Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Duvortuxizumab (JNJ-64052781) Plus Ibrutinib in Lymphoma

• Status: Withdrawn
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether duvortuxizumab and ibrutinib can be combined safely and to establish the maximum tolerated dose (MTD) in Part 1 and the recommended Phase 2 dose (RP2D) and to further explore the safety of duvortuxizumab in combination with ibrutinib at the RP2D in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) in Part 2.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• The participant has a B-cell malignancy (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL], mantle cell lymphoma [MCL], or chronic lymphocytic leukemia [CLL]) with tumor progression following at least one (MCL and CLL) or two (DLBCL and FL) prior standard therapies

• The participant has a radiographically measurable tumor that requires treatment according to the treating physician

• The participant is able to carry out daily life activities with significant difficulty

• The participant has adequate organ and blood cell counts

• Sexually active participants must use medically acceptable methods of contraception during the course of the study

Exclusion Criteria:

• The participant has a brain tumor or significant side effects, including severe neurological side effects, from a previous anti-cancer treatment

• Current severe, uncontrolled systemic disease including an ongoing, active infection or history of clinically significant heart problems

• History of autoimmune disease, allogeneic hematopoietic stem cell transplant, or organ transplant

• The participant has received any of the following: ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor at any time; an agent targeting CD19-positive cells or CD3-expressing T cells at any time; or warfarin, a vitamin K antagonist, or a blood transfusion (red blood cells and/or platelets) within 1 week of starting the study

• The participant is pregnant, breastfeeding, or planning to become pregnant or father a child