Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- evaluation of activity of the induction phase in terms of complete remission rate
研究概览
简要总结
This is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in HIV+ patients with Burkitt's lymphoma.
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was thought to limit the ability to administer intensive chemotherapeutic regimens due to infection rate. However, the advent of highly active antiretroviral therapy (HAART) and evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive patients with the same intensive chemotherapy regimens used to treat immuno-competent patients. Data suggest that these current approaches, along with supportive care, may result in improved patient outcomes, similar to those in the immuno-competent patient population.
详细描述
The activity of feasibility of the proposed program will be assessed in HIV+ patients with Burkitt lymphoma with the aim to improve tolerability, minimize source consuming and supporting treatment and redu ce late sequels. Available combinations in this setting are really source demanding and toxic combinations showing high rates of septic complication and a treatment-related mortality of near 20%.
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
- •Histologic diagnosis of Burkitt's lymphoma (WHO 2008)
- •HIV sero-positivity
- •Age ≥18 and ≤60 years
- •ECOG-PS ≤3
排除标准
- •CNS parenchymal involvement
- •Absolute neutrophil count <1.000 cells/μL and platelets count <75 × 109/L (Burkitt unrelated)
- •Creatinine >1,5N (Burkitt unrelated)
- •SGOT and/or SGTP >2,5N (Burkitt unrelated)
- •Bilirubin >2N (Burkitt unrelated)
- •Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance
- •Significant cardiac disease or acute myocardial infarction in the last 12 months
- •Severe active infection (except for HBV and/or HCV co-infection)
研究组 & 干预措施
intensive short term immuno-chemotherapy
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
干预措施: Induction Phase (Drug)
intensive short term immuno-chemotherapy
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
干预措施: Consolidation Phase (on day +50) (Drug)
intensive short term immuno-chemotherapy
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
干预措施: Intensification phase (Drug)
intensive short term immuno-chemotherapy
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
干预措施: BEAM conditioning (Drug)
intensive short term immuno-chemotherapy
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
干预措施: Consolidation radiotherapy (Radiation)
结局指标
主要结局
evaluation of activity of the induction phase in terms of complete remission rate
时间窗: at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days
Objective lymphoma response achieved after the induction phase of the experimental treatment.
次要结局
- Feasibility and tolerability of intensification phase in terms of prevalence of grade ≥4 adverse events(participants will be followed for the duration of the whole experimental program, an expected average of 100 days)
- Activity of the whole investigational program in terms of complete remission rate(at the end of the whole program, an expected average of 100 days)
- Feasibility and tolerability of the consolidation phase followed by BEAM conditioning and autologous stem cell transplantation in terms of prevalence of grade ≥4 adverse events(participants will be followed for the duration of the whole experimental program, an expected average of 100 days)
- Feasibility and tolerability of the investigational intensive chemotherapy in terms of grade ≥4 adverse events(participants will be followed for the duration of the whole experimental program, an expected average of 100 days)
研究者
Andres J. M. Ferreri
MD
IRCCS San Raffaele