EUCTR2012-000251-14-IT进行中（未招募）不适用
A PHASE III MULTICENTER, RANDOMIZED STUDY COMPARING CONSOLIDATION WITH (90)YTTRIUM-LABELED IBRITUMOMAB TIUXETAN (ZEVALIN®) RADIOIMMUNOTHERAPY VS AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT) IN PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA (FL) AGED 18-65 YEARS - FIL_FLAZ-12
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点开始时间: 2012年4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
- •1.Age 18-65; 2.Histologically documented diagnosis of grade I-IIIa FL defined according to WHO guidelines 2008 (Re-biopsy required); 3.Collection of BM and PB for MRD analysis; 4.Relapsed or refractory disease after = 2 chemotherapy lines at least one containing rituximab (rituximab maintenance is not considered a therapeutic line); 5.Clinical indication of systemic treatment i.e. Stage II-IV who require therapy according to SIE and GELF criteria; 6.ECOG performance status 0-2 (unless disease-related); 7.Availability of histological material for centralized revision; 8.Laboratory values: •ANC = 1500/mmc and/or platelets = 100000/mmc (unless due to marrow involvement by lymphoma) •Serum creatinine = 1.5 x ULN (unless disease-related) •bilirubin = 1.5 x ULN (or = 3.0 x ULN, if patient has Gilbert’s syndrome), AST/SGOT and/or ALT/SGPT = 2.5 x ULN if not disease related or = 5.0 x ULN in case of lymphoma liver involvement; 9.Adequate cardiac function: LVEF > 50% by echocardiography or MUGA scan; 10.Not pregnant or breast-feeding; 11.Willingness to use effective contraception during the study and 3 months after the end of treatment; 12.No other prior malignancies except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM stage of T1a or T1b) or other cancer from which the patient has been disease-free for > 5 years; 13.Signed informed written consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 245
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Grade IIIb FL, transformed FL or histologies different from FL; 2.Previous treatment with > 2 lines of chemotherapy ± rituximab (rituximab maintenance is not considered a treatment line); 3.Previous ASCT or RIT treatment; 4.CNS involvement by lymphoma; 5.HBV positivity (except of patients HbcAb positive and HbsAg negative, HBV-DNA negative, provided lamivudine prophylaxis is given); 6.HCV positivity with active virus replication (HCV-RNA copies in serum), active hepatitis or impaired liver function. 7.HIV positivity; 8.Any concurrent medical condition requiring long term use (greater than one month) of systemic corticosteroids; 9.Active bacterial, viral, or fungal infection requiring systemic therapy; 10.Any concurrent medical or psychiatric condition which might impair administration of therapy or preclude the ability to give informed consent; 11.Treatment within an experimental agent within 30 days prior to study entry; 12.Myelosuppressive chemotherapy or biological therapy within three weeks before study entry (use rituximab course delivered as maintenance is not an exclusion therapy); 13.Major surgery other than diagnosis within four weeks prior to study entry.14.Previous i.v. or i.m. treatments with murine or animal derived antibodies.
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