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ACTIVE NOT RECRUITING
NCT05502250
PHASE2

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

Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland

View on ClinicalTrials.gov

Summary

This trial investigates the efficacy and safety of the drug tislelizumab in combination with chemotherapy as a treatment for patients with R/R HL. Tislelizumab is given in combination with chemotherapy (gemcitabine and cisplatin) followed by consolidation with tislelizumab alone. The study primary question is whether this strategy works as well as the standard treatment with intensive chemotherapy and autologous stem cell transplant.

Official title: Tislelizumab Plus Gemcitabine and Cisplatin for Relapsed or Refractory Hodgkin Lymphoma Followed by Tislelizumab Consolidation in Patients in Metabolic Complete Remission (TIGERR-HL). An Open Label Phase II Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2023-07-14

Completion Date

2031-03

Last Updated

2026-03-06

Healthy Volunteers

No

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.

Locations (15)

BE-Bruxelles-STLUC

Brussels, Belgium

DK-Aarhus N-AUH

Aarhus, Denmark

DK-Copenhagen-RIGSHOSPITALET

Copenhagen, Denmark

DK-Odense-OUH

Odense, Denmark

NL-Amersfoort-MEANDERMC

Amersfoort, Netherlands

NL-Amsterdam-AMC

Amsterdam, Netherlands

NL-Arnhem-RIJNSTATE

Arnhem, Netherlands

NL-Eindhoven-MAXIMAMC

Eindhoven, Netherlands

NL-Goes-ADRZ

Goes, Netherlands

NL-Groningen-UMCG

Groningen, Netherlands

NL-Hoofddorp-SPAARNEGASTHUIS

Hoofddorp, Netherlands

NL-Leeuwarden-MCL

Leeuwarden, Netherlands

NL-Maastricht-MUMC

Maastricht, Netherlands

NL-Rotterdam-ERASMUSMC

Rotterdam, Netherlands

NL-Den Haag-HAGA

The Hague, Netherlands