Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04229979 · ClinicalTrials.gov registry record · Phase 3
Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2
A Phase 3 study of Acute Myeloid Leukemia, sponsored by Sellas Life Sciences Group.
- Active
- Registry status
- Phase 3
- Development phase
- 127
- Enrollment target
- 20
- Study locations
NCT04229979: Active Phase 3 study of Acute Myeloid Leukemia, sponsored by Sellas Life Sciences Group.
NCT04229979 is a Phase 3 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Sellas Life Sciences Group. The registered enrollment target is 127 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04229979, a Phase 3 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Sellas Life Sciences Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 127 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Interval between randomization and death from any cause
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Decitabine
- DRUG Cytarabine
- BIOLOGICAL Galinpepimut-S
Study Locations (20)
Other
- CHU Amiens-Picardie - Hopital Sud - Amiens
- CHU Angers - Angers
- CHU de Caen - Caen
California
- UCLA Medical Hematology and Oncology - Los Angeles
- The Oncology Institute of Hope and Innovation - Whittier
New York
- Northwell Health Cancer Institute - Lake Success
- New York Medical College - Valhalla
Texas
- Baylor Scott and White Research Institute - Dallas
- University of Texas - MD Anderson Cancer Center - Houston
Alabama
- O'Neal Comprehensive Cancer Center - Birmingham
Colorado
- Colorado Blood Cancer Institute - SCRI - PPDS - Denver
Florida
- Mayo Clinic Jacksonville Florida - Jacksonville
Georgia
- Augusta University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2021-02-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What the registry record for NCT04229979 still lists
NCT04229979 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT04229979 names 20 study sites across 15 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT04229979 about?
NCT04229979 is a clinical study titled "Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2". 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 incomple...
What is the current status of trial NCT04229979?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 127 participants. The study started on 2021-02-08. Estimated completion is 2026-12.
What conditions does trial NCT04229979 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04229979?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Decitabine (DRUG), Cytarabine (DRUG), Galinpepimut-S (BIOLOGICAL).
Who is sponsoring clinical trial NCT04229979?
This trial is sponsored by Sellas Life Sciences Group, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04229979 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04229979's enrollment target sits among peer trials
127 64th of 306 higher than 243 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
RECRUITING · Phase 3
-
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
RECRUITING · Phase 3
-
Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome
ACTIVE NOT RECRUITING · Phase 3
-
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
ACTIVE NOT RECRUITING · Phase 3
-
Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
ACTIVE NOT RECRUITING · Phase 3
-
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03017820 · 127 participants · Phase 1
A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma
- NCT03609580 · 127 participants · Phase 1
Post-operative Urinary Retention (POUR) Following Thoracic Surgery
- NCT06285643 · 127 participants · Phase 2
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
- NCT06809400 · 127 participants · Phase 1
A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI