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Clinical Trials in the UK / NCT06788509
Enrolling by invitation Phase 1

A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

NCT06788509 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Started
2024-12-30
Last updated
2026-08-28

Condition(s) studied

Leukemia, Myeloid, AcuteLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinMyelodysplastic SyndromesNeoplasmsSolid Tumor, AdultProstatic Neoplasms, Castration-Resistant

Investigational drug(s) / intervention(s)

JNJ-75348780JNJ-67856633JNJ-54179060JNJ-64264681JNJ-74856665JNJ-70218902JNJ-64619178JNJ-80948543JNJ-87801493

JNJ-75348780: Participants from the parent study (75348780LYM1001 \[NCT04540796\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-75348780.

JNJ-67856633: 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.

JNJ-54179060: Participants from the parent study (67856633LYM1002 \[NCT04876092\]) who are deriving benefit from study treatment will continue to receive JNJ-54179060 orally.

JNJ-64264681: Participants from the parent studies (64264681LYM1001 \[NCT04210219\], 64264681LYM1002 \[NCT04657224\]) who are deriving benefit from study treatment will continue to receive JNJ-64264681 orally.

JNJ-74856665: Participants from the parent study (74856665AML1001 \[NCT04609826\]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally.

JNJ-70218902: Participants from the parent study (70218902EDI1001 \[NCT04397276\]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally.

JNJ-64619178: Participants from the parent study (64619178EDI1001 \[NCT03573310\]) who are deriving benefit from study treatment will continue to receive JNJ-64619178 orally.

JNJ-80948543: Participants from the parent studies (80948543LYM1001 \[NCT05424822\]; and 80948543LYM1002 \[NCT06660563\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-80948543.

JNJ-87801493: 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.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Have participated in a parent study, with a linked intervention specific appendix (ISA) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study * Satisfy all ISA specific inclusion criteria * Sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the platform study with details per the relevant ISA * Be willing and able to adhere to the lifestyle restrictions specified in the relevant ISA Exclusion Criteria: * Have any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study * Have unacceptable toxicities or overt disease progression observed at time of rollover to the respective ISA * Meets any exclusion criteria within the pertinent ISA

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Macquarie University Hospital Macquarie University Australia
Linear Clinical Research Ltd Nedlands Australia
Scientia Clinical Research Randwick Australia
Ghent University Hospital Ghent Belgium
Dep. of Hematology, Rigshospitalet Copenhagen Denmark
Odense Universitetshospital Odense C Denmark
Hopital Claude Huriez Lille France
CHU Nantes Nantes France
Institut Gustave Roussy Villejuif France
Arensia Exploratory Medicine Tbilisi Georgia
Alexandra Hospital Athens Greece
Rambam Med.Center - Hematology Institute Haifa Israel
Rambam Medical Center Haifa Israel
Carmel Medical Center Haifa Israel
Hadassah University Hospita Ein Kerem Jerusalem Israel
Tel Aviv Sourasky Medical Center Tel Aviv Israel
National Hospital Organization Nagoya Medical Center Nagoya Japan
The Cancer Institute Hospital of JFCR Tokyo Japan
Arensia Exploratory Medicine Chisinau Moldova
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz Gdansk Poland
Pratia MCM Krakow Krakow Poland
Aidport Sp z o o Skorzewo Poland
Severance Hospital Yonsei University Health System Seoul South Korea
Hosp Univ Vall D Hebron 1 Barcelona Spain
Hosp Univ Vall D Hebron Barcelona Spain
Hosp. Clinic de Barcelona Barcelona Spain
Hosp Univ Fund Jimenez Diaz Madrid Spain
Hosp. Univ. 12 de Octubre Madrid Spain
Clinica Univ. de Navarra Pamplona Spain
Hosp Clinico Univ de Salamanca Salamanca Spain
Chang Kung Memorial Hospital Kaohsiung City Taiwan
China Medical University Hospital Taichung Taiwan
National Cheng Kung University Hospital Tainan Taiwan
National Taiwan University Hospital Taipei Taiwan
Medical Center of Limited Liability Company Arensia Exploratory Medicine Kyiv Ukraine
University Hospitals Of Leicester Nhs Trust Leicester United Kingdom
St Bartholomews Hospital London United Kingdom
University Hospitals Plymouth NHS Trust Plymouth United Kingdom

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06788509 on ClinicalTrials.gov ↗ ← All trials in the UK