A phase II study to evaluate the activity of 177-Lu-DOTA Rituximab in adult patients with relapsed/refractory low-grade B-cell lymphomas.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- To study the Overall Response Rates to treatment with 177Lu-DOTA-Rituximab by performing PET/CECT or a Contrast enhanced CT scan chest abdomen and pelvis at 12 weeks after therapy and BM examination for those with baseline involvement.
研究概览
简要总结
Low grade B-cell lymphomas represent 25% of the Non-Hodgkin lymphoma which are controllable, but incurable. The initial treatment of symptomatic patients is with Rituximab+Bendamustine/R-CVP/R-CHOP. If remission lasts > 2 years, they are subjected to the same R-chemotherapy regimen. In our setting the options are limited for relapsed disease.
Radioimmunotherapy is a safe and effective option combining antiCD20 with radionuclide to ensure targeted delivery. Both Y90-Ibritumomab tiuxetan and I131-Tositumomab approved in relapsed setting are not available in India.
177Lu-DOTA-Rituximab is an effective radioimmunotherapy option in Low grade B cell NHL like Follicular lymphoma and Marginal zone lymphoma which has showed promising results in population who have relapsed/refractory to standard chemotherapy regimens. Relapsed Mantle Cell Lymphoma although part of the Low-Grade Lymphomas respond poorly and might affect the outcomes and hence excluded from the study.
177-Lu-DOTA-Rituximab has been tested in a phase I/II study of relapsed indolent lymphomas. We plan to evaluate the clinical activity of the effective dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Life expectancy of patients > 3 months.
- •2.ECOG PS 0-2 3.CD20 positive Low-grade B-cell Non-Hodgkin’s lymphoma.
- •a.Follicular lymphoma Grade 1-3a, b.Marginal zone lymphoma c.Other indolent lymphomas.
- •4.Relapsed disease< 2years from previous therapy or 5.Relapsed disease > 2 years from R-chemo, if a re-challenge is not feasible.
- •(Who have received at least 2 lines of chemotherapy that includes Bendamustine/Anthracycline based regimen orcurrently ineligible for anthracyclines.) 6.No cytotoxic chemotherapy administered in the past 6 weeks, other than a prephase (steroid based).
- •7.Last Rituximab administration at least 6 months before the date of enrolment.
- •8.Hematological condition: ANC > 1500/mm3, Platelet count > 100,000/mm3, ALC < 5000/mm3 within a week from the start of treatment 9.Serum chemistry: Total Bilirubin < 1.5mg/dL, unless predominantly unconjugated hyperbilirubinemia.
- •ALT < 2.5 times the Upper limit of normal.
- •10.Bone marrow biopsy- Reveals < 25% infiltration by tumor cells and >1 site of disease.
排除标准
- •Radiation to pelvis, femoral or lumbar spine in the past.
- •Active CNS lymphoma.
- •Mantle Cell Lymphoma and Large Cell Transformation of indolent lymphoma
- •Known case of Hepatitis B, C or HIV.
结局指标
主要结局
To study the Overall Response Rates to treatment with 177Lu-DOTA-Rituximab by performing PET/CECT or a Contrast enhanced CT scan chest abdomen and pelvis at 12 weeks after therapy and BM examination for those with baseline involvement.
时间窗: To study the Overall Response Rates to treatment with 177Lu-DOTA-Rituximab by performing PET/CECT or a Contrast enhanced CT scan chest abdomen and pelvis at 12 weeks after therapy and BM examination for those with baseline involvement.
次要结局
- 2 year Progression Free Survival from the time of enrollment onto the study to progression defined as appearance of a new lesion or loss of response attained at 12 weeks, showing a more than 20% increase in the sum of longest diameters of target lesions or for small lymph nodes measuring less than 15mm post therapy, a minimum absolute increase of 5mm and the long diameter should exceed 15mm or death due to any cause whichever is earlier(2 year)
- 2-year Overall Survival- from the time of enrollment onto the study to death due to any cause(2 year)
- The rate of hematological and non-hematological toxicities will be studied by adverse events monitoring- Duration and Severity of all adverse events as defined by Common Terminology Criteria for Adverse Events v5.0(2 years)
- To study the mutational profiling especially TP53 mutation among POD 24 patients and their response to Lu-DOTA-Rituximab(2 year)