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| ID | Type | Description | Link |
|---|---|---|---|
| PLATFORMPACAN1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2024-515457-21-00 | Registry Identifier | EUCT number |
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The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long Term Safety Assessment (Platform Study) | Other | The platform rollover study provides continued long-term access to study treatment(s) (JNJ-64264681; JNJ-67856633 (safimaltib); JNJ-54179060 (ibrutinib); JNJ-75348780; JNJ-74856665; JNJ-64619178; JNJ-70218902; JNJ-80948543; JNJ-87801493) for participants currently receiving the active study treatment in parent studies and deriving benefit from it. Eligible participants in parent study will rollover to this platform study which will be adapted into Intervention Specific Appendix (ISA) within the platform study. Participants will initiate the platform study under the relevant ISA, and will continue to receive study treatment at the dose they received in parent study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-75348780 | Drug | Participants from the parent study (75348780LYM1001 [NCT04540796]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-75348780. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. | Up to approximately 3 years and 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research and Development, LLC Clinical Trial | Janssen Research and Development LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research Ltd | Nedlands | 6009 | Australia | |||
| Scientia Clinical Research |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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.
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| JNJ-67856633 | Drug | Participants from the parent studies (64264681LYM1002 [NCT04657224], 67856633LYM1002 [NCT04876092] and 67856633LYM1001 [NCT03900598]) who are deriving benefit from study treatment will continue to receive JNJ-67856633 orally. |
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| JNJ-54179060 | Drug | Participants from the parent study (67856633LYM1002 [NCT04876092]) who are deriving benefit from study treatment will continue to receive JNJ-54179060 orally. |
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| JNJ-64264681 | Drug | Participants from the parent studies (64264681LYM1001 [NCT04210219], 64264681LYM1002 [NCT04657224]) who are deriving benefit from study treatment will continue to receive JNJ-64264681 orally. |
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| JNJ-74856665 | Drug | Participants from the parent study (74856665AML1001 [NCT04609826]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally. |
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| JNJ-70218902 | Drug | Participants from the parent study (70218902EDI1001 [NCT04397276]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally. |
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| JNJ-64619178 | Drug | Participants from the parent study (64619178EDI1001 [NCT03573310]) who are deriving benefit from study treatment will continue to receive JNJ-64619178 orally. |
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| JNJ-80948543 | Drug | Participants from the parent studies (80948543LYM1001 [NCT05424822]; and 80948543LYM1002 [NCT06660563]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-80948543. |
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| JNJ-87801493 | Drug | Participants from the parent study (87801493LYM1001 [NCT06139406]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-87801493 in combination with subcutaneous JNJ-80948543. |
|
| Randwick |
| 2031 |
| Australia |
| Ghent University Hospital | Ghent | 9000 | Belgium |
| Hopital Claude Huriez | Lille | 59000 | France |
| CHU Nantes | Nantes | 44093 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Arensia Exploratory Medicine | Tbilisi | Postal code 0112 | Georgia |
| Alexandra Hospital | Athens | 115 28 | Greece |
| Rambam Med.Center - Hematology Institute | Haifa | 3109601 | Israel |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Hadassah University Hospita Ein Kerem | Jerusalem | 9112001 | Israel |
| National Hospital Organization Nagoya Medical Center | Nagoya | 460-0001 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135 8550 | Japan |
| Arensia Exploratory Medicine | Chisinau | 2025 | Moldova |
| Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz | Gdansk | 80 214 | Poland |
| Pratia MCM Krakow | Krakow | 30-727 | Poland |
| Aidport Sp z o o | Skorzewo | 60-185 | Poland |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Hosp Univ Vall D Hebron 1 | Barcelona | 08035 | Spain |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Hosp. Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Chang Kung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| China Medical University Hospital | Taichung | 404327 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Medical Center of Limited Liability Company Arensia Exploratory Medicine | Kyiv | 01135 | Ukraine |
| University Hospitals Of Leicester Nhs Trust | Leicester | Le1 5ww | United Kingdom |
| St Bartholomews Hospital | London | EC1A 7BE | United Kingdom |
| University Hospitals Plymouth NHS Trust | Plymouth | PL6 8DH | United Kingdom |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009190 | Myelodysplastic Syndromes |
| D009369 | Neoplasms |
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D001855 | Bone Marrow Diseases |
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
| C000729293 | JNJ-64264681 |
| C000631033 | JNJ-64619178 |
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