Phase 2 study to evaluate efficacy and safety of Lutetium-177 Rituximab in relapsed/refractory Diffuse large B cell Lymphoma and Follicular Lymphoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To determine the objective response rate following Lu177-Rituximab in relapsed/ refractory DLBCL & Follicular Lymphoma Patients.
研究概览
简要总结
Diffuse large B-cell Lymphoma (DLBCL) and follicular lymphoma (FL) are common cancers. DLBCL has a cure rate of about 55-60%. FL remains incurable, but can be controlled. While many patients respond well to initial treatment, those whose cancer does not respond or returns after treatment have very limited treatment options and poor outcomes. Further treatments such as chemotherapy and stem cell transplants often fail in these difficult cases. CART therapy is useful in some such patients but is very expensive and remains out-of-reach for the majority of our patients. “Radioimmunotherapy” is a treatment that uses a combination of radiation and targeted medicines to kill cancer cells. This treatment has shown promising outcomes in patients with FL and DLBCL in cases where chemotherapy has not helped much. One such “radioimmunotherapy” is called “Lutetium-177 labeled Rituximab or simply Lu177-Rituximab. This is a medicine in which Lu-177 is linked with a medicine called rituximab. The Lu-177-Rituximab has shown encouraging results in earlier studies but its effectiveness in relapsed DLBCL and FL is not well studied, especially when the disease has come back after transplant. This study aims to evaluate the safety and effectiveness of Lu177-Rituximab in such patients. Patients who have failed standard therapies or relapsed after stem cell transplant will receive this treatment. The study will measure how well the cancer responds and assess any side effects of Lu-177-Rituximab.
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
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with DLBCL Primary Mediastinal B cell Lymphoma PMBCL Follicular Lymphoma FL and Transformed FL with any one of the following criteria will be eligible to participate in the study.
- •Primary refractory showing Stable disease or Progression after 4 cycles of first line chemo immunotherapy or relapsing within 3 months of completion of treatment -Refractory to second line or subsequent line of chemo immunotherapy showing Stable disease or Progression after 2 or more cycles of second line or subsequent line of chemotherapy -Relapse after Autologous bone marrow transplant Relapse Progression or Stable disease will be documented on FDG PET CT as per internationally accepted criteria and guidelines 2.Patients showing less than 25 percent marrow involvement by tumor cells on bone marrow biopsy 3.Age greater than or equal to 18 years 4.ECOG performance status less than or equal to 2 5.Normal haematological function Hb greater than 8 g per dl Platelet count greater than 75000 per cubic mm Absolute neutrophil count greater than 1000 per cubic mm Use of growth factors or transfusions to meet these requirements are permitted 6.Adequate renal function Calculated creatinine clearance greater than 30 ml per minute 7.Adequate liver function Total bilirubin less than 1.5 times institutional upper limit of normal AST SGOT or ALT SGPT less than or equal to 2.5 times institutional upper limit of normal 8.Serum albumin greater than 30 g per L or 3 g per dL 9.Patients who are not eligible for have no access to or are deemed unsuitable for standard of care therapies including CAR T cell therapy bispecific antibody therapy or salvage chemotherapy followed by autologous stem cell transplantation.
排除标准
- •1.Past history of second malignancy 2.Participants who are receiving any other investigational agents.
- •3.Patients who have received any cancer directed therapy within 3 weeks of screening for this study.
- •4.Prior radiopharmaceutical therapy 5.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
- •6.Uncontrolled intercurrent illness including or psychiatric illness or social situations that would limit compliance with study requirements.
- •7.Pregnant women and breastfeeding women.
- •Breast feeding women may be eligible if they agree to stop breast feeding completely for 1 year.
- •8.Patient’s refusal to give informed consent and participate in the study.
- •9.Clinically significant or uncontrolled cardiac disease such as congestive heart failure requiring treatment (New York Heart Association more than Class 2, uncontrolled hypertension, clinically significant arrhythmia.
- •Acute coronary syndrome or acute myocardial infarction less than equal to 6 months prior to administration of study intervention.
- •Active HIV or HBV infections
- •Non-study-related minor surgical procedure less than equal to 5 days, or major surgical procedure less than equal to 21 days, prior to the administration of study intervention; in all cases, the participant must be sufficiently recovered and stable before treatment administration.
结局指标
主要结局
To determine the objective response rate following Lu177-Rituximab in relapsed/ refractory DLBCL & Follicular Lymphoma Patients.
时间窗: 36 months
次要结局
- 1.To evaluate the 1 year PFS following Lu177-Rituximab therapy in relapsed/ refractory DLBCL & Follicular Lymphoma Patients.(2.To evaluate safety profile of Lu177 Rituximab therapy in relapsed/ refractory DLBCL & Follicular Lymphoma Patients in terms of incidence of more than equal to grade 3 toxicity)
研究者
Dr Sachin Punatar
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre