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NCT04065399 (Revumenib in mNPM1-mutant relapsed/refractory Leukemias): BVCT ex-ante prediction vs. reported outcome

On 18 Jun 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 12 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (non-superior efficacy compared with SoC).

Clinical Trial

NCTID
NCT04065399
Acronym
AUGMENT-101
Drug Name
Revumenib (SNDX-5613)
Drug MoA
MENIN-MLL1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
mNPM1-mutant relapsed/refractory Leukemias
Human Patients
413
Sponsor
Syndax Pharmaceuticals
Phase
Phase 2

Prediction of , index 943

Prospective Prediction
Prediction Index
943
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
513 days in advance
Readout Data Interpretation
Revumenib achieved 23% CR/CRh; which is inferior to CLT019's 81% CR
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (non-superior efficacy compared with SoC)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
447
Lead sponsor
Syndax Pharmaceuticals
Conditions
Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Mixed Lineage Acute Leukemia; Mixed Phenotype Acute Leukemia; Acute Leukemia of Ambiguous Lineage
Interventions
DRUG: revumenib; DRUG: cobicistat
Design
Sequential · None
Primary purpose
Treatment
Start
2019-11-05
Primary completion
2027-12-15
Completion
2027-12-15
Primary outcomes
  • Number of participants with dose-limiting toxicities (DLTs) (Phase 1) (Approximately 1 year)
  • Number of participants with treatment-emergent adverse events (TEAEs) (Phase 1) (Approximately 1 year)
  • Cmax (Phase 1) (Approximately 1 year)
  • Tmax (Phase 1) (Approximately 1 year)
  • AUC0-t (Phase 1) (Approximately 1 year)

NCT04065399 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials