drugset / Trial / NCT04229979
Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2
RandomizedParallel-groupOpen-labelTreatment
Summary
To assess the safety and efficacy of galinpepimut-S (GPS) compared with investigator's choice of best available therapy (BAT) on overall survival (OS) in subjects with acute myeloid leukemia (AML) who are in second or later complete remission (CR2) or second or later complete remission with incomplete platelet recovery (CRp2).
Timeline
- Start
- 2021-02-08
- Primary completion
- 2025-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | — | Other |
| Comparator | Cytarabine | Small molecule | — | Other |
| Comparator | Decitabine | Small molecule | — | Other |
| Subject | Galinpepimut-S | Vaccine | — | Subcutaneous |
| Comparator | Venetoclax | Small molecule | — | — |
| Background | sargramostim | Protein / enzyme biologic | 70 ug | Subcutaneous |