Clinical trial • Phase III • Haematology

LISAFTOCLAX for Chronic lymphocytic leukemia | Small lymphocytic lymphoma

Phase III trial of LISAFTOCLAX for Chronic lymphocytic leukemia | Small lymphocytic lymphoma.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Chronic lymphocytic leukemia | Small lymphocytic lymphoma
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
26-01-2024
First CTIS Authorization Date
13-05-2024

Trial design

Randomised, open-label, control arm: continue on the same btki used prior to study entry — acalabrutinib 100 mg twice daily or ibrutinib 420 mg once daily or zanubrutinib 160 mg twice daily (or 320 mg once daily) as btki monotherapy. Phase III trial in Bulgaria, Poland, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Control Arm: Continue on the same BTKi used prior to study entry — Acalabrutinib 100 mg twice daily OR Ibrutinib 420 mg once daily OR Zanubrutinib 160 mg twice daily (or 320 mg once daily) as BTKi monotherapy.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
440

Eligibility

Recruits 440 Vulnerable population flag is set. All participants must provide written informed consent ("Ability and willingness to provide written informed consent" is an inclusion requirement). Study provides subject information and informed consent forms (including pregnancy and pregnant-partner specific forms) and layperson synopses in multiple languages; no paediatric/assent procedures are included because minimum age is ≥18..

Pregnancy Exclusion
Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of study treatment; further pregnancy testing will be performed monthly).
Vulnerable Population
Vulnerable population flag is set. All participants must provide written informed consent ("Ability and willingness to provide written informed consent" is an inclusion requirement). Study provides subject information and informed consent forms (including pregnancy and pregnant-partner specific forms) and layperson synopses in multiple languages; no paediatric/assent procedures are included because minimum age is ≥18.

Inclusion criteria

  • {"criterion_text":"- Aged ≥ 18 years.\n- Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible. • Received a BTKi (acalabrutinib, ibrutinib, or zanubrutinib) monotherapy as 1st, 2nd, or 3rd line therapy for ≥ 12 months and have best response as either a or b: a. Stable disease b. PR with any of the following baseline risk factors: • Lymph node(s) diameter ≥ 2.5 cm, • ALC ≥ 25x 109 /L • Have ≥ 1 high-risk factor(s) (del17p/p53mut, unmutated IGHV, complex karyotype ≥ 5 factors (≥ 3 chromosomal abnormalities and ≥ 1 biological/structural aberrations).\n- ECOG performance status 0-2.\n- Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of randomization as follows: • Absolute neutrophil count ≥ 1.0 × 109/L • Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia • Total hemoglobin ≥ 9 g/dL -.\n- Adequate renal function • Creatinine clearance must be > 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 – age) x actual bodyweight) / (72 x creatinine), for women x 0. 85) or an equally accurate method.\n- Adequate liver function as indicated by: • Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert’s Syndrome • Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value • Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value, • International Normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5 × ULN.\n- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements."}

Exclusion criteria

  • {"criterion_text":"- Achieved complete response (CR) or CRi status or disease progression while on BTKi (acalabrutinib, ibrutinib, zanubrutinib) monotherapy prior to study entry.\n- Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ grade 1 or baseline, except alopecia or neuropathy.\n- Failure to recover, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, patients who have had major surgery within 28 days and minor surgery such as a biopsy within 14 days from first dose of study drug.\n- QTcF interval＞ 480ms or other remarkable abnormality of ECG, including second-degree type II atrioventricular block, third-degree atrioventricular block, or bradycardia (ventricular rate consistently less than 50 beats per minute).\n- Underlying clinically significant cardiovascular disease such as: symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening or any cardiovascular disability status of New York Heart Association Class ≥ 2.\n- Known hypersensitivity to any active substance or to any of the excipients of one of the drugs used in the trial.\n- Uncontrolled medical condition (e.g., diabetes).\n- Known to have central nervous system (CNS) involvement.\n- Prior malignancy within 2 years of treatment that required radiotherapy, or systemic therapy.\n- Patients treated with strong CYP3A4 inhibitors/inducers (patients can be washed out allowing 5 half-lives prior to study treatment and/or switched to non-prohibited drug.\n- History of stroke or intracranial hemorrhage within 3 months prior to registration for study screening or known bleeding disorders.\n- Transformation of CLL to Richter’s condition.\n- Use of investigational agents which might interfere with the study drug within 28 days prior to registration for study screening.\n- Vaccination with live vaccines within 14 days prior to screening (30 days for patients in Czech Republic).\n- Active infection requiring systemic antibiotic/antifungal medication, known clinically active hepatitis B or C, or HIV, HCV infection or active COVID-19. (Patients who have received COVID-19 vaccination will be considered as eligible for the study.) (For patients from the Czech Republic, HBV, HCV and HIV testing is mandated at screening for these criteria to be met).\n- Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of study treatment; further pregnancy testing will be performed monthly).\n- Fertile men or women of childbearing potential unless: surgically sterile or ≥ 2 years after the onset of menopause or willing to use two methods of reliable contraception including one highly effective contraceptive method (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 3 months after the end of study treatment.\n- Prior treatment with venetoclax or other Bcl-2 inhibitors.\n- An individual organ/system impairment score of 4 as assessed by the cumulative illness rating scale (CIRS) definition limiting the ability to receive the study treatment, or any other life-threatening illness, medical condition, or organ system dysfunction that, in the investigator´s opinion, could compromise the patients’ safety or interfere with the absorption or metabolism of the study drugs (e.g., inability to swallow tablets or impaired resorption in the gastrointestinal tract).\n- Patients receiving acalabrutinib capsule-based therapy (not tablet) who require treatment with proton pump inhibitors (e.g, omeprazole esomeprazole, lansoprazole etc,) at study entry. (Patients receiving proton pump inhibitors who switch to H2 receptors antagonists or antacids are eligible for enrollment).\n- Patients who require or are receiving anticoagulation therapy with warfarin or equivalent vitamin K antagonists within 7 days of first dose of the study drug(s).\n- Patients who are pregnant or breastfeeding.\n- Has received the following within 7 days prior to the first dose of study drug: • Steroid therapy at a dose greater than prednisone 20 mg daily (or equivalent) for anti-neoplastic intent. • CYP3A inhibitors such as fluconazole, ketoconazole, and clarithromycin or potent CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John’s wort.\n- Radiation within 14 days of study entry."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS assessed by IRC defined as the time from randomization to the first occurrence of progression or relapse using the iwCLL guidelines (Hallek Metal 2018) or death from any cause, whichever occurs first.","definition_or_measurement_approach":"PFS assessed by IRC defined as the time from randomization to the first occurrence of progression or relapse using the iwCLL guidelines (Hallek Metal 2018) or death from any cause, whichever occurs first."}

Secondary endpoints

  • {"endpoint_text":"- Key secondary endpoint: Overall survival (OS) defined as the time from randomization to the time of death from any cause.","definition_or_measurement_approach":"Overall survival (OS) defined as the time from randomization to the time of death from any cause."}
  • {"endpoint_text":"- Other secondary efficacy endpoints: PFS assessed by investigator is defined as the time from randomization to the first occurrence of progression or relapse using the iwCLL guidelines (Hallek Metal 2018) or death from any cause, whichever occurs first.","definition_or_measurement_approach":"PFS by investigator defined as time from randomization to progression/relapse per iwCLL or death."}
  • {"endpoint_text":"- Other secondary efficacy endpoints: Overall response rate (ORR) is defined as the proportion of patients with complete response (CR), complete response with incomplete recovery (CRi) and partial repose (PR).","definition_or_measurement_approach":"ORR = proportion of patients with CR, CRi or PR."}
  • {"endpoint_text":"- Other secondary efficacy endpoints: Proportion of patients with CR/CRi.","definition_or_measurement_approach":"Proportion of patients achieving CR or CRi."}
  • {"endpoint_text":"- Other secondary efficacy endpoints: Duration of Response.","definition_or_measurement_approach":"Duration of Response measured from initial response until progression or relapse."}
  • {"endpoint_text":"- Other secondary efficacy endpoints: Proportion of patients with undetectable minimal residual disease.","definition_or_measurement_approach":"Proportion with undetectable MRD as defined by study-specified assay."}
  • {"endpoint_text":"- Safety endpoints: Incidence and severity of adverse events, serious adverse events and changes in laboratory results, including hematology and biochemistry, during and within 30 days of treatment discontinuation.","definition_or_measurement_approach":"Incidence and severity graded by CTCAE (not explicitly stated in JSON) and laboratory result changes during treatment and within 30 days of discontinuation."}
  • {"endpoint_text":"- Safety endpoints: Incidence of adverse events of interest, including atrial fibrillation and tumor lysis syndrome.","definition_or_measurement_approach":"Incidence of specified AEs of interest tracked during study."}
  • {"endpoint_text":"- Pharmacokinetics endpoint: Population PK analysis.","definition_or_measurement_approach":"Population pharmacokinetic analysis of lisaftoclax (PK sampling and modelling)."}
  • {"endpoint_text":"- Patient-Reported Outcome (PRO) Measures endpoint: The PRO outcome measures will evaluate the European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire Core-30 (QLQ-C30) and associated CLL module (QLQ-CLL17).","definition_or_measurement_approach":"PROs assessed using EORTC QLQ-C30 and QLQ-CLL17 questionnaires."}
  • {"endpoint_text":"- Health Economics and Outcomes Research (HEOR) endpoint: A EuroQoL5-Dimension (EQ-5D-5L) questionnaire will be used","definition_or_measurement_approach":"Health economics measures assessed with EQ-5D-5L questionnaire."}

Recruitment

Planned Sample Size
440
Recruitment Window Months
84
Consent Approach
Written informed consent required from each participant ("Ability and willingness to provide written informed consent" is an inclusion requirement). Specific subject information and informed consent forms (including pregnancy and pregnant-partner forms) and layperson synopses are provided in multiple languages (English, Bulgarian, Czech, Hungarian, Romanian, Spanish, Slovak, Polish, French, Italian, German, Dutch/Belgian variants). Participants are adults (≥18) so consent is provided by the participant; no pediatric assent procedures are specified.

Geography

Total Number Of Sites
76
Total Number Of Participants
232

Bulgaria

Earliest CTIS Part Ii Submission Date
26-04-2024
Latest Decision Or Authorization Date
20-05-2024
Processing Time Days
24
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Medical Center Pulmovision Ltd.
Contact Person Name
Emel Bekirova
Contact Person Email
emel.bekirova@outlook.com
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
Department of Clinical Hematology
Contact Person Name
Mariya Todorova
Contact Person Email
dr.maria.dtodorova@gmail.com
Site Name
Acibadem City Clinic Tokuda University Hospital EAD
Department Name
Clinic of Hematology
Contact Person Name
Ismail Amine
Site Name
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Department Name
Department for Clinical Hematology, Clinic for Clinical Hematology
Contact Person Name
Tanya Yankova
Contact Person Email
t.yankova@hematology.bg
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Clinical Hematology
Contact Person Name
Atanas Radinoff
Contact Person Email
aradinoff@hotmail.com
Site Name
MBAL Sveta Marina EAD
Department Name
Clinic for Clinical Hematology
Contact Person Name
Ilina Micheva
Contact Person Email
ilinamicheva@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
20-05-2024
Processing Time Days
18
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Aidport Sp. z o.o.
Contact Person Name
Łukasz Pruchniewski
Contact Person Email
rejestracja@aidport.pl
Site Name
In Vivo Sp. z o.o.
Contact Person Name
Jaroslaw Czyz
Contact Person Email
jczyz@onet.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematoonkologii i Chorób Wewnętrznych z Pododdziałem Chemioterapii Dziennej
Contact Person Name
Paweł Robak
Site Name
Pratia S.A.
Contact Person Name
Wojciech Jurczak
Contact Person Email
biuro.mcm@pratia.com

Italy

Earliest CTIS Part Ii Submission Date
24-04-2024
Latest Decision Or Authorization Date
14-05-2024
Processing Time Days
20
Number Of Sites
20
Number Of Participants
45

Sites

Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncoematologia clinico sperimentale
Contact Person Name
Pietro Bulian
Contact Person Email
pbulian@cro.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Department* Unità Operativa Oncologia medica ed Ematologia
Contact Person Name
Armando Santoro
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
UOC Ematologia
Contact Person Name
Francesco Rotondo
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
UOC Ematologia
Contact Person Name
Marta Coscia
Site Name
University Hospital Of Ferrara
Department Name
Ematologia
Contact Person Name
Gian Matteo Rigolin
Contact Person Email
gianmatteo.rigolin@unife.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Ematologia e Trapianto di cellule staminali emopoietiche
Contact Person Name
Luca Laurenti
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncoematologia
Contact Person Name
Enrico Derenzini
Contact Person Email
enrico.derenzini@ieo.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
SC-Ematologia e TMO
Contact Person Name
Paolo Sportoletti
Contact Person Email
paolo.sportoletti@unipg.it
Site Name
Azienda Ospedale-Universita Padova
Department Name
UOC Ematologia
Contact Person Name
Andrea Visentin
Contact Person Email
andrea.visentin@unipd.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Ematologia
Contact Person Name
Candida Vitale
Contact Person Email
candida.vitale@unito.it
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
Oncologia-ematologia
Contact Person Name
Daniele Vallisa
Contact Person Email
d.vallisa@ausl.pc.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
U.O Ematologia e Trapianto di cellule staminali
Contact Person Name
Nicola Di Renzo
Contact Person Email
direnzo.ematolecce@gmail.com
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Ematologia
Contact Person Name
Marina Motta
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
UO Ematologia
Contact Person Name
Monica Tani
Contact Person Email
monicatani22@gmail.com
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
SSD Ematologia e Trapianti
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate
Contact Person Name
Fiorella Ilariucci
Contact Person Email
fiorella.ilariucci@ausl.re.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia
Contact Person Name
Paolo Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
Universita' Campus Bio-medico Di Roma
Department Name
UOC Ematologia e Trapianto di cellule staminali
Contact Person Name
Luigi Rigacci
Contact Person Email
l.rigacci@policlinicocampus.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Unità Operativa Ematologia e Terapie Cellulari
Contact Person Name
Adalberto Ibatici
Contact Person Email
adalberto.ibatici@hsanmartino

France

Earliest CTIS Part Ii Submission Date
24-04-2024
Latest Decision Or Authorization Date
16-05-2024
Processing Time Days
22
Number Of Sites
12
Number Of Participants
35

Sites

Site Name
Groupe Hospitalier Saint Vincent
Department Name
Clinique Saint Anne - Service Hematologie-Oncologie
Contact Person Name
Aurore Iltis-Roux
Contact Person Email
ailtis-roux@solcrr.org
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service Hématologie
Contact Person Name
Cécile Tomowiak
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Service Hematologie
Contact Person Name
Marlene Ochmann
Contact Person Email
marlene.ochmann@chu-orleans.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hopital Estaing - Service d’hematologie clinique et therapie cellulaire adulte
Contact Person Name
Olivier Tournilhac
Site Name
Hopital NOVO
Department Name
Service Hématologie
Contact Person Name
Ioana Vaida
Contact Person Email
ioana.vaida@ght-novo.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Service d’hématologie
Contact Person Name
Katell Le Du
Contact Person Email
dr.ledu@groupeconfluent.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hotel Dieu - Service Hematologie Clinique
Contact Person Name
Anne Lok
Contact Person Email
anne.lok@chu-nantes.fr
Site Name
Centre Leon Berard
Department Name
Departement de cancerologie medicale
Contact Person Name
Anne-Sophie Michallet
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service Hématologie et Thérapie Cellulaire
Contact Person Name
Carpline Dartigeas
Contact Person Email
c.dartigeas@chu-tours.fr
Site Name
Centre Hospitalier Le Mans
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Antoine Lacassagne
Department Name
Departement d'Oncologie Medicale
Contact Person Name
Luca Inchiappa
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Institut de Cancerologie du Gard - Service Hematologie Clinique
Contact Person Name
Agathe Waultier-Rascalou

Belgium

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
12-09-2024
Processing Time Days
14
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology
Contact Person Name
Hélène Vellemans
Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematology
Contact Person Name
Lien Deleu
Contact Person Email
Lien.deleu@azdelta.be
Site Name
CHU Helora
Department Name
Hematology
Contact Person Name
Vanessa Delrieu
Contact Person Email
Vanessa.delrieu@helora.be
Site Name
UZ Leuven
Department Name
Hematology
Contact Person Name
Ann Janssens
Contact Person Email
Ann.janssens@uzleuven.be
Site Name
Antwerp University Hospital
Department Name
Hematology
Contact Person Name
Matthias Vanderkerken
Contact Person Email
Matthias.vanderkerken@uza.be
Site Name
Clinique Saint-Pierre
Department Name
Internal Medicine/Oncology/Hematology
Contact Person Name
Thierry Connerotte
Contact Person Email
Thierry.connerotte@cspo.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Hematology
Contact Person Name
Fritz Offner
Contact Person Email
Fritz.offner@ugent.be
Site Name
UZ Leuven (duplicate entry consolidated)
Department Name
Hematology

Spain

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
16-05-2024
Processing Time Days
27
Number Of Sites
12
Number Of Participants
45

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Contact Person Name
Lucrecia Yáñez
Contact Person Email
lucrecia.yanez@scsalud.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
Francesc Bosch
Contact Person Email
fboschct@vhio.net
Site Name
Hospital Son Llatzer
Department Name
Hematology
Contact Person Name
Martin Mascaró Riera
Contact Person Email
mmascar1@hsll.es
Site Name
University Hospital Son Espases
Department Name
Hematology
Contact Person Name
Antonio Gutiérrez
Contact Person Email
antoniom.gutierrez@ssib.es
Site Name
Hospital Del Mar
Department Name
Hematology
Contact Person Name
Eva Gimeno
Contact Person Email
94015@hospitaldelmar.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Contact Person Name
Mónica Ballesteros
Contact Person Email
monicabandres@hotmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology
Contact Person Name
Miguel Argüello
Contact Person Email
marguello@santpau.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Contact Person Name
Tycho Baumann
Contact Person Email
tycho.baumann@gmail.com
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
Hematology
Contact Person Name
Carmen Mas Ochoa
Contact Person Email
mas_maroch@gva.es
Site Name
Hospital Universitario De La Princesa
Department Name
Hematology
Contact Person Name
Javier Loscertales
Contact Person Email
jloscertales@gmail.com
Site Name
Hospital Del Mar (duplicate/other unit)
Department Name
Hematology
Site Name
Hospital Universitario De La Princesa (additional unit)
Department Name
Hematology

Czechia

Earliest CTIS Part Ii Submission Date
24-04-2024
Latest Decision Or Authorization Date
16-05-2024
Processing Time Days
22
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. Interní hematologická klinika
Contact Person Name
Martin Šimkovič
Contact Person Email
simkovicm@lfhk.cuni.cz

Slovakia

Earliest CTIS Part Ii Submission Date
24-04-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
19
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
National Oncology Institute
Department Name
Onco-hematology II
Contact Person Name
Eva Mikušková
Contact Person Email
eva.mikuskova@nou.sk
Site Name
Univerzitna Nemocnica Martin
Department Name
klinika hematológie a transfuziológie
Contact Person Name
Juraj Sokol
Contact Person Email
juraj.sokol@me.com

Romania

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
20-05-2024
Processing Time Days
32
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Institutul Clinic Fundeni
Department Name
Secția Hematologie 3
Contact Person Name
Ana-Maria Moldovianu
Contact Person Email
ana.moldovianu@gmail.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Secția Clinica Hematologie
Contact Person Name
Ciprian Tomuleasa
Contact Person Email
ciprian.tomuleasa@umfcluj.ro
Site Name
Spitalul Clinic Municipal De Urgenta Timisoara
Department Name
Clinica de Hematologie
Contact Person Name
Ioana Ioniță
Contact Person Email
mdioanaionita@yahoo.com

Hungary

Earliest CTIS Part Ii Submission Date
23-04-2024
Latest Decision Or Authorization Date
14-05-2024
Processing Time Days
21
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Hematológia
Contact Person Name
László Rejtő
Site Name
University Of Debrecen
Department Name
Belgyógyászati Klinika, Hematológia
Contact Person Name
Árpád Illés
Contact Person Email
tengyelne.viola@med.unideb.hu
Site Name
Semmelweis University
Department Name
Belgyógyászati és Hematológiai Klinika
Contact Person Name
Zsolt György Nagy

Germany

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
14-05-2024
Processing Time Days
25
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Gemeinschaftspraxis Haematologie Onkologie
Contact Person Name
Thomas Illmer
Contact Person Email
illmer@onkologie-dresden.net
Site Name
Onkozentrum Dresden Freiberg Meissen
Department Name
Gemeinschaftspraxis Haematologie & Onkologie
Contact Person Name
Steffen Doerfel
Contact Person Email
doerfel@onkozentrum.de
Site Name
Klinische Forschung Karlsruhe GmbH
Contact Person Name
Juergen Fischer
Contact Person Email
feasibility.germany@pratia.com
Site Name
Sana Klinikum Offenbach GmbH
Contact Person Name
Thomas Wehler
Contact Person Email
Thomas.wehler@sana.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III
Contact Person Name
Clemens-Martin Wendtner

Sponsor

Primary sponsor

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

Contract research organisations

Name
Cromos Pharma Ireland Limited
Responsibilities
Managing Clinical Trial in all approved EU countries, including site selection, monitoring and close out activities. On behalf of the Sponsor, also negotiate, execute and deliver study related agreements, make payments to sites and investigators

Third parties

  • {"country":"Ireland","full_name":"Cromos Pharma Ireland Limited","duties_or_roles":"Managing Clinical Trial in all approved EU countries, including site selection, monitoring and close out activities. On behalf of the Sponsor, also negotiate, execute and deliver study related agreements, make payments to sites and investigators","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Lisaftoclax
Active Substance
LISAFTOCLAX
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Starting Dose
20 mg
Dose Levels
Escalating doses from 20 mg up to 400 mg during daily ramp-up; maintenance 400 mg QD
Frequency
Once daily (QD)
Maximum Dose
400 mg
Dose Escalation Increase
Initial 20 mg with escalation up to 400 mg during daily ramp-up; maintenance 400 mg QD
Combination Treatment
Yes

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