Public trial registry of the CCC-Munich

Trial JCAR17-BCM-003

Trial Trial design Status In-/Exclusion Therapy Participants Documents Permissions Tumorboards

Trial
World
Trial acronym
:
JCAR17-BCM-003
World
Full title
:

EINE GLOBALE RANDOMISIERTE MULTIZENTRUMSPHASE 3
VERSUCHE ZUM VERGLEICH DER WIRKSAMKEIT UND SICHERHEIT
VON JCAR017 ZUM PFLEGESTANDARD BEI ERWACHSENEN
SUBJEKTE MIT HOHEM RISIKO, TRANSPLANTIERBAR
REZITIEREN ODER REFRAKTĂ„R
AGGRESSIVE B-ZELL-NON-HODGKIN-LYMPHOME
(VERWANDELN)

World
Description
:

This is a randomized, open-label, parallel-group, multi-center, Phase 3 study to demonstrate the
efficacy and safety of JCAR017 (also known as lisocabtagene maraleucel or liso-cel) versus
SOC salvage therapies in subjects with aggressive B-cell NHL (defined as diffuse large B-cell
lymphoma [DLBCL] not otherwise specified [NOS] (de novo or transformed follicular
lymphoma [tFL]), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6
rearrangements with DLBCL histology (double-hit lymphoma/ triple-hit lymphoma
[DHL/THL]), or follicular lymphoma Grade 3B [FL3B]) who are refractory to front-line
immunochemotherapy or have relapsed within 12 months and are eligible for HDCT and HSCT.

World
EudraCT number
:
World
NCT number
:
World
Responsible organization
:
Medizinische Klinik III, Telefon: 089440072551
Indications
Classification Code Description
- Bloodcancer (leukemia, lymphoma)
Trial design
World
Trial type
:
Interventional
World
Blinding type
:
Open
World
Phase
:
III
Status
World
Status
:
Recruitment finished
Votes
World
Institutional review board - vote
:
Unknown
Initiiation & lock
World
Date of lock (planned / actual)
:
2023-12-08 / Unknown
Participants
Function Prename Surname Organization
World Principal Investigator CHRISTIAN SCHMIDT Keine Organisationseinheit angegeben Magnifier