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

Stichting Hemato-Oncologie voor Volwassenen Nederland15 个研究点分布在 3 个国家目标入组 75 人2023年7月14日

适应症Hodgkin Lymphoma

干预措施gemcitabine, cisplatin and tislelizumab

概览

阶段: 2 期
干预措施: gemcitabine, cisplatin and tislelizumab
疾病 / 适应症: Hodgkin Lymphoma
发起方: Stichting Hemato-Oncologie voor Volwassenen Nederland
入组人数: 75
试验地点: 15
主要终点: 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.
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2023年7月14日

结束日期

2031年3月1日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Stichting Hemato-Oncologie voor Volwassenen Nederland

责任方

Sponsor

入排标准

入选标准

•Histologically confirmed classical HL (according to the latest version of the WHO classification).
•Primary refractory to first line chemotherapy, or in first relapse after any polychemotherapy regimen (e.g. ABVD, baseline BEACOPP or escalated BEACOPP, or other induction regimens).
•In case of relapse, the relapse must be histologically confirmed. In case histologic biopsy is not possible, at least confirmation of the relapse by fine needle aspirate (FNA) or sequential imaging is required.
•Measurable disease, based on Lugano criteria 2014 \[40\]; i.e. CT scans showing at least 2 or more clearly demarcated lesions with a long axis ≥ 1.5 cm and a short axis diameter ≥ 1.0 cm, or 1 clearly demarcated lesion with a long axis ≥ 2.0 cm and a short axis diameter ≥ 1.0 cm. These lesions must be FDG-PET-positive.
•Age 18-70 years inclusive.
•WHO/ECOG Performance Status ≤ 1 (see appendix C).
•No major organ dysfunction, unless HL-related:
•Total bilirubin \< 1.5x ULN (unless due to lymphoma involvement of the liver or a known history of Gilbert's syndrome; in that case bilirubin may be elevated up to 3 x ULN).
•ALT/AST \< 3x ULN (unless due to lymphoma involvement of the liver; in that case ALT/AST may be elevated up to 5 x ULN).
•GFR \> 60 ml/min as estimated by the Cockcroft\&Gault formula.

排除标准

•Previous treatment with an PD-1 or PDL-1 blocking agent.
•Patients who have been using other investigational agents within at least 5 half lives or 4 weeks, whichever is longer, of the most recent agent used prior to start of protocol treatment.
•Patients who were treated with myelosuppressive chemotherapy or biological therapy within at least 5 half lives or 4 weeks, whichever is longer, before start of protocol treatment.
•Patients who were treated with steroids for more than 25 mg /day for at least 14 days before start of protocol treatment.
•Patients receiving radiation therapy within 2 weeks prior to start of protocol treatment. Emergency radiation therapy is allowed, as long as measurable disease (at non-irradiated sites) persists.
•Prior allogeneic stem cell transplantation or solid organ transplantation.
•Peripheral neuropathy \> grade
•Active autoimmune diseases or history of autoimmune diseases that may relapse.
•Note: Patients with the following diseases are not excluded and may proceed to further screening:
•Controlled Type I diabetes.

研究组 & 干预措施

Single-arm

4 cycles of gemcitabine and cisplatin (GP) + tislelizumab followed by 13 cycles of tislelizumab

干预措施: gemcitabine, cisplatin and tislelizumab

结局指标

主要结局

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.

时间窗: Approximately up to 48 months following first patient enrollment

Single-arm

次要结局

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.(Approximately up to 28 months following first patient enrollment)
Rate of CTCAE grade 3/4 toxicities of tislelizumab consolidation treatment.(Approximately up to 36 months following first patient enrollment)
Rate of CTCAE grade 2 to 4 immune related toxicities of tislelizumab in combination with GP chemotherapy.(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.(Approximately up to 84 months following first patient enrollment)
Rate of CTCAE grade 3/4 toxicities of tislelizumab in combination with GP chemotherapy.(Approximately up to 28 months following first patient enrollment)
Overall survival (OS) defined as time from registration to death from any cause.(Approximately up to 84 months following first patient enrollment)
Progression free survival (PFS) as time-to-event outcome.(Approximately up to 36 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.(Approximately up to 84 months following first patient enrollment)