A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

Phase 1

• Conditions: Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Neoplasms; Solid Tumor, Adult; Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Interventions: Drug: JNJ-75348780; Drug: JNJ-67856633; Drug: JNJ-54179060; Drug: JNJ-64264681; Drug: JNJ-74856665; Drug: JNJ-70218902; Drug: JNJ-64619178

• Registration Number: NCT06788509
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-30
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2028-01-19
• Study Completion: 2028-01-21

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long Term Safety Assessment (Platform Study)	JNJ-64264681	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) 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.
Long Term Safety Assessment (Platform Study)	JNJ-74856665	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) 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.
Long Term Safety Assessment (Platform Study)	JNJ-70218902	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) 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.
Long Term Safety Assessment (Platform Study)	JNJ-54179060	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) 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.
Long Term Safety Assessment (Platform Study)	JNJ-75348780	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) 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.
Long Term Safety Assessment (Platform Study)	JNJ-64619178	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) 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.
Long Term Safety Assessment (Platform Study)	JNJ-67856633	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) 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs)	Up to approximately 3 years and 7 months	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.

Trial Locations

Locations (16)

Chang Kung Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan

Ghent University Hospital; 🇧🇪 Gent, Belgium

Hopital Claude Huriez; 🇫🇷 Lille, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Arensia Exploratory Medicine; 🇲🇩 Chisinau, Moldova, Republic of

Alexandra Hospital; 🇬🇷 Athens, Greece

National Hospital Organization Nagoya Medical Center; 🇯🇵 Nagoya-shi, Japan

The Cancer Institute Hospital of JFCR; 🇯🇵 Tokyo, Japan

Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz; 🇵🇱 Gdansk, Poland

Pratia MCM Krakow; 🇵🇱 Krakow, Poland

Aidport Sp z o o; 🇵🇱 Skorzewo, Poland

Medical Center of Limited Liability Company Arensia Exploratory Medicine; 🇺🇦 Kyiv, Ukraine

University Hospitals Plymouth NHS Trust; 🇬🇧 Plymouth, United Kingdom

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan