Open Label, Single-arm, Phase IIIb Clinical Trial to Evaluate the Safety of Switching From Intravenous Rituximab to Subcutaneous Rituximab During First Line Treatment for CD20+ Non-Hodgkin's Follicular Lymphoma and Diffuse Large B-cell Lymphoma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 39
- 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, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of rituximab IV. Participants with FL will be given 1400 mg rituximab SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
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
- •Age ≥ 18 and ≤ 80 years at time of enrolment.
- •Life expectancy ≥ 6 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Fertile men or women of childbearing potential must use effective contraception until at least 12 months after the last dose; women must not be pregnant.
- •Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system.
- •Induction only:
- •Participants with Follicular Lymphoma should meet Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria to initiate treatment.
- •At least tumor >/= 1.5 cm as measured by computed tomography (CT) scan.
- •FL treatment-related criteria
- •Currently being treated with rituximab IV during first-line therapy and has received at least one full dose of rituximab IV.
排除标准
- •Transformed lymphoma.
- •Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma.
- •History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for >/= 5 years prior to dosing. Note: Participants with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study.
- •Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Note: Participants receiving corticosteroid treatment with </= 30 mg/day of prednisone or equivalent must be on a stable regimen for at least 4 weeks prior to start of dosing.
- •Inadequate renal, hematologic, or hepatic function.
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
- •For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment.
- •For participants with FL: contraindication to standard chemotherapy.
- •Other serious underlying medical conditions.
- •Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis.
- •Active and/or severe infections (excluding nail fungal infections) or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to dosing.
- •Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Note: Participants testing positive for Hepatitis B or C virus antibodies but with an undetectable viral load may be included.
- •History of Human Immunodeficiency Virus (HIV) positive status.
研究组 & 干预措施
Subcutaneous Rituximab
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab will be treated with subcutaneous (SC) rituximab. Participants with FL will be administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL will be administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
干预措施: Rituximab (Drug)
结局指标
主要结局
Percentage of Participants With Administration-Associated Reactions (AARs)
时间窗: From start of treatment to end of treatment (up to 32 months)
AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
次要结局
- Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)(From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months))
- Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)(From start of treatment to end of treatment (up to 32 months))
- Percentage of Participants With At Least One Serious Adverse Event (SAE)(From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months))
- Event-Free Survival (EFS)(From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months))
- Progression-Free Survival (PFS)(From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months))
- Overall Survival (OS)(From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months))
- Disease-Free Survival (DFS)(From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months))
- Treatment Response Rate(4-6 weeks after the last dose of Induction (Up to approximately 8 months))