Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

28 Sep 2017 → ongoing

Decision date (initial)

2024-08-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2023-507329-40-00

EudraCT number

2016-004356-30

ClinicalTrials.gov

NCT03229200

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

The primary objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib and to allow for continued treatment of drug combinations from the parent study for subjects who meet the selection criteria.

Secondary objectives 1

1. To collect long-term safety data for these subjects treated with ibrutinib and to characterize the drug safety profile in long-term treatment with ibrutinib.

Conditions and MedDRA coding

1. Follicular Lymphoma 2. Chronic Lymphocytic Leukemia 3. Waldenstrom macroglobulinemia 4. Multiple Myeloma 5. Marginal Zone Lymphoma 6. Diffuse Large B-Cell Lymphoma 7. Urothelial Carcinoma 8. Breast Cancer 9. Acute Myeloid Leukemia 10. Graft vs Host Disease 11. Mantle Cell Lymphoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Subject must have participated in an eligible ibrutinib clinical trial, may derive clinical benefit from continued treatment or restart of treatment with ibrutinib in the opinion of the treating physician and does not have access to commercial ibrutinib within their region and/or the drug is not reasonably accessible to the patient within the respective region
2. Ongoing continuous treatment with ibrutinib
3. Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.
4. Subject or their legally authorized representative must voluntarily sign and date an informed consent approved by an independent ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study
5. Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days for females and males after the last dose of drug
6. Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator discretion should be applied.

Exclusion criteria 5

1. Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment
2. Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject’s participation in the protocol
3. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this protocol or within 90 days of last dose of drug treatment. Male subjects who plan to father a child while enrolled in this protocol or within 90 days after the last dose of drug treatment
4. Unwilling or unable to participate in all required evaluations and procedures
5. Unable to understand the purpose and risks of the protocol and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Assessment of percentage of patients rolling over from each parent study

Secondary endpoints 1

1. Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 3

Locations

7 EU/EEA countries · 19 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 49 files

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

Application history

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