Examining the safety of ziftomenib combinations for patients with relapsed acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and tolerability of ziftomenib when combined with standard treatments for patients suffering from relapsed or refractory acute myeloid leukemia (AML). The study will evaluate the antileukemic response of ziftomenib in conjunction with agents such as FLAG-IDA, low-dose cytarabine, and gilteritinib. Participants must have specific genetic mutations associated with AML, and the trial aims to determine the effectiveness of these combinations in improving patient outcomes.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Has been diagnosed with relapsed/refractory AML.
* Has a documented NPM1 mutation or KMT2A rearrangement.
* Has a documented FLT3 mutation (cA-3 only).
* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
* Has adequate hepatic and renal function as defined per protocol.
* Has an ejection fraction above a protocol defined limit.
* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
* Has agreed to use contraception as defined per protocol.

Key Exclusion Criteria:

* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
* Has clinically active central nervous system leukemia.
* Has an active and uncontrolled infection.
* Has a mean corrected QT interval (QTcF) \> 480ms.
* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \<14 days or within 5 drug half-lives prior to the first dose of study intervention.
* Has had major surgery within 4 weeks prior to the first dose of study intervention.
* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
* Participant is pregnant or lactating.

Where it's running

• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• UCLA Health - Bowyer Oncology Center
  Los Angeles, California, United States Recruiting
• UC Irvine Health Chao Family Comprehensive Cancer Center
  Orange, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting

Study contacts

• Study coordinator: Kura Medical Information
• Email: medinfo@kuraoncology.com
• Phone: 844-KURAONC (844-587-2662)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• T cell receptor depletion for blood cancer treatment

  This study is testing a new way to treat blood cancers by using a special treatment before a stem cell transplant to see if it helps both kids and adults do better after the procedure.

  Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT05735717

• Investigating Ziftomenib with Other Treatments for Acute Myeloid Leukemia

  This study is testing if a new drug called ziftomenib, when combined with other treatments, can help people with acute myeloid leukemia who have certain genetic mutations feel better and stay safe during treatment.

  Recruiting at 44 sites Phase 1 Kura Oncology, Inc. · Phoenix, Arizona and 43 other locations · NCT05735184

• Reduced-intensity donor stem cell transplant with treosulfan/fludarabine and post-transplant cyclophosphamide for leukemia and MDS

  This trial tests a lower-intensity donor stem cell transplant using treosulfan plus fludarabine with post-transplant cyclophosphamide to try to reduce toxicity and prevent graft-versus-host disease in people aged 2–75 with acute leukemias or myelodysplastic syndromes.

  Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT07493538

• Triple-drug approach for AML using eganelisib with azacitidine and venetoclax

  This early-stage trial tests whether adding eganelisib to azacitidine and venetoclax can be safe and show signs of benefit in adults with acute myeloid leukemia.

  Recruiting at 2 sites Phase 1 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT07439211

• Revumenib with Mezigdomide for relapsed or refractory acute leukemia

  This trial will test whether combining revumenib and mezigdomide is safe for people aged 12 and older with relapsed or refractory acute leukemia that has KMT2A, NUP98, or NPM1 genetic changes.

  Recruiting at 7 sites Phase 1/2 Memorial Sloan Kettering Cancer Center · Duarte, California and 9 other locations · NCT07356154

• Combining Venetoclax with Intensive Therapy for Acute Myeloid Leukemia Patients

  This study is testing if adding a drug called Venetoclax to standard chemotherapy can help newly diagnosed acute myeloid leukemia patients who aren't responding well to their initial treatment.

  Recruiting Affiliated Hospital of Nantong University · Nantong, Jiangsu · NCT06643962

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.