NCT01527422已完成1 期
Protocol CCAM 05-02 " Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma"
Fernando Cabanillas2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R
研究概览
简要总结
We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of G-CSF.
详细描述
1.1 Primary Objective:
- To identify the ideal dose of the combination of CHOP-R with PEG-Filgrastim (Neulasta) using first a fixed dose of Neulasta and an escalating dose of GM-CSF (Leukine) up to 250 mcg. When that dose is reached, if possible, the dose of Neulasta will be increased stepwise. CHOP-R will be delivered every 14 days at a fixed standard dose with dose adjustments of PEG-Filgrastim and GM-CSF upwards and downwards according to nadir or zenith blood counts.
1.2 Secondary Objective: 2. To generate preliminary pilot data as to the effectiveness of the regimen in inducing very early remissions as measured by the CT-PET scan technique.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with previously untreated aggressive non-Hodgkin's Lymphoma. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
- •Must have measurable or evaluable disease.
- •Stage I-IV patients are eligible
- •Patients must be 18 years or older.
- •No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria)
- •Written Consent
排除标准
- •HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
- •Patients with inadequate bone marrow and organ function as defined below:
- •Neutrophils <1,000/l
- •Platelets <100,000/l
- •Billirubin >2
- •Creatinine >2.0 or estimated CrCl <30 cc/min
- •CNS involvement by Lymphoma.
- •Uncontrolled intercurrent disease including arrhythmias, angina pectoris, Class III-IV Congestive heart failure (CHF symptoms on less than ordinary exertion or at rest) or active infection.
- •Active infection or fever > 38.2 degrees C unless due to lymphoma.
- •Subject is not using adequate contraceptive precautions.
- •Pregnancy or breast feeding
结局指标
主要结局
Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R
时间窗: up to 3 years
次要结局
未报告次要终点
研究者
Fernando Cabanillas
Hematolgy-Oncologyst
Auxilio Mutuo Cancer Center
研究点 (2)
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