Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- Probability of Event Free Survival (EFS)
研究概览
简要总结
Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy according to registered indication. Patients will be followed up for safety and efficacy evaluation in accordance with routine practice. The study will be non-interventional and by its design purely observational. All treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Histologically confirmed cluster of differentiation antigen 20 (CD20) positive Diffuse Large B-Cell Lymphoma according to the World Health Organization/Revised European-American Classification of Lymphoid Neoplasms (WHO/REAL) classification
- •Age > or =18 years
- •Performance status < or = 2 on the Eastern Cooperative Oncology Group (ECOG) scale
- •Women of child-bearing potential must agree to use effective contraception for the entire treatment period and during the 12 months thereafter
排除标准
- •Transformed lymphoma (secondary to "low-grade" follicular lymphoma)
- •Grade 1, 2 or 3a follicular lymphoma
- •Primary or secondary central nervous system (CNS) involvement
- •Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer
- •Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
- •Poor renal function: Serum creatinine > 2.0 mg/dl (177 micromol/L)
- •Pregnancy
- •Poor hepatic function: total bilirubin > 2.0 mg/dl (34 micromol/L), aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) or alkaline phosphatase (AP) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma.
- •Known human immunodeficiency virus (HIV) infection or active viral hepatitis, specifically hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial
- •Life expectancy < 6 months
- •Known sensitivity or allergy to murine products
- •Treatment within a clinical trial within 30 days prior to trial entry
研究组 & 干预措施
Diffuse Large B-Cell Lymphoma (DLBCL)
Participants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
干预措施: Cyclophosphamide (Drug)
Diffuse Large B-Cell Lymphoma (DLBCL)
Participants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
干预措施: Hydroxydaunorubicin (Drug)
Diffuse Large B-Cell Lymphoma (DLBCL)
Participants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
干预措施: Oncovin (Drug)
Diffuse Large B-Cell Lymphoma (DLBCL)
Participants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
干预措施: Prednisone (Drug)
Diffuse Large B-Cell Lymphoma (DLBCL)
Participants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
干预措施: Rituximab (Drug)
结局指标
主要结局
Probability of Event Free Survival (EFS)
时间窗: Up to 41 months
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.
次要结局
- Percentage of Participants Who Were Alive(Up to 41 months)