A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 119
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.
详细描述
Eligible patients will be randomized to treatment with pixantrone plus rituximab or gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience progressive disease during study treatment, early follow- up, or intermediate follow-up, they enter the survival follow up period. Patients who complete study treatment or discontinue study treatment for any other reason will participate in the follow-up periods.
Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week follow-up period.
Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will enter an additional 72-week follow-up period.
Survival Follow-Up: All patients will be monitored for survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or follicular grade 3 lymphoma on the basis of tissue biopsy.
- •Patients with de novo DLBCL must have received 1-3 treatment regimens for DLBCL. Patients with follicular grade 3 lymphoma must have received 1-3 treatment regimens for follicular lymphoma (any grade). Patients with DLBCL transformed from indolent lymphoma must have received at least 1-4 treatment regimens for NHL.
- •Received rituximab containing a multi-agent therapy for the treatment of NHL.
- •Not eligible for high-dose chemotherapy and stem cell transplant.
- •Patients with DLBCL transformed from indolent lymphoma must have had a complete or partial response to a therapy for NHL lasting at least 12 weeks.
排除标准
- •Primary refractory de novo DLBCL or primary refractory follicular grade 3 lymphoma, defined as documented progression within 12 weeks of the last cycle of the first-line multi-agent regimen.
- •Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
- •Any experimental therapy ≤ 28 days prior to randomization
- •Other malignancy within last 5 years except for the following: curatively treated basal cell/squamous cell skin cancer, carcinoma in situ of the cervix, superficial transitional cell bladder carcinoma, or in situ ductal carcinoma of the breast after complete resection
- •Any contraindication or known allergy or hypersensitivity to any study drugs
- •Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies. Low-dose corticosteroids for the treatment of non cancer-related illnesses are permitted.
研究组 & 干预措施
Pixantrone + Rituximab
Pixantrone and Rituximab
干预措施: Pixantrone + Rituximab (Drug)
Gemcitabine + Rituximab
Gemcitabine and Rituximab
干预措施: Gemcitabine + Rituximab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From the date of randomization to the date of progressive disease or death due to any cause (whichever is first reported) (Up to 100 weeks)
PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first)
次要结局
- Overall Response Rate(From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks))
- Overall Survival(From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks))
- Number of Treatment Emergent Adverse Events (TEAE) Related to Study Drug(From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks))
- Complete Response Rate(From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks))