Ziftomenib for AML
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a new drug, ziftomenib, in treating acute myeloid leukemia (AML), a type of blood cancer. Researchers aim to determine if adding ziftomenib to standard AML treatments benefits patients with specific genetic changes in their cancer cells. The trial includes two separate studies: one for older or less healthy patients using a gentler treatment approach, and another for patients who can handle more intense treatment. This trial may suit individuals who have not yet received treatment for AML and have certain genetic markers in their cancer. Participants will not know if they are receiving ziftomenib or a placebo, as the study is double-blinded. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the Ziftomenib for AML trial?
The trial information does not specify if you need to stop taking your current medications. However, since the trial involves adding ziftomenib to standard AML treatments, it's best to discuss your current medications with the trial team to ensure there are no interactions.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ziftomenib is generally safe for patients with AML (acute myeloid leukemia) when used with standard treatments. In studies combining ziftomenib with venetoclax and azacitidine, patients tolerated the treatment well at the tested doses. The results also suggested effectiveness, with no serious safety issues identified.
Another study used ziftomenib with 7+3 chemotherapy (cytarabine and daunorubicin). This combination achieved a high success rate and was well-tolerated. Safety remained consistent across different doses, with no dangerous side effects observed.
These findings suggest that ziftomenib, when used with either treatment combination, maintains a strong safety record in similar patient groups.12345Why are researchers excited about this trial's treatment for AML?
Researchers are excited about Ziftomenib for acute myeloid leukemia (AML) because it offers a novel approach by targeting a specific mutation that current treatments may not address effectively. Unlike the standard options like chemotherapy, which broadly attack dividing cells, Ziftomenib focuses on inhibiting the menin-MLL interaction, a key driver in certain AML subtypes. This targeted mechanism could lead to more effective treatment with potentially fewer side effects. Additionally, Ziftomenib is being tested in combination with existing drugs like venetoclax and azacitidine, which could enhance its efficacy and offer new hope for patients who have limited options with traditional therapies.
What evidence suggests that this trial's treatments could be effective for AML?
Research has shown that ziftomenib could help treat acute myeloid leukemia (AML) with specific genetic changes. In this trial, participants in the nonintensive therapy study may receive ziftomenib with venetoclax and azacitidine, which previous studies have shown to significantly improve outcomes. Another arm of this trial uses ziftomenib with cytarabine and daunorubicin, common AML treatments. In earlier studies, 94% of patients experienced a reduction in cancer symptoms with this combination. These results suggest that ziftomenib might be a useful addition to current AML treatments.13678
Are You a Good Fit for This Trial?
This trial is for adults with acute myeloid leukemia (AML) who have specific genetic mutations (NPM1-m or KMT2A-r), are FLT3 wild-type, and haven't been treated before. They must be over 18, in fairly good health (ECOG 0-2), and if they can have children, agree to use contraception. People with certain heart conditions or severe liver/kidney issues may not qualify.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Nonintensive Therapy Study
Participants receive venetoclax and azacitidine, plus either ziftomenib or a placebo
Treatment - Intensive Therapy Study
Participants receive cytarabine and daunorubicin (induction), cytarabine (consolidation), and either ziftomenib or a placebo (maintenance)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ziftomenib
Trial Overview
The trial tests Ziftomenib combined with standard AML treatments: Venetoclax + Azacitidine for older/sicker patients, or Cytarabine + Daunorubicin for fitter patients. It's a double-blind study where neither doctors nor participants know if they're getting Ziftomenib or a placebo alongside their cancer treatment.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Ziftomenib in combination with venetoclax+azacitidine
Ziftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), placebo (maintenance)
Ziftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), ziftomenib (maintenance)
Placebo in combination with venetoclax+azacitidine
Placebo+cytarabine+daunorubicin (induction), placebo+cytarabine (consolidation), placebo (maintenance)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kura Oncology, Inc.
Lead Sponsor
Citations
1.
onclive.com
onclive.com/view/ziftomenib-with-7-3-shows-early-promise-in-newly-diagnosed-npm1-mutated-kmt2a-rearranged-amlZiftomenib With 7+3 Shows Early Promise in Newly ...
Ziftomenib combined with 7+3 chemotherapy shows a 94% objective response rate in newly diagnosed NPM1-mutated and KMT2A-rearranged AML patients.
Kura Oncology and Kyowa Kirin Report Positive Updated ...
In the ongoing study, ziftomenib dosed once daily at 600 mg in combination with 7+3 continued to demonstrate robust and evolving clinical ...
3.
ir.kuraoncology.com
ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-launch-clinical-trial-evaluatingKura Oncology and Kyowa Kirin Launch Clinical Trial ...
This cohort evaluates ziftomenib, a once-daily, investigational oral menin inhibitor, combined with cytarabine and daunorubicin (7+3) as well as ...
clinical trial updates from 2024 ASH annual meeting
Meanwhile, ziftomenib combined with venetoclax and azacitidine (NCT05735184) produced 50% (24/48) ORR and 25% (12/48) CR/CRh rate in KMT2Ar/ ...
NCT07007312 | Studies to Assess Ziftomenib in ...
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations.
6.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/214/530335/Ziftomenib-Combined-with-Intensive-Induction-7-3Ziftomenib Combined with Intensive Induction (7+3) in Newly ...
Conclusion: In the ongoing KOMET-007 study, ziftomenib combined with 7+3 was well tolerated, with a consistent safety profile across dose levels ...
NCT05735184 | A Study to Investigate the Safety and ...
The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML. Official ...
AML-732: Ziftomenib Combined With Intensive Induction ...
In the ongoing KOMET-007 study, ziftomenib 600 mg QD plus 7+3 was well tolerated with robust clinical activity in newly diagnosed AML. No DS was reported; ...
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