NCT00466258已完成4 期
LINFOTARGAM: First-line Treatment With Dose-dense Chemotherapy Plus Rituximab (R-CHOP/14) and Highly Active Antiretroviral Therapy (HAART) in Patients With Diffuse Large B Cell Lymphoma (DLBCL) and Infection With the Human Immunodeficiency Virus (HIV)
PETHEMA Foundation16 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)
研究概览
简要总结
Main objective:
- To evaluate the applicability of the treatment:
- To evaluate the treatment toxicity according to the Common Terminology Criteria (CTC) version 3.0 of the National Cancer Institute (NCI).
- To evaluate opportunistic and non-opportunistic infections after 6 cycles of treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) administered every 14 days and highly active antiretroviral therapy (HAART) in patients with diffuse large B cell lymphoma (DLBCL) and HIV infection.
- To evaluate the adherence to the treatment with 6 cycles of R-CHOP considering the delays in the administration of the cycles and the reductions in the doses of chemotherapy (planned dose administered in predicted term).
Secondary objectives:
- To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days (R-CHOP/14):
- To determine the global response and complete remission tax.
- To evaluate the duration of the response.
- To evaluate the probability of event-free survival in 5 years.
- To evaluate the probability of global survival in 5 years.
- To identify predictive factors of response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection.
- To evaluate the impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count).
详细描述
This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HIV infection diagnosed with DLBCL in any stage (I-IV according to the Ann Arbor classification) not previously treated for the lymphoma.
- •Patients with CD20-positive diffuse large B-cell lymphoma
- •Aged from 18 to 70 years old
- •Any score of International Prognostic Index. (It is also applicable in patients with non-Hodgkin lymphoma [NHL] infected with HIV.)
- •ECOG performance status 0 to 3
- •Written informed consent
- •Absolute neutrophil count > 1.5 x 10^9/L.
- •Absence of synchronic or non-synchronic neoplasia with the exception of non-melanoma skin tumors or in situ cervical carcinoma.
- •CD4+ lymphocyte count > 100/µL
排除标准
- •Patients with diffuse large B cell lymphoma previously treated.
- •Patients with primary central nervous system lymphoma.
- •Patients with Burkitt or Burkitt-like NHL.
- •CD4+ lymphocyte count < 100/µL
- •Opportunistic infections or other AIDS-related neoplasias in activity.
- •Active drug-addiction.
- •Pregnant or lactating women or adults of fertile age who do not use an effective contraceptive method.
- •Patients with serious altered renal function (creatinine > 2.5 x upper limit of normal [ULN]) or hepatic [bilirubin, ALT or AST > 2.5 x ULN], except if the investigators suspect that they are caused by the disease.
- •Cardiac insufficiency with ejection fraction < 40%
- •Patients with serious psychiatric diseases that can interfere with their capacity to understand the study (including alcoholism or active drug-addiction).
- •ECOG > 3
- •Patients with a known hypersensitivity to murine proteins or any other component of the study drugs.
结局指标
主要结局
treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)
时间窗: 6 months
opportunistic and non-opportunistic infections rate after 6 cycles of treatment with R-CHOP administered every 14 days and HAART in patients with DLBCL and HIV infection
时间窗: 6 months
adherence to the treatment with 6 cycles of R-CHOP considering the delays in the administration of the cycles and the reductions in the doses of chemotherapy (planned dose administered in predicted term)
时间窗: 6 months
次要结局
- efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days(1 year)
- global response and complete remission rate(1 year)
- duration of the response(5 years)
- event-free survival probability in 5 years(5 years)
- global survival probability in 5 years(5 years)
- predictive factors of the response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection(2 years)
- impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count)(1 year)
研究者
研究点 (16)
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