ACTRN12609001077257已完成2 期
This is a multi-centre phase II trial of early treatment intensification with R-ICE (rituximab – ifosfamide, carboplatin, etoposide) chemotherapy followed by BEAM ( BCNU(BCNU is Carmustine), etoposide, ara-C (ara-C is Cytarabine), melphalan) high dose chemotherapy and autologous stem cell transplantation for patients with poor prognosis diffuse large B-cell lymphoma as identified by interim-treatment PET/CT (Positron emission tomography - computed tomography) performed after four cycles of R-CHOP-14 (rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone - CHOP - every 14 days) chemotherapy.
Australasian Leukaemia and Lymphoma Group (ALLG)0 个研究点目标入组 162 人开始时间: 2009年12月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •1.Age 18 - 70 years
- •2.Male and female patients
- •3.Diagnosis of CD20-positive diffuse large B-cell lymphoma on biopsy
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- •5. Low-intermediate, high-intermediate, high risk, or low risk disease with bulk (>7.5 cm)
- •6. Previously untreated (except for corticosteroids if required)
- •Patients considered suitable for dose-intense chemotherapy with R-CHOP-14 with Pegfilgrastim support
- •Eligible and fit for high dose chemotherapy with Z-BEAM and autologous stem-cell transplantation
- •Signed informed consent form
- •A positive baseline fluorodeoxyglucose(FDG) positron emission tomography(PET)
排除标准
- •Exclusion criteria
- •1.Life-expectancy < 3 months
- •2.Transformed NonHodgkin lymphoma (NHL) or types of NHL other than DLBCL
- •3.Primary Central Nervous System (CNS) or gastrointestinal Mucosa-Associated Lymphoid Tissue (MALT)lymphoma
- •4.CD20-negative NHL
- •5. Documented Human Immunodeficiency Viris (HIV)
- •6. Seropositivity for Hepatitis B [Either 1. HbsAg (surface antigen) positive or 2. HbcAb (core antibody) positive and HbsAb (surface antibody) titre of < 100 iu/ml] unless clearly due to vaccination
- •7.Patients with good prognosis low risk disease (IPI = 0, 1) plus absence of bulk (= 7.5 cm).
- •8.Hypersensitivity to components of Zevalin including ibritumomab tiuxetan, Yttrium chloride, other murine proteins, or to any exipients
- •9.Pregnant woman
- •10.Previously treated lymphoma
- •11.Any serious active disease or co-morbid medical condition (according to investigator’s decision)
- •12.Non-compensated cardiac failure
- •13.Chronic lung disease with hypoxaemia
- •14.Severe psychiatric disease
- •15.Poor renal function (creatinine > 150 micromol/L), poor hepatic function (total bilirubin level > 30 mmol/L, transaminases > 2.5 maximum normal level) unless abnormalities are related to the lymphoma
- •16.Poor bone marrow reserve as defined by neutrophils < 1.5 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration
- •17.Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma
- •18.Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
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