AI
Are volunteers still being accepted for this research endeavor?
"According to clinicaltrials.gov, this research is currently seeking participants; it was initially posted on July 18th 2023 and updated most recently on August 7th of the same year."
Answered by AI
What risks are associated with Dose Validation/Expansion: Ziftomenib/Venetoclax in R/R NPM1-m (A-3) for individuals?
"Due to limited data supporting safety and efficacy, our team at Power has assessed the security of Dose Validation/Expansion: Ziftomenib/Venetoclax in R/R NPM1-m (A-3) as a 1 on a scale from 1 to 3."
Answered by AI
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