64264681LYM1001
Research type
Research Study
Full title
Protocol Title A Phase 1, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
IRAS ID
273071
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen Cilag Internation NV
Eudract number
2019-003194-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
64264681LYM1001 is a Phase 1 study of JNJ-64264681 (the study drug) in participants with B-cell Non-Hodgkin Lymphoma (NHL) (a category of B-cell malignancies with many sub-types including: diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenström’s macroglobulinemia, and small lymphocytic lymphoma), or Chronic Lymphocytic Leukemia (CLL). JNJ 64264681 is an oral inhibitor of Bruton’s tyrosine kinase (BTK), and is being developed to treat B-cell lymphomas and leukemias. JNJ-64264681 has been tested for safety in healthy volunteers for up to 10 days and for up to 1 month in animals.
Approximately 108 participants will be included in this two-part study. Part 1 aims to identify safe doses of JNJ-64264681 that can be used for further study in various forms of B-cell NHL or CLL. Part 1 also studies how JNJ-64264681 is absorbed and cleared from the body and its effects on cancer cells.
Design of study:
Part 1 of the study employs the traditional “3+3” oncology Phase 1 dose escalation design, described in IRAS section A-13.
The first treatment group in the study will start with a dose within the range shown to be safe when dosed for up to 10 days in healthy volunteers.
To support the design of Phase 2 studies in the future, Part 2 is included to further evaluate study drug safety and to obtain preliminary evidence of activity in specific sub-types of B-cell malignancies, using the recommended dose(s) identified in Part 1. Part 2 consists of groups of ~20 participants with CLL or a specific disease sub-type of NHL.
Participants will take the study drug continuously as long as it is to their benefit. Participants will be carefully monitored throughout the study for any side-effects or changes in their condition.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0062
Date of REC Opinion
6 Apr 2020
REC opinion
Further Information Favourable Opinion