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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

February 8, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Acute Myeloid Leukemia
Interventions
BIOLOGICAL

Galinpepimut-S

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

DRUG

Azacitidine

injection

DRUG

Venetoclax

tablet

DRUG

Decitabine

injection

DRUG

Cytarabine

injection

OTHER

Observation

palliative management

BIOLOGICAL

GM-CSF

subcutaneous injection

OTHER

Montanide

adjuvant

Trial Locations (73)

100

National Taiwan University Hospital, Taipei

704

National Cheng Kung University Hospital, Tainan City

807

Kaohsiung Medical University Hospital, Kaohsiung City

1088

Semmelweis Egyetem, Budapest

7624

Pécsi Tudományegyetem, Pécs

9028

Petz Aladár Egyetemi Oktató Kórház, Győr

10003

Hospital de San Pedro de Alcantara, Cáceres

10532

New York Medical College, Valhalla

10676

"General Hospital of Athens Evaggelismos", Athens

11000

University Clinical Center of Serbia, Belgrade

11042

Northwell Health Cancer Institute, Lake Success

11526

"General Hospital of Athens Laiko", Athens

11527

"General Hospital of Athens G. Gennimatas", Athens

"General Hospital of Athens Ηippokration", Athens

12462

"University General Hospital Attikon", Chaïdári

14000

CHU de Caen, Caen

14004

C.H. Regional Reina Sofia, Córdoba

18057

Universitätsklinik Rostock, Rostock

20155

Virginia Cancer Specialists, Gainesville

26504

University General Hospital of Patras, Rio

28007

Hospital General Universitario Gregorio Marañon, Madrid

28046

Hospital Universitario La Paz, Madrid

29607

Bon Secours St. Francis Cancer Center, Greenville

30912

Augusta University, Augusta

31008

Clinica Universidad Navarra, Pamplona

32224

Mayo Clinic Jacksonville Florida, Jacksonville

33011

Hospital Universitario Central de Asturias, Oviedo

35205

O'Neal Comprehensive Cancer Center, Birmingham

37007

Complejo Asistencial Universitario de Salamanca, Salamanca

38043

CHU de Grenoble, Grenoble

40705

Taichung Veterans General Hospital, Taichung

41013

Hospital Universitario Virgen del Rocio, Seville

44000

Hôtel Dieu - Nantes, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

45500

University General Hospital of Ioannina, Ioannina

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

49000

CHU Angers, Angers

50006

Changhua Christian Hospital, Chang-hua

54636

"University General Hospital of Thessaloniki Ahepa", Thessaloniki

57010

"General Hospital of Thessaloniki G. Papanikolaou", Chortiatis

60612

Rush University Cancer Center, Chicago

68100

University General Hospital of Alexandroupoli, Alexandroupoli

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

70112

Tulane Cancer Center - Liberty, New Orleans

75246

Baylor Scott and White Research Institute, Dallas

75571

Hôpital Saint Antoine, Paris

77030

University of Texas - MD Anderson Cancer Center, Houston

80000

CHU Amiens-Picardie - Hopital Sud, Amiens

80218

Colorado Blood Cancer Institute - SCRI - PPDS, Denver

86000

CHU de Poitiers, Poitiers

90095

UCLA Medical Hematology and Oncology, Los Angeles

90603

The Oncology Institute of Hope and Innovation, Whittier

94805

Institut Gustave Roussy, Villejuif

97239

Oregon Health and Science University, Portland

98109

Swedish Cancer Institute, Seattle

110029

All India Institute of Medical Sciences, New Delhi

141015

Fortis Hospital, Ludhiāna

402007

Clinical Centre of Vojvodina, Novi Sad

500084

Yashoda Hospital, Hyderabad

670103

Malabar Cancer Centre, Kannur

800014

State Cancer Institute, Indira Gandhi Institute of Medical Sciences, Patna

09116

Klinikum Chemnitz gGmbH, Chemnitz

04103

Universitatsklinikum Leipzig, Leipzig

85-168

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz

80-952

Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii, Gdansk

81-519

Szpitale Pomorskie Sp. z o.o., Gdynia

25-734

Swietokrzyskie Centrum Onkologii, Kielce

59-220

Wojewodzki Szpital Specjalistyczny w Legnicy, Legnica

10-228

Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii, Olsztyn

45-372

Szpital Wojewodzki w Opolu, Opole

32-090

SP ZOZ Szpital Uniwersytecki w Krakowie, Słomniki

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

50-367

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

Sponsors
All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Sellas Life Sciences Group

INDUSTRY