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).

A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

Lymphoma, Non-Hodgkin

Lymphoma, B-Cell

Lymphoma, Mantle-Cell

Mantle Cell Lymphoma

Lymphoma

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

Leukemia, Lymphocytic, Chronic, B-Cell

Chronic Lymphocytic Leukemia

Leukemia

Prostatic Neoplasms, Castration-Resistant

Castration-Resistant Prostatic Cancer

Prostatic Neoplasms

Genitourinary Cancer

Advanced Solid Tumors

Prostate Neoplasms

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

Leukemia, Myeloid, Acute

Acute Myeloid Leukemia

Myelodysplastic Syndromes

JNJ-80948543

JNJ-64264681

JNJ-67856633

JNJ-75348780

JNJ-70218902

JNJ-74856665

JNJ-87801493

JNJ-54179060

JNJ-64619178

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

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.

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.

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).

Ghent University Hospital

Hopital Claude Huriez

CHU Nantes

Institut Gustave Roussy

Arensia Exploratory Medicine

Alexandra Hospital

Rambam Medical Center

Hadassah University Hospita Ein Kerem

National Hospital Organization Nagoya Medical Center

The Cancer Institute Hospital of JFCR

Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

Pratia MCM Krakow

Aidport Sp z o o

Severance Hospital Yonsei University Health System

Chang Kung Memorial Hospital

China Medical University Hospital

National Cheng Kung University Hospital

National Taiwan University Hospital

Medical Center of Limited Liability Company Arensia Exploratory Medicine

University Hospitals Of Leicester Nhs Trust

St Bartholomews Hospital

University Hospitals Plymouth NHS Trust

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.

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.

A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

Trials at a glance

Trials at a glance

A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

Outcome measures

Primary outcome measures