CTRI/2021/02/031578尚未招募2 期
A phase II study to evaluate the activity of 177-Lu-DOTA Rituximab in adult patients with relapsed/refractory low-grade B-cell lymphomas. - 177-Lu-DOTA Rituximab Study
Tata Research Administrative Council TRAC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1.Life expectancy of patients > 3 months.
- •2.ECOG PS 0-2
- •3.CD20 positive Low-grade B-cell Non-Hodgkinâ??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
- •1. Radiation to pelvis, femoral or lumbar spine in the past.
- •2. Active CNS lymphoma.
- •3. Mantle Cell Lymphoma and Large Cell Transformation of indolent lymphoma
- •4. Known case of Hepatitis B, C or HIV.
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