A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects with Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516405-23-00

Acronym

SLSG18-301

Enrollment

101

Registered

2024-10-31

Start date

2021-06-08

Completion date

Unknown

Last updated

2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia (AML) in second or later complete remission (CR2) or second or later complete remission with incomplete platelet recovery (CRp2)

Brief summary

Median overall survival (OS)

Detailed description

Leukemia Free Survival (LFS); 6-, 9-, and 12-month OS; 6-, 9-, and 12- month LFS, and presence of MRD.

Interventions

DRUGAzacitidine Accord 25 mg/mL powder for suspension for injection

DRUGSargramostim (GM-CSF)

DRUGAlexan 20 mg/ml oldatos injekció vagy infúzió

DRUGGalinpepimut-S

DRUGVidaza 25 mg/ml powder for suspension for injection

DRUGVenclyxto 100 mg film-coated tablets

DRUGDacogen 50 mg powder for concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Median overall survival (OS)	—

Secondary

Measure	Time frame
Leukemia Free Survival (LFS); 6-, 9-, and 12-month OS; 6-, 9-, and 12- month LFS, and presence of MRD.	—

Countries

France, Germany, Greece, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026