An Open Multicenter Phase II Study of Efficacy and Toxicity of Maintenance Subcut. Rituximab After Induction With Rituximab in Patients With Relapsed or Refractory Mantle-cell Lymphoma Non-eligible for HSCT
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)
研究概览
简要总结
-
Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy
-
Secondary endpoints:
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Quality of response obtained after subcutaneous Rituximab maintenance.
-
Progression-Free Survival (PFS)
-
Overall Survival (OS)
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Time to Next Therapy (TTNT)
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Value of MRD in the disease outcome
-
Toxicity
详细描述
This is a phase II trial evaluating the role of maintenance with subcutaneous Rituximab in patients with stage II-IV relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with R-GemOx-D.
Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles.
Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy.
Patients will be evaluated every 2 months during treatment study phase and every 4 months in the follow up phase. More details in Appendix 1 (Schedule of Assessments)
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
- •Basal diagnosis of mantle-cell lymphoma in relapse or refractory.
- •Achievement of a CR or PR after salvage therapy with R-GemOxD (6 to 8 cycles) as previously described4-
- •Age > 18 years.
- •One or maximum two prior chemotherapy or immunochemotherapy lines.
- •Patients should not be considered candidates for high-dose chemotherapy and autologous stem-cell transplantation.
- •No clinical evidence of CNS involvement
- •Signed informed consent
- •Serum creatinine less than 2 and/or bilirrubin less than 2.5 UNL.
- •Pregnant or lactating woman. FCBP must agree to ongoing pregnancy testing during the course or study and commit to use effective contraception during the study
排除标准
- •Prior organ transplantation.
- •HIV positive.
- •HBV related disease
- •Any serious active disease or co-morbid medical condition (according to the investigator's decision)
- •Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 cervix carcinoma.
- •Less than 50% of tumor response.
- •Platelet counts less than 50 x 109/L.
- •Neutrophil counts less than 1.0 x 109/L.
研究组 & 干预措施
subcutaneous rituximab
MabThera 1400 mg solution for subcutaneous injection
干预措施: subcutaneous Rituximab (Drug)
结局指标
主要结局
Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)
时间窗: 2 YEARS
2 years after last patient randomized in maintenance
次要结局
未报告次要终点