revumenib (SNDX-5613) / Syndax Pharma 
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17 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
revumenib (SNDX-5613) / Syndax Pharma
NCT06284486: A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

Not yet recruiting
2
8
US
Venetoclax, ABT-199, GDC-0199, Revumenib, SNDX-5613
M.D. Anderson Cancer Center, Syndax Pharmaceuticals, Break Through Cancer, AbbVie
Acute Myeloid Leukemia
12/26
12/28
NCT06229912: A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes

Recruiting
2
15
US
Revumenib, SNDX- 5613
M.D. Anderson Cancer Center, Syndax Pharmaceuticals
Leukemia, HOX Gene
12/26
12/28
NCT05761171: A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

Recruiting
2
78
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Calaspargase Pegol, Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl), Asparlas, Calaspargase Pegol-mknl, EZN-2285, SC-PEG E. Coli L-Asparaginase, Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Echocardiography, EC, Fludarabine Phosphate, 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara, SH T 586, Hydrocortisone Sodium Succinate, (11beta)-21-(3-Carboxy-1-oxopropyl)-11,17-dihydroxypregn-4-ene-3,20-dione, Monosodium Salt, A-Hydrocort, Buccalsone, Corlan, Cortisol Sodium Succinate, Cortop, Efcortelan, Emergent-EZ, Flebocortid, Hidroc Clora, Hycorace, Hydro-Adreson, Hydrocort, Hydrocortisone 21-Sodium Succinate, Hydrocortisone Na Succinate, Kinogen, Nordicort, Nositrol, Sinsurrene, Sodium hydrocortisone succinate, Solu-Cortef, Solu-Glyc, Lumbar Puncture, LP, Spinal Tap, Methotrexate, Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Prednisolone, (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione, .delta.1-Hydrocortisone, Adnisolone, Aprednislon, Capsoid, Cortalone, Cortisolone, Dacortin H, Decaprednil, Decortin H, Delta(1)Hydrocortisone, Delta- Cortef, Delta-Cortef, Delta-Diona, Delta-F, Delta-Phoricol, Delta1-dehydro-hydrocortisone, Deltacortril, Deltahydrocortisone, Deltasolone, Deltidrosol, Dhasolone, Di-Adreson-F, Dontisolon D, Estilsona, Fisopred, Frisolona, Gupisone, Hostacortin H, Hydeltra, Hydeltrasol, Klismacort, Kuhlprednon, Lenisolone, Lepi-Cortinolo, Linola-H N, Linola-H-Fett N, Longiprednil, Metacortandralone, Meti Derm, Meticortelone, Opredsone, Panafcortelone, Precortisyl, Pred-Clysma, Predeltilone, Predni-Coelin, Predni-Helvacort, Prednicortelone, Prednisolonum, Prelone, Prenilone, Sterane, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Revumenib, Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613, SNDX-5613, SNDX5613, Vincristine Sulfate, Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate
Children's Oncology Group
Recurrent Acute Leukemia of Ambiguous Lineage, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage, Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged, Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Refractory Acute Leukemia of Ambiguous Lineage, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage, Refractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged, Refractory Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia, Refractory Mixed Phenotype Acute Leukemia
12/27
12/27
ACTRN12622000582752: AMLM26/T4 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - SNDX5613

Recruiting
1/2
92
 
Australasian Leukaemia & Lymphoma Group, Australasian Leukaemia & Lymphoma Group
acute myeloid leukaemia
 
 
NCT05731947: Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors

Recruiting
1/2
158
US
Revumenib, SNDX-5613, Chemotherapy
Syndax Pharmaceuticals
Colorectal Cancer, Solid Tumors
12/24
08/27
Beat AML, NCT03013998: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Hourglass Jan 2023 - Mar 2023 : Data from Beat AML trial for acute myeloid leukemia
Recruiting
1/2
2000
US
Samalizumab (BAML-16-001-S1), BI 836858 (BAML-16-001-S2), Laboratory Biomarker Analysis, Daunorubicin (BAML-16-001-S1), Cytarabine (BAML-16-001-S1), Azacitidine (BAML-16-001-S2), AG-221 (BAML-16-001-S3), Enasidenib, Azacitidine (BAML-16-001-S3), Entospletinib (BAML-16-001-S4), GS-9973, ENTO, Azacitidine (BAML-16-001-S4), Entospletinib (BAML-16-001-S5), Decitabine (BAML-16-001-S5), Entospletinib (BAML-16-001-S6), Daunorubicin (BAML-16-001-S6), Cytarabine (BAML-16-001-S6), Pevonedistat (BAML-16-001-S9), TAK-924, MLN4924, Azacitidine (BAML-16-001-S9), AG-120 (BAML-16-001-S16), Azacitidine (BAML-16-001-S16), Gilteritinib (BAML-16-001-S8 Group 1), Decitabine (BAML-16-001-S8 Group 1), AZD5153 (BAML-16-001-S10), Venetoclax (BAML-16-001-S10), TP-0903 (BAML-16-001-S14), Decitabine (BAML-16-001-S14), Decitabine (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S8 Group 2), AZD5991 (BAML-16-001-S18), Azacitidine (BAML-16-001-S18), SNDX-5613 (BAML-16-001-S17), Azacitidine (BAML-16-001-S17), Venetoclax (BAML-16-001-S17), Gilteritinib (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S12 Arm A), Azacitidine (BAML-16-001-S12 Arm A), Venetoclax (BAML-16-001-S12 Arm B), Azacitidine (BAML-16-001-S12 Arm B), ZE46-0134 (BAML-16-001-S21)
Beat AML, LLC
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
12/26
12/26
AUGMENT-101, NCT04065399 / 2020-004104-34: A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Calendar Jan 2024 - Dec 2024: Market entry for acute leukemias
Hourglass Feb 2024 - Mar 2024 : Q1'24 - PDUFA date from FDA for R/R KMT2Ar acute leukemia
Dec 2022 - Dec 2023: Submission in US for relapsed/refractory acute leukemia
Jul 2023 - Sep 2023: Data from AUGMENT-101 trial for r/r AML
Checkmark Updated data from P1 portion of P1/2 AUGMENT-101 trial for AML
More
Recruiting
1/2
413
Europe, Canada, US, RoW
revumenib, SNDX-5613, cobicistat
Syndax Pharmaceuticals, Syndax Pharmaceuticals, Inc
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage
12/24
12/24
SAVE, NCT05360160: A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia

Recruiting
1/2
43
US
SNDX-5613, Venetoclax, ASTX727
M.D. Anderson Cancer Center, Astex Pharmaceuticals, Inc., Syndax Pharmaceuticals
Acute Myeloid Leukemia
12/26
12/26
NCT06222580: SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

Recruiting
1
30
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration and Biopsy, Gilteritinib, ASP-2215, ASP2215, Revumenib, Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613, SNDX-5613, SNDX5613
Uma Borate
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
12/25
12/25
NCT05886049: Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene

Recruiting
1
28
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Daunorubicin, Daunomycin, Daunorrubicina, DNR, Leukaemomycin C, Rubidomycin, Rubomycin C, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Revumenib, Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613, SNDX-5613, SNDX5613, Transthoracic Echocardiography, TTE
National Cancer Institute (NCI)
Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation
12/27
12/27
AUGMENT-102, NCT05326516: A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia

Hourglass Jan 2023 - Mar 2023 : Data from AUGMENT-102 trial for relapsed/refractory leukemias
Completed
1
30
Canada, US
Revumenib, SNDX-5613, Chemotherapy Regimen 1, Chemotherapy Regimen 2
Syndax Pharmaceuticals
Relapsed/Refractory Leukemias, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Mixed Phenotype Acute Leukemia, Acute Myeloid Leukemia, Acute Undifferentiated Leukemia
07/24
07/24
NCT06177067: Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Recruiting
1
24
US
Revumenib, SNDX-5613, Venetoclax, Venclextra®, Azacitidine, VIDAZA®, 5-azacitidine, intrathecal (IT) chemotherapy, ITMHA, methotrexate/hydrocortisone/cytarabine, Cytarabine, Ara-C, Cytosar®, Methotrexate, MTX, Trexall®
St. Jude Children's Research Hospital, Syndax Pharmaceuticals
Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Acute Leukemia of Ambiguous Lineage
01/26
07/26
NCT05406817: Study of Radiolabeled Revumenib in Adults With Acute Leukemia

Recruiting
1
8
US
Revumenib, SNDX-5613
Syndax Pharmaceuticals
Acute Leukemia
09/24
12/24
NCT06226571: A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Recruiting
1
76
US
SNDX-5613, Chemotherapy Regimen, HiDAC
Syndax Pharmaceuticals
Acute Myeloid Leukemias
02/27
02/27
NCT06313437: Revumenib in Combination With 7+3 + Midostaurin in AML

Not yet recruiting
1
22
US
Revumenib, SNDX-5613, Trans N-ethyl-2-((4-(7-((4-(ethylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2- yl)pyrimidin-5-yl)oxy)-5-fluoro-N-isopropylbenzamide, Midostaurin, Rydapt, Cytarabine, cytosine arabinoside (ara-C), Daunorubicin, Daunomycin
Maximilian Stahl, MD, Syndax Pharmaceuticals
Acute Myeloid Leukemia, AML, Adult, AML With Gene Mutations, AML, Leukemia
03/26
03/27
NCT06575296: Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant

Not yet recruiting
1
27
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Echocardiography, EC, Electronic Health Record Review, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, Revumenib, Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613, SNDX-5613, SNDX5613
City of Hope Medical Center, National Cancer Institute (NCI)
Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Childhood Acute Leukemia, Childhood Acute Leukemia of Ambiguous Lineage, Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia
12/25
12/25
NCT05918913: Expanded Access Program for Revumenib

Available
N/A
US
Revumenib, SNDX-5613
Syndax Pharmaceuticals
Relapsed/Refractory Acute Leukemia
 
 

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