Pegfilgrastim on Day +3 Compared to Day +1 for Patients With Refractory or Relapsed Aggressive Lymphoma Receiving Salvage Chemotherapy - a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Neutrophil count <500/ mcL
研究概览
简要总结
Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells, specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named filgrastim. Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. It has a much longer half-life than the parent filgrastim. It is removed from the body within the neutrophils. According to the American Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours after the completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore it is cleared before and after neutropenia. Comparative low quality studies suggest that deferring pegfilgrastim delivery until neutrophil counts start dropping may result in improved its efficacy. This was further tested in a few small randomized controlled trials (high quality studies, considered the "gold standard" of studies) in different settings (including first chemotherapy for lymphoma, and solid cancer) with inconsistent results. Pegfilgrastim (given 24 hours after completion of chemotherapy) is a standard part of any salvage chemotherapy for patient with refractory or relapsed aggressive lymphoma. The investigators plan a randomized controlled trial comparing the efficacy of pegfilgrastim given 72 hours (day +3) vs. 24 hours (day +1) after completion of salvage chemotherapy in patients with refractory or relapsed aggressive lymphoma. The investigators will evaluate whether that change of pegfilgrastim schedule affects the risk of fever during neutropenia, neutrophil count, length of hospitalization, mortality, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age 18 years or above)
- •Refractory or relapsed aggressive lymphoma, including Hodgkin's and non-Hodgkin's lymphoma
- •Candidate for salvage chemotherapy. Salvage chemotherapy includes one of the following regimens: Ifosfamide, etoposide, vincristine (ICE), Cisplatin, cytarabine, and dexamethasone (DHAP), Etoposide, methylprednisolone, cytarabine, cisplatin (ESHAP). Chemotherapy dose reduction will be allowed.
- •Chemotherapy with or without immunotherapy
- •Therapy in hospital or at the outpatient clinic
排除标准
- •Indolent lymphoma; we will exclude patients with transformed lymphoma.
- •Treatment with GCSFs for the primary disease (e.g. aplastic anemia, MDS).
- •Uncontrolled infection
- •Pregnant women
研究组 & 干预措施
Pegfilgrastim +1
Pegfilgrastim will be given 24 hours (day +1) after completion of salvage chemotherapy
干预措施: Pegfilgrastim (Drug)
Pegfilgrastim +3
Pegfilgrastim will be given 72 hours (day +3) after completion of salvage chemotherapy
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
Neutrophil count <500/ mcL
时间窗: day 8 to 10
Number of participants with neutrophil count below 500 /mcL
Febrile neutropenia
时间窗: 30 days
Number of participants with fever and neutropenia
次要结局
- Mortality(30 days)
- Development of clinically documented infections (CDI), microbiologically-documented infections (MDI) and clinically-significant bloodstream infections (BSI), not present at the time of randomization(30 days)
- Hospitalization(30 days)
- Neutrophil count <100/ mcL(day 8 to 10)
- Adverse events(30 days)
- Number of febrile days(30 days)
研究者
LIAT VIDAL FISHER
MD MSc
Rabin Medical Center
