A Phase 1 interventional study of Revumenib in Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia and Refractory Leukemia, sponsored by Syndax Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Syndax Pharmaceuticals · Phase 1, Interventional, and Treatment
The primary purpose of this study is to characterize the pharmacokinetic (PK) parameters of revumenib and its major metabolite, N-deethyl revumenib (M1) after a single dose of revumenib in participants with severe liver or kidney impairment or normal liver and kidney function.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's planned enrollment of 18 is below the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Syndax Pharmaceuticals is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
Compared within Hematologic Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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 New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
PK evaluation Period: Participants will receive a single Reduced Dose A of revumenib on Day 1. Optional Treatment Period: If the Investigator believes it is in the best clinical interest of the participant, the participant may start the Optional Treatment Period immediately after completing the PK Evaluation Period on Study Day 2. Participants who start the Optional Treatment Period will receive revumenib twice daily (Q12h), which may be continued for up to 2 years.
Drug: Revumenib
PK evaluation Period: Participants will receive a single Reduced Dose B of revumenib on Day 1. Optional Treatment Period: If the Investigator believes it is in the best clinical interest of the participant, the participant may start the Optional Treatment Period immediately after completing the PK Evaluation Period on Study Day 2. Participants who start the Optional Treatment Period will receive revumenib twice daily, which may be continued for up to 2 years.
Drug: Revumenib
PK evaluation Period: Participants will receive a single Recommended Dose of revumenib on Day 1. Optional Treatment Period: If the Investigator believes it is in the best clinical interest of the participant, the participant may start the Optional Treatment Period immediately after completing the PK Evaluation Period on Study Day 2. Participants who start the Optional Treatment Period will receive revumenib twice daily, which may be continued for up to 2 years.
Drug: Revumenib
Administered as oral tablets.
Also known as: SNDX-5613
Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of Revumenib
Time frame: Up to 1 day postdose
Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of M1
Time frame: Up to 1 day postdose
Maximum Observed Concentration (Cmax) of Revumenib
Time frame: Up to 1 day postdose
Maximum Observed Concentration (Cmax) of M1
Time frame: Up to 1 day postdose
Terminal Elimination Half-Life (t1/2) of Revumenib
Time frame: Up to 1 day postdose
Terminal Elimination Half-Life (t1/2) of M1
Time frame: Up to 1 day postdose
Number of Participants With Adverse Events
Time frame: Up to 25 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Revumenib