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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 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.

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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).

Conditions Studied

Acute Myeloid Leukemia

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

6 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, categorized as Phase 3. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (10% higher). The listed sponsor is Sellas Life Sciences Group, which has 6 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.