EUCTR2006-004850-26-IT进行中（未招募）不适用
A phase II, open-label, prospective, multicenter study to evaluate theefficacy and safety of subsequent treatment with the Zevalin(ibritumomab tiuxetan) study in patients with follicular grade I-IIlymphoma after 4 cycles of Fludarabine-Mitoxantrone-Rituximab(FMR) 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:
相关药物
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 FL grade I-II according to the REAL/WHO classification (from
- •initial diagnosis made prior to starting FMR therapy);
- •2. FLIPI ? 3; 3
- •3. Central pathology review confirming the FL grade I-II diagnosis and CD20 positivity, and
- •no evidence/evidence with an infiltration <25% of FL in bone marrow;
- •4. The first part of the treatment of FL must have been 4 cycles of standard FM chemotherapy
- •(fludarabine 25 mg/m2/day on days 1 to 3 and mitoxantrone 10 mg/m2 on day 1) in
- •combination with rituximab (375 mg/m2); Complete remission (CR), unconfirmed complete
- •remission (CRu), partial response, and non-responder according to the International
- •Workshop Response Criteria for NHL described by Cheson et al (13) after four cycles of
- •FMR. 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 FMR;
- •5. Patients 18-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. 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;
- •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
- •8. Abnormal renal function: serum creatinine > 2.0 x ULN within 1 week of accrual;
- •9. Nonrecovery from the toxic effects of FMR 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 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
- •18. Unwillingness or inability to comply with the protocol.
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