NCT02321592已完成2 期
GHSG-AFM13 An Open-label, Randomized, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The study is designed
- to demonstrate efficacy of AFM13 with an optimized treatment schedule
- to decide whether AFM13 warrants further investigation in a phase III clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of classical HL reconfirmed by histopathology and relapsed or refractory disease after standard therapy including brentuximab vedotin and anti-PD1 or PD-L1 antibodies
- •Age: 18 years or older (both genders)
- •ECOG performance status ≤2
- •Life expectancy >3 months
- •Measurable site of disease with ≥ 1.5cm diameter which is evaluable by CT/MRI and FDG-avid by PET
- •Completion of, if applicable, radiotherapy, chemotherapy, antibodies and immunoconjugates including brentuximab vedotin and/or another investigational drug which could interact with this trial not less than 4 weeks (or 5 half-lifes of the drug, whatever occurs later) prior to first dose of study drug
- •Completion of, if applicable, an autologous stem cell transplantation (ASCT) at least 3 months prior tofirst dose of study drug
- •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
排除标准
- •Any significant diseases (other than HL) or clinically significant findings including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participation in the study such as
- •unstable angina pectoris, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ≤ 6 months prior to first study drug, uncontrolled cardiac arrhythmia, cerebrovascular accidents ≤ 6 months before study drug start
- •severely impaired lung function as defined by spirometry (FEV1) and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
- •Liver disease as indicated by AST >3 ULN (> 5 ULN if liver involvement is present)
- •any severe or uncontrolled other disease which might increase the risk associated with study participation or study drug administration and impair the ability to evaluate the patient or for the patient to complete the study
- •Major organ dysfunction (except for HL-related reduced values e.g. in case of bone marrow or organ infiltration) as indicated by
- •Absolute Neutrophil Count (ANC) ≤1.5 x 109/l
- •Platelets <75 x 109/l
- •Hemoglobin level ≤9.0 g/dl (may be maintained by transfusions)
- •Total bilirubin >2 ULN (if >2 ULN direct bilirubin is required and should be ≤1.5 x ULN); Alkaline Phosphatase >3 ULN, AST or ALT ≥3 ULN (unless due to Hodgkin Lymphoma or diagnosed Gilbert´s Syndrome)
- •Blood creatinine level >2.0 mg/dl
- •History of a previous malignancy ≤3 years prior to first dose of study drug except basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or completely resected melanoma in stage TNMpT1
- •Patients with a history of HIV seropositivity, chronic active hepatitis, or another uncontrolled active infection within 4 weeks prior to first dose of study drug
- •Patients with evidence of current central nervous system (CNS) involvement
- •Prior allogeneic stem cell transplantation (SCT)
- •Patients receiving systemic corticosteroid treatment > 10 mg daily prednisone equivalents or other chronic systemic immunosuppressive agents within 2 weeks prior to first dose of study drug or during study treatment
- •Major surgery within 4 weeks prior to first dose of study drug
- •Known hypersensitivity to recombinant proteins or any excipient in the drug formulation
- •General intolerance of any protocol medication including obligatory concomitant medication
- •Pregnant or nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter. Male patients not willing to ensure that during the study and at least 3 months thereafter no fathering takes place
- •Patient´s lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
- •Patients unwilling to comply with the protocol
- •Patients who have a relationship of dependence or employer-employee relationship to the sponsor or the investigator
研究组 & 干预措施
Arm A
Active Comparator
AFM13 is administered three times a week (e.g. monday-wednesday-friday) for 8 consecutive weeks.
Arm A ist closed.
干预措施: AFM13 (Drug)
Arm B
Active Comparator
AFM13 is administered three times a week (e.g. monday-wednesday-friday) for 2 consecutive weeks followed by a weekly appication 6 consecutive weeks.
Arm B is closed.
干预措施: AFM13 (Drug)
Arm C
Active Comparator
AFM13 is administered for five consecutive days a week as continuous infusion for 8 consecutive weeks
干预措施: AFM13 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: at week 11
次要结局
- Quality of Life (QoL)-score(1 year)
- Remission status based on CT/MRI and PET-CT(3 weeks after end of treatment)
- Progression Free Survival (PFS)(2 years)
- Overall Survival (OS)(2 years)
- Adverse events (AEs) including acute treatment-associated toxicities(2 years)
研究者
Prof. Dr. Andreas Engert
Prof.
University of Cologne
研究点 (1)
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