PCYC-1145-LT - Long-term safety rollover for ibrutinib trials
Research type
Research Study
Full title
Extended treatment protocol for subjects continuing to benefit from ibrutinib after completion of ibrutinib clinical trials
IRAS ID
280018
Contact name
Dr. Kirit Ardeshna
Contact email
Sponsor organisation
Pharmacyclics Switzerland GmbH, an AbbVie company
Eudract number
2016-004356-30
Clinicaltrials.gov Identifier
102,688, IND Number
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
This is a multicentre, open-label study to provide continued access to ibrutinib to participants who have completed parent studies and collect long-term safety data. Participants must have been benefiting from treatment with ibrutinib on their previous study and have no access to ibrutinib for their underlying disease within their region.
The main purpose of the study is to monitor the long-term safety of ibrutinib. This would be done by monitoring for any serious adverse events, in particular any events that lead to a dose reduction or
discontinuation with ibrutinib. The additional objective is to provide long-term access to ibrutinib and to allow for continued treatment for participants continuing to benefit. A Participants enrolled in this treatment protocol will receive oral ibrutinib at the same dose and schedule they were receiving at the end of their respective parent study. Treatment with ibrutinib may continue as long as the participants continue to benefit, or until ibrutinib becomes available free of charge in their region.
Once enrolled on the study, participants will be provided with enough ibrutinib to cover approximately 3 months of treatment or until their next treatment visit. Participants will be assessed by their treating doctor at the treatment visits to ask about side-effects, discuss further intake of ibrutinib, and provide enough of the medication until their next visit. Thirty days after taking their last dose of ibrutinib or prior to the start of a different therapy for their underlying disease, participants will be assessed by their treating doctor again to check side-effects and collect unused ibrutinib medication. After this, participants may be contacted by their Treating Doctor if there are any unresolved side-effects.REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0203
Date of REC Opinion
1 Jul 2020
REC opinion
Further Information Favourable Opinion