Clinical trial • Phase III • Oncology
ACALABRUTINIB for Chronic lymphocytic leukemia
Phase III trial of ACALABRUTINIB for Chronic lymphocytic leukemia.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Chronic lymphocytic leukemia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 14-06-2024
- First CTIS Authorization Date
- 11-07-2024
Trial design
Randomised, open-label, arm a: obinutuzumab (gazyvaro, concentrate for infusion; product ma eu/1/14/937/001; iv, product maxtotaldoseamount 1000 mg) in combination with chlorambucil (chlorambucil 2 mg tablets; dosing referenced as 0.5 mg/kg per day in product entry). exact administration schedule not specified in the available source text.-controlled Phase III trial across 40 sites in Spain, Italy, Lithuania and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arm A: obinutuzumab (Gazyvaro, concentrate for infusion; product MA EU/1/14/937/001; IV, product maxTotalDoseAmount 1000 mg) in combination with chlorambucil (Chlorambucil 2 mg tablets; dosing referenced as 0.5 mg/kg per day in product entry). Exact administration schedule not specified in the available source text.
- Target Sample Size
- 323
Eligibility
Recruits 323 The protocol indicates vulnerable population considerations: participation of subjects 'in situation of vulnerability' is not permitted per the protocol (note in translations: e.g. prisoners or institutionalised patients). Written informed consent by the subject is required; the trial enrols adults only (no paediatric participants), so assent procedures are not applicable..
- Pregnancy Exclusion
- Women who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab in combination with chlorambucil, whichever is longer.
- Vulnerable Population
- The protocol indicates vulnerable population considerations: participation of subjects 'in situation of vulnerability' is not permitted per the protocol (note in translations: e.g. prisoners or institutionalised patients). Written informed consent by the subject is required; the trial enrols adults only (no paediatric participants), so assent procedures are not applicable.
Inclusion criteria
- {"criterion_text":"- \"• Men and women ≥ 65 years of age, or > 18 and < 65 years of age provided that they meet at least one of the following criteria: o Creatinine clearance 30 to 69 mL/min using the Cockcroft-Gault equation. o A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric (CIRS-G). • ECOG performance status of 0, 1, or 2. • Diagnosis of CD20+ CLL that meets published diagnostic criteria (Hallek 2008) • Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment: o Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL). o Massive (ie, ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly. o Massive nodes (ie, ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy. o Progressive lymphocytosis with an increase of > 50% over a 2-month period or a lymphocyte doubling time (LDT) of < 6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts (ALC) obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In subjects with initial blood lymphocyte counts of < 30 x 10^9/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded. o Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy. o Constitutional symptoms documented in the subject's chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs: - Unintentional weight loss ≥ 10% within the previous 6 months before Screening. - Significant fatigue (ie, ECOG performance status 2; inability to work or perform usual activities). - Fevers higher than 100.5°F or 38.0°C for 2 or more weeks before Screening without evidence of infection. - Night sweats for > 1 month before Screening without evidence of infection. • Meet the following laboratory parameters: o Absolute neutrophil count ≥ 750 cells/μL (0.75 x 10^9/L) or ≥ 500 cells/μL (0.50 x 10^9/L) in subjects with documented bone marrow involvement and independent of growth factor support 7 days before assessment. o Platelet count ≥ 50,000 cells/μL (50 x 10^9/L), or ≥ 30,000 cells/μL (30 x 10^9/L) in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded. o Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN). o Total bilirubin ≤ 1.5 x ULN. o Estimated creatinine clearance (ie, estimated glomerular filtration rate [eGFR] using Cockcroft-Gault) ≥ 30 mL/min. • Able to receive all outpatient treatment, all laboratory monitoring, and all radiologic evaluations. • Women who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab in combination with chlorambucil, whichever is longer. • Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study and for 90 days after the last dose of obinutuzumab or chlorambucil, whichever is later. • Men must agree to refrain from sperm donation during the study and for 90 days after the last dose of obinutuzumab or chlorambucil, whichever is later. • Are willing and able to adhere to the study visit schedule, understand and comply with other protocol requirements, and provide written informed consent and authorization to use protected health information.\""}
Exclusion criteria
- {"criterion_text":"- \"• Any prior systemic treatment for CLL (note: Prior localized radiotherapy is allowed). • Known central nervous system (CNS) lymphoma or leukemia. • Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome. • Missing or incomplete documentation of FISH results reflecting the presence or absence of 17p del and the percentage of cells with the deletion in subject records before randomization. • Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP) defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (> 20mg daily of prednisone daily or equivalent). • Corticosteroid use > 20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. For example, subjects requiring steroids at daily doses > 20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for leukemia control or white blood cell count (WBC) lowering are excluded\""}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint of the study is PFS as assessed by IRC review per IWCLL 2008 criteria. The primary analysis is a comparison of PFS between Arm A and Arm B.","definition_or_measurement_approach":"PFS assessed by Independent Review Committee (IRC) using IWCLL 2008 criteria; primary analysis compares PFS between Arm A (obinutuzumab + chlorambucil) and Arm B (acalabrutinib + obinutuzumab)."}
Secondary endpoints
- {"endpoint_text":"- \"Efficacy: The first secondary endpoint is a comparison of IRC-assessed PFS between Arm A and Arm C. Other secondary endpoints are as follows and compare Arm A versus Arm B and Arm A versus Arm C • OS. Safety: • Frequency, severity, and relatedness of adverse events. • Frequency of adverse events requiring discontinuation of study drug or dose reductions. • Change in laboratory assessments.\"","definition_or_measurement_approach":"IRC-assessed PFS comparisons (Arm A vs Arm C); additional efficacy endpoints include OS and IRC-assessed ORR per IWCLL 2008; safety endpoints include frequency/severity/relatedness of AEs, AEs leading to discontinuation or dose reduction, and changes in laboratory assessments."}
- {"endpoint_text":"- \"Efficacy: The first secondary endpoint is a comparison of IRC-assessed PFS between Arm A and Arm C. Other secondary endpoints are as follows and compare Arm A versus Arm B and Arm A versus Arm C • OS. Safety: • Frequency, severity, and relatedness of adverse events. • Frequency of adverse events requiring discontinuation of study drug or dose reductions. • Change in laboratory assessments.\"","definition_or_measurement_approach":"As above (duplicate secondary endpoint entry in source)."}
Recruitment
- Planned Sample Size
- 323
- Recruitment Window Months
- 123
- Consent Approach
- Written informed consent required from each participant. Subject information and informed consent forms (L1) and related ICF documents are provided in multiple languages (documents listed for English, Spanish, Italian, Lithuanian, Dutch/Flemish, French, German, Hungarian, Polish, Swedish and others). Pregnant-partner and PK-specific ICFs are also provided where applicable. As the trial enrols adults only, no paediatric assent procedures are indicated.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 212
Spain
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 11-07-2024
- Processing Time Days
- 8
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Javier De la Serna
- Principal Investigator Email
- javier.serna@salud.madrid.org
- Contact Person Name
- Javier De la Serna
- Contact Person Email
- javier.serna@salud.madrid.org
- 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 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
- Contact Person Email
- garciavela.joseantonio@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Hematology
- Principal Investigator Name
- Miguel Argüello
- Principal Investigator Email
- marguello@santpau.cat
- Contact Person Name
- Miguel Argüello
- Contact Person Email
- marguello@santpau.cat
Italy
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 16-07-2024
- Processing Time Days
- 13
- Number Of Sites
- 9
- Number Of Participants
- 31
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
- Department Name
- SCDU Ematologia
- Principal Investigator Name
- Daniela Pietrasanta
- Principal Investigator Email
- dpietrasanta@ospedale.al.it
- Contact Person Name
- Daniela Pietrasanta
- Contact Person Email
- dpietrasanta@ospedale.al.it
- Site Name
- Istituto San Raffaele
- Department Name
- Divisione di Oncologia Sperimentale-Neoplasie Linfocitarie B
- 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
- Azienda Ospedaliero Universitaria Parma
- Department Name
- Dipartimento di Ematologia
- Principal Investigator Name
- Filomena Russo
- Principal Investigator Email
- frusso@ao.pr.it
- Contact Person Name
- Filomena Russo
- Contact Person Email
- frusso@ao.pr.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Dipartimento di Onco-Ematologia
- Principal Investigator Name
- Carmelo Carlo-Stella
- Principal Investigator Email
- carmelo.carlostella@hunimed.eu
- Contact Person Name
- Carmelo Carlo-Stella
- Contact Person Email
- carmelo.carlostella@hunimed.eu
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Unità di Ematologia – Dipartimento di Oncologia ed Ematologia
- Principal Investigator Name
- Monica Tani
- Principal Investigator Email
- monica.tani@auslromagna.it
- Contact Person Name
- Monica Tani
- Contact Person Email
- monica.tani@auslromagna.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC di Ematologia
- Principal Investigator Name
- Luca Laurenti
- Principal Investigator Email
- luca.laurenti@unicatt.it
- Contact Person Name
- Luca Laurenti
- Contact Person Email
- luca.laurenti@unicatt.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- U.O. di Oncologia Medica
- Principal Investigator Name
- Gerardo Musuraca
- Principal Investigator Email
- gerardo.musuraca@irst.emr.it
- Contact Person Name
- Gerardo Musuraca
- Contact Person Email
- gerardo.musuraca@irst.emr.it
- Site Name
- Careggi University Hospital
- Department Name
- S.O.D.C. Ematologia
- Principal Investigator Name
- Alessandro Sanna
- Principal Investigator Email
- sannaa@aou-careggi.toscana.it
- Contact Person Name
- Alessandro Sanna
- Contact Person Email
- sannaa@aou-careggi.toscana.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- U.O. Ematologia
- Principal Investigator Name
- Alessandra Tucci
- Principal Investigator Email
- alessandra.tucci@asst-spedalicivili.it
- Contact Person Name
- Alessandra Tucci
- Contact Person Email
- alessandra.tucci@asst-spedalicivili.it
Lithuania
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 24-07-2024
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Hematology, oncology and transfusion center
- Principal Investigator Name
- Ilma Tavorienė
- Principal Investigator Email
- Ilma.Tavoriene@santa.lt
- Contact Person Name
- Ilma Tavorienė
- Contact Person Email
- Ilma.Tavoriene@santa.lt
- Site Name
- Klaipedos universiteto ligonine VšĮ
- Department Name
- Department of Oncohematology
- Principal Investigator Name
- Ligita Kasnauskienė
- Principal Investigator Email
- ligita.malciute@gmail.com
- Contact Person Name
- Ligita Kasnauskienė
- Contact Person Email
- ligita.malciute@gmail.com
- Site Name
- Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinikos
- Department Name
- Oncolohy hematology clinic
- Principal Investigator Name
- Rolandas Gerbutavicius
- Principal Investigator Email
- Rolandas.Gerbutavicius@kaunoklinikos.lt
- Contact Person Name
- Rolandas Gerbutavicius
- Contact Person Email
- Rolandas.Gerbutavicius@kaunoklinikos.lt
Sweden
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 12-07-2024
- Processing Time Days
- 9
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Department of Hematology , Getingevagen 4, SE-221 85 Lund, Sweden
- Principal Investigator Name
- Daniel Roth
- Principal Investigator Email
- daniel.roth@skane.se
- Contact Person Name
- Daniel Roth
- Contact Person Email
- daniel.roth@skane.se
Poland
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 04-08-2024
- Processing Time Days
- 32
- Number Of Sites
- 8
- Number Of Participants
- 59
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Klinika Hematoonkologii i Transplantacji Szpiku UM w Lublinie
- Principal Investigator Name
- Małgorzata Wach
- Principal Investigator Email
- mijwach@poczta.onet.pl
- Contact Person Name
- Małgorzata Wach
- Contact Person Email
- mijwach@poczta.onet.pl
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Kraków
- Principal Investigator Name
- Wojciech Jurczak
- Principal Investigator Email
- biuro.mcm@pratia.com
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- biuro.mcm@pratia.com
- Site Name
- Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
- Department Name
- Oddział Hematologiczny
- Principal Investigator Name
- Wojciech Homenda
- Principal Investigator Email
- wojhom@sl.home.pl
- Contact Person Name
- Wojciech Homenda
- Contact Person Email
- wojhom@sl.home.pl
- Site Name
- Szpitale Pomorskie Sp. z o.o.
- Department Name
- Oddział Hematologii i Transplantologii Szpiku
- Principal Investigator Name
- Adam Witkowski
- Principal Investigator Email
- adam.wit12@gmail.com
- Contact Person Name
- Adam Witkowski
- Contact Person Email
- adam.wit12@gmail.com
- 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
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Hematologii
- Principal Investigator Name
- Jarosław Czyż
- Principal Investigator Email
- jczyz@onet.pl
- Contact Person Name
- Jarosław Czyż
- Contact Person Email
- jczyz@onet.pl
- Site Name
- Copernicus Podmiot Leczniczy Sp. z o.o.
- Department Name
- Wojewódzkie Centrum Onkologii
- Principal Investigator Name
- Hanna Ciepłuch
- Principal Investigator Email
- ciepluch@gumed.edu.pl
- Contact Person Name
- Hanna Ciepłuch
- Contact Person Email
- ciepluch@gumed.edu.pl
- Site Name
- Szpital Wojewodzki W Opolu Sp. z o.o.
- Department Name
- Oddział Kliniczny Hematologii, Onkologii Hematologicznej i Chorób Wewnętrznych
- Principal Investigator Name
- Dariusz Woszczyk
- Principal Investigator Email
- dariusz.s.woszczyk@gmail.com
- Contact Person Name
- Dariusz Woszczyk
- Contact Person Email
- dariusz.s.woszczyk@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 18-07-2024
- Processing Time Days
- 15
- Number Of Sites
- 6
- Number Of Participants
- 13
Sites
- Site Name
- UZ Leuven
- Department Name
- Hematology
- Principal Investigator Name
- Ann Janssens
- Principal Investigator Email
- ann.janssens@uzleuven.be
- Contact Person Name
- Ann Janssens
- Contact Person Email
- ann.janssens@uzleuven.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Principal Investigator Name
- Fritz Offner
- Principal Investigator Email
- fritz.offner@ugent.be
- Contact Person Name
- Fritz Offner
- Contact Person Email
- fritz.offner@ugent.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Hematology
- Principal Investigator Name
- Eric Van Den Neste
- Principal Investigator Email
- eric.vandenneste@saintluc.uclouvain.be
- Contact Person Name
- Eric Van Den Neste
- Contact Person Email
- eric.vandenneste@saintluc.uclouvain.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- Hematology
- Principal Investigator Name
- Sylvia Snauwaert
- Principal Investigator Email
- sylvia.snauwaert@azsintjan.be
- Contact Person Name
- Sylvia Snauwaert
- Contact Person Email
- sylvia.snauwaert@azsintjan.be
- Site Name
- GasthuisZusters Antwerpen
- Department Name
- Hematology
- Principal Investigator Name
- Jan Lemmens
- Principal Investigator Email
- jan.lemmens@gza.be
- Contact Person Name
- Jan Lemmens
- Contact Person Email
- jan.lemmens@gza.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- Hematology
- Principal Investigator Name
- Sylvia Snauwaert
- Principal Investigator Email
- sylvia.snauwaert@azsintjan.be
- Contact Person Name
- Sylvia Snauwaert
- Contact Person Email
- sylvia.snauwaert@azsintjan.be
France
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Service d’Hématologie
- Principal Investigator Name
- Vincent RIBRAG
- Principal Investigator Email
- vincent.ribrag@gustaveroussy.fr
- Contact Person Name
- Vincent RIBRAG
- Contact Person Email
- vincent.ribrag@gustaveroussy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d’Hématologie Biologique
- Principal Investigator Name
- Vincent LEVY
- Principal Investigator Email
- vincent.levy@aphp.fr
- Contact Person Name
- Vincent LEVY
- Contact Person Email
- vincent.levy@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 16
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- SLK-Kliniken Heilbronn GmbH
- Department Name
- Klinikum am Gesundbrunnen Klinik für Innere Medizin III
- Principal Investigator Name
- Uwe Martens
- Principal Investigator Email
- uwe.martens@slk-kliniken.de
- Contact Person Name
- Uwe Martens
- Contact Person Email
- uwe.martens@slk-kliniken.de
- Site Name
- Onkologische Schwerpunktpraxis
- Principal Investigator Name
- Hendrik Riesenberg
- Principal Investigator Email
- hendrik.riesenberg@onkologie-bielefeld.de
- Contact Person Name
- Hendrik Riesenberg
- Contact Person Email
- hendrik.riesenberg@onkologie-bielefeld.de
- Site Name
- Haematologisch Onkologische Schwerpunktpraxis
- Principal Investigator Name
- Björn Schöttker
- Principal Investigator Email
- b.schoettker@onkopraxis-wuerzburg.de
- Contact Person Name
- Björn Schöttker
- Contact Person Email
- b.schoettker@onkopraxis-wuerzburg.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 17-07-2024
- Processing Time Days
- 14
- Number Of Sites
- 4
- Number Of Participants
- 58
Sites
- Site Name
- University Of Debrecen
- Department Name
- Klinikai Központ
- 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
- 1.sz. Belgyógyászati Klinika
- Principal Investigator Name
- Zsolt Nagy
- Principal Investigator Email
- nagy.zsolt@med.semmelweis-univ.hu
- Contact Person Name
- Zsolt Nagy
- Contact Person Email
- nagy.zsolt@med.semmelweis-univ.hu
- 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
- Orszagos Onkologiai Intezet
- Department Name
- Kemoterápia A Belgyógyászati Osztály
- Principal Investigator Name
- András Rosta
- Principal Investigator Email
- roan@oncol.hu
- Contact Person Name
- András Rosta
- Contact Person Email
- roan@oncol.hu
Sponsor
Primary sponsor
- Full Name
- Acerta Pharma B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Contract research organisations
- Name
- Inotiv Inc.
- Responsibilities
- Clinical chemistry ,PK sample testing
- Name
- PPD Development LP
- Responsibilities
- Support with CTIS system; Clinical Management, Medical Monitoring (EMEA), Investigator recruitment, Central testing of samples
- Name
- PPD Global Central Labs
- Responsibilities
- Clinical chemistry, Clinical haematology,Analytical chemistry
- Name
- Signant Health Global LLC
- Responsibilities
- IVRS30 – treatment randomisation
- Name
- Flagship Biosciences Inc.
- Responsibilities
- cytogenetics and FISH testing
- Name
- Perceptive Informatics Inc.
- Responsibilities
- Medical image analysis/ review - X-ray, MRI, ultrasound, etc,Primary/ surrogate endpoint test
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- Routine clinical pathology testing, immunophenotyping
- Name
- Sitero LLC
- Name
- Astrazeneca Pharmaceuticals LP
Third parties
- {"country":"United States","full_name":"Inotiv Inc.","duties_or_roles":"Clinical chemistry ,PK sample testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Support with CTIS system; Clinical Management, Medical Monitoring (EMEA), Investigator recruitment, Central testing of samples","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Sitero LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Clinical chemistry, Clinical haematology,Analytical chemistry","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Flagship Biosciences Inc.","duties_or_roles":"cytogenetics and FISH testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IVRS30 – treatment randomisation","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Astrazeneca Pharmaceuticals LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc,Primary/ surrogate endpoint test","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Routine clinical pathology testing, immunophenotyping","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Calquence 100 mg film-coated tablets
- Active Substance
- ACALABRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation number: EU/1/20/1479/003
- Starting Dose
- 100 mg
- Maximum Dose
- 200 mg (total, per product entry)
- Investigational Product Name
- Calquence 100 mg hard capsules
- Active Substance
- ACALABRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation number: EU/1/20/1479/001
- Starting Dose
- 100 mg
- Maximum Dose
- 200 mg (total, per product entry)
- Investigational Product Name
- Gazyvaro 1,000 mg concentrate for solution for infusion.
- Active Substance
- OBINUTUZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Marketing authorisation number: EU/1/14/937/001
- Orphan Designation
- Yes
- Starting Dose
- 1000 mg (product maxTotalDoseAmount)
- Maximum Dose
- 1000 mg
- Investigational Product Name
- Chlorambucil 2 mg tablets
- Active Substance
- CHLORAMBUCIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation number: PL 39699/0041
- Starting Dose
- 0.5 mg/kg (per product maxDailyDoseAmount entry)
- Maximum Dose
- 0.5 mg/kg (per product entry)
- Combination Treatment
- Yes
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Other published trials that may interest you.
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