EUCTR2007-005580-95-FR进行中（未招募）不适用
An open label, multicenter, non randomized phase II study to evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) in patients with follicular non Hodgkin’s lymphoma with no prior treatment - FL2008 RGM
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Goelams
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
- •Histologicaly confirmed follicular lymphoma grade 1, 2 or 3a, (see appendix 4) with material available for central review (appendix 8).
- •Not previously treated.
- •Age must be > 18 years.
- •Having signed a written informed consent
- •Performance status < 2 on the ECOG scale (see appendix 7).
- •Stage II, III or IV (Ann Arbor)
- •Must have disease measurable in at least 2 dimensions either clinically or radiologically
- •Low tumor burden according to the GELF criteria: none of the following criteria
- •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
- •Transformation to high-grade lymphoma (secondary to low-grade” FL).
- •Grade 3b follicular lymphoma.
- •Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningiosis).
- •Patients regularly taking corticosteroids during the last 4 weeks.
- •Patients with prior or concomitant malignancies except non-melanomatous 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 creatinin > 2.0 mg/dl (197 µmol/L),
- •Poor hepatic function: Total bilirubin > 2.0 mg/dl (34 µmol/L), AST (SGOT) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma.
- •Known HIV infection or active HBV or HCV infection.
研究者
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