EUCTR2006-004851-39-IT进行中（未招募）不适用
A PHASE II, OPEN-LABEL, PROSPECTIVE, MULTICENTER STUDYTO EVALUATE THE EFFICACY AND SAFETY OF SUBSEQUENTTREATMENT WITH THE ZEVALIN (IBRITUMOMAB TIUXETAN)IN ELDERLY ( 60 YEARS) PATIENTS WITH DIFFUSE LARGE BCELLLYMPHOMA AFTER 4 CYCLES OF CHOP21 ?RITUXIMAB(CHOP21-R) THERAPY. - ND
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2007年5月11日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Histologically confirmed, Ann Arbor stage II, III, or IV DLBCL according to the REAL/WHO
- •classification (from initial diagnosis made prior to starting CHOP21-R therapy);
- •2. Central pathology review confirming the DLBCL diagnosis and CD20 positivity, and no
- •evidence/evidence with an infiltration <25% of DLBCL in bone marrow;
- •3. The first part of the treatment of DLBCL must have been 4 cycles of standard CHOP21 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), unconfirmed complete remission (CRu), partial response, and nonresponder
- •according to the International Workshop Response Criteria for NHL described by Cheson
- •et al (18) afterfour cycles of CHOP21-R. CT scans of the neck, thorax, abdomen, and pelvis and PET
- •total body must have been performed within 3 weeks after the last dose of the last course of CHOP21-
- •5. Patients 60-years-of-age or older at time of accrual;
- •6. WHO performance status (PS) of 0 to 2 within 1 week of accrual;
- •7. Absolute neutrophil count (ANC) ? 1.5 x 109/L within 1 week of accrual;
- •8. Hemoglobin (Hgb) ? 10 g/dL within 1 week of accrual;
- •9. Platelets. 150 x 109/L within 1 week of accrual.
- •10. Life expectancy of 3 months or longer
- •11. 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) no
- •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
- •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;
- •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 accrual;
- •8. Abnormal renal function: serum creatinine > 2.0 x ULN within 1 week of accrual;
- •9. Nonrecovery from the toxic effects of CHOP21-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 anduncontrolled hypertension,
- •chronic renal disease, or active uncontrolled infection) which could compromise participation in the
- •13. Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from
- •the toxic effects of such therapy;
- •14. Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such
- •15. 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;
- •16. Unwillingness or inability to comply with the protocol.
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