EUCTR2007-005506-42-IT进行中（未招募）1 期
HIGH-DOSE SEQUENTIAL CHEMOTHERAPY AND RITUXIMAB (R-HDS) IN HIV+ PATIENTS WITH NON-HODGKIN LYMPHOMA (NHL) REFRACTORY OR RELAPSED AFTER 1st LINE TREATMENT - ND
OSPEDALE S. RAFFAELE0 个研究点目标入组 10 人开始时间: 2007年12月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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 diagnosis of diffuse large B-cell or follicular (Gr. III) CD20+ lymphoma or primary effusion lymphoma (PEL), primary resistant or relapsing after conventional chemotherapy (CHOP or CHOP-like regimen)
- •2.HIV infection with CD4+ count > 200 cells/dL and negative HIV-RNA
- •3.Age 19-65 years
- •4.ECOG performance status 0-3 (if > 60 years old = ECOG performance status 0-2
- •5.Adequate bone marrow (PLT ³100000 mm3, Hb ³9 gr/dL, ANC ³2000 mm3), renal (creatinine clearance ³60 mL/min), cardiac (VEF > 50%), and hepatic function (total serum bilirubin ≤3 mg/dL, AST/ALT and GGT ≤3 per upper normal limit value), within 1 week prior to study start (unless the abnormality is due to lymphoma involvement)
- •6.Absence of symptomatic coronary artery disease, cardiac arhythmias not well controlled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
- •7.No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin and of other cancers without evidence of disease at least from 5 years and Kaposi sarcoma in an inactive phase
- •8.No concurrent opportunistic diseases:
- •a.HBV chronic hepathitis does NOT represent an exclusion criteria, only if the infection is controlled by adequate antiviral therapy (lamivudine) and HBV-DNA must be negative
- •b.HCV chronic hepathitis does NOT represent an exclusion criteria, unless the above mentioned hepatic function criteria are not satisfied
- •9.Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •10.Female patients must be non-pregnant and non-lactating. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
- •11.No treatment with other experimental drugs within the 6 weeks previous to enrolment
- •12.Given written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •age < 18 years; -criteria not in line with inclusion criteria; -partecipation to pther trials; inability to give consenst
研究者
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