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临床试验/NCT02238873
NCT02238873Unknown3 期

Pegfilgrastim on Day +3 Compared to Day +1 for Patients With Refractory or Relapsed Aggressive Lymphoma Receiving Salvage Chemotherapy - a Randomized Controlled Trial

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Pegfilgrastim will be given 24 hours (day +1) after completion of salvage chemotherapy

干预措施: Pegfilgrastim (Drug)

Pegfilgrastim +3

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

LIAT VIDAL FISHER

MD MSc

Rabin Medical Center

研究点 (1)

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