NCT01929265已完成2 期
A Phase II Study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-follicular Non-Hodgkin's 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
- 73
- 试验地点
- 25
- 主要终点
- Complete remission rate (CR)
研究概览
简要总结
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).
详细描述
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).
The study includes and induction phase and a consolidation phase.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign an informed consent form
- •Histological (bone marrow or lymph nodes biopsy) proven diagnosis of B-cell CD20- positive non-follicular NHL according to REAL/WHO Classification:
- •i. small lymphocytic lymphoma-SLL (bone marrow or lymph nodes biopsy ii. lymphoplasmacytic/citoid lymphoma/ Waldenstrom macroglobulinemia(bone marrow or lymph nodes biopsy) iii. nodal marginal zone lymphoma (lymph nodes biopsy)
- •Untreated patients
- •Stage III or IV or stage II with more than three involved sites
- •Presence of at least one of the following criteria for the definition of active disease:
- •Systemic symptoms
- •Hemoglobin less than 10 g/dL (due to lymphoma)
- •Platelets less than 100 x 10 9/L (due to lymphoma)
- •Diffuse bone marrow infiltrate
- •Lymphocyte doubling time less than 12 months (in leukemic cases)
- •Bulky disease (>7 cm)
- •Aged 18 - 75 Life expectancy >6 months
- •ECOG performance status 0-2
- •LVEF ≥45% or FS ≥37%
- •ANC ≥1 x 10 9/l and Platelets count ≥75 x 10 9/l, unless due to bone marrow involvement by follicular lymphoma
- •Creatinine up to 1.5 x ULN
- •Conjugated bilirubin up to 2 x ULN
- •Alkaline phosphatase and transaminases up to 2 x ULN
- •Written informed content
排除标准
- •Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin
- •Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL)
- •Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
- •History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent
- •Medical condition requiring long term use (>1 months) of systemic corticosteroids
- •Active bacterial, viral, or fungal infection requiring systemic therapy
- •Concurrent medical condition which might exclude administration of therapy
- •Cardiac insufficiency (NYHA grade III/IV)
- •Myocardial infarction within 6 months of entry on study
- •Severe chronic obstructive pulmonary disease with hypoxemia
- •Severe diabetes mellitus difficult to control with adequate insulin therapy
- •Hypertension that is difficult to control
- •Impaired renal function with creatinine clearance <30 ml/min
- •HIV positivity
- •HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive(these patientes need to receive prophylaxis with Lamivudine)
- •HCV positivity with the exception of patients with HCV RNA negative.
- •CNS involvement by lymphoma
- •Participation at the same time in another study in with investiogational drugs are used
- •Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
- •Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
- •Women in pregnancy or breastfeeding
研究组 & 干预措施
Rituximab - Bendamustine (RB)
Experimental
1 arm: Rituximab - Bendamustine (RB)
1 arm for all patients
干预措施: Bendamustine (Drug)
结局指标
主要结局
Complete remission rate (CR)
时间窗: 5 months
Evaluated at the end of treatment
次要结局
- Overall survival (OS)(at 2 years)
- Safety analysis(5 months)
- Overall response rate (ORR)(5 months)
- Disease free survival (PFS)(at 2 years)
- Progression free survival (PFS)(at 2 years)
研究者
研究点 (25)
Loading locations...
相似试验
已完成
2 期
Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell LymphomaDiffuse Large B-Cell LymphomaLymphoma, Diffuse Large-CellDiffuse Large-Cell LymphomaLymphomaNCT01234467UNC Lineberger Comprehensive Cancer Center23
Unknown
2 期
Bendamustine Plus Subcutaneous Rituximab in Patients With Diffuse Large B-cell LymphomaDiffuse Large B Cell LymphomaNCT02753062Asan Medical Center22
终止
1 期
Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple MyelomaMultiple MyelomaNCT01484626Loyola University3
终止
2 期
Bendamustine Plus Brentuximab Vedotin in HL and CD30+ PTCL in First Salvage SettingLymphatic DiseasesNCT02499627Fondazione Italiana Linfomi - ETS43
终止
1 期
Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple MyelomaMultiple MyelomaNCT01177683Sherif Farag, MB, BS32