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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

Status
Enrolling by invitation
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06788509
Enrollment
80
Registered
2025-01-23
Start date
2024-12-30
Completion date
2028-01-21
Last updated
2025-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Neoplasms, Solid Tumor, Adult, Metastatic Castration-resistant Prostate Cancer (mCRPC)

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).

Interventions

Participants from the parent study (75348780LYM1001 \[NCT04540796\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-75348780.

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.

Participants from the parent study (67856633LYM1002 \[NCT04876092\]) who are deriving benefit from study treatment will continue to receive JNJ-54179060 orally.

Participants from the parent studies (64264681LYM1001 \[NCT04210219\], 64264681LYM1002 \[NCT04657224\]) who are deriving benefit from study treatment will continue to receive JNJ-64264681 orally.

Participants from the parent study (74856665AML1001 \[NCT04609826\]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally.

Participants from the parent study (70218902EDI1001 \[NCT04397276\]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally.

Participants from the parent study (64619178EDI1001 \[NCT03573310\]) who are deriving benefit from study treatment will continue to receive JNJ-64619178 orally.

Sponsors

Janssen Research & Development, LLC
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsAn 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.

Countries

Belgium, France, Georgia, Greece, Israel, Japan, Moldova, Poland, South Korea, Spain, Taiwan, Ukraine, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026