Clinical trial • Phase II • Oncology

Ibrutinib for Chronic lymphocytic leukemia (CLL)

Phase II trial of Ibrutinib for Chronic lymphocytic leukemia (CLL). 120 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Chronic lymphocytic leukemia (CLL)
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

Phase II trial across 7 sites in Italy.

Biomarker Stratified
True, TP53 aberration (subclonal TP53 deletion by FISH <20%) (Cohort 2 defined by TP53 subclone <20%)
Target Sample Size
120

Eligibility

Recruits 120 No vulnerable population selected; trial includes adults >=18 years; informed consent forms available (L1_ICF_Redacted, L1_ICF_Pre-Screening_Redacted)..

Vulnerable Population
No vulnerable population selected; trial includes adults >=18 years; informed consent forms available (L1_ICF_Redacted, L1_ICF_Pre-Screening_Redacted).

Inclusion criteria

  • {"criterion_text":"- >=18 years old\n- Documented diagnosis of CLL according to International workshop on CLL (IwCLL) 2008 criteria\n- Previously untreated (steroid treatment previously administered to control autoimmune complications is allowed)\n- Negative HBsAg and negative HBcAb or positive HBcAb and negative for HBV DNA by quantitative PCR, HCV antibody negative or, in case of HCV antibody positive, HCV RNA negative\n- Progressive disease requiring treatment according to IwCLL 2008 criteria\n- Cohort 2 only: Evidence of a small (<20%) subclone carrying TP53 deletion by FISH"}

Exclusion criteria

  • {"criterion_text":"- Histologically documented transformation from CLL to aggressive lymphoma (Richter transformation)\n- History of stroke or intracranial hemorrhage within 6 months prior to enrollment\n- Concomitant use of warfarin or other Vitamin K antagonists\n- Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor\n- Evidence of clonal TP53 mutations detected by Sanger sequencing and/or del17p in =20% of the nuclei by FISH"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- TP53 mutated subclone size at WEEK 2,4,12,24,48,72,96 and yearly thereafter compared to baseline [i.e. (TP53 mutated alleles at WEEK 2,4,12,24,48,72,96 and yearly thereafter)/(TP53 mutated alleles at baseline)]","definition_or_measurement_approach":"Measured as the ratio of TP53 mutated alleles at each timepoint (WEEK 2,4,12,24,48,72,96 and yearly thereafter) to TP53 mutated alleles at baseline, as specified in the endpoint bracket: (TP53 mutated alleles at timepoint)/(TP53 mutated alleles at baseline)."}

Recruitment

Planned Sample Size
120
Recruitment Window Months
116
Consent Approach
Informed consent required from adult participants (>=18 years). Subject information and informed consent forms available (documents: L1_ICF_Redacted, L1_ICF_Pre-Screening_Redacted). No paediatric assent procedures (minors excluded).

Geography

Total Number Of Sites
7
Total Number Of Participants
120

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
7
Number Of Participants
120

Sites

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
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
Ematologia
Principal Investigator Name
Andrea Ferrario
Principal Investigator Email
andrea.ferrario@asst-settelaghi.it
Contact Person Name
Andrea Ferrario
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 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
Hospital Santa Maria Della Misericordia
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Falzetti Franca
Principal Investigator Email
franca.falzetti@unipg.it
Contact Person Name
Falzetti Franca
Contact Person Email
franca.falzetti@unipg.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Ematologia
Principal Investigator Name
Ester Orlandi
Principal Investigator Email
eorlandi@smatteo.pv.it
Contact Person Name
Ester Orlandi
Contact Person Email
eorlandi@smatteo.pv.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
IBRUTINIB
Active Substance
Ibrutinib
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
marketingAuthNumber: -; prodAuthStatus: 2
Orphan Designation
Yes
Maximum Dose
420 mg daily

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