Rituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After Induction Therapy of Rituximab Combined With Bendamustine (BR) or Cyclophosphamide, Vincristine, Doxorubicin, Prednisone (RCHOP) or Lenalidomide (R2): a Multicenter Clinical Study
试验速览
- 阶段
- 4 期
- 入组人数
- 789
- 试验地点
- 1
- 主要终点
- MRD negative rate of bone marrow at 24 weeks
研究概览
简要总结
This multi-center clinical study will evaluate the efficacy of Rituximab maintenance treatment of newly diagnosed follicular lymphoma after induction therapy of BR, RCHOP or R2.
详细描述
Follicular lymphoma (FL) is a lymphoma of B cells in follicular center. It is a common pathological subtype of lymphoma, and its incidence rate is only next to diffuse large B cell lymphoma (DLBCL). The initial remission rate is high, but the tumor generally recurrent, making it difficult to be completely cured. This study attempts to explore the efficacy and safety of rituximab monotherapy maintenance after BR, RCHOP, R2 regimen induction therapy in the treatment of follicular patients, and to find the best way to maximize survival benefit and reduce treatment toxicity for FL patients. The study can improve the quality of life, prolong the survival and avoid the transformation to invasive lymphoma in patients with follicular lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
- •Treatment naive
- •Age ≥ 18 years
- •Indications for treatment confirmed
- •Must has measurable lesion in CT or PET-CT prior to treatment
- •Considered suitable for RCHOP, BR or R2 regimens
- •Informed consented
排除标准
- •Transformed follicular lymphoma or 3B follicular lymphoma;
- •HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
- •Central nervous system or meninges involved
- •Any drug contraindication in the treatment plan
- •Patients judged by other researchers to be unsuitable for inclusion in the study
研究组 & 干预措施
BR+R
Induction Therapy: Rituximab Combined With Bendamustine Maintenance Treatment: Rituximab
干预措施: BR for 6 cycles +R for 8 cycles (Drug)
RCHOP+R
Induction Therapy: Rituximab Combined With Cyclophosphamide, Vincristine, Doxorubicin, Prednisone Maintenance Treatment: Rituximab
干预措施: RCHOP for 6 cycles +R for 8 cycles (Drug)
R2+R2
Induction Therapy: Lenalidomide Combined With Rituximab Maintenance Treatment: Lenalidomide Combined With Rituximab
干预措施: R2 for 6 cycles + R2 maintenance (Drug)
结局指标
主要结局
MRD negative rate of bone marrow at 24 weeks
时间窗: At 24 weeks
Percentage of participants with negative MRD estimated by q-RT-PCR of bone marrow
次要结局
- Event-free survival(Baseline up to data cut-off (up to approximately 4 years))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Up to 30 days after completion of study treatment)
- MRD negative rate of peripheral blood at 24 weeks(At 24 weeks)
- Overall survival(Baseline up to data cut-off (up to approximately 4 years))
- Time to Progression(Baseline up to data cut-off (up to approximately 4 years))
- Progression Free Survival(Baseline up to data cut-off (up to approximately 4 years))
- Overall response rate(21 days after 6 cycles of induction therapy (each cycle is 21 days))
- Progression of disease within 24 months(Baseline up to data cut-off (24 months))
- Duration of response(Baseline up to data cut-off (up to approximately 4 years))
- Time to Next Anti-lymphoma Treatment(Baseline up to data cut-off (up to approximately 4 years))
研究者
Zhao Weili
First Deputy Director, Hematology Department
Ruijin Hospital