EUCTR2012-005378-73-IT进行中（未招募）不适用
Allogeneic Transplantation after a Conditioning with Thiotepa, Busulfan and Fludarabin for the treatment of refractory/early relapsed aggressive B-cell non Hodgkin lymphomas: a Phase II Multi-Center Trial
FONDAZIONE NEOPLASIE SANGUE ONLUS0 个研究点开始时间: 2013年1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
- •Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy.
- •Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy
- •Patients younger than 65 years old
- •A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered
- •Patient must be competent to give 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 42
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients treated with an autologous transplant as salvage therapy
- •Patients with progressive lymphomas despite conventional therapies
- •Patients with progressive lymphomas despite conventional therapies
- •Uncontrolled CNS involvement with disease
- •Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- •Females who are pregnant or breastfeeding
- •Organ dysfunction defined as follows:
- •?Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
- •?Pulmonary: DLCO <40% predicted
- •?Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4x the upper limit of normal
- •?Renal: creatinine clearance <50 cc/min (24 hour urine collection)
- •Karnofsky performance score < 60%
- •Patients with poorly controlled hypertension despite multiple antihypertensives
- •Documented fungal disease that is progressive despite treatment
- •Viral infections: HIV positive patients.
- •Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded.
- •Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
- •Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
- •Patients with active non-hematologic malignancies (except non-melanoma skin cancers).
- •Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence
研究者
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