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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
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
...and 5 more locations
Progression free survival (PFS) probability at 2 years after registration. PFS is defined as time from registration to progression or death from any cause, whichever comes first.
Single-arm
Time frame: Approximately up to 48 months following first patient enrollment
Overall response rate (ORR: mCR and mPR rates) (as assessed by FDG-PET/CT) after 2 and 4 cycles of tislelizumab in combination with GP chemotherapy induction.
Single-arm
Time frame: Approximately up to 28 months following first patient enrollment
Rate of CTCAE grade 3/4 toxicities of tislelizumab in combination with GP chemotherapy.
Single-arm
Time frame: Approximately up to 28 months following first patient enrollment
Rate of CTCAE grade 2 to 4 immune related toxicities of tislelizumab in combination with GP chemotherapy.
Single-arm
Time frame: Approximately up to 36 months following first patient enrollment
Rate of CTCAE grade 3/4 toxicities of tislelizumab consolidation treatment.
Single-arm
Time frame: Approximately up to 36 months following first patient enrollment
Progression free survival (PFS) as time-to-event outcome.
Single-arm
Time frame: Approximately up to 36 months following first patient enrollment
Event free survival (EFS) defined as time from registration to start new HL treatment, progression or death from any cause, whichever comes first.
Single-arm
Time frame: Approximately up to 84 months following first patient enrollment
Disease free survival (DFS) defined as time from start of consolidation therapy to relapse or death from any cause, whichever comes first.
Single-arm
Time frame: Approximately up to 84 months following first patient enrollment
Overall survival (OS) defined as time from registration to death from any cause.
Single-arm
Time frame: Approximately up to 84 months following first patient enrollment
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