A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05201781
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cilta-cel — DRUG
    Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.

Study Details

The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

Key Dates

Start date
Mar 9, 2022
Status verified
Jun 2026
Primary completion
Jul 29, 2037
Completion
Jun 1, 2042

Study Design

Enrollment
295 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Cilta-cel
    Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT03758417, NCT04181827, NCT05347485, NCT04133636, and NCT03548207) in the global development program will be enrolled into this study once the individual's participation in the particular interventional study has ended or a study has been terminated. Participants will not receive any treatment in this study and will be followed-up at least once per year on delayed adverse events for up to 15 years after receiving the last dose of cilta-cel.

Primary Outcome Measure

Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy [ Time Frame: Up to 15 years ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer Center-ScottsdalePhoenixArizona85054-
City of HopeDuarteCalifornia91010-
University of California San FranciscoSan FranciscoCalifornia94143-
Stanford University Medical CenterStanfordCalifornia94305-5623-
Moffitt Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
Indiana UniversityIndianapolisIndiana46202-
Kansas University Medical CenterWestwoodKansas66205-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02215-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Mayo Clinic RochesterRochesterMinnesota55902-
Washington University School Of MedicineSt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Mount Sinai Medical CenterNew YorkNew York10029-
Montefiore Medical CenterThe BronxNew York10467-
Levine Cancer InstituteCharlotteNorth Carolina28204-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Sarah Cannon Research InstituteNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
Froedtert MemorialMilwaukeeWisconsin53226-

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