EUCTR2019-002105-22-ES进行中（未招募）1 期
A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma
BeiGene Ltd.0 个研究点目标入组 100 人开始时间: 2021年12月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female = 18 years
- •2. Histologically confirmed diagnosis of relapsed or refractory cHL
- •3. Relapsed cHL (disease progression after PR or CR to the most recent therapy).
- •Patients will be allocated to one of two cohorts based on the following criteria:
- •Cohort 1: Relapsed or refractory to prior autologous HSCT
- •- Has failed to achieve a response or has had disease progression after autologous
- •- Is not a candidate for additional autologous or allogeneic HSCT
- •Cohort 2: Relapsed or refractory to salvage chemotherapy, and has not received prior
- •autologous or allogeneic HSCT
- •- Has received at least 1 prior systemic regimen for cHL
- •- Is not a candidate for autologous or allogeneic HSCT
- •4. Measurable disease defined as = 1 FDG-avid nodal lesion that is > 1.5 cm in the longest diameter, or = 1 FDG-avid extra-nodal lesion (eg, hepatic nodules) that is > 1 cm in the longest diameter
- •5. Able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded [FFPE] blocks or approximately 15 freshly cut, unstained FFPE slides) from an evaluable core or excisional biopsy with an associated pathological report
- •6. ECOG performance status of 0 or 1
- •7. Life expectancy = 12 weeks
- •8. Adequate organ function, as indicated by the following laboratory values:
- •a. Absolute neutrophil count (ANC) = 1.0 x 109/L, independent of growth factor support
- •within 7 days of first dose
- •b. Platelet = 75 x 109/L, independent of transfusion, growth factor support or or
- •thrombopoietin receptor agonist within 7 days of first dose
- •c. Hemoglobin (Hgb) = 8 g/dL or = 5 mmol/L
- •d. Creatinine clearance > 30 mL/min
- •e. AST (SGOT) and ALT (SGPT) = 2.5 x the ULN or = 5 x ULN if liver lymphoma involvement is present
- •f. Serum total bilirubin = 1.5 x ULN (total bilirubin level < 4 x ULN for patients with
- •Gilbert syndrome)
- •9. No evidence of dyspnea at rest and a pulse oximetry of > 92% while breathing room air
- •of dyspnea at rest and a pulse oximetry of > 92% while breathing room air
- •10. DLCO (adjusted for alveolar volume) > 60% of predicted value; FEV1 and FVC,
- •FEV1/ FVC all > 50% predicted value
- •11. Female patients of childbearing potential must be willing to use a highly effective method
- •of contraception for the duration of the study and for = 120 days after the last dose of
- •tislelizumab, and have a negative urine or serum pregnancy test within 7 days before the
- •first dose of study drug.
- •12. Males are eligible to enter and participate in the study if they have been vasectomized or
- •if they agree to use barrier contraception with other highly effective methods during the study treatment period and for = 120 days after the last dose of
- •tislelizumab
- •13. Ability to provide written informed consent and can understand and comply with the
- •requirements of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma
- •2. Prior allogeneic hematopoietic stem cell transplantation
- •3. History of severe hypersensitivity reaction to monoclonal antibodies
- •4. New York Heart Association (NYHA) class III or IV heart failure, unstable angina,
- •severe uncontrolled ventricular arrhythmia, electrocardiographic evidence of acute
- •ischemia, or myocardial infarction within 6 months of first day of screening
- •5. Prior malignancy within the past 3 years except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or other site for which in situ carcinoma has metastatic potential
- •6. Prior therapy targeting PD-1, PD-L1, PD-L2, or CTLA-4 pathways
- •7. Has received:
- •- Systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to Cycle 1 Day 1
- •- Recent treatment with another monoclonal antibody within 4 weeks prior to Cycle 1 Day 1
- •- Investigational treatment or device within 4 weeks (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1 and may qualify for the study if all other criteria are met)
- •8. Active autoimmune disease or history of autoimmune disease that may relapse
- •- Patients with the following are not excluded and may proceed to further screening:
- •Vitiligo, eczema, type I diabetes mellitus, and endocrine deficiencies including thyroiditis managed with replacement hormone and/or physiologic corticosteroids
- •- Patients with the following should be evaluated for the presence of target organ involvement and the potential need for systemic treatment, but should otherwise be eligible: Rheumatoid arthritis and/or other arthropathies, Sjögren’s syndrome, or
- •psoriasis controlled with topical medication, and patients with positive serology such
- •as positive antinuclear antibody or anti-thyroid antibody
- •9. Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of the first dose of tislelizumab
- •? Adrenal replacement doses of = 10 mg daily prednisone equivalent in the absence of
- •active autoimmune disease
- •? Topical, ocular, intra-articular, intranasal, and inhalational corticosteroid (with
- •minimal systemic absorption)
- •? A brief course of corticosteroid for prophylaxis (eg, contrast dye allergy) or for
- •treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction
- •caused by contact allergen)
- •10. History of interstitial lung disease or noninfectious pneumonitis or has evidence of
- •interstitial lung disease or noninfectious pneumonitis
- •11. Serious acute or chronic infection requiring systemic therapy
- •12. Known central nervous system (CNS) lymphoma
- •13. Underlying medical conditions that, in the investigator’s opinion, will render the
- •administration of study drug hazardous or obscure the interpretation of toxicity or AEs
- •14. Known history of infection with HIV, human T-cell lymphotropic virus-1, or human
- •T-cell lymphotropic virus-2
- •15. Serologic status reflecting active hepatitis B or C infection as follows:
- •? Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible only if hepatitis B virus (HBV) DNA is undetectable by an assay with sensitivity = 20 IU/mL. If so, patients may either undergo regularly scheduled monitoring of
- •HBV DNA or less frequent monitoring of HBV DNA while o
研究者
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