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 (HOVON164HL)

NCT05502250 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Stichting Hemato-Oncologie voor Volwassenen Nederland
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	75
Start date	2023-07-14
Completion	2031-03

Conditions

• Hodgkin Lymphoma

Interventions

• gemcitabine, cisplatin and tislelizumab

Primary outcomes

• 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. — Approximately up to 48 months following first patient enrollment
  Single-arm

Countries

Belgium, Denmark, Netherlands