Prospective, Open-label, Multicentric, ph. II Study of R-GemOx and Dexametasone in Patients With Agressive Lymphomas Refractory or Relapsed to Previous Treatment and Non Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplanted
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 28
- 主要终点
- The primary endpoint is to evaluate Overall response rate (ORR)
研究概览
简要总结
The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
详细描述
The purpose of this study is to determine efficacy (overall response rate (ORR) and complete response) tolerance and toxicity of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •DLBCL and MCL diagnosed patients in primary resistance or relapsed not eligible for intensification chemotherapy followed by Autologous stem cell transplantation (ASCT) for age, comorbidity or previous ASCT.
- •Any IPI or ECOG, capable of understanding the nature of the trial.
- •Writtern Informed Consent.
排除标准
- •Nursing pregnant or lactation period women, or fertile age adults not using effective contraceptive method.
- •CNS lymphoma patients.
- •Patients with severa renal (creatinine> 2,5 UNL) or hepatic (Bilirrubin or ALT/AST> 2,5 UNL) impairement not provided by the same disease
- •HIV positive patients.
- •Serious psychiatric diseases patients that could interfere with their skill to understand the study (including alcoholism or drug addiction).
- •Murine proteins or any other component of the medicines of the study hypersensitivity patients.
- •Patients who have received more than 2 therapeutic previous lines. (for previous ASCT patients, induction and conditioning for the TAPH treatment is considered a single line therapy).
研究组 & 干预措施
no arms
no arms were present for the study, only 2 different cohorts:MCL and LDCGB
干预措施: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone (Drug)
结局指标
主要结局
The primary endpoint is to evaluate Overall response rate (ORR)
时间窗: 3 years and 2 months
The primary endpoint is to evaluate the number of patients with complete remission, unconfirmed complete remission and partial response according to International Workshop to Standardize Response Criteria for NHL, of R-GEMOX combination administered every 14 days
次要结局
- Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)(3 years and 2 months)
- To identify clinical response predictive factors(3 years 2 months)
研究者
Ana Mendez Lopez
Sponsor's secretary
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea