Clinical trial NCT06788509: A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
Official title: An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Neoplasms
Solid Tumor, Adult
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2025-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 outcomes:
measure: Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs)
timeFrame: Up to approximately 3 years and 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Lille
country: France
facility: Hopital Claude Huriez
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine
city: Athens
country: Greece
facility: Alexandra Hospital
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Nagoya-shi
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Chisinau
country: Moldova, Republic of
facility: Arensia Exploratory Medicine
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Skorzewo
country: Poland
facility: Aidport Sp z o o
city: Kaohsiung City
country: Taiwan
facility: Chang Kung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company Arensia Exploratory Medicine
city: Leicester
country: United Kingdom
facility: University Hospitals Of Leicester Nhs Trust
city: London
country: United Kingdom
facility: St Bartholomews Hospital
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
Study officials:
affiliation: Janssen Research and Development LLC
name: Janssen Research and Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: