EUCTR2005-001727-11-DE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 subsequent treatment with the Zevalin (ibritumomab tiuxetan) study regimen versus observation in patients with diffuse large B-cell lymphoma who are in complete remission after first-line CHOP-rituximab (CHOP-R) therapy - Zevalin in aggressive lymphoma (DLBCL) phase III
Schering AG, Global Medical Development0 个研究点目标入组 400 人开始时间: 2006年2月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- •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, with generally accepted
- •adjustments in dose or frequency due to toxicity, patient scheduling, etc.) 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 (see Appendix 2) after first-line treatment with CHOP-
- •R. CT scans of chest, abdomen, pelvis, and neck (if applicable) must have been
- •performed within 6 weeks after the last dose of the last course of CHOP R.
- •Applicability of the neck CT means that the patient had involvement of the neck
- •region by palpation / physical examination at first diagnosis
- •5. Central radiographic review of the CT scans (chest, abdomen, pelvis and if
- •applicable, neck) 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
- •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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