NCT01313611终止2 期
BRIEF: Bendamustine and Rituximab In Elderly Follicular: A Multicentric Phase II Study Evaluating the Benefit of a Short Induction Treatment by Bendamustine and Rituximab Followed by Maintenance Therapy With Rituximab In Elderly (≥ 60 Years Old) Patients With Untreated Follicular Lymphoma Patients, With an Intermediate or High FLIPI Score
The Lymphoma Academic Research Organisation116 个研究点 分布在 2 个国家目标入组 62 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 116
- 主要终点
- Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine
研究概览
简要总结
The objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and without high tumor burden.
This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30 Maintenance schedule: 12 infusions of rituximab, each 8 weeks
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed follicular lymphoma CD20+, all grades except the grade 3b with a lymph node biopsy performed within 6 months before study entry and with material available for central review
- •A minimal initial immunology is required, including : CD20, bcl-2, CD10 and CD5
- •Age must be ≥ 60 years
- •Patients not previously treated
- •Patients with an intermediate or high risk FLIPI score requiring 2 or more of the following adverse prognostic factors:
- •Age >60 ans
- •Ann Arbor Stage (III-IV vs. I-II)
- •Hemoglobin level ( < 12g/dL vs. ≥ 12 g/dL)
- •Number of nodal areas (< 5 vs. ≥ 5) (Note: LDH should not be considered as an adverse prognostic factor in this study since it is considered as high tumor burden in the GELF criteria)
- •Low burden disease at study entry according to the GELF criteria
- •Patients with at least one measurable site of disease: patients with only blood or marrow or splenic infiltration are excluded
- •Performance status ≤ 2 on the ECOG scale
- •Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) including:
- •Hemoglobin ≥ 8.0 g/dL (5.0 mmol/L)
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- •Platelet count ≥ 100 x 109/L
- •Adequate renal function: calculated creatinine clearance > 50 ml/min (according to MDRD method) unless these abnormalities are related to lymphoma
- •Adequate hepatic function: Total bilirubin < 2.0 mg/dl (34 µmol/L), AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal unless these abnormalities are related to lymphoma
- •Adequate cardiac function: LEVF ≥ 50% calculated by echocardiography or scintigraphy
- •Having previously signed a written informed consent
排除标准
- •Other histological types of lymphoma than follicular lymphoma
- •Grade 3b follicular lymphoma
- •Patients previously on watch and wait since more than 6 months from diagnosis
- •Patients previously treated for lymphoma, except splenectomy
- •Patients with low FLIPI score (0 or 1 adverse prognostic factors not considering elevated LDH)
- •Bulky disease at study entry according to the GELF criteria
- •Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
- •Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer or previous cancer in CR without any treatment in the last 5 years
- •Positive HIV, HBV (anti-HBc positivity) and HCV serologies before inclusion
- •Poor Performance status > 2 on the ECOG scale
- •Known contra-indication to study product
- •Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
- •Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent.
研究组 & 干预措施
Rituximab + bendamustine
Experimental
干预措施: Rituximab + bendamustine (Drug)
结局指标
主要结局
Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine
时间窗: 12 weeks
次要结局
- Duration of response(From the time of attainment of CR or PR to the date of first documented disease progression, relapse or death from any cause)
- Progression free survival(From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause.)
- Overall survival(From the date of randomization to the date of death from any cause)
- Time before retreatment(From the end of primary treatment until the institution of the next therapy)
- Immediate toxicity(12 weeks)
- Long term toxicity(Until death of the patients)
- Evaluation of QoL(7 years)
- Complete response rate according to Cheson criteria 1999 after 24 months of maintenance therapy with Rituximab(26 months)
- Partial and objective response rates at the end of induction phase(12 weeks)
研究者
研究点 (116)
Loading locations...
相似试验
已完成
2 期
Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)Marginal Zone B-cell LymphomaNCT02433795Seoul National University Hospital27
已完成
2 期
Immunochemotherapy With Rituximab-Bendamustine-Cytarabine (R-BAC) for Patients With Mantle Cell LymphomaLymphoma, Mantle-CellNCT00992134St. Bortolo Hospital41
终止
2 期
Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia AHemophilia ANCT00306670Georgetown University2
Unknown
2 期
Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FILDiffuse Large B-cell LymphomaNCT01990144Fondazione Italiana Linfomi - ETS49
Unknown
2 期
Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First LineFollicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.NCT01127841Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas60