Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia (NCT07411586) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia
United States32 participantsStarted 2026-05-28
Plain-language summary
The goal of Phase 1 is to find the recommended dose of ziftomenib and olutasidenib in patients with relapsed/refractory AML that has a mutation in the NPM1 and IDH1 genes.
The goal of Phase 1b is to learn if the recommended dose of ziftomenib and olutasidenib found in Phase 1 can help to control the disease.
The safety and effects of this combination will also be studied in both parts.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \> 18 years
. Diagnosis of relapsed or refractory AML (including biphenotypic or bilineage leukemia) as defined by ≥ 5% marrow blasts; patients with isolated extramedullary AML without marrow involvement are not eligible
. AML disease must be characterized by IDH1 and NPM1 co-mutations as determined by local molecular testing (next generation sequencing, PCR)
. Eastern Cooperative Oncology Group (ECOG) Performance Status \</=2
. Adequate renal function with CrCl ≥30 ml/min to be calculated using Cockroft Gault formula
. Adequate hepatic function (total bilirubin \< 3.0x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT \< 3x ULN unless considered due to leukemic involvement, in which case total bilirubin \< 5x ULN or AST and/or ALT \< 5x ULN will be considered eligible
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
. In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation of study therapy will be 14 days from last cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half- lives of the prior therapy whichever is shorter. Cytarabine (up to 2 gm/m2), leukapheresis, and oral hydroxyurea are permitted in patients with rapidly proliferative disease before the start of study therapy for clinical benefit as needed. Hydroxyurea can also be administered during cycles 1-2 of study therapy for cytoreduction as deemed necessary by the treating physician and after discussion with the PI. Concurrent intrathecal therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.
Exclusion criteria
. Patients with t (15;17) karyotypic abnormality or acute promyelocytic leukemia (French American- British \[FAB\] class M3-AML).
. Patients with any concurrent uncontrolled clinically significant medical condition including life- threatening severe infection, or psychiatric illness, which could place the patient at unacceptable risk of study treatment or be unable to consent or comply with protocol therapy. Patients with controlled infections are allowed. Other prior or concurrent malignancies will be considered after discussion with the PI.
. Patients with active, uncontrolled, leukemia involvement of the CNS
. Patients with grade II-IV active or extensive chronic graft-versus-host disease (cGHVD) status post stem cell transplant requiring topical therapy. Patients must have discontinued calcineurin inhibitors at least 2 weeks prior to the start of the study therapy.
. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
. Subject has a white blood cell count \> 20 x 10⁹/L. (Note: Hydroxyurea, leukapheresis, and cytarabine is permitted to meet this criterion- see above Inclusion criteria #8.)