EUCTR2005-003796-20-BE进行中（未招募）不适用
Efficacy and safety of a single dose of 14.8 MBq/kg (0.4 mCi/kg)90Y-ibritumomab tiuxetan (Zevalin) in elderly patients with diffuse large B-cell lymphoma and FDG-PET positive partial remission following first-line R-CHOP therapy. A Phase II clinical trial (HOVON 77) - HOVON 77
HOVON Foundation0 个研究点目标入组 37 人开始时间: 2006年12月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 37
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
- •-Age = 60 years old
- •-WHO performance status of 0-2 (see Appendix E)
- •-Life expectancy of at least 3 months
- •-Histologically confirmed CD20 positive Diffuse large B-cell lymphoma (DLBCL), according to the WHO classification (see Appendix B)
- •-First-line induction treatment with R-CHOP or R-CHOP-like chemotherapy (only CHOP in combination with rituximab; CHOP14 and CHOP21 are both allowed)
- •-Partial response on CT-scans after first-line treatment, with measurable disease
- •-PET-positive residual mass
- •-Patient is not eligible for high dose chemotherapy followed by autologous stem cell transplantation
- •-Less than 25% bone marrow involvement at the end of first-line treatment during PR analysis (measurement in a representative bone marrow biopsy)
- •-Absolute neutrophil count (ANC) = 1.5 x 109/l
- •-Hemoglobin (Hb) = 6 mmol/l
- •-Platelets = 150 x 109/l
- •-Written informed consent obtained according to local guidelines
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Hypoplastic bone marrow at biopsy
- •-Prolonged pancytopenia during induction chemotherapy and delayed courses during R-CHOP induction (more than two weeks delay due to insufficient bone marrow reserve)
- •-Known hypersensitivity to murine antibodies or proteins
- •-Significant splenomegaly
- •-Patients with abnormal liver function (total bilirubin > 2.0 x ULN)
- •-Patients with abnormal renal function (serum creatinine > 2.0 x ULN)
- •-Presence of CNS involvement by NHL
- •-Presence of any other active neoplasms or history of prior malignancy, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma during the past 5 years
- •-More than one prior R-CHOP or R-CHOP-like chemotherapy regimen for DLBCL
- •-Patients who have received prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional)
- •-Patients who have received G-CSF or GM-CSF therapy within two weeks prior to study enrollment
- •-Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
- •-Patients who have received biologic therapy, immunotherapy, R-CHOP(-like) chemotherapy, surgery, or an investigational drugs less than 4 weeks prior to first day of study treatment or who have not recovered from the toxic effects of such therapy
- •-Patients who have received systemic corticosteroids at doses higher than 20 mg/day prednisolone or equivalent less than 2 weeks prior to 90Y-ibritumomab tiuxetan administration
- •-Known diagnosis of HIV infection
- •-Patients unwilling or unable to comply with the protocol
研究者
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