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

NCT04229979 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: SLSG18-301
• Study Type: interventional
• Target: 127
• Locations: 10 countries
• Sites: 73

Brief 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

Acute Myeloid Leukemia

Keywords

maintenance; complete remission; overall survival; galinpepimut-S; randomized; Wilms Tumor-1 protein

Outcome Measures

Primary Outcomes (1)

• OS

  Interval between randomization and death from any cause

  5 years

Secondary Outcomes (3)

• LFS

  5 years

• OS rate (%)

  At 6, 9 and 12 months

• LFS rate (%)

  At 6, 9, and 12 months

Study Arms (2)

Galinpepimut-S + Montanide + GM-CSF

EXPERIMENTAL

Galinpepimut-S injections will be administered as follows, until disease relapse: 1. First 6 galinpepimut-S injections: every 2 weeks (Weeks 0 - 10) followed by a 4-week period of no treatment. The first series of 6 injections of galinpepimut-S define the initial immunization induction phase. 2. Injections 7 to 12: every 4 weeks (Weeks 14 - 34) followed by a 6-week period of no treatment. The second series of injections of galinpepimut-S define the early immune booster phase. 3. Injections 13 to 15: every 6 weeks (Weeks 40 - 52). The third series of injections of galinpepimut-S define the late immune booster phase. 4. Injections 16-20: every 2 months (in Year 2). 5. Injection 21 and thereafter: every 3 months (in Year 3). Y2 and Y3 define the maintenance phase. Note: Galinpepimut-S is admixed with Montanide adjuvant before administered as a subcutaneous injection. GM-CSF is administered two days before and on the same day as the galinpepimut-S + Montanide injection.

Biological: Galinpepimut-S; Biological: GM-CSF; Other: Montanide

Best Available Therapy

ACTIVE COMPARATOR

Four options, as monotherapy or as combination of agents listed below, (per treating investigator's choice): 1. Observation (whereby palliative management with hydroxyurea is allowed), or 2. HMA (decitabine or azacitidine), and/or 3. Venetoclax, and/or 4. Low-dose ara-C

Drug: Azacitidine; Drug: Venetoclax; Drug: Decitabine; Drug: Cytarabine; Other: Observation

Interventions

Galinpepimut-S BIOLOGICAL

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

Also known as: SLS-001, GPS

Galinpepimut-S + Montanide + GM-CSF

Azacitidine DRUG

injection

Best Available Therapy

Venetoclax DRUG

tablet

Best Available Therapy

Decitabine DRUG

injection

Best Available Therapy

Cytarabine DRUG

injection

Also known as: Ara-C

Best Available Therapy

Observation OTHER

palliative management

Best Available Therapy

GM-CSF BIOLOGICAL

subcutaneous injection

Also known as: sargramostim

Galinpepimut-S + Montanide + GM-CSF

Montanide OTHER

adjuvant

Galinpepimut-S + Montanide + GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to understand and provide signed informed consent for the study that fulfills Institution Review Board (IRB) guidelines.
• Male or female patients ≥18 years of age on the day of signing informed consent.
• Must have a diagnosis of AML according to the WHO criteria (primary/de novo or secondary, including treatment-related \[e.g., due to prior anthracycline use\], as well as cases due to progression of antecedent hematological disorder \[e.g., MDS, MPN, or MDS/MPN 'overlap' syndrome).
• Must be in second morphological complete remission (with or without platelet recovery; CR2/CRp2) for relapsed AML based upon the CRp criteria as follows:
• \<5% myeloblasts in bone marrow
• Absence of Auer rods
• Absence of circulating peripheral blasts
• Peripheral blood absolute neutrophil count (ANC) \>1000 cells/µL
• Peripheral blood platelet count \>20,000/µL
• Absence of extramedullary disease
• Patients must have \> 300 lymphocytes/ μL.
• Must not be candidates at the time of study entry for allogeneic stem cell transplant (Allo-SCT) due to intercurrent medical conditions, patient's preference or lack of an available donor.
• Must have received the last dose of re-induction antileukemic therapy at least 4 weeks or ten half-lives of induction therapy (whichever is shorter) prior to receiving study treatment.
• Must be consented within 6 months of having achieved CR2/CRp2 or later.
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3.

You may not qualify if:

• For subjects randomized to GPS maintenance monotherapy:
• Continuation of any agents administered as part of induction of CR2/CRp2 or later
• Receiving any concurrent anti-AML systemic therapy
• Prior clinically significant allergic reaction to Montanide, sargramostim (GM-CSF) or filgrastim (granulocyte colony stimulating factor \[G-CSF\]).
• Received any consolidation and/or maintenance antileukemic therapy, investigational agent, systemic corticosteroid therapy, or other immunosuppressive therapy within 4 weeks prior or 10 half lives, whichever is shorter prior to receiving study treatment. Systemic corticosteroids for chronic conditions (at doses ≤10 mg/day of prednisone or equivalent) or permitted, as are inhalational, intra-ocular, intra-articular and topical corticosteroids as well as any corticosteroids or other immunosuppressive therapies that do not act systemically (e.g. budesonide) at any dose level.
• Imminently planned hematopoietic stem cell transplant (autologous or allogeneic, with any degree of match donor).
• Acute promyelocytic leukemia or any morphologic and molecular variants, inclusive.
• Serious concurrent illness that in the opinion of the Investigator would pose an undue risk to the subject being participating in the clinical study.
• Currently have, central nervous system leukemia.
• Received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Vaccines for Covid-19 used under an EUA, are considered an authorized (though not an approved or cleared) medical product for use in clinical care. Vaccines used for the prevention of Covid-19 are allowed to be used.
• Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks, or in the case of drugs 10 half lives, whichever is shorter, prior to the first dose of study treatment.
• Patients who had an SCT after their most recent re-induction that resulted in CR2 or CRp2 or later are not eligible. Patients with prior SCT are allowed only if they had SCT prior to their latest re-induction or achieved CR by means of transplant ("hot transplant").
• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy exceeding 10 mg daily of prednisone equivalent within 7 days prior the first dose of study drug. The use of physiologic doses of corticosteroids and/or immunosuppressive agents may be approved after consultation with the Sponsor. Steroids taken as short-term therapy (≤ 7 days) for antiemesis are permissible.
• Known additional malignancy that is progressing or has required active treatment within the past 5 years, even if currently inactive or unapparent.
• Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.

Sponsors & Collaborators

• Sellas Life Sciences Group: lead
• PPD Development, LP: collaborator

Study Sites (73)

O'Neal Comprehensive Cancer Center

Birmingham, Alabama, 35205, United States

Location

UCLA Medical Hematology and Oncology

Los Angeles, California, 90095, United States

Location

The Oncology Institute of Hope and Innovation

Whittier, California, 90603, United States

Location

Colorado Blood Cancer Institute - SCRI - PPDS

Denver, Colorado, 80218, United States

Location

Mayo Clinic Jacksonville Florida

Jacksonville, Florida, 32224, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Rush University Cancer Center

Chicago, Illinois, 60612, United States

Location

Tulane Cancer Center - Liberty

New Orleans, Louisiana, 70112, United States

Location

Northwell Health Cancer Institute

Lake Success, New York, 11042, United States

Location

New York Medical College

Valhalla, New York, 10532, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Bon Secours St. Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

Baylor Scott and White Research Institute

Dallas, Texas, 75246, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists

Gainesville, Virginia, 20155, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98109, United States

Location

CHU Amiens-Picardie - Hopital Sud

Amiens, 80000, France

Location

CHU Angers

Angers, 49000, France

Location

CHU de Caen

Caen, 14000, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Hôtel Dieu - Nantes

Nantes, 44000, France

Location

Hôpital Saint Antoine

Paris, 75571, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Universitatsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinik Rostock

Rostock, 18057, Germany

Location

University General Hospital of Alexandroupoli

Alexandroupoli, 68100, Greece

Location

General Hospital of Athens "Evaggelismos"

Athens, 10676, Greece

Location

General Hospital of Athens "Laiko"

Athens, 11526, Greece

Location

General Hospital of Athens "G. Gennimatas"

Athens, 11527, Greece

Location

General Hospital of Athens "Ηippokration"

Athens, 11527, Greece

Location

University General Hospital "Attikon"

Chaïdári, 12462, Greece

Location

General Hospital of Thessaloniki "G. Papanikolaou"

Chortiatis, 57010, Greece

Location

University General Hospital of Ioannina

Ioannina, 45500, Greece

Location

University General Hospital of Patras

Rio, 26504, Greece

Location

University General Hospital of Thessaloniki "Ahepa"

Thessaloniki, 54636, Greece

Location

Semmelweis Egyetem

Budapest, 1088, Hungary

Location

Petz Aladár Egyetemi Oktató Kórház

Győr, 9028, Hungary

Location

Pécsi Tudományegyetem

Pécs, 7624, Hungary

Location

Malabar Cancer Centre

Kannur, Kerala, 670103, India

Location

Yashoda Hospital

Hyderabad, 500084, India

Location

Fortis Hospital

Ludhiāna, 141015, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

State Cancer Institute, Indira Gandhi Institute of Medical Sciences

Patna, 800014, India

Location

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

Gdansk, 80-952, Poland

Location

Szpitale Pomorskie Sp. z o.o.

Gdynia, 81-519, Poland

Location

Swietokrzyskie Centrum Onkologii

Kielce, 25-734, Poland

Location

Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, 59-220, Poland

Location

Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii

Olsztyn, 10-228, Poland

Location

Szpital Wojewodzki w Opolu

Opole, 45-372, Poland

Location

SP ZOZ Szpital Uniwersytecki w Krakowie

Słomniki, 32-090, Poland

Location

Instytut Hematologii i Transfuzjologii

Warsaw, 02-776, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, 50-367, Poland

Location

University Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinical Centre of Vojvodina

Novi Sad, 402007, Serbia

Location

Hospital de San Pedro de Alcantara

Cáceres, 10003, Spain

Location

C.H. Regional Reina Sofia

Córdoba, 14004, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Clinica Universidad Navarra

Pamplona, 31008, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Changhua Christian Hospital

Chang-hua, 50006, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Jamy O, Cicic D. REGAL: galinpepimut-S vs. best available therapy as maintenance therapy for acute myeloid leukemia in second remission. Future Oncol. 2025 Jan;21(1):73-81. doi: 10.1080/14796694.2024.2433935. Epub 2024 Nov 28.

  PMID: 39606837 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Pathologic Complete Response

Interventions

Azacitidine; venetoclax; Decitabine; Cytarabine; Observation; Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim; Monatide (IMS 3015)

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Arabinonucleosides; Methods; Investigative Techniques; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Dragan Cicic Chief Development Officer, MD

  Sellas Life Sciences Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, multicenter, randomized, parallel group study

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 18, 2020
• Study Start: February 8, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5); US (17); FR (9); GR (10); PL (10); TW (5); HU (3); DE (3); ES (9); SE (2)