Tislelizumab, Gemcitabine and Cisplatin for R/R Hodgkin Lymphoma Followed by Tislelizumab Consolidation in Patients in Metabolic Complete Remission

PHASE2RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

July 14, 2023

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2030

Conditions
Hodgkin Lymphoma
Interventions
DRUG

gemcitabine, cisplatin and tislelizumab

"All patients will receive 2 cycles of gemcitabine and cisplatin (GP) + tislelizumab. Each cycle lasts 21 days. Treatment is given through an IV line on day 1 and 8.~After 2 cycles a FDG-PET-CT scan will be performed. Patients who respond well will proceed with 2 additional cycles of GP + tislelizumab . Patients with insufficient response will stop with the study treatment and they will continue treatment according to local practice.~After 4 cycles of GP + tislelizumab another FDG-PET-CT scan will be performed. If this scan shows that the disease is under control (metabolic complete remission) patients will proceed with 13 cycles of tislelizumab consolidation treatment (21 day cycles). Treatment is given on day 1 through an IV line."

Trial Locations (15)

Unknown

RECRUITING

BE-Bruxelles-STLUC, Brussels

RECRUITING

DK-Aarhus N-AUH, Aarhus

RECRUITING

DK-Copenhagen-RIGSHOSPITALET, Copenhagen

RECRUITING

DK-Odense-OUH, Odense

RECRUITING

NL-Amersfoort-MEANDERMC, Amersfoort

RECRUITING

NL-Amsterdam-AMC, Amsterdam

RECRUITING

NL-Arnhem-RIJNSTATE, Arnhem

RECRUITING

NL-Eindhoven-MAXIMAMC, Eindhoven

RECRUITING

NL-Goes-ADRZ, Goes

RECRUITING

NL-Groningen-UMCG, Groningen

RECRUITING

NL-Hoofddorp-SPAARNEGASTHUIS, Hoofddorp

RECRUITING

NL-Leeuwarden-MCL, Leeuwarden

RECRUITING

NL-Maastricht-MUMC, Maastricht

RECRUITING

NL-Rotterdam-ERASMUSMC, Rotterdam

RECRUITING

NL-Den Haag-HAGA, The Hague

All Listed Sponsors
collaborator

Danish Lymphoma Group

UNKNOWN

lead

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER