Treatment With Infusional Dose-adjusted Etoposide/Vincristine/Doxorubicin/Bolus Cyclophosphamide/Dexamethasone and Rituximab (DA-EDOCH14-R) in Patients With Poor-prognosis Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- efficacy of the EDOCH14-R scheme at an adjusted dose
研究概览
简要总结
Poor prognosis dufuse large B-cell lymphoma (DLBCL) represents 50% of all DLBCL with overall cure rates ranging from 50-60% with modern dose-dense immunochemotherapy regimens such as R-CHOP14. Using an alternative strategy, as infusional and dose-adjusted R-EPOCH, the investigators have shown an 83% of complete responses (CR), with an estimated 5-year overall survival (OS) rate of 75% (García-Suárez et al. British Journal of Haematology 2007, 136:276). Despite this improvement in outcome, the search for new treatment strategies should continue. Therefore, compared with prior R-EPOCH the investigators decided to investigate whether the introduction of dexamethasone (40 mg IV on days 1-5) in place of prednisone (based upon data which demonstrated that the former was associated with enhanced Central Nervious System penetration) and the reduction of treatment intervals from 3 to 2 weeks would be feasible and might improve the outcome in this group of patients.
详细描述
Medication, Dose and Method for Administration:
- Rituximab: 375 mg/m2, endovenous, according to the protocol of the service, day 1 (except in the first cycle, in which it will be on day 5).
- Etoposide: 50 mg/m2/day, in continuous 24-hour infusion, days 1 to 4.
- Adriamycin: 10 mg/m2/day, in continuous 24-hour infusion of, days 1 to 4.
- Vincristine: 0.4 mg/m2/day, in continuous 24-hour infusion, days 1 to 4
- Dexamethasone: 40 mg, endovenous, days 1 to 5. Followed by prednisone 30 mg (day +6), 20 mg (day +7), and 10 mg (day +8).
- Cyclophosphamide: 750 mg/m2, endovenous, in 30 minutes, day 5, after ending the continuous infusion of adriamycin, etoposide and vincristine.
- MESNA (If the dose of Cyclophosphamide is > 1 g/m2
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing the Informed Consent.
- •Histology: diffuse large B-cell lymphoma de novo (primary mediastinal B-cell lymphomas will be included provided that they have a mass greater than 7 cm in larger diameter) and follicular NHL grade 3b.
- •aaIPI: 2-
- •Age: Between 18 and 70 years.
- •General Condition (ECOG/WHO): Proper organic function, defined by: FEVI ≥ 40%, serum creatinine < 150 µmol/L, serum bilirubin < 30 µmol/L, control of other medical conditions such as: infection, leukocytes ≥ 3.5 x 109/l and platelets ≥ 100 x 109/l (except if they are caused by lymphomatous infiltration of bone marrow or of the spleen).
排除标准
- •HIV-positive.
- •Pregnancy or breastfeeding.
- •Serious disease compromising the performance of the therapeutic regimen.
- •Recent history of another malignant disease (except skin cancer different from melanoma or carcinoma in-situ of the cervix), prior radiotherapy or chemotherapy, history of indolent lymphoma.
- •CNS infiltration at diagnosis.
研究组 & 干预措施
Poor prognosis DLBCL
Newly diagnosed patients with DLBCL and an age-adjusted IPI 2-3
干预措施: Dexamethasone and dose-dense immunochemoterapy (Drug)
结局指标
主要结局
efficacy of the EDOCH14-R scheme at an adjusted dose
时间窗: Between December 2009 and January 2012
次要结局
- hematological and extra-hematological toxicity of the EDOCH14-R scheme(Between december 2009 and January 2012)