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KILT - GLA 2021-6

KILT -> A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma

EU Clinical Trials Register

Leitung: Herr Prof. Dr. med. Gerald Wulf

 

Herr Prof. Dr. med. Gerald Wulf

Universitätsmedizin Göttingen

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Informationen zur Studie

Beschreibung

A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma

Studientherapie

Lacutamab (monoclonal anti-KIR3DL2 antibody)

Studienstatus

Rekrutierung gestartet/nimmt Patienten auf

Zusatzinformationen

Allgemeine Infos zum Antrag

Name und Adresse des Antragsteller

Frau Emmanuelle Robert-Eydoux
emmanuelle.robert-eydoux@lysarc.org

Studie gesponsert durch (Name und Kontakt)

LYSARC - The Lymphoma Academic Research Organisation (Institution, 12227)
Centre Hospitalier Lyon-Sud
Chemin du Grand Revoyet 165
69310 Pierre-Bénite

Primäres Ziel der Studie

To evaluate the median modified progression-free survival (mPFS) of Lacutamab in patients treated
with Gemcitabine-oxaliplatine at relapse followed by a Lacutamab maintenance, in R/R patients with
KIR3DL2 positive PTCL-NOS, PTCL-TFH (including AITL, Follicular T-cell lymphoma, Nodal
peripheral T-cell lymphoma with TFH phenotype), ALCL, ATL, HSTL, EATL, MEITL, NKT,
ANKL, PCGD-TCL, SPTCL.

Studienpopulation

Patients aged over 18 years old with KIR3DL2+ Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), peripheral T cell lymphoma (PTCL) with T-follicular helper (TFH) phenotype (e.g angioimmunoblastic T-cell lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell
lymphoma with TFH phenotype), anaplastic large-cell lymphoma (ALCL), HTLV-1 associated T-cell
lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL) and other rare PTCL, as enteropathyassociated T-cell lymphoma (EATL), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), NK/T-cell lymphoma (NKT), aggressive NK cell leukemia (ANKL), primary cutaneous gamma/delta positive T-cell lymphoma (PCGD-TCL), subcutaneous panniculitis-like T-cell
lymphoma (SPTCL)

Spezifische Infos zum Antrag

Therapie
Anzahl der Studienzentren (International und nur Deutschland)

32 centers from LYSA in France & 8 centers from LYSA in Belgium
Germany: 13 centers
South Korea: 6 centers

Biomarker-Programm geplant

Nein

Zusätzliche Dokumente

Beteiligte Arbeitsgruppen

T-Zell Lymphome (T-NHL)