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Enrolling by Invitation

NCT Number: NCT06788509

A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

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).

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Key information

Conditions

Leukemia, Myeloid, Acute Bone Marrow Diseases Chronic Disease Disease Attributes Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Solid Tumor, Adult Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear Clinical Research Ltd, Nedlands, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-75348780

Drug

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

JNJ-67856633

Drug

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.

Other names: safimaltib

JNJ-54179060

Drug

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

Other names: ibrutinib

JNJ-64264681

Drug

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

JNJ-74856665

Drug

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

JNJ-70218902

Drug

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

JNJ-64619178

Drug

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

JNJ-80948543

Drug

Participants from the parent studies (80948543LYM1001 [NCT05424822]; and 80948543LYM1002 [NCT06660563]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-80948543.

JNJ-87801493

Drug

Participants from the parent study (87801493LYM1001 [NCT06139406]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-87801493 in combination with subcutaneous JNJ-80948543.

Primary outcomes

  1. Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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