HL35 -An Australasian Leukaemia and Lymphoma Group open label phase II study of the effect of of R-CHOP in combination with pembrolizumab in patients with newly diagnosed primary mediastinal B Cell Lymphoma (PMBL).

Australasian Lymphoma and Leukaemia Group0 个研究点目标入组 35 人开始时间: 2021年11月10日最近更新: 2024年6月10日

适应症

试验速览

暂无简介。

•1.Subjects aged equal to greater than 18 years at time of enrolment.
•2.Able to give informed consent.
•3.Clinical and histological diagnosis of PMBL, according to the current World Health Organization classification.
•4.No previous treatment for lymphoma including chemotherapy, radiotherapy or other investigational drug.
•5.Eastern Collaborative Oncology Group performance status 0-<=1.
•6.Platelets >= 100x109/l; neutrophils >= 1.0x109/l at the time of study entry.
•7.Creatinine clearance >=30ml/min (calculated according to MRDR or Cockcroft Gault equation)
•8.Total bilirubin less than or equal to 1.5 × ULN, AST and ALT less or equal to 2..5 x ULN
•9.LVEF greater or equal to 45%

•1.Known hypersensitivity to any study medication, including previous grade >=3 hypersensitivity reactions to monoclonal antibody therapy.
•2.Active autoimmune disease; requiring immunosuppressive therapy within 6 months of study entry.
•3.Other lymphoma subtypes, other than PMBL.
•4.Central nervous system, meningeal or spinal cord involvement by lymphoma.
•5.Prior therapy with any antibody or drug targeting T-cell coregulatory proteins (immune checkpoints) such as PD-1, PD-L1, or cytotoxic T-lymphocyte antigen-4 (CTLA-4).
•6.Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. – Please note that a short course of steroids (e.g. Oral Prednisolone 1mg/kg daily or equivalent for <=7 days duration) will be permitted if indicated for lymphoma symptoms (but should be avoided if possible)

发起方

Australasian Lymphoma and Leukaemia Group