CTRI/2023/11/060108已完成2 期
Chemotherapy with low dose immune therapy as salvage regimen in relapsed/ refractory Hodgkins Lymphoma: A phase II study
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER3 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年12月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- complete response rate in all evaluable patients
研究概览
简要总结
This is a trial of salvage chemotherapy in patients with relapsed Hodgkins lymphoma. Patients will receive therapy with salvage chemotherapy (physician’s choice from one of the following regimens: (ICE, GVDex, DHAP, GDP, BeGEV) along with low dose nivolumab 40mg with first and 3rd cycles. Response will be assessed after 3 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Relapsed/ refractory Hodgkins Lymphoma having previously received at least 1-2 lines of standard chemotherapy.
- •Demonstrated disease recurrence or progression or refractoriness by clear evidence on PET-CT or other imaging studies with or without biopsy confirmation
- •ECOG performance status 0 to 1
- •Written informed consent for adults over 18 years of age and consent from parents/ legal guardians for those below
- •Written assent for those 12-18 years and verbal assent for those 7-12 years old.
- •Negative urine/ serum pregnancy test in women of childbearing potential (WOCBP)
- •Female patients in the reproductive age group MUST AGREE TO use suitable contraception during therapy
- •Acceptable bone marrow and organ function at screening
- •Measurable disease must be present either on physical examination or imaging studies.
排除标准
- •Any anti-cancer therapy (other than palliative radiation and steroids) within the last three weeks
- •CNS involvement by disease
- •Inter-current severe illness or medical condition such as active uncontrolled infection, uncontrolled diabetes, or significant cardiac dysfunction would preclude safe administration of the protocol treatment.
- •Prior therapy with immune checkpoint inhibitors
- •Prior therapy with auto SCT/ alloSCT
- •Human Immunodeficiency Virus (HIV) infection/and/or Anti-retroviral therapy and/or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study).
- •Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HBeAg and HBV DNA titers must be negative, and patients would be continued on appropriate prophylaxis with antivirals throughout the study).
- •Uncontrolled medical conditions, including but not limited to uncontrolled diabetes mellitus and hypertension which may interfere with the safe delivery of salvage chemotherapy or immune therapy.
- •History of significant autoimmune or connective tissue disorders, which may be exacerbated by the use of nivolumab.
结局指标
主要结局
complete response rate in all evaluable patients
时间窗: 9 weeks from start of treatment
次要结局
- Progression Free survival(1 year)
研究者
Prasanth Ganesan
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
研究点 (3)
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