NCT01127841Unknown2 期
Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas18 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- the primary endpoint is the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL
研究概览
简要总结
Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.
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.
- •Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue.
- •Follicular lymphoma patients previously treated with the combination of rituximab and chemotherapy (R-CHOP, R-CVP, R-fludarabine), having received rituximab maintenance, refractory to a first line (excluding radiotherapy) or relapsed after having achieved any response to previous treatment.
- •Signed written informed consent
排除标准
- •Clinical suspicion or documentation of histological transformation.
- •Patients with hypersensitivity to rituximab.
- •Prior autologous or allogeneic transplant.
- •CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis).
- •Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA).
- •HCV infection. HIV infection or other conditions of severe immunosuppression.
- •Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
- •Congestive heart failure> NYHA grade
- •Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, ULN) or creatinine clearance <50 ml / h, not related to lymphoma.
- •Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to lymphoma.
- •Women who are nursing or pregnant.
- •Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma.
- •Severe acute or chronic infection in activity.
- •Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.
研究组 & 干预措施
Rituximab and Bendamustine
Experimental
干预措施: Rituximab and Bendamustine (Drug)
结局指标
主要结局
the primary endpoint is the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL
时间窗: Four years
Evaluation of response to induction treatment at 6 months after inclusion of the patient. Evaluation of response to maintenance treatment at 2 years after finishing the induction treatment.
次要结局
- Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response.(Four years)
研究者
研究点 (18)
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