Clinical trial • Phase II • Oncology
VENETOCLAX for Chronic lymphocytic leukaemia (treatment-naïve)
Phase II trial of VENETOCLAX for Chronic lymphocytic leukaemia (treatment-naïve). 55 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Chronic lymphocytic leukaemia (treatment-naïve)
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 02-07-2024
- First CTIS Authorization Date
- 05-08-2024
Trial design
Phase II trial across 14 sites in Italy.
- Target Sample Size
- 55
Eligibility
Recruits 55 No vulnerable population selected; trial enrols adults (Age =18 but <65 years); informed consent obtained via standard subject information and informed consent form documents (L1_ICF available). No assent procedures described..
- Vulnerable Population
- No vulnerable population selected; trial enrols adults (Age =18 but <65 years); informed consent obtained via standard subject information and informed consent form documents (L1_ICF available). No assent procedures described.
Inclusion criteria
- {"criterion_text":"- Age =18 but <65 years"}
- {"criterion_text":"- Active CLL/SLL requiring treatment according to iwCLL 2018 criteria"}
- {"criterion_text":"- No previous CLL/SLL therapy"}
- {"criterion_text":"- Appropriate medullary function: a. ANC =1.0 x 109/L; B. Plt =25 x 109/L; c. Hb =8.0 g/dl"}
Exclusion criteria
- {"criterion_text":"- Previous treatment for CLL/SLL"}
- {"criterion_text":"- Known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C (HCV). Subjects who are positive for HBcAb, HBsAb or the hepatitis C antibody should have a negative result of the polymerase chain reaction (PCR) prior to enlistment. Those who test positive for PCR will be excluded."}
- {"criterion_text":"- Note hypersensitivity to one or more drugs in the study"}
- {"criterion_text":"- Known hemorrhagic disorders (e.g. von Willebrand's disease) or haemophilia"}
- {"criterion_text":"- History of stroke or intracranial bleeding in the 6 months prior to enlistment"}
- {"criterion_text":"- Major surgery within 4 weeks of first dose of the drug in the study"}
- {"criterion_text":"- Cardiovascular disease currently active and clinically significant such as uncontrolled arrhythmia or congestive heart failure of class 3 or 4 as defined by the functional classification of the New York Heart Association or a history of myocardial infarction, unstable angina"}
- {"criterion_text":"- History of other malignant malignancies, except in situ carcinoma or malignant cancers treated with curative intent"}
- {"criterion_text":"- Known story or suspected transformation of Richter"}
- {"criterion_text":"- Hypersensitivity known to one or more drugs in the study"}
- {"criterion_text":"- Inadequate kidney function: CrCl <30 ml/min"}
- {"criterion_text":"- Autoimmune hemolytic anemia or uncontrolled autoimmune platelets"}
- {"criterion_text":"- Need for warfarin or derivatives therapy"}
- {"criterion_text":"- Treatment within 7 days before the first dose of the drug in the study with one of the following: a. Steroid therapy with antineoplastic intent B. Moderate or powerful cytochrome inhibitors P450 3A (CYP3A) (see Appendix G for examples) C. Moderate or strong CYP3A inducers (see Appendix G for examples)"}
- {"criterion_text":"- Administration or consumption of any of the following within 3 days before the first dose of the drug in the study: a. Pompelmo or grapefruit products B. Seville oranges (including jam containing Seville oranges) c. Carambola"}
Endpoints
Primary endpoints
- {"endpoint_text":"- uMRD (<10-4) evaluated by 6-color cytofluorymetry in BM as the best response at any time during treatment up to 3 months after supplementation of combination therapy (VR or VR followed by VI)","definition_or_measurement_approach":"Evaluated by 6-color cytofluorymetry in bone marrow (BM); uMRD defined as <10-4 and assessed as the best response at any time during treatment up to 3 months after supplementation of combination therapy (VR or VR followed by VI)."}
Recruitment
- Planned Sample Size
- 55
- Recruitment Window Months
- 72
- Consent Approach
- Informed consent obtained from participants; subject information and informed consent form documents (L1_ICF and L1_ICF_Privacy_Redacted) are available. Participants are adults (Age =18 but <65); consent provided by participant. No assent or additional consent processes described.
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 55
Italy
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 05-08-2024
- Processing Time Days
- 26
- Number Of Sites
- 14
- Number Of Participants
- 55
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- 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
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Ematologia
- Principal Investigator Name
- Marina Motta
- Principal Investigator Email
- marina.motta@spedalicivili.brescia.it
- Contact Person Name
- Marina Motta
- Contact Person Email
- marina.motta@spedalicivili.brescia.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Ematologia
- Principal Investigator Name
- Alessandro Rambaldi
- Principal Investigator Email
- arambaldi@asst-pg23.it
- Contact Person Name
- Alessandro Rambaldi
- Contact Person Email
- arambaldi@asst-pg23.it
- Site Name
- Azienda Socio Sanitaria Territoriale Dei Sette Laghi
- Department Name
- Ematologia
- Principal Investigator Name
- Andrea Ferrario
- Principal Investigator Email
- andrea.ferrario@asst-settelaghi.it
- Contact Person Name
- Andrea Ferrario
- Contact Person Email
- andrea.ferrario@asst-settelaghi.it
- Site Name
- Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
- Department Name
- 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
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Ematologia
- Principal Investigator Name
- Marta Coscia
- Principal Investigator Email
- marta.coscia@unito.it
- Contact Person Name
- Marta Coscia
- Contact Person Email
- marta.coscia@unito.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Ematologia
- Principal Investigator Name
- Anna Maria Frustaci
- Principal Investigator Email
- annamaria.frustaci@ospedaleniguarda.it
- Contact Person Name
- Anna Maria Frustaci
- Contact Person Email
- annamaria.frustaci@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- Ematologia
- Principal Investigator Name
- Gianluca Gaidano
- Principal Investigator Email
- gianluca.gaidano@med.unipo.it
- Contact Person Name
- Gianluca Gaidano
- Contact Person Email
- gianluca.gaidano@med.unipo.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- 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
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- Ematologia
- Principal Investigator Name
- Francesca Maria Quaglia
- Principal Investigator Email
- francescamaria.quaglia@gmail.com
- Contact Person Name
- Francesca Maria Quaglia
- Contact Person Email
- francescamaria.quaglia@gmail.com
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- Ematologia
- Principal Investigator Name
- Livio Trentin
- Principal Investigator Email
- livio.trentin@unipd.it
- Contact Person Name
- Livio Trentin
- Contact Person Email
- livio.trentin@unipd.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Ematologia
- Principal Investigator Name
- Gianluigi Reda
- Principal Investigator Email
- gianluigi.reda@policlinico.mi.it
- Contact Person Name
- Gianluigi Reda
- Contact Person Email
- gianluigi.reda@policlinico.mi.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Ematologia
- Principal Investigator Name
- Marzia Varettoni
- Principal Investigator Email
- m.varettoni@smatteo.pv.it
- Contact Person Name
- Marzia Varettoni
- Contact Person Email
- m.varettoni@smatteo.pv.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Ematologia
- Principal Investigator Name
- Paolo Sportoletti
- Principal Investigator Email
- paolo.sportoletti@unipg.it
- Contact Person Name
- Paolo Sportoletti
- Contact Person Email
- paolo.sportoletti@unipg.it
Sponsor
Primary sponsor
- Full Name
- Ospedale San Raffaele S.r.l.
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- VENETOCLAX
- Active Substance
- VENETOCLAX
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Maximum Dose
- 400 mg
- Combination Treatment
- Yes
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