PCYC-1143-CA Phase 3 study of Ibrutinib in subjects with MCL
Research type
Research Study
Full title
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma
IRAS ID
227113
Contact name
Kim Linton
Contact email
Sponsor organisation
Pharmacyclics LLC
Eudract number
2017-000129-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
102,688, IND
Duration of Study in the UK
4 years, 10 months, 18 days
Research summary
This research is studying ibrutinib in a combination with venetoclax or placebo in patients with Mantle Cell Lymphoma (MCL). The reason for doing this study is to find out:
• How well giving 2 drugs together works better than giving just 1 drug for the treatment of MCL.
• The side effects of the giving the 2 drugs together.
• How long the 2 study drugs stay in patients’ blood.
• Whether special tests can predict how effective the 2 study drugs will be for patients.
Approximately 287 participants, age 18 and older, from EU, USA, Canada and Australia will take part in this study.
The study will start with an open-label Safety Run-in Period (Part 1). Patients assigned to this part will receive 560mg of ibrutinib (4 capsules) daily and up to 400mg of venetoclax (4 tablets) daily. The dose of venetoclax will begin at 20 mg and will be increased to 400 mg daily over a period of 5 weeks to try and limit side effects. Up to 27 patients may be enrolled to participate in Part 1 of the study.
Patients assigned to Phase 3 – Part 2 of the study will be randomised at a 1:1 ratio to 1 of 2 treatment arms. Patients will have a 50/50 chance of receiving combination of ibrutinib and venetoclax or combination of ibrutinib and placebo. Patients and the Study Doctor will not know if patients are taking venetoclax or placebo.
Approximately 260 eligible patients will be enrolled to participate in Part 2 of the study.
The time patients will be in this study will vary from person to person and will depend on patients’ response to the treatment and when they enrol. All patients will receive assigned treatment for up to 2 years. After completion of the 2 years, they will receive ibrutinib alone until the disease worsens or they experience significant side effects. Patients’ participation is expected to last approximately 4 years. During the study patients will be required to attend study visits at the study centre and will undergo various assessments which will include CT (Computed Tomography), PET (Positron Emission Tomography) scan, MRI (Magnetic Resonance Imaging), Endoscopy, Bone Marrow Biopsy, Blood and Urine tests.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0325
Date of REC Opinion
10 Oct 2017
REC opinion
Further Information Favourable Opinion