NCT04876092CompletedPhase 1
A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL
A Phase 1b Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov · Last updated 21 Aug 2025
Brief summary (registry, in English)
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 lymphocytic leukemia (CLL).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 4 May 2021
- Start date
- 28 Jul 2021
- Primary completion date
- 13 Feb 2025
- Lead sponsor
- Janssen Research & Development, LLC
- NCT number
- NCT04876092
- EU CT number
- 2024-512689-32-00
- EudraCT number
- 2021-000191-12
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 45
- From 28 Jul 2021 to the primary completion date, 13 Feb 2025
- 6 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with JNJ-67856633 or another MALT1 inhibitor that is associated with disease progression or intolerable toxicities
Other
- Known (active) Central Nervous System (CNS) involvement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Skorzewo | Poland | Completed |
| Universitetssjukhuset Lund, Onkologiska Kliniken, Lund Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.