Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 64264681LYM1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-003194-25 | EudraCT Number | ||
| 2024-512686-13-00 | Registry Identifier | EUCT number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D[s]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part 1 and to evaluate the safety of JNJ-64264681 at the RP2D(s) in Part 2.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-64264681: Dose Escalation and Expansion | Experimental | Participants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64264681 | Drug | JNJ-64264681 capsule will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicity (DLT) | The DLTs are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher (as specified in protocol). | Up to 21 days |
| Part 1 and Part 2: Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of JNJ-64264681 | Plasma concentration of JNJ-64264681 will be evaluated. | Up to 2 years |
| Percentage Occupancy of the Target | The pharmacodynamics of JNJ-64264681 will be assessed by determining the percentage of target occupancy. Blood samples will be obtained for pharmacodynamic assessments (target occupancy). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States | ||
| Arensia Exploratory Medicine |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 2 years |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve a complete response (CR) + partial response (PR) or better according to the Revised Response Criteria for Malignant Lymphoma and the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Response Criteria and International Workshop for Waldenstrom Macroglobulinemia (IWWM) Response Criteria. | Up to 2 years |
| Time to Response (TTR) | TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria. | Up to 2 years |
| Duration of Response (DOR) | DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of either the first documented evidence of disease progression or death according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria. | Up to 2 years |
| Complete Response (CR) Rate | CR rate is defined as the percentage of participants who achieve a best response of CR according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria. | Up to 2 years |
| Progression-free Survival (PFS) | PFS is defined as the time from the date of the first dose of the study drug to the date of either the first documented disease progression (according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria), or death due to any cause. | Up to 2 years |
| Tbilisi |
| 0112 |
| Georgia |
| Arensia Exploratory Medicine | Chisinau | MD-2025 | Moldova |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80 214 | Poland |
| Pratia Onkologia Katowice | Katowice | 40 519 | Poland |
| Pratia MCM Krakow | Krakow | 30-727 | Poland |
| Centrum Medyczne Pratia Poznan | Skorzewo | 60 185 | Poland |
| Chang-Gung Memorial Hospital, Kaohsiung | Kaohsiung County | 83301 | Taiwan |
| China Medical University Hospital | Taichung | 40402 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Medical Center of Limited Liability Company Arensia Exploratory Medicine | Kyiv | 01135 | Ukraine |
| Queen Mary University of London | Charterhouse Square | EC1M 6BQ | United Kingdom |
| Plymouth Hospitals NHS Trust | Plymouth | PL6 8DH | United Kingdom |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729293 | JNJ-64264681 |
Not provided
Not provided
Not provided