A Phase 1 interventional study of Ziftomenib and Fludarabine in AML, AML With Mutated NPM1 and Hematologic Malignancy, sponsored by Kura Oncology, Inc.. Recruiting at 45 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Kura Oncology, Inc. · Phase 1, Interventional, and Treatment
The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's planned enrollment of 171 is above the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Kura Oncology, Inc. is the lead sponsor of 18 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral ziftomenib; sequential cohorts of escalating dose levels of ziftomenib to identify the safety and tolerability of the combination regimens. Participants will be enrolled in 1 of 5 dose escalation cohorts: A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC) A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)
Drug: Ziftomenib · Drug: Fludarabine · Drug: Idarubicin · Drug: Cytarabine · Drug: Gilteritinib · Biological: Granulocyte colony-stimulating factor
Oral ziftomenib; Following the determination of the maximum tolerated dose in Phase 1a, participants will be enrolled in 1 of 5 dose validation/expansion cohorts: A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC) A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)
Drug: Ziftomenib · Drug: Fludarabine · Drug: Idarubicin · Drug: Cytarabine · Drug: Gilteritinib · Biological: Granulocyte colony-stimulating factor
Oral administration
Also known as: KO-539
Intravenous infusion
Intravenous infusion
Intravenous Infusion
Oral administration
Also known as: Xospata
Subcutaneous injection
Rate of dose limiting toxicities (DLTs) per dose level
Assessed by the NCI-CTCAE v5.0
Time frame: During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)
Descriptive statistics of adverse events
Assessed by the NCI-CTCAE v5.0
Time frame: First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the patient is lost to follow-up, whichever comes first
Complete remission (CR) rate for cohorts A-1, A-2, B-1, and B-2
Assessed by ELN 2022 criteria
Time frame: Up to 12 months following discontinuation of treatment
Complete remission (CR) / Complete remission with partial hematologic recovery (CRh) rate for cohort A-3
Assessed by ELN 2022 criteria
Time frame: Up to 12 months following discontinuation of treatment
Composite complete remission (CRc) rate
Assessed by ELN 2022 criteria
Time frame: Up to 12 months following discontinuation of treatment
Morphologic leukemia-free state (MLFS) rate
Assessed by ELN 2022 criteria
Time frame: Up to 12 months following discontinuation of treatment
OS
To assess overall survival
Time frame: Up to 12 months following discontinuation of treatment
6-month OS
To assess proportion of patients alive at 6 months
Time frame: Up to 6 months following discontinuation of treatment
Median EFS
To assess median event free survival
Time frame: Up to 12 months following discontinuation of treatment
6-month EFS
To assess 6-month event free survival
Time frame: Up to 6 months following discontinuation of treatment
DOR
To assess duration of remission
Time frame: Up to 12 months following discontinuation of treatment
MRD assessment
To assess minimum residual disease in bone marrow as assessed by multiparameter flow cytometry (MFC) and molecular analysis
Time frame: Up to 12 months following discontinuation of treatment
HSCT
To assess proportion of patients that undergo a hematopoietic stem-cell transplant
Time frame: Up to 12 months following discontinuation of treatment
Transfusion independence
To assess rate of transfusion independence
Time frame: Up to 12 months following discontinuation of treatment
Ziftomenib Cmax
To assess the maximum plasma combination of ziftomenib and its metabolites
Time frame: Cycle 1 (Each cycle is 28 days)
Ziftomenib Tmax
To assess the time to observed maximum plasma concentration of ziftomenib and its metabolites
Time frame: Cycle 1 (Each cycle is 28 days)
Ziftomenib AUC(0-last)
To assess the area under the plasma concentration-time-curve from time 0 to time of last measurable concentration of ziftomenib and its metabolites
Time frame: Cycle 1 (Each cycle is 28 days)
Ziftomenib AUC(tau)
To assess the area under the plasma concentration-time-curve over a dosing interval for ziftomenib and its metabolites
Time frame: Cycle 1 (Each cycle is 28 days)
Gilteritinib Cmax
To assess the maximum plasma combination of gilteritinib
Time frame: Cycle 1 (Each cycle is 28 days)
Gilteritinib Tmax
To assess the time to observed maximum plasma concentration of gilteritinib
Time frame: Cycle 1 (Each cycle is 28 days)
Gilteritinib AUC(0-last)
To assess the area under the plasma concentration-time-curve from time 0 to time of last measurable concentration of gilteritinib
Time frame: Cycle 1 (Each cycle is 28 days)
Gilteritinib AUC(tau)
To assess the area under the plasma concentration-time-curve over a dosing interval for gilteritinib
Time frame: Cycle 1 (Each cycle is 28 days)
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Not enrolling at this site — choose another above.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Dec 2026, 34 months after the start.
Of 95 industry-sponsored phase 1 interventional studies under Hematologic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 78. This study's planned 34 months is below that.
Counting every sponsor, half of 159 studies reached it within 51 months; a quarter within 28 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Ziftomenib
Kura Oncology, Inc.