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NCT05326516 (SNDX-5613 Chemotherapy Regimen 1… in R/​R Acute Leukemia): BVCT ex-ante prediction vs. reported outcome

On 18 Jun 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 14 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet non-superior compared with SoC CAR-T; thus commercially insufficient.

Clinical Trial

NCTID
NCT05326516
Acronym
AUGMENT-102
Drug Name
SNDX-5613 (Revumenib) Chemotherapy Regimen 1 Chemotherapy Regimen 2
Drug MoA
menin/KMT2A inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
R/​R Acute Leukemia
Human Patients
30
Sponsor
Syndax Pharmaceuticals
Phase
Phase 1

Prediction of , index 940

Prospective Prediction
Prediction Index
940
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
362 days in advance
Readout Data Interpretation
52% confirmed CR (vs 81% CR for CLT019).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet non-superior compared with SoC CAR-T; thus commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
AUGMENT-102: A Phase 1, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability and Preliminary Anti-Leukemic Activity of SNDX-5613 in Combination With Chemotherapy in Patients With Relapsed/Refractory Leukemias Harboring Alterations in KMT2A/MLL, Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes
Phase
Phase 1
Status
Completed
Enrollment
30
Lead sponsor
Syndax Pharmaceuticals
Conditions
Relapsed/Refractory Leukemias; Acute Lymphoblastic Leukemia; Acute Lymphocytic Leukemia; Mixed Phenotype Acute Leukemia; Acute Myeloid Leukemia; Acute Undifferentiated Leukemia
Interventions
DRUG: Revumenib; DRUG: Chemotherapy Regimen 1; DRUG: Chemotherapy Regimen 2
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2022-03-09
Primary completion
2024-07-29
Completion
2024-07-29
Primary outcomes
  • Number of Participants With Dose Limiting Toxicities From Revumenib (Day 1 through up to 30 days after last dose of study intervention)
  • Number of Participants With Treatment-emergent Adverse Events (Day 1 through up to 30 days after last dose of study intervention)

NCT05326516 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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