Clinical trial • Phase II • Haematology

Venetoclax for Chronic lymphocytic leukemia (relapsed/refractory)

Phase II trial of Venetoclax for Chronic lymphocytic leukemia (relapsed/refractory). open-label, none/not specified-controlled. 31 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Chronic lymphocytic leukemia (relapsed/refractory)
Trial Stage
Phase II
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
02-07-2024
First CTIS Authorization Date
05-08-2024

Trial design

open-label, none/not specified-controlled Phase II trial in Italy.

Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True, MRD (minimal residual disease)
Target Sample Size
31

Eligibility

Recruits 31 No vulnerable population selected in the CTIS record. The CTIS entry indicates isVulnerablePopulationSelected=false and no specific vulnerable-population consent/assent arrangements are described..

Vulnerable Population
No vulnerable population selected in the CTIS record. The CTIS entry indicates isVulnerablePopulationSelected=false and no specific vulnerable-population consent/assent arrangements are described.

Inclusion criteria

  • {"criterion_text":"-Documented CLL requiring treatment according to the IWCLL criteria (Hallek et al. 2008)"}
  • {"criterion_text":"-Relapsed/refractory CLL patients who received at least 1 prior therapy"}
  • {"criterion_text":"-Adequate bone marrow function without transfusion < 2 weeks of screening as follows: a. Absolute neutrophil count (ANC) =1.0 x 109/L (growth factors administration is allowed) b. Platelets =30 x 109/L. If thrombocytopenia due to BM involvement, platelets should be = 20 x 109/L c. Hemoglobin value =8.0 g/dl"}

Exclusion criteria

  • {"criterion_text":"-Transformation of CLL to aggressive NHL (Richter’s transformation or pro-lymphocytic leukemia)"}
  • {"criterion_text":"-Known central nervous system (CNS) involvement"}
  • {"criterion_text":"-Inadequate renal function: CrCl <30 mL/min"}
  • {"criterion_text":"-Previous treatment with BTK and/or BCL2 inhibitors (patients previously treated with PI3K inhibitors are eligible)"}
  • {"criterion_text":"-Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia"}
  • {"criterion_text":"-Requires the use of warfarin, marcumar, or phenprocoumon (potential drug-drug interaction increasing exposure of warfarin or phenprocoumon): low molecular weight drugs e.g. heparin are acceptable"}
  • {"criterion_text":"-Treatment, administration or consumption of any of the following within 3 days prior to the first dose of venetoclax (see also Appendix G). a. Strong Cytochrome P450 3A (CYP3A) inhibitors b. Moderate CYP3A inhibitors c. Moderate or strong CYP3A inducers d. PI3K inhibitors (e.g. Idelalisib); e. Grapefruit or grapefruit products f. Seville oranges (including marmalade containing Seville oranges) g. Star fruit"}
  • {"criterion_text":"-Known history of human immunodeficiency virus (HIV) or active with hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded."}
  • {"criterion_text":"-History of other malignancies, except: a. Malignancy treated with curative intent and with no known active disease present for =3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician. b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. c. Adequately treated carcinoma in situ without current evidence of disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Minimal residual disease (MRD) negativity rate evaluated by multi-colour flow cytometry analysis (limit of detection 10-4) within the treatment period","definition_or_measurement_approach":"Evaluated by multi-colour flow cytometry analysis with a limit of detection 10^-4, measured within the treatment period"}

Recruitment

Planned Sample Size
31
Recruitment Window Months
86
Consent Approach
Not specified in the CTIS record; a Subject information and informed consent form (L1_ICF_Redacted) is listed but details on assent, age-specific documents, who provides consent, or available languages are not provided in the available CTIS data.

Geography

Total Number Of Sites
17
Total Number Of Participants
31

Italy

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
05-08-2024
Processing Time Days
24
Number Of Sites
17
Number Of Participants
31

Sites

Site Name
Azienda Ulss 3 Serenissima
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Renato Bassan
Principal Investigator Email
renato.bassan@ulss12.ve.it
Contact Person Name
Renato Bassan
Contact Person Email
renato.bassan@ulss12.ve.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Marco Ladetto
Principal Investigator Email
marco.ladetto@ospedale.al.it
Contact Person Name
Marco Ladetto
Contact Person Email
marco.ladetto@ospedale.al.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
ONCOEMATOLOGIA
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
ASST Grande Ospedale Metropolitano Niguarda
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Alessandra Tedeschi
Principal Investigator Email
alessandra.tedeschi@ospedaleniguarda.it
Contact Person Name
Alessandra Tedeschi
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Fausto Rossini
Principal Investigator Email
f.rossini@hsgerardo.org
Contact Person Name
Fausto Rossini
Contact Person Email
f.rossini@hsgerardo.org
Site Name
Humanitas Mirasole S.p.A.
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Carmelo Carlo-Stella
Principal Investigator Email
carmelo.carlostella@unimi.it
Contact Person Name
Carmelo Carlo-Stella
Contact Person Email
carmelo.carlostella@unimi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
ONCOEMATOLOGIA
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
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Lucia Farina
Principal Investigator Email
lucia.farina@istitutotumori.mi.it
Contact Person Name
Lucia Farina
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
ONCOEMATOLOGIA
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
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 Dei Sette Laghi
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Andrea Ferrario
Principal Investigator Email
andrea.ferrario@asst-settelaghi.it
Contact Person Name
Andrea Ferrario
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Alessandro Rambaldi
Principal Investigator Email
gquaresmini@hpg23.it
Contact Person Name
Alessandro Rambaldi
Contact Person Email
gquaresmini@hpg23.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Valentina Rossi
Principal Investigator Email
rossi.valentina@asst-fbf-sacco.it
Contact Person Name
Valentina Rossi
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Luca Arcaini
Principal Investigator Email
eorlandi@smatteo.pv.it
Contact Person Name
Luca Arcaini
Contact Person Email
eorlandi@smatteo.pv.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Gianluigi Reda
Principal Investigator Email
gianluigi.reda@policlinico.mi.it
Contact Person Name
Gianluigi Reda
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Massimo Massaia
Principal Investigator Email
massimo.massaia@unito.it
Contact Person Name
Massimo Massaia
Contact Person Email
massimo.massaia@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Marina Motta
Principal Investigator Email
marina.motta@spedalicivili.brescia.it
Contact Person Name
Marina Motta

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
Route
ORAL USE
Orphan Designation
Yes
Maximum Dose
400 mg (max daily dose amount 400 mg)
Combination Treatment
Yes

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