Clinical trial • Phase III • Oncology

ACALABRUTINIB for Chronic lymphocytic leukemia (treatment-naïve, without del(17p) or TP53 mutation)

Phase III trial of ACALABRUTINIB for Chronic lymphocytic leukemia (treatment-naïve, without del(17p) or TP53 mutation).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Chronic lymphocytic leukemia (treatment-naïve, without del(17p) or TP53 mutation)
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
16-05-2024
First CTIS Authorization Date
17-07-2024

Trial design

Randomised, open-label, investigator's choice of chemoimmunotherapy: fludarabine/cyclophosphamide/rituximab (fcr) or bendamustine/rituximab (br). (product details in ctis: fludarabine [max daily 25 mg/m2], cyclophosphamide [max daily 250 mg/m2], rituximab [max daily 375 mg/m2]; bendamustine [max daily 90 mg/m2] with rituximab [375 mg/m2]).-controlled Phase III trial across 59 sites in Slovakia, Czechia, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator's choice of chemoimmunotherapy: fludarabine/cyclophosphamide/rituximab (FCR) or bendamustine/rituximab (BR). (Product details in CTIS: FLUDARABINE [max daily 25 mg/m2], CYCLOPHOSPHAMIDE [max daily 250 mg/m2], RITUXIMAB [max daily 375 mg/m2]; BENDAMUSTINE [max daily 90 mg/m2] with RITUXIMAB [375 mg/m2]).
Target Sample Size
578

Eligibility

Recruits 578 The record indicates isVulnerablePopulationSelected = true. Subject information and informed consent forms (L1 SIS and ICF) are provided per country (multiple country-specific ICF documents listed). The protocol inclusion criteria set minimum age ≥18 years, so consent is from adult participants; no explicit assent procedures for minors are provided in the available criteria/documents..

Vulnerable Population
The record indicates isVulnerablePopulationSelected = true. Subject information and informed consent forms (L1 SIS and ICF) are provided per country (multiple country-specific ICF documents listed). The protocol inclusion criteria set minimum age ≥18 years, so consent is from adult participants; no explicit assent procedures for minors are provided in the available criteria/documents.

Inclusion criteria

  • {"criterion_text":"- 1. Men and women ≥18 years of age."}
  • {"criterion_text":"- 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0–2."}
  • {"criterion_text":"- 3. Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018): Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing B-cell marker (CD19, CD20, and CD23) and CD5. Prolymphocytes may comprise <55% of blood lymphocytes. Presence of ≥5x109 B lymphocytes/L (5000/µL) in the peripheral blood (at any point since the initial diagnosis)."}
  • {"criterion_text":"- 4. Active disease per IWCLL 2018 criteria that requires treatment (see Section 4.5.6)."}
  • {"criterion_text":"- 5. Meet the following laboratory parameters: a) Adequate bone marrow function independent of growth factor or transfusion support within 1 week of Screening, as follows: i.ANC ≥750 cells/μL (0.75x109/L); ANC ≥500 cells/μL (0.50x109/L) in subjects with documented bone marrow involvement of CLL ii.Platelet count ≥50,000 cells/μL (50x109/L); platelet count ≥30,000 cells/μL (30x109/L) in subjects with documented bone marrow involvement of CLL b)Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5xULN. c)Total bilirubin ≤2xULN, unless directly attributable to Gilbert’s syndrome d)Estimated creatinine clearance of ≥50 mL/min, calculated using the formula of Cockcroft and Gault (if male, [140Age] x Mass (kg) / [72 x creatinine mg/dL]; multiply by 0.85 if female); estimated creatinine clearance of ≥70 mL/min for subjects selected by investigator to receive FCR in Arm C"}

Exclusion criteria

  • {"criterion_text":"- 1. Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisone daily are permitted)."}
  • {"criterion_text":"- 2. Detected del(17p) or TP53 mutation."}
  • {"criterion_text":"- 3. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter’s transformation, PLL, or diffuse large B cell lymphoma [DLBCL]), or central nervous system (CNS) involvement by leukemia."}
  • {"criterion_text":"- 4. Any comorbidity or organ system impairment rated with a single CIRS score of 4 (excluding the eyes/ears/nose/throat/larynx organ system), or a total CIRS score of >6."}
  • {"criterion_text":"- 5. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura."}
  • {"criterion_text":"- 6. History of confirmed progressive multifocal leukoencephalopathy (PML)."}
  • {"criterion_text":"- 7. Received any investigational drug within 30 days before first dose of study drug."}
  • {"criterion_text":"- 8. Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug."}
  • {"criterion_text":"- 9. History of prior malignancy that could affect compliance with the protocol, or interpretation of results, except for the following: •Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study. •Other cancers not specified above which have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the Independent Review Committee (IRC) according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria.","definition_or_measurement_approach":"Time from randomization to first occurrence of disease progression or death from any cause, as determined by the Independent Review Committee (IRC) per IWCLL 2018 criteria."}

Secondary endpoints

  • {"endpoint_text":"- 1: Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator assessment.","definition_or_measurement_approach":"Time from randomization to first occurrence of progression or death as determined by investigator assessment."}
  • {"endpoint_text":"- 2: PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the IRC assessment and investigator assessment","definition_or_measurement_approach":"Time from randomization to first occurrence of progression or death per both IRC and investigator assessments."}
  • {"endpoint_text":"- 3: Event-free survival (EFS), defined as the time from randomization to the first occurrence of disease progression, initiation of subsequent anti-chronic lymphocytic leukemia (CLL) therapy, or death from any cause per IRC assessment and the investigator assessment","definition_or_measurement_approach":"Time from randomization to disease progression, start of subsequent anti-CLL therapy, or death as per IRC and investigator assessments."}
  • {"endpoint_text":"- Overall response rate (ORR), defined as the proportion of subjects with a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) per IRC assessment and investigator assessment","definition_or_measurement_approach":"Proportion of subjects achieving CR, CRi, nPR, or PR by IRC and investigator assessment (IWCLL 2018 criteria)."}
  • {"endpoint_text":"- Duration of objective response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause per IRC assessment and investigator assessment","definition_or_measurement_approach":"Time from first documented objective response to disease progression or death per IRC and investigator assessments."}
  • {"endpoint_text":"- Time to next Therapy (TTNT), defined as the time from randomization to institution of non-protocol specified treatment for CLL","definition_or_measurement_approach":"Time from randomization to start of non-protocol-specified treatment for CLL."}
  • {"endpoint_text":"- Minimal residual disease (MRD) negativity rate (determined as the proportion of subjects with MRD-negativity) measured in the peripheral blood by flow cytometry (10-4) at the start of Cycle 9 (in Arm A), the start of Cycle 10 (in Arm B), and 12 weeks after the start of Cycle 6 (in Arm C)","definition_or_measurement_approach":"Proportion MRD-negative in peripheral blood measured by flow cytometry at specified cycle timepoints (threshold 10^-4) per arm-specific schedule."}
  • {"endpoint_text":"- Overall survival (OS), defined as the time from randomization to death from any cause.","definition_or_measurement_approach":"Time from randomization to death from any cause."}

Recruitment

Planned Sample Size
578
Recruitment Window Months
18
Consent Approach
Informed consent is obtained from adult participants (minimum age ≥18). Country-specific subject information and informed consent forms (L1 SIS and ICF) are provided (multiple country-language ICF documents listed in the record). No assent procedures for minors are provided in the available protocol criteria; pregnant-partner ICFs are present as addenda in several countries.

Geography

Total Number Of Sites
59
Total Number Of Participants
406

Slovakia

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
36
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Narodny Onkologicky Ustav
Department Name
Oncohematology Clinic LFUK and NOÚ
Principal Investigator Name
Eva Mikušková
Principal Investigator Email
eva.mikuskova@nou.sk
Contact Person Name
Eva Mikušková
Contact Person Email
eva.mikuskova@nou.sk

Czechia

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
39
Number Of Sites
5
Number Of Participants
41

Sites

Site Name
University Hospital Olomouc
Department Name
Hematologicka klinika, ambulantni pavilon budova P3
Principal Investigator Name
Peter Turcsaniy
Principal Investigator Email
peter.turcsanyi@fnol.cz
Contact Person Name
Peter Turcsaniy
Contact Person Email
peter.turcsanyi@fnol.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika Hematoonkologie
Principal Investigator Name
Roman Hajek
Principal Investigator Email
roman.hajek@fno.cz
Contact Person Name
Roman Hajek
Contact Person Email
roman.hajek@fno.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. Interni hematologicka klinika
Principal Investigator Name
Martin Simkovic
Principal Investigator Email
simkovicm@gmail.com
Contact Person Name
Martin Simkovic
Contact Person Email
simkovicm@gmail.com
Site Name
Fakultni Nemocnice Plzen
Department Name
Hematologicko-onkologicke oddeleni
Principal Investigator Name
Daniel Lysak
Principal Investigator Email
lysak@fnplzen.cz
Contact Person Name
Daniel Lysak
Contact Person Email
lysak@fnplzen.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interni hematologicka a onkologicka klinika
Principal Investigator Name
Anna Panovska
Principal Investigator Email
panovska.anna@fnbrno.cz
Contact Person Name
Anna Panovska
Contact Person Email
panovska.anna@fnbrno.cz

Denmark

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
21-07-2024
Processing Time Days
38
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Aarhus Universitetshospital
Department Name
Hematology
Principal Investigator Name
Hans Bentzen
Principal Investigator Email
hansbent@rm.dk
Contact Person Name
Hans Bentzen
Contact Person Email
hansbent@rm.dk
Site Name
Region Sjaelland
Department Name
Hematology
Principal Investigator Name
Christian Bjorn
Principal Investigator Email
cbpo@regionsjaelland.dk
Contact Person Name
Christian Bjorn
Contact Person Email
cbpo@regionsjaelland.dk
Site Name
Rigshospitalet
Department Name
Hematology
Principal Investigator Name
Lisbeth Enggaard
Principal Investigator Email
lisbeth.enggaard@regionh.dk
Contact Person Name
Lisbeth Enggaard
Contact Person Email
lisbeth.enggaard@regionh.dk

Italy

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
39
Number Of Sites
6
Number Of Participants
46

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Dipartimento di Oncologia Medica
Principal Investigator Name
Gerardo Musuraca
Principal Investigator Email
erardo.musuraca@irst.emr.it
Contact Person Name
Gerardo Musuraca
Contact Person Email
erardo.musuraca@irst.emr.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Ematologia
Principal Investigator Name
Gianluca Gaidano
Principal Investigator Email
gianluca.gaidano@med.uniupo.it
Contact Person Name
Gianluca Gaidano
Contact Person Email
gianluca.gaidano@med.uniupo.it
Site Name
Azienda Ospedatora Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Ematologia
Principal Investigator Name
Candida Vitale
Principal Investigator Email
Candida.vitale@unito.it
Contact Person Name
Candida Vitale
Contact Person Email
Candida.vitale@unito.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
U.O. di ematologia
Principal Investigator Name
Monica Tani
Principal Investigator Email
monica.tani@ausl.ra.it
Contact Person Name
Monica Tani
Contact Person Email
monica.tani@ausl.ra.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Oncoematologia
Principal Investigator Name
Paolo Ghia
Principal Investigator Email
ghia.paolo@hsr.it
Contact Person Name
Paolo Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
SC Ematologia
Principal Investigator Name
Anna Maria Frustaci
Principal Investigator Email
annamaria.frestaci@ospedaleniguarda.it
Contact Person Name
Anna Maria Frustaci

Sweden

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
39
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Uppsala University Hospital
Department Name
Immunology, Genetics and Pathology
Principal Investigator Name
Mattias Mattsson
Principal Investigator Email
mattias.mattsson@akademiska.se
Contact Person Name
Mattias Mattsson
Contact Person Email
mattias.mattsson@akademiska.se
Site Name
Region Oerebro Laen
Department Name
Medicine
Principal Investigator Name
Bengt Rasmussen
Principal Investigator Email
bengt.rasmussen@regionorebrolan.se
Contact Person Name
Bengt Rasmussen

Austria

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
34
Number Of Sites
2
Number Of Participants
18

Sites

Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Universitätsklinik f. Innere Medizin III der PMU Salzburg
Principal Investigator Name
Alexander Egle
Principal Investigator Email
a.egle@salk.at
Contact Person Name
Alexander Egle
Contact Person Email
a.egle@salk.at
Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
3. Med. Abteilung für Hämatologie und Onkologie
Principal Investigator Name
Thomas Nösslinger
Principal Investigator Email
thomas.noesslinger@oegk.at
Contact Person Name
Thomas Nösslinger
Contact Person Email
thomas.noesslinger@oegk.at

France

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
39
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
hématologie clinique
Principal Investigator Name
Sophie De Guibert
Principal Investigator Email
Sophie.DE.GUIBERT@chu-rennes.fr
Contact Person Name
Sophie De Guibert
Site Name
Centre Henri Becquerel
Department Name
Hématologie
Principal Investigator Name
Stéphane Lepretre
Principal Investigator Email
stephane.lepretre@chb.unicancer.fr
Contact Person Name
Stéphane Lepretre
Site Name
Institut Gustave Roussy
Department Name
Hématologie
Principal Investigator Name
Vincent Ribrag
Principal Investigator Email
vincent.ribrag@gustaveroussy.fr
Contact Person Name
Vincent Ribrag
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
hématologie clinique
Principal Investigator Name
Guillaume Cartron
Principal Investigator Email
g-cartron@chu-montpellier.fr
Contact Person Name
Guillaume Cartron
Contact Person Email
g-cartron@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hémato-oncologie
Principal Investigator Name
Catherine Thieblemont
Principal Investigator Email
catherine.thieblemont@aphp.fr
Contact Person Name
Catherine Thieblemont
Contact Person Email
catherine.thieblemont@aphp.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Hématologie
Principal Investigator Name
Loïc Ysebaert
Principal Investigator Email
Ysebaert.Loic@iuct-oncopole.fr
Contact Person Name
Loïc Ysebaert
Contact Person Email
Ysebaert.Loic@iuct-oncopole.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
hématologie clinique
Principal Investigator Name
Damien Roos-Weil
Principal Investigator Email
damien.roosweil@aphp.fr
Contact Person Name
Damien Roos-Weil
Contact Person Email
damien.roosweil@aphp.fr
Site Name
Hopital Necker Enfants Malades
Department Name
Hématologie Adultes
Principal Investigator Name
Laurent Frenzel
Principal Investigator Email
laurent.frenzel@aphp.fr
Contact Person Name
Laurent Frenzel
Contact Person Email
laurent.frenzel@aphp.fr

Bulgaria

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
02-08-2024
Processing Time Days
50
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of clinical hematology
Principal Investigator Name
Maria Dimitrova
Principal Investigator Email
manasieva64@abv.bg
Contact Person Name
Maria Dimitrova
Contact Person Email
manasieva64@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of clinical hematology
Principal Investigator Name
Atanas Radinov
Principal Investigator Email
aradinoff@hotmail.com
Contact Person Name
Atanas Radinov
Contact Person Email
aradinoff@hotmail.com
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Hristo Botev AD
Department Name
Department of internal diseases
Principal Investigator Name
Liliya Sivcheva
Principal Investigator Email
lillysivcheva@yahoo.com
Contact Person Name
Liliya Sivcheva
Contact Person Email
lillysivcheva@yahoo.com

Hungary

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
39
Number Of Sites
4
Number Of Participants
42

Sites

Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Hematológiai Osztály
Principal Investigator Name
Miklós Egyed
Principal Investigator Email
dregyedmiklos@yahoo.com
Contact Person Name
Miklós Egyed
Contact Person Email
dregyedmiklos@yahoo.com
Site Name
Semmelweis University
Department Name
Belgyógyászati és Hematológiai Klinika
Principal Investigator Name
Zsolt Nagy
Principal Investigator Email
nagy.zsolt@med.semmelweis-univ.hu
Contact Person Name
Zsolt Nagy
Site Name
University Of Debrecen
Department Name
Belgyógyászati Klinika
Principal Investigator Name
Árpád Illés
Principal Investigator Email
illesarpaddr@gmail.com
Contact Person Name
Árpád Illés
Contact Person Email
illesarpaddr@gmail.com
Site Name
Semmelweis University
Department Name
Belgyógyászati és Hematológiai Klinika
Principal Investigator Name
Tamás Masszi
Principal Investigator Email
study.tmasszi@gmail.com
Contact Person Name
Tamás Masszi
Contact Person Email
study.tmasszi@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
35
Number Of Sites
9
Number Of Participants
134

Sites

Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Hematologii
Principal Investigator Name
Jaroslaw Czyz
Principal Investigator Email
jczyz@onet.pl
Contact Person Name
Jaroslaw Czyz
Contact Person Email
jczyz@onet.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddzial Onkologii i Radioterapii
Principal Investigator Name
Judyta Strzała
Principal Investigator Email
jstrzala@szpitalepomorskie.eu
Contact Person Name
Judyta Strzała
Contact Person Email
jstrzala@szpitalepomorskie.eu
Site Name
Pratia S.A.
Principal Investigator Name
Wojciech Jurczak
Principal Investigator Email
wjurczak.mcm@mp.pl
Contact Person Name
Wojciech Jurczak
Contact Person Email
wjurczak.mcm@mp.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Chorob Wewnetrznych, Zawodowych, Nadcisnienia Tetniczego i Onkologii Klinicznej
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
tomasz.wrobel@umed.wroc.pl
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz.wrobel@umed.wroc.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Klinika Hematoonkologii i Transplantacji Szpiku UM
Principal Investigator Name
Malgorzata Wach
Principal Investigator Email
mijwach@poczta.onet.pl
Contact Person Name
Malgorzata Wach
Contact Person Email
mijwach@poczta.onet.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
tomasz.wrobel@umed.wroc.pl
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz.wrobel@umed.wroc.pl
Site Name
In Vivo Sp. z o.o.
Principal Investigator Name
Jaroslaw Czyz
Principal Investigator Email
jczyz@onet.pl
Contact Person Name
Jaroslaw Czyz
Contact Person Email
jczyz@onet.pl
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Dzienny Oddzial Chemioterapii i Hematologii
Principal Investigator Name
Jacek Krzanowski
Principal Investigator Email
jacek.krzanowski@gmail.com
Contact Person Name
Jacek Krzanowski
Contact Person Email
jacek.krzanowski@gmail.com
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematologii z Pododdziałem Chemioterapii, Klinika Hematologii
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

Netherlands

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
39
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
Amphia Hospital
Department Name
Internist Hematology
Principal Investigator Name
Marjolein van der Klift
Principal Investigator Email
MvanderKlift@amphia.nl
Contact Person Name
Marjolein van der Klift
Contact Person Email
MvanderKlift@amphia.nl
Site Name
Flevoziekenhuis Stichting
Department Name
Hematology
Principal Investigator Name
Koen de Heer
Principal Investigator Email
kdeheer@flevoziekenhuis.nl
Contact Person Name
Koen de Heer
Contact Person Email
kdeheer@flevoziekenhuis.nl
Site Name
Jeroen Bosch Ziekenhuis
Department Name
Hematology
Principal Investigator Name
Djamilla Issa
Principal Investigator Email
d.issa@jbz.nl
Contact Person Name
Djamilla Issa
Contact Person Email
d.issa@jbz.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Internist
Principal Investigator Name
Ellen van der Spek
Principal Investigator Email
EvanderSpek@Rijnstate.nl
Contact Person Name
Ellen van der Spek
Contact Person Email
EvanderSpek@Rijnstate.nl
Site Name
Amsterdam UMC Stichting
Department Name
Hematology
Principal Investigator Name
Arnon Kater
Principal Investigator Email
a.p.kater@amsterdamumc.nl
Contact Person Name
Arnon Kater
Contact Person Email
a.p.kater@amsterdamumc.nl
Site Name
Amphia Hospital (duplicate listing removed if present)
Department Name
Internist Hematology

Spain

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
35
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Hospital Universitario Infanta Leonor
Department Name
Hematology
Principal Investigator Name
Jose Angel Hernandez Rivas
Principal Investigator Email
Jahernandezr@salud.madrid.org
Contact Person Name
Jose Angel Hernandez Rivas
Contact Person Email
Jahernandezr@salud.madrid.org
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology
Principal Investigator Name
Miguel Arguello
Principal Investigator Email
marguello@santpau.cat
Contact Person Name
Miguel Arguello
Contact Person Email
marguello@santpau.cat
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Laura Abril Sabater
Principal Investigator Email
labril@iconcologia.net
Contact Person Name
Laura Abril Sabater
Contact Person Email
labril@iconcologia.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Principal Investigator Name
Santiago Osorio Prendes
Principal Investigator Email
sanosorio2000@gmail.com
Contact Person Name
Santiago Osorio Prendes
Contact Person Email
sanosorio2000@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Principal Investigator Name
Lucrecia Yanez San Segundo
Principal Investigator Email
lucrecia.yanez@scsalud.es
Contact Person Name
Lucrecia Yanez San Segundo
Contact Person Email
lucrecia.yanez@scsalud.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Hematology
Principal Investigator Name
Jose Antonio Garcia Vela
Principal Investigator Email
garciavela.joseantonio@gmail.com
Contact Person Name
Jose Antonio Garcia Vela
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Francesc Bosch Albareda
Principal Investigator Email
fboschct@vhio.net
Contact Person Name
Francesc Bosch Albareda
Contact Person Email
fboschct@vhio.net
Site Name
Hospital Universitario Infanta Leonor (duplicate listing removed if present)

Germany

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
36
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Haematologisch Onkologische Schwerpunktpraxis
Department Name
Facharzt für Innere Medizin, Hämatologie und Internistische Onkologie
Principal Investigator Name
Björn Schöttker
Principal Investigator Email
B.Schoettker@onkopraxis-wuerzburg.de
Contact Person Name
Björn Schöttker
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
Principal Investigator Name
Barbara Eichhorst
Principal Investigator Email
barbara.eichhorst@xn--ukkoeln-606c.de
Contact Person Name
Barbara Eichhorst

Sponsor

Primary sponsor

Full Name
Acerta Pharma B.V.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
ACALABRUTINIB
Active Substance
ACALABRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Orphan Designation
Yes
Maximum Dose
200 mg
Investigational Product Name
VENETOCLAX
Active Substance
VENETOCLAX
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Maximum Dose
400 mg
Investigational Product Name
OBINUTUZUMAB
Active Substance
OBINUTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Orphan Designation
Yes
Maximum Dose
1000 mg
Investigational Product Name
BENDAMUSTINE
Active Substance
BENDAMUSTINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Maximum Dose
90 mg/m2
Investigational Product Name
FLUDARABINE
Active Substance
FLUDARABINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Maximum Dose
25 mg/m2
Investigational Product Name
RITUXIMAB
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Maximum Dose
375 mg/m2
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Maximum Dose
250 mg/m2
Combination Treatment
Yes

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