An Open-Label, Multinational, Multicenter, Phase IIIB Study to Assess Safety of Rituximab Following Subcutaneous Administration in Patients With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 13
- 主要终点
- Percentage of Participants With Administration-Associated Reactions (AARs)
研究概览
简要总结
This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC) administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL) (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell lymphoma (DLBCL) (treatment plus 24 months of follow-up).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, cluster of differentiation (CD)20+ DLBCL or CD20+ follicular NHL grade 1 to 3a, according to the world health organization (WHO) classification system
- •Currently being treated with rituximab IV in the Induction or Maintenance setting, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square meter (mg/m^2) administered without interruption or early discontinuation because of tolerability issues
- •Expectation and current ability for the participants to receive at least four additional cycles of treatment during the Induction phase or six additional cycles of treatment during the Maintenance phase (participants with follicular NHL)
排除标准
- •Transformed lymphoma or FL IIIB
- •History of other malignancy that could affect compliance with the protocol or interpretation of results. This includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for greater than or equal to (>/=) 5 years prior to dosing
研究组 & 干预措施
Rituximab
Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction.
干预措施: Rituximab (Drug)
Rituximab
Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction.
干预措施: Cyclophosphamide (Drug)
Rituximab
Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction.
干预措施: Doxorubicin (Drug)
Rituximab
Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction.
干预措施: Vincristine (Drug)
Rituximab
Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction.
干预措施: Prednisone (Drug)
Rituximab
Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction.
干预措施: Fludarabine (Drug)
结局指标
主要结局
Percentage of Participants With Administration-Associated Reactions (AARs)
时间窗: Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants)
AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof.
次要结局
- Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria(From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months]))
- Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria(From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months]))
- Overall Survival (OS)(From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months]))
- Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria(From the date of the initial complete response (CR)/complete response unconfirmed (CRu) until date of relapse or death from any cause (up to end of induction treatment [Up to 32.7 Months]))
- Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria(From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months]))
- Healthcare Professional Questionnaire Score(End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants))
- Patient-Reported Rituximab Administration Questionnaire (RASQ) Score(Up to 53.8 Months)