A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

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).

Conditions

• Leukemia, Myeloid, Acute
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma, Non-Hodgkin
• Myelodysplastic Syndromes
• Neoplasms
• Solid Tumor, Adult
• Prostatic Neoplasms, Castration-Resistant

Interventions

DRUG

JNJ-75348780

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

DRUG

JNJ-67856633

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.

DRUG

JNJ-54179060

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

DRUG

JNJ-64264681

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

DRUG

JNJ-74856665

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

DRUG

JNJ-70218902

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

DRUG

JNJ-64619178

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

DRUG

JNJ-80948543

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

DRUG

JNJ-87801493

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.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research and Development, LLC Clinical Trial · Janssen Research and Development LLC

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-30

Primary Completion

2028-01-19

Completion

2028-10-30

FDA Drug

Yes

Countries

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

Study Locations