EUCTR2018-004522-29-GB进行中（未招募）1 期
Phase Ib/II trial of Histone Deacetylase Inhibitor CXD101 in combination with Programmed Cell Death Protein-1 Inhibitor Pembrolizumab for relapsed or refractory Diffuse Large B-cell Lymphoma - PLACARD
niversity College London0 个研究点目标入组 45 人开始时间: 2019年7月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Biopsy-confirmed DLBCL, relapsed/ refractory after =2 lines of prior therapy and not suitable for ASCT or relapsed post ASCT. Eligibile histologies include:
- •a.diffuse large B-cell lymphoma NOS
- •b.transformed indolent non-Hodgkin lymphoma (including Richter’s transformation)
- •c.EBV positive DLBCL NOS
- •d.high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations,
- •e.high grade B-cell lymphoma NOS
- •f.primary mediastinal B-cell lymphoma
- •g.Other WHO classified variants of DLBCL may be permitted with the agreement of at least two TMG clinicians.
- •2.Measurable disease (of > 15mm in a node or > 10mm in extranodal tissue)
- •3.Age = 18 years
- •4.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •5.Adequate organ and bone marrow function: Hb >80g/L, neutrophils >1.0x10^9/L and platelets >75x10^9/L (without platelet transfusion support)
- •6.International normalised ratio (INR) or prothrombin time (PT) or Activated partial thromboplastin time (aPTT): =1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- •7.Adequate renal function: estimated creatinine clearance >60ml/min as calculated using the Cockroft-Gault equation
- •8.Adequate liver function, including:
- •a.Bilirubin =1.5 x upper limit of normal (ULN).
- •b.Aspartate or alanine transferase (AST or ALT) =2.5x ULN
- •9.Negative serum or urine pregnancy test for women of childbearing potential (WOCBP)
- •10.Willing to comply with the contraceptive requirements of the trial
- •11.Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Post-transplant lymphoproliferative disorder.
- •2.Women who are pregnant or breast feeding, or males expecting to conceive or father children at any point from the start of study treatment until 4 months after the last administration of study treatment
- •3.Patients with corrected QTc (QTcF or QTcB) interval >450msec
- •4. Clinically significant cardiac or respiratory disease:
- •a. Cardiac disease: Myocardial infarction, severe/unstable angina pectoris within 6 months prior to starting study treatment, NYHA class III-IV heart failure
- •b. Pulmonary disease causing = grade 2 dyspnoea or patient requiring oxygen
- •5.Known involvement of the central nervous system with lymphoma
- •6.Clinically significant active infection requiring antibiotic or antiretroviral therapy
- •7.Active autoimmune disease that has required systemic treatment in the past 2 years
- •8.History of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •9.History of immune hepatitis or myocarditis
- •10.Systemic anti-cancer therapy within 4 weeks prior to starting study treatment(12 weeks for CAR T-cells)
- •11.Prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids for radiation toxicity and not have had radiation pneumonitis.
- •12.Received a live vaccine within 30 days prior to starting study treatment
- •13.Have taken an IMP/investigational device within 4 weeks prior to starting study treatment
- •14.Major surgery within 4 weeks prior to starting study treatment
- •15.Prior therapy with an anti-PD-1 or anti-PD-L1 or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg. CTLA-4, OX 40, CD137)
- •16.Prior allogeneic haematopoietic stem cell transplant, solid organ allogeneic transplant or allogeneic CAR T-cell therapy. Prior use of autologous CAR T-cell therapy is allowed but patient must be = 12 weeks post infusion prior to starting study treatment
- •17.Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy, or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)- related illness
- •18.Positive serology for hepatitis B or C unless (a) hepatitis B positive due to vaccination (HBsAb positive, all other tests negative) or (b) past hepatitis B infection with low risk of reactivation (HBsAb positive & HBcAb positive, other tests (including hepatitis B DNA) negative – PI/co- investigator approval needed – see section 6.2.3 in the protocol for more details
- •19.Severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients and/or a history of allergies to the excipients of CXD101
- •20.History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- •21.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
- •22.Non-haematological malignancy within the past 3 years (some exceptions apply - listed in trial protocol)
- •23.Current or prior use of immunosuppressive therapy within 7 days prior to start of treatment except the following: intranasal, inhaled, topical steroids or local steroid injections (eg. Intra-articular injection); systemic cortic
研究者
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