Non-Hodgkin lymphoma and chronic lymphocytic leukemia Cancer
Conditions
Interventions
The platform rollover study provides continued long-term access to study treatment(s) (JNJ-64264681
JNJ-67856633 (safimaltib)
JNJ-54179060 (ibrutinib)
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
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 2. Satisfy all ISA specific inclusion criteria 3. 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
Exclusion criteria
Exclusion criteria: 1. 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 the subject’s participation in the study 2. Have unacceptable toxicities or overt disease progression observed at the time of rollover to the respective ISA 3. Meets any exclusion criteria within the pertinent ISA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Serious Adverse Events (SAEs) and Grage Greater than or equals to (>=) 3 Related Adverse Events (AEs). Timeframe: Up to approximately 3 years and 7 months. Description: An AE in 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Belgium, France, Georgia, Greece, Israel, Japan, Poland, Taiwan, Ukraine, United Kingdom
Contacts
Public ContactVlad Melnyk
Outcome results
None listed