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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522279-27-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revumenib + Intensive Chemotherapy | Experimental | Participants will receive revumenib plus an intensive chemotherapy regimen. |
|
| Placebo + Intensive Chemotherapy | Placebo Comparator | Participants will receive placebo plus an intensive chemotherapy regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revumenib | Drug | Participants will receive revumenib orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival | Up to 2 years | |
| Measurable Residual Disease Complete Remission Rate | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Up to 5 years | |
| Rate of Complete Remission | Up to 2 years | |
| Rate of Composite Complete Remission |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Syndax Pharmaceuticals | Contact | 781-419-1400 | clinicaltrials@syndax.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Recruiting | Melbourne | Victoria | 3004 | Australia | |
| Clinical Trial Site |
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| Placebo | Drug | Participants will receive placebo (non-active agent) orally. |
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| Intensive Chemotherapy Regimen | Drug | Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion. |
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| Up to 2 years |
| Overall Response Rate | Up to 2 years |
| Duration of Complete Remission | Up to 2 years |
| Duration of Composite Complete Remission | Up to 2 years |
| Duration of Response | Up to 2 years |
| Number of Participants with a Treatment-emergent Adverse Event | Up to 2 years |
| Change from Baseline in Patient-reported Fatigue Questionnaire Scores | Up to 2 years |
| Recruiting |
| Gosford |
| 2250 |
| Australia |
| Clinical Trial Site | Recruiting | Wollongong | 2500 | Australia |
| Clinical Trial Site | Recruiting | Linz | 4030 | Austria |
| Clinical Trial Site | Recruiting | Ghent | 9000 | Belgium |
| Clinical Trial Site | Recruiting | Jaú | 17210-080 | Brazil |
| Clinical Trial Site | Recruiting | Porto Alegre | 90610-910 | Brazil |
| Clinical Trial Site | Recruiting | Montreal | H1T 2M4 | Canada |
| Clinical Trial Site | Recruiting | Toronto | M5G 2C1 | Canada |
| Clinical Trial Site | Recruiting | Bayonne | 64100 | France |
| Clinical Trial Site | Recruiting | Bordeaux | 33000 | France |
| Clinical Trial Site | Recruiting | Batumi | Adjara | 6000 | Georgia |
| Clinical Trial Site | Recruiting | Tbilisi | 0112 | Georgia |
| Clinical Trial Site 1 | Recruiting | Tbilisi | 0159 | Georgia |
| Clinical Trial Site 2 | Recruiting | Tbilisi | 0159 | Georgia |
| Clinical Trial Site | Recruiting | Tbilisi | 0186 | Georgia |
| Clinical Trial Site | Recruiting | Düsseldorf | North Rhine-Westphalia | 40479 | Germany |
| Clinical Trial Site | Recruiting | Herne | North Rhine-Westphalia | 44625 | Germany |
| Clinical Trial Site | Recruiting | Jena | Thuringia | 07747 | Germany |
| Clinical Trial Site | Recruiting | Hamburg | 20251 | Germany |
| Clinical Trial Site | Recruiting | Jerusalem | 91031 | Israel |
| Clinical Trial Site | Recruiting | Jerusalem | 91120 | Israel |
| Clinical Trial Site | Recruiting | Bergamo | 24127 | Italy |
| Clinical Trial Site | Recruiting | Candiolo | 10060 | Italy |
| Clinical Trial Site | Recruiting | Florence | 50134 | Italy |
| Clinical Trial Site | Recruiting | Meldola | 40-47014 | Italy |
| Clinical Trial Site | Recruiting | Milan | 20141 | Italy |
| Clinical Trial Site | Recruiting | Milan | 60-20132 | Italy |
| Clinical Trial Site | Recruiting | Palermo | 90146 | Italy |
| Clinical Trial Site | Recruiting | Pavia | 19-27100 | Italy |
| Clinical Trial Site | Recruiting | Rimini | 47923 | Italy |
| Clinical Trial Site | Recruiting | Udine | 15-33100 | Italy |
| Clinical Trial Site | Recruiting | Petaling Jaya | 46050 | Malaysia |
| Clinical Trial Site | Recruiting | Subang Jaya | 46150 | Malaysia |
| Clinical Trial Site | Recruiting | Bucharest | 020125 | Romania |
| Clinical Trial Site | Recruiting | Cluj-Napoca | 400015 | Romania |
| Clinical Trial Site | Recruiting | Busan | 48108 | South Korea |
| Clinical Trial Site | Recruiting | Goyang-si | 10408 | South Korea |
| Clinical Trial Site | Recruiting | Seoul | 03080 | South Korea |
| Clinical Trial Site | Recruiting | Seoul | 06591 | South Korea |
| Clinical Trial Site | Recruiting | Badalona | 08916 | Spain |
| Clinical Trial Site | Recruiting | Cáceres | 10003 | Spain |
| Clinical Trial Site | Recruiting | Madrid | 28007 | Spain |
| Clinical Trial Site | Recruiting | Madrid | 28033 | Spain |
| Clinical Trial Site | Recruiting | Palma | 07120 | Spain |
| Clinical Trial Site | Recruiting | Pamplona | 31008 | Spain |
| Clinical Trial Site | Recruiting | Seville | 41013 | Spain |
| Clinical Trial Site | Recruiting | Valencia | 46026 | Spain |
| Clinical Trial Site | Recruiting | Aberdeen | AB25 2ZN | United Kingdom |
| Clinical Trial Site | Recruiting | Lincoln | LN2 4AX | United Kingdom |
| Clinical Trial Site | Recruiting | London | W12 0HS | United Kingdom |
| Clinical Trial Site | Recruiting | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000728983 | revumenib |
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