A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Completed · Phase 1
Conditions studied: Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia
In brief
The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (Part A - Dose Escalation); and the safety of the RP2Ds for this combination in different histologies/participant populations (Part B - Cohort Expansion).
Key facts
- Study ID
- NCT04657224
- Run by
- Janssen Research & Development, LLC
- People needed
- 75
- Starts
- 2021-02-25
- Expected to finish
- 2025-01-16
- Last updated by the study team
- 2025-08-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Cardiac parameters within the following range: corrected QT interval (QTcF) <= 480 milliseconds
- Participants with B cell non-Hodgkin lymphoma (NHL) must have tumor tissue available at baseline as described in the protocol. This is not required for participants with chronic lymphocytic leukemia (CLL)
- Women of childbearing potential must agree to use a barrier method of contraception; use a highly effective preferably user-independent method of contraception; not to donate eggs (ova, oocytes) or freeze them for future use for the purposes of assisted reproduction during the study; not to plan to become pregnant; and not to breast-feed
You may not qualify if…
- Part A and select cohorts in Part B: Prior treatment with JNJ 64264681 or JNJ-67856633. Previously discontinued treatment with a Bruton's tyrosine kinase (BTK) or mucosa-associated lymphoid tissue lymphoma translocation protein (MALT) inhibitor other than JNJ 64264681 or JNJ-67856633 due to participant or doctor choice without evidence of progression or intolerable class-related toxicity will be eligible
- Known (active) central nervous system (CNS) involvement
- Received prior solid organ transplantation
- Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or JNJ 67856633 or excipients
- Toxicities from previous anti-cancer therapies that have not resolved to baseline levels, or to Grade less than (<) 2 (except for alopecia [>=Grade 2], vitiligo [Grade 2] and peripheral neuropathy [Grade 1])
Where it is running
- Stony Brook University Medical Center — Stony Brook, New York, United States
- Monash Medical Centre — Clayton, Australia
- Peter MacCallum Cancer Centre — Melbourne, Australia
- Linear Clinical Research Ltd — Nedlands, Australia
- Scientia Clinical Research — Randwick, Australia
- AZ St.-Jan Brugge-Oostende AV — Bruges, Belgium
- Universitair Ziekenhuis Gent - UZ GENT — Ghent, Belgium
- CHU UCL Namur - Site Godinne — Yvoir, Belgium
- CHRU de Lille Hopital Claude Huriez — Lille, France
- Chu Hotel Dieu — Nantes, France
- Centre hospitalier Lyon-Sud — Pierre-Bénite, France
- CHU Bretonneau — Tours, France
- Arensia Exploratory Medicine — Tbilisi, Georgia
- Hadassah Medical Center — Jerusalem, Israel
- Sheba Medical Center — Ramat Gan, Israel
- Tel Aviv Sourasky MC — Tel Aviv, Israel
- Arensia Exploratory Medicine — Chisinau, Moldova
- Academic Medical Center — Amsterdam, Netherlands
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
- Pratia Onkologia Katowice — Katowice, Poland
- Pratia MCM Krakow — Krakow, Poland
- Centrum Medyczne Pratia Poznan — Skorzewo, Poland
- Asan Medical Center — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- Seoul National University Hospital — Seoul, South Korea
Full record on ClinicalTrials.gov
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