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En rollover -undersøgelse til fortsat undersøgelsesbehandling og løbende sikkerhedsovervågning

2. november 2026 opdateret af: Janssen Research & Development, LLC

En Open Label, Rollover Platform-undersøgelse til fortsat undersøgelsesbehandling og løbende sikkerhedsovervågning

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).

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Macquarie University, Australien, 2109
        • Macquarie University Hospital
      • Melbourne, Australien, 3004
        • The Alfred Hospital
      • Nedlands, Australien, 6009
        • Linear Clinical Research Ltd
      • Randwick, Australien, 2031
        • Scientia Clinical Research
  • Belgien
      • Ghent, Belgien, 9000
        • Ghent University Hospital
  • Danmark
      • Copenhagen, Danmark, 2100
        • Dep. of Hematology, Rigshospitalet
      • Odense C, Danmark, DK-5000
        • Odense Universitetshospital
  • Det Forenede Kongerige
      • Leicester, Det Forenede Kongerige, Le1 5ww
        • University Hospitals Of Leicester Nhs Trust
      • London, Det Forenede Kongerige, EC1A 7BE
        • St Bartholomews Hospital
      • Plymouth, Det Forenede Kongerige, PL6 8DH
        • University Hospitals Plymouth NHS Trust
  • Frankrig
      • Lille, Frankrig, 59000
        • Hopital Claude Huriez
      • Nantes, Frankrig, 44093
        • CHU Nantes
      • Villejuif, Frankrig, 94805
        • Institut Gustave Roussy
  • Georgien
      • Tbilisi, Georgien, Postal cod
        • Arensia Exploratory Medicine
  • Grækenland
      • Athens, Grækenland, 115 28
        • Alexandra General Hospital of Athens
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Haifa, Israel, 3436212
        • Carmel Medical Center
      • Haifa, Israel, 3109601
        • Rambam Med.Center - Hematology Institute
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospita Ein Kerem
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Japan
      • Nagoya, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center
      • Tokyo, Japan, 135 8550
        • The Cancer Institute Hospital of JFCR
  • Moldova
      • Chisinau, Moldova, 2025
        • Arensia Exploratory Medicine
  • Polen
      • Gdansk, Polen, 80 214
        • Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
      • Krakow, Polen, 30-727
        • Pratia MCM Krakow
      • Skorzewo, Polen, 60-185
        • Aidport Sp z o o
  • Spanien
      • Barcelona, Spanien, 08036
        • Hosp. Clinic de Barcelona
      • Barcelona, Spanien, 08035
        • Hosp Univ Vall D Hebron
      • Barcelona, Spanien, 08035
        • Hosp Univ Vall D Hebron 1
      • Madrid, Spanien, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spanien, 28040
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona, Spanien, 31008
        • Clinica Univ. de Navarra
      • Salamanca, Spanien, 37007
        • Hosp Clinico Univ de Salamanca
  • Sydkorea
      • Seoul, Sydkorea, 03722
        • Severance Hospital Yonsei University Health System
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Chang Kung Memorial Hospital
      • Taichung, Taiwan, 404327
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
  • Ukraine
      • Kyiv, Ukraine, 01135
        • Medical Center of Limited Liability Company Arensia Exploratory Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Long Term Safety Assessment (Platform Study)

The platform rollover study provides continued long-term access to study treatment(s) (JNJ-64264681; JNJ-67856633 (safimaltib); JNJ-54179060 (ibrutinib); JNJ-75348780; JNJ-74856665; JNJ-64619178; JNJ-70218902; JNJ-80948543; JNJ-87801493) for participants currently receiving the active study treatment in parent studies and deriving benefit from it. Eligible participants in parent study will rollover to this platform study which will be adapted into Intervention Specific Appendix (ISA) within the platform study. Participants will initiate the platform study under the relevant ISA, and will continue to receive study treatment at the dose they received in parent study.
Medicin: JNJ-75348780

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

Medicin: 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.

Andre navne:
  • Safimaltib
Medicin: JNJ-54179060

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

Andre navne:
  • ibrutinib
Medicin: 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.

Medicin: JNJ-74856665

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

Medicin: JNJ-64619178

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

Medicin: 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.

Medicin: 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.

Medicin: JNJ-70218902

Participants from the parent study (70218902EDI1001 [NCT04397276]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally. Data collection is complete for JNJ-70218902 treatment; no patients will be treated further.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs)
Tidsramme: 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.
Up to approximately 3 years and 7 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research and Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. december 2024

Primær færdiggørelse (Anslået)

19. januar 2028

Studieafslutning (Anslået)

29. december 2028

Datoer for studieregistrering

Først indsendt

16. januar 2025

Først indsendt, der opfyldte QC-kriterier

17. januar 2025

Først opslået (Faktiske)

23. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PLATFORMPACAN1001
  • 2024-515457-21-00 (Registry Identifier: EUCT number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner