Phase 2 Study of Abbreviated 3 Cycles of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised Stage I or II CD20+ Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I or II.
详细描述
Unlike the limited stage diffuse Large B-cell Lymphoma (DLBCL) treated with primary chemotherapy followed by radiotherapy, patients with stage I or II DLBCL would be treated with surgical resection followed by chemotherapy in this trial. While chemotherapy is the main treatment modality and radiotherapy becomes adjuvant treatment in the former treatment scheme, surgical resection will remove all the gross lesions and chemotherapy aims to remove all microscopic disease whichever exists in the latter treatment scheme. Currently, six cycles of chemotherapy is usually performed after surgery even without any residual lesion compared with three cycles of chemotherapy in the former treatment scheme which plays primary role in the treatment scheme. The investigators will investigate whether abbreviated 3 cycles of Rituximab Plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone (R-CHOP) immunochemotherapy following complete resection is an effective and safe treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent curative resection of primary tumor
- •Pathologically confirmed CD20 positive diffuse large B-cell lymphoma (DLBCL) after surgical resection
- •Ann Arbor Stage I or II
- •No history of chemotherapy
- •Performance status: ECOG 0-2
- •Age: 18 to 70 years old
- •Complete excision with negative resection margin on pathologic report after surgery
- •Cardiac ejection fraction ≥ 50% as measured by MUGA or 2D echocardiography without clinically significant abnormalities
- •Adequate renal function: serum creatinine level below 2 mg/dL (177μmol/L)
- •Adequate liver functions: Transaminase (AST/ALT) < 3X upper normal value, Bilirubin < 2X upper normal value
- •Adequate hematologic function: hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500/mm3 and platelet count ≥ 75,000/mm3
- •Informed consent
排除标准
- •Patients with a known history of HIV (+) or HCV (+). However, HBV(+) patients are eligible if primary prophylaxis is given
- •Previous or concurrent cancer that is distinct in primary site or histology from DLBCL, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Other serious illness or medical conditions
- •Unstable cardiac disease (i.e. congestive heart failure, arrhythmia symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry
- •History of significant neurological or psychiatric disorders including dementia or seizures
- •Active uncontrolled infection (viral, bacterial or fungal infection)
- •Other serious medical illnesses
- •Known hypersensitivity to any of the study drugs or their ingredients
- •Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
- •Patient with B symptoms or Bulky disease
研究组 & 干预措施
Rituximab plus CHOP Immunochemotherapy
Interventions: conventional R-CHOP every 3 weeks for 3 cycles
- Rituximab 375 mg/M2 IV day 1
- Cyclophosphamide 750 mg/M2 IV day1
- Vincristine 1.5 mg/M2 (max. 2 mg) IV day1
- Prednisolone 50 mg bid day 1-5, every 3 weeks
干预措施: Rituximab plus CHOP Immunochemotherapy (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 2 years
Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL
次要结局
- any adverse events as a measure of safety and tolerability(from the first R-CHOP to 1 month after completion of R-CHOP)
- Overall survival(2 years)
研究者
Cheolwon Suh
Professor
Asan Medical Center