Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib

Phase 1

• Conditions: 1.Follicular Lymphoma2.Chronic Lymphocytic Leukemia3.Waldenstrom macroglobulinemia 4.Multiple Myeloma5.Marginal Zone Lymphoma6.Diffuse Large B-Cell Lymphoma7.Urothelial Carcinoma8.Breast Cancer9.Acute Myeloid Leukemia10.Graft vs Host Disease11.Mantle Cell Lymphoma; MedDRA version: 20.0Level: LLTClassification code: 10064467Term: Urothelial carcinoma Class: 10029104; MedDRA version: 21.0Level: LLTClassification code: 10008976Term: Chronic lymphocytic leukemia Class: 10029104; MedDRA version: 27.0Level: PTClassification code: 10085128Term: Follicular lymphoma Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10076596Term: Marginal zone lymphoma Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10006187Term: Breast cancer Class: 100000004864; MedDRA version: 21.0Level: PTClassification code: 10012818Term: Diffuse large B-cell lymphoma Class: 100000004864; MedDRA version: 21.0Level: PTClassification code: 10047801Term: Waldenstrom's macroglobulinaemia Class: 100000004864; MedDRA version: 20.1Level: PTClassification code: 10018651Term: Graft versus host disease Class: 100000004870; MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104

• Registration Number: CTIS2023-507329-40-00
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-31
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 501

Inclusion Criteria

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, Ongoing continuous treatment with ibrutinib, Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib., 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ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study, Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a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

Exclusion Criteria

Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment, Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject’s participation in the protocol, 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, Unwilling or unable to participate in all required evaluations and procedures, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified