Status:
COMPLETED
A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and recommended Phase 2 dose (RP2D) of JNJ-67856633 and ibrutinib in combination in participants with B cell non-Hodgkin lymphoma (NHL) and chronic...
Detailed Description
Non-Hodgkin lymphoma (NHL) represents the most frequent hematologic malignancy in the world and represents a diverse set of diseases. JNJ-67856633-ZAF (referred as JNJ-67856633) is an orally bioavaila...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Cardiac parameters within the specified range
- Women of childbearing potential must agree to all of the following during the study and for 3 months after the last dose of study drug: a) use a barrier method of contraception; b) use a highly effective contraceptive methods; c) not to donate eggs (ova, oocytes) or freeze them for future use for the purposes of assisted reproduction during the study; d) not to plan to become pregnant; e) not to breast-feed
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
- Participants must have tumor tissue availability
- Adequate organ functions
Exclusion
- Known (active) Central Nervous System (CNS) involvement
- Prior treatment with JNJ-67856633 or another MALT1 inhibitor that is associated with disease progression or intolerable toxicities
Key Trial Info
Start Date :
July 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04876092
Start Date
July 28 2021
End Date
February 13 2025
Last Update
August 21 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Rigshospitalet
Copenhagen, Denmark, 2100
2
CHRU de Lille Hopital Claude Huriez
Lille, France, 59037
3
Institut Paoli Calmettes
Marseille, France, 13009
4
CHU de Nantes hotel Dieu
Nantes, France, 44000