Rituximab with reduced dosage LMB backbone chemotherapy schedule in childhood and adolescent mature B cell lymphoma/leukemia: Evaluation of efficacy & toxicity profile in developing country setting
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of treatment schedule utilizing addition of rituximab to reduced dosage standard LMB backbone chemotherapy.
研究概览
简要总结
Mature b cell lymphoma is a curable malignancy with cure rates exceeding 90% in developed world. In developing country setting it is 70%. The lower survival rate is due tohigher treatment related toxicity and higher relapse rate. Malnutrition and delayed presentation leads to higher mortality rates. To counter higher mortality rate in malnourished children it is planned to reduce the chemotherapy dosage to 75%. The treatment intensity could be maintained if there are fewer toxicity. This would indirectly reduce the relapse rate. Dose reduction is expected to facilitate in maintaining treatment intensity To prevent relapse an additional biomolecule, rituximab, active against mature B cell lymphoma is added. In trials it has already boosted the survival rate by 15%. This would reduce the relapse rate. We expect with the strategy of reduction of chemotherapy dosage and addition of rituximab our survival rate would exceed 90%. We are conducting a pilot study testing this hypothesis and then later to expand to a phase III trial
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
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.CD 20 positive Burkitt lymphoma & Diffuse large B cell lymphoma stage III & IV stage 2.CD 20 positive Burkitt lymphoma & Diffuse large B cell lymphoma stage I & II stage non-resectable.
排除标准
- •1.Active hepatitis B infection or carriers of hepatitis B virus 2.Active hepatitis C infection or carriers of hepatitis C virus 3.HIV infected children 4.Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology 5.Follicular lymphoma, MALT, nodular marginal zone lymphoma and primary mediastinal B cell lymphoma 6.Children with cardiac dysfunction- ejection fraction < 45% 7.Pregnancy 8.Allergic to rituximab 9.Not consenting for treatment 10.Children assessed by treating physician as not fit for intensive chemotherapy.
结局指标
主要结局
To evaluate the efficacy of treatment schedule utilizing addition of rituximab to reduced dosage standard LMB backbone chemotherapy.
时间窗: To evaluate the efficacy of treatment schedule utilizing addition of rituximab to reduced dosage standard LMB backbone chemotherapy.
次要结局
- To evaluate the toxicity profile of treatment schedule utilizing addition of rituximab to reduced dosage standard LMB backbone chemotherapy.(During chemotherapy treatment)