A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Oct 2013 → ongoing

Decision date (initial)

2023-10-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Janssen Research & Development, LLC

External identifiers

EU CT number

2023-503803-27-00

EudraCT number

2012-004225-24

ClinicalTrials.gov

NCT01804686

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

The objective of this study is to collect long-term safety and efficacy data for subjects treated with ibrutinib and to provide ongoing access to ibrutinib for subjects who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol (eg, final analysis has been performed), are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

Conditions and MedDRA coding

B-cell non-Hodgkin's lymphoma and cGVHD

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants must be currently participating in a ibrutinib clinical study considered completed and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib OR Subjects must have participated in a ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and subjects with less than 6 months will be required to have more frequent initial safety assessments
2. Agrees to protocol-defined use of effective contraception
3. Negative blood or urine pregnancy test at screening

Exclusion criteria 3

1. Requires anticoagulation with warfarin or equivalent vitamin K antagonists
2. Requires treatment with strong cytochrome P450 (CYP)3A4/5inhibitors, unless previously approved by sponsor
3. Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of participants affected by an adverse event

Secondary endpoints 1

1. Number of participants with change in disease status

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 5

Locations

8 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 55 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications