NCT01427114已完成2 期
Open-labeled, Multicenter Phase II Study of Rituximab, Cyclophosphamide, Vincristine, and Prednisolone (R-CVP) Chemotherapy in Patients With Non-conjunctival Ocular Adnexal MALT Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- complete response rate
研究概览
简要总结
The purpose of this study is to determine how efficient the combination of rituximab, cyclophosphamide, vincristine, and prednisolone (R-CVP) is in the treatment of stage I or II non-conjunctival ocular adnexal MALT lymphoma (OAML).
详细描述
The treatment of stage I or II OAML is mainly composed of radiotherapy because chemotherapy including cyclophosphamide, vincristine, and prednisolone (CVP) did not show the acceptable response rate compared with radiotherapy. However, radiotherapy for this disease can cause many complications of eyes. This clinical trial was designed to examine the efficacy of R-CVP combination therapy as a first-line treatment for stage I or II non-conjunctival OAML aiming to avoid radiation hazard and increase the efficacy of CVP chemotherapy.
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
- •Histologically confirmed OAML
- •Non-conjunctival or bilateral conjunctival (TNM-based, above T1N0M0 or bT1N0M0), Ann Arbor stage I and II OAML
- •Previously untreated
- •Age ≥18 years
- •Performance status: ECOG 0-2
- •Adequate hematological function: hemoglobin ≥9 g/dL,, absolute neutrophil count (ANC) ≥1,500/μL, and platelet count ≥100,000/μL, unless abnormalities are due to bone marrow involvement by the lymphoma
- •Adequate liver function tests:
- •i. Transaminase (AST/ALT) <3 times the upper normal value ii. Bilirubin <2 times the upper normal value
- •Adequate renal function:serum creatinine level <2 mg/dL (177 μmol/L)
- •Life expectancy ≥ 6 months
- •A negative serum or urine pregnancy test before treatment must be available for both premenopausal women and for women who have <2 years after the onset of menopause.
- •Informed consent
排除标准
- •NHL subtypes other than OAML
- •Primary conjunctival OAML, unilateral involved (T1N0M0)
- •Ann Arbor stage III or IV
- •CNS involvement by the lymphoma or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks) with clinical suspicion of CNS involvement by the lymphoma
- •Pregnant or lactating women, women of child-bearing potential not using adequate contraception
- •Inadequate liver function tests:
- •i. Transaminase (AST/ALT) ≥3 times the upper normal value or ii. Bilirubin ≥2 times the upper normal value
- •Inadequate renal function:
- •i. serum creatinine level <2 mg/dL (177 μmol/L)
- •Other serious illness or medical conditions i. Unstable cardiac disease despite treatment; myocardial infarction within 6 months prior to study entry ii. History of significant neurological or psychiatric disorders including dementia or seizures
- •Active uncontrolled infection (HIV, hepatitis B, Hepatitis C, active Tuberculosis, active bacterial, or active fungal infection)
- •Any other malignancies within the past 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- •Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
- •Concomitant administration of any other experimental drug under investigation or concomitant chemotherapy, hormonal therapy, or immunotherapy
研究组 & 干预措施
R-CVP
Experimental
6 cycles of R-CVP followed by 2 cycles of rituximab
干预措施: rituximab, cyclophosphamide, vincristine, and prednisolone (Drug)
结局指标
主要结局
complete response rate
时间窗: 3 years
CR rate
次要结局
- Overall survival(5 years)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(5 years)
- Progression free survival(5 years)
研究者
Sung-Yong Kim
Assistant Professor
Konkuk University Medical Center
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
2 期
Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)Immune-related Adverse EventsAdvanced Solid TumorNCT04375228Columbia University7
已完成
2 期
Study in Patients With Primary Breast Diffuse Large B-cell LymphomaLarge B Cell Diffuse LymphomaNCT01448096Chonbuk National University Hospital33
已完成
2 期
Combination Chemo, Rituximab, and Bevacizumab in Older Patients With Stage II-IV Diffuse Large B-Cell LymphomaContiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Large Cell LymphomaNCT00121199National Cancer Institute (NCI)73
招募中
2 期
R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's MacroglobulinemiaWaldenström's MacroglobulinemiaNCT03697356Kosin University Gospel Hospital54
终止
2 期
S0349 Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Oblimersen in Treating Patients With Advanced Diffuse Large B-Cell Non-Hodgkin's LymphomaContiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Large Cell LymphomaNCT00080847National Cancer Institute (NCI)160