Acute Myeloid LeukemiasPhase 3REVEAL-ND NPM1NCT07211958
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
A Phase 3 study testing Revumenib and Intensive Chemotherapy Regimen in people with Acute Myeloid Leukemias, run by Syndax Pharmaceuticals at 173 sites in 23 countries.
Trial summary
The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Myeloid Leukemias
- What is being tested?
- Revumenib and Intensive Chemotherapy Regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 173 sitesin 23 countries
- Study dates
- 25 Nov 2025to Jan 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy.
- Presence of an NPM1 mutation.
- Eastern Cooperative Oncology Group performance status ≤2 (≤1 if >65 years old); Karnofsky or Lansky ≥40.
- Have a life expectancy of ≥3 months as judged by the Investigator.
- Negative serum pregnancy test.
- Adequate liver, kidney, and cardiac function.
Who cannot join
- Diagnosis of active acute promyelocytic leukemia.
- Active central nervous system disease.
- Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
- Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.
- Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).
- Inability to swallow oral medication.
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- Pregnant or nursing females.
- Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
173 sites in 23 countries. Contact the study team or a site near you to ask about taking part.
173 sites in 23 countries
Italy24 sites, 24 recruiting
- Recruiting
Clinical Trial Site
Alessandria, 15121
- Recruiting
Clinical Trial Site
Bari, 70124
- Recruiting
Clinical Trial Site
Bergamo, 24127
- Recruiting
Clinical Trial Site
Bologna, 40138
- Recruiting
Clinical Trial Site
Brescia, 25123
- Recruiting
Clinical Trial Site
Candiolo, 10060
- Recruiting
Clinical Trial Site
Florence, 50134
- Recruiting
Clinical Trial Site
Meldola, 47014
- Recruiting
Clinical Trial Site
Milan, 20132
- Recruiting
Clinical Trial Site
Milan, 20141
- Recruiting
Clinical Trial Site
Milan, 20162
- Recruiting
Clinical Trial Site
Monza, Monza E Brianza, 20900
- Recruiting
Clinical Trial Site
Naples, 80131
- Recruiting
Clinical Trial Site
Palermo, 90146
- Recruiting
Clinical Trial Site
Pavia, 27100
- Recruiting
Clinical Trial Site
Perugia, 06132
- Recruiting
Clinical Trial Site
Pesaro, Pesaro E Urbino, 61122
- Recruiting
Clinical Trial Site
Pisa, 56126
- Recruiting
Clinical Trial Site
Reggio Emilia, 42123
- Recruiting
Clinical Trial Site
Rimini, 47923
- Recruiting
Clinical Trial Site
Roma, 00165
- Recruiting
Clinical Trial Site
Roma, 00168
- Recruiting
Clinical Trial Site
Torino, 10128
- Recruiting
Clinical Trial Site
Udine, 33100
Spain24 sites, 24 recruiting
- Recruiting
Clinical Trial Site
Alicante, 03010
- Recruiting
Clinical Trial Site
Badalona, Barcelona, 08916
- Recruiting
Clinical Trial Site
Barcelona, 08035
- Recruiting
Clinical Trial Site
Barcelona, 08036
- Recruiting
Clinical Trial Site
Barcelona, 08041
- Recruiting
Clinical Trial Site
Burgos, 09006
- Recruiting
Clinical Trial Site
Cáceres, 10003
- Recruiting
Clinical Trial Site
Granada, 18014
- Recruiting
Clinical Trial Site
L'Hospitalet de Llobregat, Barcelona, 08908
- Recruiting
Clinical Trial Site
Las Palmas de Gran Canaria, Canary Islands, 35010
- Recruiting
Clinical Trial Site
Madrid, 28007
- Recruiting
Clinical Trial Site
Madrid, 28009
- Recruiting
Clinical Trial Site
Madrid, 28033
- Recruiting
Clinical Trial Site
Madrid, 28034
- Recruiting
Clinical Trial Site
Madrid, 28040
- Recruiting
Clinical Trial Site
Madrid, 28046
- Recruiting
Clinical Trial Site
Málaga, 29010
- Recruiting
Clinical Trial Site
Oviedo, Principality of Asturias, 33011
- Recruiting
Clinical Trial Site
Palma, 07120
- Recruiting
Clinical Trial Site
Pamplona, 31008
- Recruiting
Clinical Trial Site
Salamanca, 37007
- Recruiting
Clinical Trial Site
Santander, Cantabria, 39008
- Recruiting
Clinical Trial Site
Seville, 41013
- Recruiting
Clinical Trial Site
Valencia, 46026
France13 sites, 13 recruiting
- Recruiting
Clinical Trial Site
Angers, Loire-Atlantique, 44093
- Recruiting
Clinical Trial Site
Bayonne, 64100
- Recruiting
Clinical Trial Site
Caen, Calvados, 14033 Cedex
- Recruiting
Clinical Trial Site
Le Chesnay, Yvelines, 78150
- Recruiting
Clinical Trial Site
Lille, Nord, 59037
- Recruiting
Clinical Trial Site
Limoges, Haute-Vienne, 87042
- Recruiting
Clinical Trial Site
Marseille, Bouches-Du-Rhône, 13009
- Recruiting
Clinical Trial Site
Nice, Alpes-Maritimes, 06200
- Recruiting
Clinical Trial Site
Paris, 75012
- Recruiting
Clinical Trial Site
Pessac, Pas-de-Calais, 33608
- Recruiting
Clinical Trial Site
Pierre-Bénite, Rhône, 69495
- Recruiting
Clinical Trial Site
Rouen, Haute-Normandie, 76000
- Recruiting
Clinical Trial Site
Strasbourg, Bas-Rhin, 67098
United States11 sites, 11 recruiting
- Recruiting
Clinical Trial Site
Chapel Hill, North Carolina, 27599
- Recruiting
Clinical Trial Site
Duarte, California, 91010
- Recruiting
Clinical Trial Site
Farmington, Connecticut, 06030
- Recruiting
Clinical Trial Site
Goodyear, Arizona, 85338
- Recruiting
Clinical Trial Site
Greenville, South Carolina, 29605
- Recruiting
Clinical Trial Site
Houston, Texas, 77030
- Recruiting
Clinical Trial Site
Indianapolis, Indiana, 46237
- Recruiting
Clinical Trial Site
Morristown, New Jersey, 07962
- Recruiting
Clinical Trial Site
Providence, Rhode Island, 02903
- Recruiting
Clinical Trial Site
Shreveport, Louisiana, 71103
- Recruiting
Clinical Trial Site
Tampa, Florida, 33606
Australia11 sites, 11 recruiting
- Recruiting
Clinical Trial Site
Douglas, Queensland, 4811
- Recruiting
Clinical Trial Site
Gosford, 2250
- Recruiting
Clinical Trial Site
Kingswood, New South Wales, 2747
- Recruiting
Clinical Trial Site
Kogarah, New South Wales, 2217
- Recruiting
Clinical Trial Site
Melbourne, Victoria, 3004
- Recruiting
Clinical Trial Site
Nedlands, Western Australia, 6009
- Recruiting
Clinical Trial Site
Parkville, Victoria, 3052
- Recruiting
Clinical Trial Site
Perth, Western Australia, 6000
- Recruiting
Clinical Trial Site
Randwick, New South Wales, 2031
- Recruiting
Clinical Trial Site
South Brisbane, Queensland, 4101
- Recruiting
Clinical Trial Site
Wollongong, 2500
Germany11 sites, 11 recruiting
- Recruiting
Clinical Trial Site
Braunschweig, Lower Saxony, 38114
- Recruiting
Clinical Trial Site
Chemnitz, Saxony, 09116
- Recruiting
Clinical Trial Site
Düsseldorf, North Rhine-Westphalia, 40479
- Recruiting
Clinical Trial Site
Hamburg, 20251
- Recruiting
Clinical Trial Site
Heidelberg, Baden-Wurttemberg, 69120
- Recruiting
Clinical Trial Site
Herne, North Rhine-Westphalia, 44625
- Recruiting
Clinical Trial Site
Jena, Thuringia, 07747
- Recruiting
Clinical Trial Site
Leipzig, Saxony, 04103
- Recruiting
Clinical Trial Site
Minden, North Rhine-Westphalia, 32429
- Recruiting
Clinical Trial Site
Stuttgart, Baden-Wurttemberg, 70376
- Recruiting
Clinical Trial Site
Tübingen, Baden-Wurttemberg, 72076
South Korea9 sites, 9 recruiting
- Recruiting
Clinical Trial Site
Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], 47392
- Recruiting
Clinical Trial Site
Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], 49201
- Recruiting
Clinical Trial Site
Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], 49241
- Recruiting
Clinical Trial Site
Busan, 48108
- Recruiting
Clinical Trial Site
Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], 41944
- Recruiting
Clinical Trial Site
Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], 42472
- Recruiting
Clinical Trial Site
Goyang-si, 10408
- Recruiting
Clinical Trial Site
Seoul, 03080
- Recruiting
Clinical Trial Site
Seoul, 06591
United Kingdom8 sites, 8 recruiting
- Recruiting
Clinical Trial Site
Aberdeen, AB25 2ZN
- Recruiting
Clinical Trial Site
Derby, DE22 3NE
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Clinical Trial Site
Leicester, LE1 5WW
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Clinical Trial Site
Lincoln, LN2 5QY
- Recruiting
Clinical Trial Site
London, W12 0HS
- Recruiting
Clinical Trial Site
Oxford, Oxfordshire, OX3 7LJ
- Recruiting
Clinical Trial Site
Southampton, SO16 6YD
- Recruiting
Clinical Trial Site
Sutton, SM2 5PT
Austria7 sites, 7 recruiting
- Recruiting
Clinical Trial Site
Graz, Styria, 8036
- Recruiting
Clinical Trial Site
Innsbruck, Tyrol, 6020
- Recruiting
Clinical Trial Site
Klagenfurt, Kaerten, 9020
- Recruiting
Clinical Trial Site
Leoben, Styria, 8700
- Recruiting
Clinical Trial Site
Linz, 4030
- Recruiting
Clinical Trial Site
Sankt Pölten, Lower Austria, 3100
- Recruiting
Clinical Trial Site
Vienna, 1100
Israel7 sites, 7 recruiting
- Recruiting
Clinical Trial Site
Haifa, 3109601
- Recruiting
Clinical Trial Site
Jerusalem, Jerusalem, 9124001
- Recruiting
Clinical Trial Site
Jerusalem, 91031
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Clinical Trial Site
Jerusalem, 91120
- Recruiting
Clinical Trial Site
Petah Tikva, Central District, 4941492
- Recruiting
Clinical Trial Site
Tel Aviv, Tel Aviv, 6423906
- Recruiting
Clinical Trial Site
Tel Litwinsky, Tel Aviv, 5265601
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Clinical Trial Site
Alsancak, İzmir, 35575
- Recruiting
Clinical Trial Site
Ankara, 06100
- Recruiting
Clinical Trial Site
Antalya, 07025
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Clinical Trial Site
Gaziantep, 27080
- Recruiting
Clinical Trial Site
Mezitli, Mersin, 33200
- Recruiting
Clinical Trial Site
Şişli, Istanbul, 34385
Argentina5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Adrogué, Buenos Aires, C1430EFA
- Recruiting
Clinical Trial Site
Buenos Aires, Buenos Aires F.D., 1181
- Recruiting
Clinical Trial Site
Buenos Aires, C1039
- Recruiting
Clinical Trial Site
Córdoba, Córdoba Province, X5000
- Recruiting
Clinical Trial Site
Salta, A4400
Brazil5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Barretos, São Paulo, 14784-400
- Recruiting
Clinical Trial Site
Fortaleza, Paraná, 60430-372
- Recruiting
Clinical Trial Site
Jaú, 17210-080
- Recruiting
Clinical Trial Site
Porto Alegre, 90610-910
- Recruiting
Clinical Trial Site
São Paulo, Estado de Bahia, 05651-901
Georgia5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Batumi, Adjara, 6000
- Recruiting
Clinical Trial Site
Tbilisi, 0112
- Recruiting
Clinical Trial Site 1
Tbilisi, 0159
- Recruiting
Clinical Trial Site 2
Tbilisi, 0159
- Recruiting
Clinical Trial Site
Tbilisi, 0186
Romania5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Bucharest, 020125
- Recruiting
Clinical Trial Site
Bucharest, 030171
- Recruiting
Clinical Trial Site
Cluj-Napoca, 400015
- Recruiting
Clinical Trial Site
Iași, 700483
- Recruiting
Clinical Trial Site
Târgu Mureş, Mureș County, 540136
Hungary4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Budapest, 1088
- Recruiting
Clinical Trial Site
Debrecen, Hajdú-Bihar, H-4032
- Recruiting
Clinical Trial Site
Győr, Gyor-Moson-Sopron Varmegye, H-9024
- Recruiting
Clinical Trial Site
Szekszárd, Tolna County, 7100
Malaysia4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Johor Bahru, Johor, 80000
- Recruiting
Clinical Trial Site
Kuala Lumpur, 59100
- Recruiting
Clinical Trial Site
Petaling Jaya, 46050
- Recruiting
Clinical Trial Site
Subang Jaya, 46150
Singapore4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Singapore, Central Singapore, 169608
- Recruiting
Clinical Trial Site
Singapore, Central Singapore, 308433
- Recruiting
Clinical Trial Site
Singapore, South West, 119074
- Recruiting
Clinical Trial Site
Singapore, South West, 228510
Canada3 sites, 3 recruiting
- Recruiting
Clinical Trial Site
London, Ontario, N6A 5W9
- Recruiting
Clinical Trial Site
Montreal, H1T 2M4
- Recruiting
Clinical Trial Site
Toronto, M5G 2C1
Poland3 sites, 3 recruiting
- Recruiting
Clinical Trial Site
Olsztyn, Warmian-Masurian Voivodeship, 10-228
- Recruiting
Clinical Trial Site
Opole, Opole Voivodeship, 45-061
- Recruiting
Clinical Trial Site
Wałbrzych, Kuyavian-Pomeranian Voivodeship, 58-309
Greece2 sites, 2 recruiting
- Recruiting
Clinical Trial Site
Athens, Attica, 124 62
- Recruiting
Clinical Trial Site
Patras, North Aegean, 26504
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation
The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.
- Conditions
- Acute Myeloid Leukemias
- Being tested
- Revumenib, Placebo, Intensive Chemotherapy Regimen
- Keywords
- SNDX-5613, Nucleophosmin 1, NPM1, Acute Myeloid Leukemias, AML, Revumenib, Newly diagnosed AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevumenibDrug
Also called SNDX-5613
Participants will receive revumenib orally.
PlaceboDrug
Participants will receive placebo (non-active agent) orally.
Intensive Chemotherapy RegimenDrug
Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Revumenib + Intensive Chemotherapy | Experimental | Participants will receive revumenib plus an intensive chemotherapy regimen. Receives: Drug: Revumenib; Drug: Intensive Chemotherapy Regimen |
| Placebo + Intensive Chemotherapy | Placebo comparator | Participants will receive placebo plus an intensive chemotherapy regimen. Receives: Drug: Placebo; Drug: Intensive Chemotherapy Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
Measured: Up to 2 years
Measurable Residual Disease Complete Remission Rate
Measured: Up to 2 years
Secondary outcomes (9)
Overall Survival
Measured: Up to 5 years
Rate of Complete Remission
Measured: Up to 2 years
Rate of Composite Complete Remission
Measured: Up to 2 years
Overall Response Rate
Measured: Up to 2 years
Duration of Complete Remission
Measured: Up to 2 years
Duration of Composite Complete Remission
Measured: Up to 2 years
Duration of Response
Measured: Up to 2 years
Number of Participants with a Treatment-emergent Adverse Event
Measured: Up to 2 years
Change from Baseline in Patient-reported Fatigue Questionnaire Scores
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start25 Nov 2025
- Primary completionJun 2029 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211958
- Sponsor's protocol ID
- SNDX-5613-0710
- Other IDs
- 2025-522279-27-00, 2025
- Acronym
- REVEAL-ND NPM1
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation
- ClinicalTrials.gov ID
- NCT07211958
- Acronym / sponsor ID
- REVEAL-ND NPM1 / SNDX-5613-0710
- Conditions
- Acute Myeloid Leukemias
- Keywords
- SNDX-5613, Nucleophosmin 1, NPM1, Acute Myeloid Leukemias, AML, Revumenib, Newly diagnosed AML
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revumenib + Intensive Chemotherapy | Experimental | Drug: Revumenib, Drug: Intensive Chemotherapy RegimenParticipants will receive revumenib plus an intensive chemotherapy regimen. |
| Placebo + Intensive Chemotherapy | Placebo comparator | Drug: Placebo, Drug: Intensive Chemotherapy RegimenParticipants will receive placebo plus an intensive chemotherapy regimen. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy.
- Presence of an NPM1 mutation.
- Eastern Cooperative Oncology Group performance status ≤2 (≤1 if >65 years old); Karnofsky or Lansky ≥40.
- Have a life expectancy of ≥3 months as judged by the Investigator.
- Negative serum pregnancy test.
Key exclusion criteria (9 listed)
- Diagnosis of active acute promyelocytic leukemia.
- Active central nervous system disease.
- Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
- Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.
- Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevumenibAlso: SNDX-5613Participants will receive revumenib orally. | Drug | Revumenib + Intensive Chemotherapy |
| PlaceboParticipants will receive placebo (non-active agent) orally. | Drug | Placebo + Intensive Chemotherapy |
| Intensive Chemotherapy RegimenParticipants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion. | Drug | Placebo + Intensive Chemotherapy, Revumenib + Intensive Chemotherapy |
Primary outcome
Event Free Survival
Time frame: Up to 2 years
Measurable Residual Disease Complete Remission Rate
Time frame: Up to 2 years
9 secondary outcomes
Overall Survival
Time frame: Up to 5 years
Rate of Complete Remission
Time frame: Up to 2 years
Rate of Composite Complete Remission
Time frame: Up to 2 years
Overall Response Rate
Time frame: Up to 2 years
Duration of Complete Remission
Time frame: Up to 2 years
Duration of Composite Complete Remission
Time frame: Up to 2 years
Duration of Response
Time frame: Up to 2 years
Number of Participants with a Treatment-emergent Adverse Event
Time frame: Up to 2 years
Change from Baseline in Patient-reported Fatigue Questionnaire Scores
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
173 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Revumenib and Intensive Chemotherapy Regimen in people with Acute Myeloid Leukemias, run by Syndax Pharmaceuticals at 173 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 173 sites in Italy, Spain, France, United States, Australia and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syndax Pharmaceuticals (781-419-1400, clinicaltrials@syndax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Free Survival (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.