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ACTIVE NOT RECRUITING Phase 3

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

NCT04229979 · View on ClinicalTrials.gov ↗

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 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

FieldValue
Enrollment Target 127 participants
Start Date 2021-02-08
Est. Completion 2026-12
Phase Phase 3

Sponsor

Sellas Life Sciences Group

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04229979

The ClinicalTrials.gov registry entry for NCT04229979 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sellas Life Sciences Group, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04229979 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04229979?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Decitabine (DRUG), Cytarabine (DRUG), Galinpepimut-S (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04229979?

This trial is sponsored by Sellas Life Sciences Group, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial