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Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2

NCT04229979 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2025-10-01

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

Galinpepimut-S

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

DRUG

Azacitidine

injection

DRUG

Venetoclax

tablet

DRUG

Decitabine

injection

DRUG

Cytarabine

injection

OTHER

Observation

palliative management

BIOLOGICAL

GM-CSF

subcutaneous injection

OTHER

Montanide

adjuvant

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Sellas Life Sciences Group

    lead INDUSTRY

Principal Investigators

  • Dragan Cicic Chief Development Officer, MD · Sellas Life Sciences Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Poland
  • Serbia
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04229979 on ClinicalTrials.gov