BridgeMD
New treatment option for Acute Myeloid Leukemia (AML)
Official title A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07623616
What this study is testing
What is ziftomenib?
ziftomenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia (aml).
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
- This is the first study to administer ziftomenib to Japanese patients. In this study, the efficacy, safety, and pharmacokinetics of ziftomenib will be evaluated in patients with relapsed or refractory NPM1-mutated acute myeloid leukemia
- Phase 2: a mid-size study of how well it works
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
- Voluntary written informed consent and willingness to comply with all study procedures
- Age ≥ 18 years
- Confirmed diagnosis of acute myeloid leukemia (AML)
- Patients with R/R AML with NPM1-m
- No available standard of care expected to provide clinical benefit, ineligible for or declined standard therapy.
You likely can't join if
- Diagnosis of acute promyelocytic leukemia.
- Donor lymphocyte infusion \< 30 days prior to study entry.
- Clinically active central nervous system (CNS) leukemia.
- Prior hematopoietic stem cell transplantation (HSCT) without adequate hematologic recovery.
- Active Grade ≥ 2 acute graft-versus-host disease or moderate/severe chronic graft-versus-host disease.
- Prior treatment with a menin inhibitor.
See the full eligibility criteria
- Voluntary written informed consent and willingness to comply with all study procedures
- Age ≥ 18 years
- Confirmed diagnosis of acute myeloid leukemia (AML)
- Patients with R/R AML with NPM1-m
- No available standard of care expected to provide clinical benefit, ineligible for or declined standard therapy.
- ECOG performance status 0-2.
- White blood cell count ≤ 30,000/mm³ at screening (hydroxyurea permitted for cytoreduction).
- Adequate organ function according to protocol requirements.
- Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and for at least 187 days after the last dose of study treatment.
- Males with female partners of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 97 days after the last dose of study treatment.
- Diagnosis of acute promyelocytic leukemia.
- Donor lymphocyte infusion \< 30 days prior to study entry.
- Clinically active central nervous system (CNS) leukemia.
- Prior hematopoietic stem cell transplantation (HSCT) without adequate hematologic recovery.
- Active Grade ≥ 2 acute graft-versus-host disease or moderate/severe chronic graft-versus-host disease.
- Prior treatment with a menin inhibitor.
- Receipt of chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 14 days or 5 half-lives prior to first dose.
- Unresolved toxicities from prior therapy \> Grade 1.
- Requirement for strong CYP3A4 inducers.
- Active or uncontrolled infection, including hepatitis B, hepatitis C, or HIV.
- Conditions predisposing to serious or life-threatening infection or significant immunodeficiency.
- Cardiovascular disease or QTcF \> 480 ms.
- Interstitial lung disease.
- Major surgery within 4 weeks prior to first dose.
- Women who are pregnant or lactating
- Any medical, psychiatric, or social condition that may interfere with study participation or safety, or that makes the patient unsuitable in the investigator's judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Chiba, Japan
- Gifu, Japan
- Hyōgo, Japan
- Ibaraki, Japan
- Kagoshima, Japan
- Kanagawa, Japan
- Kyoto, Japan
- Miyagi, Japan
- Nagano, Japan
- Nagasaki, Japan
- Okayama, Japan
- Osaka, Japan
- Saitama, Japan
- Tochigi, Japan
- Tokyo, Japan
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 Chiba, Japan; Gifu, Japan; Hyōgo, Japan; Ibaraki, Japan; Kagoshima, Japan; Kanagawa, Japan and 9 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.