Clinical trial • Phase III • Oncology

LISAFTOCLAX for Myelodysplastic syndrome (higher-risk)

Phase III trial of LISAFTOCLAX for Myelodysplastic syndrome (higher-risk).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Myelodysplastic syndrome (higher-risk)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-12-2024
First CTIS Authorization Date
22-04-2025

Trial design

Randomised, control arm: placebo (lisaftoclax) plus azacitidine (azacitidine seacross 25 mg/ml powder for suspension for injection). investigational arm: lisaftoclax (apg-2575) plus azacitidine. dose and schedule not specified in the ctis json record. Phase III trial across 93 sites in Belgium, France, Poland and others.

Randomised
Yes
Comparator
Control arm: Placebo (Lisaftoclax) plus Azacitidine (Azacitidine Seacross 25 mg/mL powder for suspension for injection). Investigational arm: Lisaftoclax (APG-2575) plus Azacitidine. Dose and schedule not specified in the CTIS JSON record.
Target Sample Size
131

Eligibility

Recruits 131 Participants must be able to understand and voluntarily sign a written informed consent form; the consent form must be signed prior to any trial-specific procedures. The protocol requires participant capacity to consent; no procedures for assent of minors are described (trial enrols adults ≥18). Separate partner/pregnancy information forms are included in documentation..

Pregnancy Exclusion
Negative urine or serum pregnancy test prior to dosing in women of childbearing potential. Women of childbearing potential (postmenopausal women must have been postmenopausal for at least 12 months to be considered of non-childbearing potential) and their partners are willing to use contraception as deemed effective by the investigator during treatment and for at least 6 months after the last dose of study drug.
Vulnerable Population
Participants must be able to understand and voluntarily sign a written informed consent form; the consent form must be signed prior to any trial-specific procedures. The protocol requires participant capacity to consent; no procedures for assent of minors are described (trial enrols adults ≥18). Separate partner/pregnancy information forms are included in documentation.

Inclusion criteria

  • {"criterion_text":"- Aged ≥ 18 years old.\n- Newly Diagnosed MDS is defined according to 2022 World Health Organization classification (5th Edition)\n- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n- Life expectancy ≥ 3 months.\n- Able to receive oral medication.\n- Adequate organ functions as defined below: - Creatinine clearance ≥ 30 ml/min (calculated with Cockcroft formula, as shown in Annex 3) - Total bilirubin < 1.5 × ULN (except Gilbert's syndrome, hyperbilirubinemia due to regular blood transfusions as assessed by the investigator) - Aspartate aminotransferase (ALT) and alanine aminotransferase (AST) ≤ 2.5 × ULN\n- Negative urine or serum pregnancy test prior to dosing in women of childbearing potential. Women of childbearing potential (postmenopausal women must have been postmenopausal for at least 12 months to be considered of non-childbearing potential) and their partners are willing to use contraception as deemed effective by the investigator during treatment and for at least 6 months after the last dose of study drug.\n- Subjects must have the ability to understand and voluntarily sign a written informed consent form that must be signed prior to performing any trial-specific study procedures.\n- Subjects must be willing to participate in the study and are able to complete study procedures and follow-up examinations."}

Exclusion criteria

  • {"criterion_text":"- Previous diagnosis of xxx\n- Any of the following cardiac abnormalities (as determined by the study physician based on clinical examination assessments): - Any history of myocardial infarction within 6 months - Congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV) or left ventricular ejection fraction (LVEF) < 40% - Symptomatic ventricular arrhythmia uncontrolled by medication - Any history of familial long QT syndrome - The mean QT interval calculated from 3 electrocardiogram (ECG) readings (1 to 3 minutes apart) is > 470 (Using Fridercia's correction: QTcF = QT/RR0.33)\n- Second malignancies or previous malignancies with a disease-free interval of less than 1 year at the time of signing the informed consent (except for subjects with adequately resected cutaneous basal cell or squamous cell carcinoma or resected carcinoma in situ).\n- Have history of HSCT.\n- Other clinically significant uncontrolled symptoms, including but not limited to: uncontrolled active systemic infection (virus, bacteria or fungi), known clinically active hepatitis B or C, or HIV infection. (as determined by the study physician based on clinical examination assessments).\n- Have malabsorption syndrome or other conditions and are not suitable for enteral drug administration.\n- Have any other conditions or illnesses which, in the investigator's judgment, makes them unsuitable for participation in this study, , including but not limited to; • Women who are breast feeding or planning to donate eggs within 6 months after the end of the study treatment • History of hypersensitivity to compounds related to lisaftoclax or AZA or to any of their excipients • History of bleeding disorders or active uncontrolled coagulopathy."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- xxx","definition_or_measurement_approach":""}
  • {"endpoint_text":"- xxx","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- To compare the efficacy of xxx","definition_or_measurement_approach":""}
  • {"endpoint_text":"- To evaluate the safety of xxx","definition_or_measurement_approach":""}
  • {"endpoint_text":"- To evaluate the population pharmacokinetics (Pop PK) following treatment with xxx","definition_or_measurement_approach":""}
  • {"endpoint_text":"- To evaluate Health Economics Outcomes Research (HEOR) measures of lisaftoclax xxx based on EuroQol 5 Dimension (EQ-5D).","definition_or_measurement_approach":"HEOR measures assessed using the EuroQol 5 Dimension (EQ-5D) instrument as stated."}

Recruitment

Planned Sample Size
131
Recruitment Window Months
57
Consent Approach
Written informed consent must be obtained from each subject prior to any trial-specific procedures. Subjects must be able to understand and voluntarily sign the informed consent form. Country-specific subject information sheets and ICFs are provided; multiple language versions are available (including English, Dutch, French, German, Spanish, Greek, Hungarian, Polish, Bulgarian, Italian, Czech, Finnish, Swedish, Norwegian). Separate pregnancy-related and partner ICFs are provided where applicable.

Geography

Total Number Of Sites
93
Total Number Of Participants
377

Belgium

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
14-11-2025
Processing Time Days
221
Number Of Sites
9
Number Of Participants
27

Sites

Site Name
UZ Leuven
Department Name
Hematology
Principal Investigator Name
Marielle Beckers
Principal Investigator Email
marielle.beckers@uzleuven.be
Contact Person Name
Marielle Beckers
Contact Person Email
marielle.beckers@uzleuven.be
Site Name
Algemeen Ziekenhuis Klina
Department Name
Hematology
Principal Investigator Name
Stef Meers
Principal Investigator Email
stef.meers@klina.be
Contact Person Name
Stef Meers
Contact Person Email
stef.meers@klina.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Hematology
Principal Investigator Name
Dominiek Mazure
Principal Investigator Email
Dominiek.Mazure@uzgent.be
Contact Person Name
Dominiek Mazure
Contact Person Email
Dominiek.Mazure@uzgent.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematology
Principal Investigator Name
Dries Deeren
Principal Investigator Email
dries.deeren@azdelta.be
Contact Person Name
Dries Deeren
Contact Person Email
dries.deeren@azdelta.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Hematology
Principal Investigator Name
Koenraad Van Eijgen
Principal Investigator Email
koen.vaneygen@azgroeninge.be
Contact Person Name
Koenraad Van Eijgen
Contact Person Email
koen.vaneygen@azgroeninge.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Hematology
Principal Investigator Name
Bert Heyrman
Principal Investigator Email
bert.heyrman@zas.be
Contact Person Name
Bert Heyrman
Contact Person Email
bert.heyrman@zas.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Hematology
Principal Investigator Name
Bert Heyrman
Principal Investigator Email
bert.heyrman@zas.be
Contact Person Name
Bert Heyrman
Contact Person Email
bert.heyrman@zas.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematology
Principal Investigator Name
Alexander Schauwvlieghe
Principal Investigator Email
alexander.Schauwvlieghe@azsintjan.be
Contact Person Name
Alexander Schauwvlieghe
Site Name
Algemeen Ziekenhuis Groeninge (Kortrijk entry)
Department Name
Hematology
Principal Investigator Name
Koenraad Van Eijgen
Principal Investigator Email
koen.vaneygen@azgroeninge.be
Contact Person Name
Koenraad Van Eijgen
Contact Person Email
koen.vaneygen@azgroeninge.be

France

Earliest CTIS Part Ii Submission Date
08-04-2025
Latest Decision Or Authorization Date
19-11-2025
Processing Time Days
225
Number Of Sites
13
Number Of Participants
52

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hematology and cellular therapy
Principal Investigator Name
Marie-Pierre Gourin
Principal Investigator Email
marie-pierre.gourin@chu-limoges.fr
Contact Person Name
Marie-Pierre Gourin
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology and Cell Therapy
Principal Investigator Name
Alice Garnier
Principal Investigator Email
alice.garnier@chu-nantes.fr
Contact Person Name
Alice Garnier
Contact Person Email
alice.garnier@chu-nantes.fr
Site Name
Hopital Saint Louis
Department Name
Hematology
Principal Investigator Name
Lionel Ades
Principal Investigator Email
lionel.ades@aphp.fr
Contact Person Name
Lionel Ades
Contact Person Email
lionel.ades@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Department of Clinical Hematology and Cell Therapy
Principal Investigator Name
Sophie Dimicoli-Salazar
Principal Investigator Email
sophie.dimicoli-salazar@chu-bordeaux.fr
Contact Person Name
Sophie Dimicoli-Salazar
Site Name
Centre Hospitalier Le Mans
Department Name
Hematology
Principal Investigator Name
Kamel Laribi
Principal Investigator Email
klaribi@ch-lemans.fr
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Blood diseases
Principal Investigator Name
Sylvain Thepot
Principal Investigator Email
sylvain.thepot@chu-anger.fr
Contact Person Name
Sylvain Thepot
Contact Person Email
sylvain.thepot@chu-anger.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematological oncology and cellular therapy
Principal Investigator Name
Jose-Miguel Torregrosa-Diaz
Contact Person Name
Jose-Miguel Torregrosa-Diaz
Site Name
L'Hopital Prive Du Confluent
Department Name
Hematology
Principal Investigator Name
Jacques Delaunay
Principal Investigator Email
jacques.delaunay@groupeconfluent.fr
Contact Person Name
Jacques Delaunay
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Hematology
Principal Investigator Name
Ali Arar
Principal Investigator Email
ali.arar@chu-orleans.fr
Contact Person Name
Ali Arar
Contact Person Email
ali.arar@chu-orleans.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hematology and Cell Therapy
Principal Investigator Name
Emmanuel Gyan
Principal Investigator Email
emmanuel.gyan@univ-tours.fr
Contact Person Name
Emmanuel Gyan
Contact Person Email
emmanuel.gyan@univ-tours.fr
Site Name
Hopital NOVO
Department Name
Hematology
Principal Investigator Name
Riad Benramdane
Principal Investigator Email
riad.benramdane@ght-novo.fr
Contact Person Name
Riad Benramdane
Contact Person Email
riad.benramdane@ght-novo.fr
Site Name
Institut Gustave Roussy
Department Name
Hematology
Principal Investigator Name
Christophe Willekens
Principal Investigator Email
christophe.willekens@gustaveroussy.fr
Contact Person Name
Christophe Willekens
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hematology
Principal Investigator Name
Thomas Cluzeau
Principal Investigator Email
cluzeau.t@chu-nice.fr
Contact Person Name
Thomas Cluzeau
Contact Person Email
cluzeau.t@chu-nice.fr

Poland

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
27-11-2025
Processing Time Days
229
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematologii Ogólnej i Chorób Wewnętrznych
Principal Investigator Name
Tadeusz Robak
Principal Investigator Email
robaktad@csk.umed.lodz.pl
Contact Person Name
Tadeusz Robak
Contact Person Email
robaktad@csk.umed.lodz.pl
Site Name
Mtz Clinical Research Powered By Pratia
Principal Investigator Name
Krzysztof Mądry
Principal Investigator Email
badacz@pratia.com
Contact Person Name
Krzysztof Mądry
Contact Person Email
badacz@pratia.com
Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku
Principal Investigator Name
Janusz Hałka
Principal Investigator Email
janusz.halka@poliklinika.net
Contact Person Name
Janusz Hałka
Contact Person Email
janusz.halka@poliklinika.net
Site Name
Wojewodzki Szpital Specjalistyczny W Legnicy
Department Name
Oddział Hematologiczny
Principal Investigator Name
Jadwiga Hołojda
Principal Investigator Email
jadwiga.holojda@szpital.legnica.pl
Contact Person Name
Jadwiga Hołojda
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Andrzej Mital
Principal Investigator Email
amital@wp.pl
Contact Person Name
Andrzej Mital
Contact Person Email
amital@wp.pl
Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Hematologii, Klinika Hematologii i Transfuzjologii
Principal Investigator Name
Ewa Lech-Marańda
Principal Investigator Email
emaranda@ihit.waw.pl
Contact Person Name
Ewa Lech-Marańda
Contact Person Email
emaranda@ihit.waw.pl

Italy

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
312
Number Of Sites
13
Number Of Participants
54

Sites

Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Medical Oncology Department
Principal Investigator Name
Elena Crisà
Principal Investigator Email
Elena.crisa@ircc.it
Contact Person Name
Elena Crisà
Contact Person Email
Elena.crisa@ircc.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
SCDU Hematology
Principal Investigator Name
Daniela Cilloni
Principal Investigator Email
daniela.cilloni@unito.it
Contact Person Name
Daniela Cilloni
Contact Person Email
daniela.cilloni@unito.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Hematology
Principal Investigator Name
Andrea Patriarca
Principal Investigator Email
andrea.patriarca@uniupo.it
Contact Person Name
Andrea Patriarca
Contact Person Email
andrea.patriarca@uniupo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Hematology
Principal Investigator Name
Claudio Cerchione
Principal Investigator Email
claudio.cerchione@irst.emr.it
Contact Person Name
Claudio Cerchione
Contact Person Email
claudio.cerchione@irst.emr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Division of Oncohematology
Principal Investigator Name
Enrico Derenzini
Principal Investigator Email
enrico.derenzini@ieo.it
Contact Person Name
Enrico Derenzini
Contact Person Email
enrico.derenzini@ieo.it
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
Hematology
Principal Investigator Name
Marta Coscia
Principal Investigator Email
marta.coscia@asst-settelaghi.it
Contact Person Name
Marta Coscia
Site Name
University Hospital Of Ferrara
Department Name
Hematology Oncology
Principal Investigator Name
Gian Matteo Rigolin
Principal Investigator Email
rglgmt@unife.it
Contact Person Name
Gian Matteo Rigolin
Contact Person Email
rglgmt@unife.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Hematology
Principal Investigator Name
Giovanni Marconi
Principal Investigator Email
giovanni.marconi@unibo.it
Contact Person Name
Giovanni Marconi
Contact Person Email
giovanni.marconi@unibo.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Hematology
Principal Investigator Name
Valeria Santini
Principal Investigator Email
valeria.santini@unifi.it
Contact Person Name
Valeria Santini
Contact Person Email
valeria.santini@unifi.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Hematology and Oncology
Principal Investigator Name
Matteo Giovanni Della Porta
Principal Investigator Email
matteo.della_porta@hunimed.eu
Contact Person Name
Matteo Giovanni Della Porta
Contact Person Email
matteo.della_porta@hunimed.eu
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Hematology
Principal Investigator Name
Massimo Breccia
Principal Investigator Email
massimo.breccia@uniroma1.it
Contact Person Name
Massimo Breccia
Contact Person Email
massimo.breccia@uniroma1.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Biomedicina e Prevenzione
Principal Investigator Name
Maria Teresa Voso
Principal Investigator Email
voso@med.uniroma2.it
Contact Person Name
Maria Teresa Voso
Contact Person Email
voso@med.uniroma2.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I (additional)
Department Name
Hematology
Principal Investigator Name
Pasquale Niscola
Principal Investigator Email
pniscola@gmail.com
Contact Person Name
Pasquale Niscola
Contact Person Email
pniscola@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
392
Number Of Sites
7
Number Of Participants
26

Sites

Site Name
Evangelismos S.A.
Department Name
Haematology & Lymphomas Department and BMT Unit
Principal Investigator Name
Maria Pagoni
Principal Investigator Email
marianpagoni@yahoo.com
Contact Person Name
Maria Pagoni
Contact Person Email
marianpagoni@yahoo.com
Site Name
University General Hospital Of Alexandroupoli
Department Name
Department of Hematology
Principal Investigator Name
Ioannis Kotsianidis
Principal Investigator Email
jankots@yahoo.gr
Contact Person Name
Ioannis Kotsianidis
Contact Person Email
jankots@yahoo.gr
Site Name
Olympion Therapeftirio General Clinic Of Patras S.A.
Department Name
Hematology and Oncology Department
Principal Investigator Name
Anargyros (Argiris) Symeonidis
Principal Investigator Email
argiris.symeonidis@yahoo.gr
Contact Person Name
Anargyros (Argiris) Symeonidis
Contact Person Email
argiris.symeonidis@yahoo.gr
Site Name
Laiko General Hospital Of Athens
Department Name
1st Department of Propaedeutic and Internal Medicine
Principal Investigator Name
Panagiotis Diamantopoulos
Principal Investigator Email
pandiamantopoulos@gmail.com
Contact Person Name
Panagiotis Diamantopoulos
Contact Person Email
pandiamantopoulos@gmail.com
Site Name
Alexandra Hospital
Department Name
Plasma cell Dyscrasias Unit, Department of Clinical Therapeutics
Principal Investigator Name
Meletios Athanasios Dimopoulos
Principal Investigator Email
mdimop@med.uoa.gr
Contact Person Name
Meletios Athanasios Dimopoulos
Contact Person Email
mdimop@med.uoa.gr
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Dept of Internal Medicine Hematology Unit
Principal Investigator Name
Vassiliki Pappa
Principal Investigator Email
vaspappa@med.uoa.gr
Contact Person Name
Vassiliki Pappa
Contact Person Email
vaspappa@med.uoa.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st Propaedeutic Medical Dept of Internal Medicine
Principal Investigator Name
Georgia Kaiafa
Principal Investigator Email
gdkaiafa@auth.gr
Contact Person Name
Georgia Kaiafa
Contact Person Email
gdkaiafa@auth.gr

Spain

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
382
Number Of Sites
19
Number Of Participants
90

Sites

Site Name
MD Anderson Cancer Center
Department Name
Hematology
Principal Investigator Name
Adolfo De la Fuente Burguera
Principal Investigator Email
afuente@mdanderson.es
Contact Person Name
Adolfo De la Fuente Burguera
Contact Person Email
afuente@mdanderson.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
David Valcárcel Ferreiras
Principal Investigator Email
dvalcarcelct@vhio.net
Contact Person Name
David Valcárcel Ferreiras
Contact Person Email
dvalcarcelct@vhio.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematology
Principal Investigator Name
María del Mar Tormo Díaz
Principal Investigator Email
tormo_mar@gva.es
Contact Person Name
María del Mar Tormo Díaz
Contact Person Email
tormo_mar@gva.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Hematology
Principal Investigator Name
María García Fortes
Contact Person Name
María García Fortes
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Hematology
Principal Investigator Name
José Luis Sastre Moral
Principal Investigator Email
jose.luis.sastre.moral@sergas.es
Contact Person Name
José Luis Sastre Moral
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Pau Montesinos Fernández
Principal Investigator Email
montesinos_pau@gva.es
Contact Person Name
Pau Montesinos Fernández
Contact Person Email
montesinos_pau@gva.es
Site Name
Hospital Moncloa Grupo Hla S.A.
Department Name
Hematology
Principal Investigator Name
Concepción Aláez Usón
Principal Investigator Email
Concha.alaez@gmail.com
Contact Person Name
Concepción Aláez Usón
Contact Person Email
Concha.alaez@gmail.com
Site Name
Hospital San Pedro De Alcantara
Department Name
Hematology
Principal Investigator Name
Juan Miguel Bergua Burgués
Principal Investigator Email
jmberguaburg@gmail.com
Contact Person Name
Juan Miguel Bergua Burgués
Contact Person Email
jmberguaburg@gmail.com
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Hematology
Principal Investigator Name
Blanca Xicoy Cirici
Principal Investigator Email
bxicoy@ioncologia.net
Contact Person Name
Blanca Xicoy Cirici
Contact Person Email
bxicoy@ioncologia.net
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Hematology
Principal Investigator Name
Ana Alfonso Pierola
Principal Investigator Email
aalfonso@unav.es
Contact Person Name
Ana Alfonso Pierola
Contact Person Email
aalfonso@unav.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Principal Investigator Name
Ramón García-Sanz
Principal Investigator Email
ramon.garcia@salud.madrid.org
Contact Person Name
Ramón García-Sanz
Contact Person Email
ramon.garcia@salud.madrid.org
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Hematology
Principal Investigator Name
Jordi Vila Bou
Principal Investigator Email
jordi.vilab@iconcologia.net
Contact Person Name
Jordi Vila Bou
Contact Person Email
jordi.vilab@iconcologia.net
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Hematology
Principal Investigator Name
Ana Alfonso Pierola
Principal Investigator Email
aalfonso@unav.es
Contact Person Name
Ana Alfonso Pierola
Contact Person Email
aalfonso@unav.es
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Hematology
Principal Investigator Name
Helena Pomares Marin
Principal Investigator Email
hpomares@iconcologia.net
Contact Person Name
Helena Pomares Marin
Contact Person Email
hpomares@iconcologia.net
Site Name
Hospital Universitario Central De Asturias
Department Name
Hematology
Principal Investigator Name
María Teresa Bernal Castillo
Principal Investigator Email
bernalmaria@uniovi.es
Contact Person Name
María Teresa Bernal Castillo
Contact Person Email
bernalmaria@uniovi.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
José Francisco Falantes González
Principal Investigator Email
josef.falantes.sspa@juntadeandalucia.es
Contact Person Name
José Francisco Falantes González
Site Name
Hospital Universitario La Paz
Department Name
Hematology
Principal Investigator Name
Raquel De Paz Arias
Principal Investigator Email
mraquelde.paz@salud.madrid.org
Contact Person Name
Raquel De Paz Arias
Contact Person Email
mraquelde.paz@salud.madrid.org
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Principal Investigator Name
Kyra Velazquez Kennedy
Principal Investigator Email
Kyra.vkennedy@gmail.com
Contact Person Name
Kyra Velazquez Kennedy
Contact Person Email
Kyra.vkennedy@gmail.com
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
María Díez Campelo
Principal Investigator Email
mdiezcampelo@usal.es
Contact Person Name
María Díez Campelo
Contact Person Email
mdiezcampelo@usal.es

Czechia

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
121
Number Of Sites
4
Number Of Participants
21

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. Interni klinika - klinika hematologie
Principal Investigator Name
Anna Jonášová
Principal Investigator Email
anna.jonasova@vfn.cz
Contact Person Name
Anna Jonášová
Contact Person Email
anna.jonasova@vfn.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interni hematologicka a onkologicka klinika
Principal Investigator Name
Jiří Mayer
Principal Investigator Email
mayer.jiri@fnbrno.cz
Contact Person Name
Jiří Mayer
Contact Person Email
mayer.jiri@fnbrno.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interni hematologicka klinika
Principal Investigator Name
Petra Bělohlávková
Principal Investigator Email
petra.belohlavkova@fnhk.cz
Contact Person Name
Petra Bělohlávková
Contact Person Email
petra.belohlavkova@fnhk.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie
Principal Investigator Name
Zdeněk Kořístek
Principal Investigator Email
zdenek.koristek@fno.cz
Contact Person Name
Zdeněk Kořístek
Contact Person Email
zdenek.koristek@fno.cz

Sweden

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
14
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Örebro University Hospital
Department Name
Hematology dept.
Principal Investigator Name
Bengt Rasmusssen
Principal Investigator Email
bengt.rasmussen@regionoregrolan.se
Contact Person Name
Bengt Rasmusssen

Norway

Earliest CTIS Part Ii Submission Date
03-03-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
15
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Hematology
Principal Investigator Name
Hilde Jensvoll
Principal Investigator Email
Hilde.Jensvoll@unn.no
Contact Person Name
Hilde Jensvoll
Contact Person Email
Hilde.Jensvoll@unn.no
Site Name
Sykehuset Telemark HF
Department Name
Department of Oncology, Hematology, and Palliative Care
Principal Investigator Name
Agnieszka Barchnicka
Principal Investigator Email
agnieszka.barchnicka@sthf.no
Contact Person Name
Agnieszka Barchnicka
Contact Person Email
agnieszka.barchnicka@sthf.no
Site Name
Oslo Universitetssykehus HF
Department Name
Department of Hematology
Principal Investigator Name
Andrea Lenartova
Principal Investigator Email
anlena@ous-hf.no
Contact Person Name
Andrea Lenartova
Contact Person Email
anlena@ous-hf.no
Site Name
Helse Bergen HF
Department Name
Department of Medicine
Principal Investigator Name
Astrid Olsnes
Principal Investigator Email
astrid.marta.olsnes@helse-bergen.no
Contact Person Name
Astrid Olsnes

Bulgaria

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
351
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
University Multiprofile Hospital For Active Treatment Sofiamed OOD
Department Name
Department of Clinical Hematology, 10, Dimitar Mollov Str., 1750 Sofia, Bulgaria
Principal Investigator Name
Tsvetan Alaikov
Principal Investigator Email
dr.alaikov@gmail.com
Contact Person Name
Tsvetan Alaikov
Contact Person Email
dr.alaikov@gmail.com
Site Name
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Department Name
First Department of Clinical Hematology
Principal Investigator Name
Martin Donchev
Principal Investigator Email
martin.donchev@abv.bg
Contact Person Name
Martin Donchev
Contact Person Email
martin.donchev@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Clinic of Clinical Hematology
Principal Investigator Name
Lachezar Bogdanov
Principal Investigator Email
bogdanov71@gmail.com
Contact Person Name
Lachezar Bogdanov
Contact Person Email
bogdanov71@gmail.com
Site Name
Dr. Pencho Georgiev Ambulatory For Individual Practice For Medical Aid For Clinical Hematology EOOD
Principal Investigator Name
Pencho Georgiev
Principal Investigator Email
penchogeorgiev@yahoo.com
Contact Person Name
Pencho Georgiev
Contact Person Email
penchogeorgiev@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Clinical Hematology
Principal Investigator Name
Atanas Radinoff
Principal Investigator Email
aradinoff@hotmail.com
Contact Person Name
Atanas Radinoff
Contact Person Email
aradinoff@hotmail.com

Germany

Earliest CTIS Part Ii Submission Date
20-02-2025
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
427
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Universitaetsklinik und Poliklinik fuer Innere Medizin IV
Principal Investigator Name
Michael Heuser
Principal Investigator Email
michael.heuser@uk-halle.de
Contact Person Name
Michael Heuser
Contact Person Email
michael.heuser@uk-halle.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik fuer Hämatologie, Onkologie und Tumorimmunologie
Principal Investigator Name
Kathrin Rieger
Principal Investigator Email
kathrin.rieger@charite.de
Contact Person Name
Kathrin Rieger
Contact Person Email
kathrin.rieger@charite.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Principal Investigator Name
Thomas Illmer
Principal Investigator Email
illmer@onkologie-dresden.net
Contact Person Name
Thomas Illmer
Contact Person Email
illmer@onkologie-dresden.net
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik fuer Innere Medizin III
Principal Investigator Name
Carolin Seeling
Principal Investigator Email
carolin.seeling@uniklinik-ulm.de
Contact Person Name
Carolin Seeling
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik fuer Haematologie, Zelltherapie, Haemostaseologie und Infektiologie
Principal Investigator Name
Klaus Metzeler
Principal Investigator Email
Klaus.Metzeler@medizin.uni-leipzig.de
Contact Person Name
Klaus Metzeler
Site Name
Marien Hospital Duesseldorf GmbH
Department Name
Klinik fuer Onkologie, Haematologie und Palliativmedizin
Principal Investigator Name
Aristoteles Giagounidis
Principal Investigator Email
aristoteles.giagounidis@vkkd-kliniken.de
Contact Person Name
Aristoteles Giagounidis
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik 1
Principal Investigator Name
Katja Sockel
Principal Investigator Email
katja.sockel@ukdd.de
Contact Person Name
Katja Sockel
Contact Person Email
katja.sockel@ukdd.de
Site Name
Robert Bosch Krankenhaus GmbH
Department Name
R.B.Gesellschaft für medizinische Forschung Klinik für Onkologie, Haematologie und Palliativmedizin
Principal Investigator Name
Martin Kaufmann
Principal Investigator Email
martin.kaufmann@rbk.de
Contact Person Name
Martin Kaufmann
Contact Person Email
martin.kaufmann@rbk.de
Site Name
Charite Universitaetsmedizin Berlin KöR (Lichterfelde)
Department Name
Klinik fuer Hämatologie, Onkologie und Tumorimmunologie
Principal Investigator Name
Kathrin Rieger
Principal Investigator Email
kathrin.rieger@charite.de
Contact Person Name
Kathrin Rieger
Contact Person Email
kathrin.rieger@charite.de

Finland

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
77
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
HUS-yhtymae
Department Name
Comprehensive Cancer Center
Principal Investigator Name
Mika Kontro
Principal Investigator Email
mika.kontro@helsinki.fi
Contact Person Name
Mika Kontro
Contact Person Email
mika.kontro@helsinki.fi
Site Name
Kuopio University Hospital
Department Name
Hematyologic Policlinics
Principal Investigator Name
Anu Partanen
Principal Investigator Email
anu.partanen@pshyvinvointialue.fi
Contact Person Name
Anu Partanen

Hungary

Earliest CTIS Part Ii Submission Date
31-03-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
399
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
University Of Debrecen
Department Name
Internal medicine
Principal Investigator Name
Árpád Illés
Principal Investigator Email
illes.arpad@med.unideb.hu
Contact Person Name
Árpád Illés
Contact Person Email
illes.arpad@med.unideb.hu

Sponsor

Primary sponsor

Full Name
Ascentage Pharma Group Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Everest Clinical Research
Responsibilities
Stat and programming deliverables; EDC and DM activities (different Everest affiliates listed for stat/programming and EDC/DM)
Name
IQVIA Biotech LLC
Responsibilities
Safety database processing and expedited case submission to Health Authorities
Name
Almac Clinical Services Limited
Responsibilities
Labeling, distribution, returns, destruction of IMP
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central lab, lab kits and repository
Name
Perceptive Informatics, LLC
Responsibilities
IRT system set-up and management

Third parties

  • {"country":"Canada","full_name":"Everest Clinical Research (stat and programming)","duties_or_roles":"Stat and programming deliverables including: SAP, TLG mocks and real outputs, SDTM/ADAM data and define packages, DMC charter","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"Processing cases in safety database and submission of expedited cases to Health Authorities","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Everest Clinical Research (EDC/DM)","duties_or_roles":"EDC and DM activities","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"Almac Clinical Services Limited","duties_or_roles":"Labelling, Distribution, Returns, Destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"PK sample analysis and storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Regulatory submissions and other sponsor functions (roles listed without textual description in record)","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Perceptive Informatics, LLC","duties_or_roles":"IRT system set-up and management","organisation_type":"Health care"}
  • {"country":"Greece","full_name":"Fortrea Development Ltd. Branch Of Foreign Company","duties_or_roles":"Greek CRO affiliate","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Lab kits and repository central lab","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Lisaftoclax
Active Substance
LISAFTOCLAX
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Investigational Product Name
Azacitidine Seacross 25 mg/mL powder for suspension for injection
Active Substance
AZACITIDINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
Route
IV/SC/IM
Authorisation Status
Marketing authorisation PA22766/005/001 (authorised)
Investigational Product Name
Placebo (Lisaftoclax)
Modality
Other
Combination Treatment
Yes

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