EUCTR2005-001727-11-IE进行中（未招募）不适用
A phase III, open-label, prospective, two-armed, multicenter, randomized,group sequential study to evaluate the efficacy and safety of subsequenttreatment with the Zevalin (ibritumomab tiuxetan) study regimen versusobservation in patients with diffuse large B-cell lymphoma who are incomplete remission after first-line CHOP-rituximab (CHOP-R) therapy - Zevalin in aggressive lymphoma (DLBCL) phase III
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
- 入组人数
- 400
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
- •1.Histologically confirmed, Ann Arbor stage II, III, or IV DLBCL according to the REAL/WHO classification (from initial diagnosis made prior to starting CHOP-R therapy)
- •2.Central pathology review confirming the DLBCL diagnosis and CD20 positivity, and no evidence of DLBCL in bone marrow
- •3.First-line treatment of DLBCL must have been 6 or 8 cycles of standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and at least 40 mg/m2/day prednisone on Days 1 to 5 every three weeks) in combination with rituximab (375 mg/m2)
- •4.Complete remission (CR) or unconfirmed complete remission (CRu) according to the International Workshop Response Criteria for NHL described by Cheson et al and modified for this study after first-line treatment with CHOP-R. CT scans of the neck, thorax, abdomen, and pelvis must have been performed within 6 weeks after the last dose of the last course of CHOP R
- •5.Central radiographic review of the CT scans (neck, thorax, abdomen, and pelvis) from before and after first-line treatment with CHOP-R fulfilling the radiological requirements for CR/CRu
- •6.Patients 60-years-of-age or older at time of randomization
- •7.WHO performance status (PS) of 0 to 2 within 1 week of randomization
- •8.Absolute neutrophil count (ANC) >= 1.5 x 109/L within 1 week of randomization
- •9.Hemoglobin (Hgb) >= 10 g/dL within 1 week of randomization
- •10.Platelets >= 150 x 109/L within 1 week of randomization
- •11.Life expectancy of 3 months or longer
- •12.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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Presence of any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
- •2.Prior radioimmunotherapy, radiation therapy, or any other NHL therapy except first-line CHOP-R
- •3.Presence of gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis
- •4.Histological transformation of low-grade NHL
- •5.Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg)
- •6.Known history of HIV infection
- •7.Abnormal liver function: total bilirubin > 1.5 x ULN or ALT > 2.5 x ULN within 1 week of randomization
- •8.Abnormal renal function: serum creatinine > 2.0 x ULN within 1 week of randomization
- •9.Nonrecovery from the toxic effects of CHOP-R therapy
- •10.Known hypersensitivity to murine or chimeric antibodies or proteins
- •11.G-CSF or GM-CSF therapy within two weeks (or four weeks if pegylated) prior to screening laboratory sampling
- •12.Concurrent severe and/or uncontrolled medical disease (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
- •13.Male and female patients of child-bearing potential unwilling to practice effective contraception during the study and unwilling or unable to continue contraception for 12 months after their last dose of study treatment
- •14.Female patients who are pregnant or are currently breastfeeding
- •15.Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from the toxic effects of such therapy
- •16.Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such surgery
- •17.Concurrent corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment
- •18.Unwillingness or inability to comply with the protocol
研究者
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