NCT01458548终止2 期
Treatment of Patients With Posttransplant Lymphoproliferative Disorder (PTLD) With a Sequential Treatment Consisting of Anti-CD20 Antibody Rituximab and CHOP+GCSF Chemotherapy (Including 1st+2nd Amendment)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- number of patients with complete and partial remission
研究概览
简要总结
Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PTLD with or without EBV association, confirmed after biopsy or resection
- •Measurable disease of > 2 cm in diameter and/or bone marrow involvement
- •Patients having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or other or a combination of the organ transplantations mentioned
- •Karnofsky scale >50% or ECOG ≤ 3
- •Reduction of immunosuppression with or without antiviral therapy
- •A complete surgical extirpation of tumor was not performed
- •A radiation therapy was not performed
- •Effective contraception for women in childbearing age
- •Patient's written informed consent and written consent for data collection
- •Patients are > 18 years (or ≥ 15 years with parental agreement )
排除标准
- •Life expectancy less than 6 weeks
- •Karnofsky-scale <50% or ECOG =3
- •Treatment with rituximab before
- •Known allergic reactions against foreign proteins
- •Concomitant diseases, which exclude the administration of therapy as outlined by the study protocol
- •non-compensated heart failure
- •Dilatative cardiomyopathy
- •Myocardial infarction during the last 6 months
- •Severe non-compensated hypertension
- •Severe non-compensated diabetes mellitus
- •Renal insufficiency (creatinine more than 3-fold of the upper normal value), not related to lymphoma.
- •Hepatic insufficiency with transaminase values greater than 3-fold of the normal values and/or bilirubin levels >3.0 mg/dl, not related to lymphoma
- •Clinical signs of cerebral dysfunction
- •Women during the lactation period, pregnant or of childbearing potential not using a reliable contraceptive method
- •Involvement of the central nervous system by the disease
- •Severe psychiatric disease
- •Known to be HIV positive
- •Missing written informed consent of the patient
结局指标
主要结局
number of patients with complete and partial remission
时间窗: 1 month (plus or minus 7 days) after the last cycle of chemotherapy
response duration
时间窗: from date of best response until the date of first documented progression, assessed up to 3 years
次要结局
- number of patients with treatment-related death(from start of treatment, assessed up to 12 months after the end of treatment)
- overall survival(from start of treatment until date of death from any cause, assessed up to 3 years)
研究者
Ralf Trappe
Head German PTLD Study Group
Charite University, Berlin, Germany
研究点 (4)
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