A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Neoplasms; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell; Prostatic Neoplasms, Castration-Resistant; Solid Tumor, Adult
• Intervention / Treatment: Drug: JNJ-75348780; Drug: JNJ-67856633; Drug: JNJ-54179060; Drug: JNJ-64264681; Drug: JNJ-74856665; Drug: JNJ-70218902; Drug: JNJ-64619178; Drug: JNJ-80948543; Drug: JNJ-87801493

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Nedlands, Australia, 6009
    • Linear Clinical Research Ltd
• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital
• France
  • Lille, France, 59000
    • Hopital Claude Huriez
  • Nantes, France, 44093
    • CHU Nantes
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Georgia
  • Tbilisi, Georgia, Postal code 0112
    • ARENSIA Exploratory Medicine
• Greece
  • Athens, Greece, 115 28
    • Alexandra Hospital
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Haifa, Israel, 3109601
    • Rambam Med.Center - Hematology Institute
  • Jerusalem, Israel, 9112001
    • Hadassah University Hospita Ein Kerem
• Japan
  • Nagoya, Japan, 460-0001
    • National Hospital Organization Nagoya Medical Center
  • Tokyo, Japan, 135 8550
    • The Cancer Institute Hospital of JFCR
• Moldova
  • Chisinau, Moldova, 2025
    • ARENSIA Exploratory Medicine
• Poland
  • Gdansk, Poland, 80 214
    • Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
  • Krakow, Poland, 30-727
    • Pratia McM Krakow
  • Skorzewo, Poland, 60-185
    • Aidport Sp Z O O
• South Korea
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
• Spain
  • Barcelona, Spain, 08036
    • Hosp. Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hosp Univ Vall D Hebron
  • Barcelona, Spain, 08035
    • Hosp Univ Vall D Hebron 1
  • Madrid, Spain, 28040
    • Hosp Univ Fund Jimenez Diaz
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Chang Kung Memorial Hospital
  • Taichung, Taiwan, 404327
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
• Ukraine
  • Kyiv, Ukraine, 01135
    • Medical Center of Limited Liability Company Arensia Exploratory Medicine
• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • University Hospitals of Leicester NHS Trust
  • London, United Kingdom, EC1A 7BE
    • St Bartholomews Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • University Hospitals Plymouth NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Long Term Safety Assessment (Platform Study); 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.

Drug: JNJ-75348780; Participants from the parent study (75348780LYM1001 [NCT04540796]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-75348780.; Drug: 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.; Other Names: safimaltib; Drug: JNJ-54179060; Participants from the parent study (67856633LYM1002 [NCT04876092]) who are deriving benefit from study treatment will continue to receive JNJ-54179060 orally.; Other Names: ibrutinib; Drug: 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.; Drug: JNJ-74856665; Participants from the parent study (74856665AML1001 [NCT04609826]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally.; Drug: JNJ-70218902; Participants from the parent study (70218902EDI1001 [NCT04397276]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally.; Drug: JNJ-64619178; Participants from the parent study (64619178EDI1001 [NCT03573310]) who are deriving benefit from study treatment will continue to receive JNJ-64619178 orally.; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research and Development, LLC Clinical Trial, Janssen Research and Development LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): January 19, 2028
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Lymphoma; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Prostatic Neoplasms; Neoplasms; Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Prostatic Neoplasms, Castration-Resistant; Tyrosine Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; JNJ-64619178; ibrutinib; JNJ-64264681
• Other Study ID Numbers: PLATFORMPACAN1001 (Other Identifier: Janssen Research & Development, LLC); 2024-515457-21-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes