EUCTR2005-004761-42-ES进行中（未招募）不适用
First line treatment with Rituximab asociated to CVP plus Interferon in Follicular Lymphoma. Phase II study.Asociación de Rituximab al esquema CVP + Interferón en el tratamiento de primera línea del linfoma folicular - R-CVP-IF
Fundacion Leucemia y Linfoma0 个研究点开始时间: 2005年12月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age =18 and = 75 years.
- •- Grade 1 or 2 Follicular Lymphoma, Marginal Zone Lymphoma or Lymphocitic Lymphoma (with no CLL criteria) confirmed by nodal tissue. Patients with diagnosis made in bone marrow trephine will be accepted, if no adenopathy is detected and MCL or CLL are ruled out.
- •- Follicular Lymphoma International Prognostic Index (FLIPI) = 2.
- •- No prior chemotherapy of radiotherapy. Local radiation is accepted.
- •- Adequate hepatic and renal function (acceted if related to LNH infiltration)
- •- Correct Thyroid function
- •- ECOG performance status 0 to 3.
- •- Abscence of other malignancies or impariment to receive thge drugs in the study.
- •- Signed approved informed consent before any study specific procedures are performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prior chemotherapy of radiotherapy.
- •- Active second malignancy in the previous 5 years.
- •- Previous Psiquiatric disease, specially moderate to severe depression, psycosis, autolytic attempts.
- •- Uncontrolled current cardiopathy (myocardial infarction, angina, significant cardiac arrythmia or congestive heart failure)
- •- Diabetes mellitus insulin requirement.
- •- Uncontrolled hepatic or autoimmune disease.
- •- Female subjects who are breast-feeding
- •- Female subjects, who are not surgically sterile or post-menopausal, and do not use medically acceptable methods of birth control for the duration of the study and for one year after the last dose.
- •- Acute or ongoing chronic infectious disease.
- •- Immunocopromised subjects including subjects known to be HIV possitive or acute/chronic HCV or HBV positive.
研究者
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