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

Overview

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

• 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.

Primary outcome measures

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 7 centers

• Hosp Univ Vall D Hebron 1 — Barcelona
• Hosp Univ Vall D Hebron — Barcelona
• Hosp. Clinic de Barcelona — Barcelona
• Hosp Univ Fund Jimenez Diaz — Madrid
• Hosp. Univ. 12 de Octubre — Madrid
• Clinica Univ. de Navarra — Pamplona
• Hosp Clinico Univ de Salamanca — Salamanca

Israel · 5 centers

• Rambam Med.Center - Hematology Institute — Haifa
• Rambam Medical Center — Haifa
• Carmel Medical Center — Haifa
• Hadassah University Hospita Ein Kerem — Jerusalem
• Tel Aviv Sourasky Medical Center — Tel Aviv

Taiwan · 4 centers

• Chang Kung Memorial Hospital — Kaohsiung City
• China Medical University Hospital — Taichung
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei

Australia · 3 centers

• Macquarie University Hospital — Macquarie University
• Linear Clinical Research Ltd — Nedlands
• Scientia Clinical Research — Randwick

France · 3 centers

• Hopital Claude Huriez — Lille
• CHU Nantes — Nantes
• Institut Gustave Roussy — Villejuif

Poland · 3 centers

• Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz — Gdansk
• Pratia MCM Krakow — Krakow
• Aidport Sp z o o — Skorzewo

United Kingdom · 3 centers

• University Hospitals Of Leicester Nhs Trust — Leicester
• St Bartholomews Hospital — London
• University Hospitals Plymouth NHS Trust — Plymouth

Japan · 2 centers

• National Hospital Organization Nagoya Medical Center — Nagoya
• The Cancer Institute Hospital of JFCR — Tokyo

Belgium · 1 center

• Ghent University Hospital — Ghent

Georgia · 1 center

• Arensia Exploratory Medicine — Tbilisi

Greece · 1 center

• Alexandra Hospital — Athens

Moldova · 1 center

• Arensia Exploratory Medicine — Chisinau

South Korea · 1 center

• Severance Hospital Yonsei University Health System — Seoul

Ukraine · 1 center

• Medical Center of Limited Liability Company Arensia Exploratory Medicine — Kyiv

Identifiers

NCT: NCT06788509 · PLATFORMPACAN1001 · PLATFORMPACAN1001 · 2024-515457-21-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗