Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2
Public ClinicalTrials.gov record NCT04229979. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04229979
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 127 participants
Conditions and interventions
Conditions
Interventions
- Galinpepimut-S Biological
- Azacitidine Drug
- Venetoclax Drug
- Decitabine Drug
- Cytarabine Drug
- Observation Other
- GM-CSF Biological
- Montanide Other
Biological · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 7, 2021
- Primary completion
- Nov 30, 2025
- Completion
- Nov 30, 2026
- Last update posted
- Sep 30, 2025
2021 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| O'Neal Comprehensive Cancer Center | Birmingham | Alabama | 35205 | — |
| UCLA Medical Hematology and Oncology | Los Angeles | California | 90095 | — |
| The Oncology Institute of Hope and Innovation | Whittier | California | 90603 | — |
| Colorado Blood Cancer Institute - SCRI - PPDS | Denver | Colorado | 80218 | — |
| Mayo Clinic Jacksonville Florida | Jacksonville | Florida | 32224 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Rush University Cancer Center | Chicago | Illinois | 60612 | — |
| Tulane Cancer Center - Liberty | New Orleans | Louisiana | 70112 | — |
| Northwell Health Cancer Institute | Lake Success | New York | 11042 | — |
| New York Medical College | Valhalla | New York | 10532 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Bon Secours St. Francis Cancer Center | Greenville | South Carolina | 29607 | — |
| Baylor Scott and White Research Institute | Dallas | Texas | 75246 | — |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Virginia Cancer Specialists | Gainesville | Virginia | 20155 | — |
| Swedish Cancer Institute | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04229979, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 30, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04229979 live on ClinicalTrials.gov.