NCT00136552已完成3 期
FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden
Lymphoma Study Association9 个研究点 分布在 2 个国家目标入组 360 人开始时间: 2000年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 9
- 主要终点
- Event free survival
研究概览
简要总结
The purpose of this study is to assess in a prospective multicentric study (Phase III) the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma.
详细描述
Follicular lymphoma patients with a large tumor burden will be randomized for 18 months of treatment with either:
- Arm A: CHVP + alpha2a-interferon. Patients will receive 12 courses of CHVP (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days), one course every month for 6 months then one course every other month for 12 additional months associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months.
- Arm B: CHVP + alpha2a-interferon + rituximab. Patients will receive 6 monthly courses of CHVP (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days) associated with 6 infusions of rituximab (375 mg/m2) associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed follicular lymphoma with a biopsy performed in the last 3 months
- •Patients previously untreated.
- •Patients with at least one of the following symptoms requiring initiation of treatment:
- •Bulky disease at study entry according to the Groupe d'Etudes Lymphomes Folliculare (GELF) criteria: nodal or extranodal mass > 7cm in its greater diameter
- •B symptoms
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 1
- •Elevated serum lactate dehydrogenase (LDH) or beta2-microglobulin
- •Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)
- •Symptomatic splenic enlargement
- •Compressive syndrome
- •Pleural/peritoneal effusion
- •Age must be > 18 years and less than 76 years
- •Having previously signed a written informed consent form.
排除标准
- •Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma).
- •Patients without a large tumor burden.
- •Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer.
- •Poor renal function: Serum creatinine > 150 μmol/L,
- •Known HIV infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Patients with contra-indication to interferon, adriamycin, or rituximab.
- •Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator.
- •Known sensitivity or allergy to murine products
- •Adult patient under tutelage.
结局指标
主要结局
Event free survival
次要结局
- Response rate
- Overall survival
研究者
研究点 (9)
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