First Line Treatment in HIV-related Large Cell Non Hodgkin Lymphoma at "High Risk", Including Early Consolidation With High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of an intensified first-line treatment, with conventional chemotherapy (CHOP) plus monoclonal antibody anti CD20, followed by high dose chemotherapy and PBSC transplantation in HIV-related aggressive non-Hodgkin lymphoma at "high risk" , according to the international prognostic index (IPI).
详细描述
HIV associated NHL show particularly aggressive clinical features and a worse prognosis compared to the general population. The recent introduction of highly active antiretroviral therapy (HAART)has improved HIV positive patients' clinical conditions and reduced the risk of opportunistic infections, thus making HIV+ patients more similar to HIV- patients. Several studies have shown that the early use (as first line treatment) of high dose chemotherapy (HDT) with peripheral blood stem cell transplantation (PBSCT) is superior in the HIV negative setting to conventional dose chemotherapy, at least in patients with poor prognostic factors at diagnosis. Recently, several experiences have shown the feasibility, safety and efficacy of HDT and PBSCT, in association with HAART, as salvage therapy in HIV positive patients with lymphoma who maintain a chemosensitive disease after first-line treatment failure. It is rationale therefore to explore the use of this treatment strategy earlier, within the upfront treatment of HIV-associated lymphoma, in those patients with poor prognostic factors at diagnosis, according to the international prognostic score (IPI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positivity
- •"Large cell"histology (DLBCL, Immunoblastic, Plasmablastic, Anaplastic lymphoma)
- •Age 18-60 years
- •Age-adjusted IPI 2-3
- •Ann Arbor stage I B-IV
- •Written informed consent.
排除标准
- •Burkitt lymphoma
- •Lymphoblastic lymphoma
- •Primary effusion lymphoma
- •Age-adjusted IPI 0-1
- •Performance Status (WHO) >2 (if not related to lymphoma)
- •Inadequate cardiac function (V.E.F. < 50%) or clinically evident cardiac disease
- •Inadequate pulmonary function (DLCO < 50% and/or O2 < 96%)
- •Inadequate renal function (creatinine > 2 mg/dl)
- •Inadequate liver function (AST/ALT > 3 ULN and/or PT < 70%, if not related to lymphoma)
- •Inadequate marrow function (neutrophils < 1500/cmm; platelets < 100.000/cmm, if not related to lymphoma)
- •Virologic failure to HAART (including at least one NRTI, one NNRTI and two PI) and/or CD4 count < 50/cmm.
- •CNS or meningeal lymphoma
- •Active opportunistic infections
- •Pregnancy
- •Other evolutive malignancy (except of localized non-melanoma skin cancer and in situ portio carcinoma)
- •Any other condition that contraindicates this treatment program at discretion of physician
- •HBsAg positivity with active viral replication (HBV-DNA positivity)
结局指标
主要结局
Overall survival
时间窗: 2-years
次要结局
- Partial and complete responses(Evaluation of response one month after peripheral blood transplantation)
研究者
Giuseppe Rossi
Director of Hematology
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
