Combined systemic an intrathecal chemotherapy with succeeding high dosis chemotherapy and autologous stem cell transplantation of patients with CNS relapses of agressive lymphomas. - NHL-ZNS-Rezidiv

Charité-Universitätsmedizin Berlin0 个研究点开始时间: 2007年4月18日最近更新: 2012年11月5日

适应症

试验速览

暂无简介。

•-histologically verified highly malignant non-Hodgkin lymphoma;
•-confirmed CNS relapse (meningeal or intraparenchymal localised), verified by
•cytological and immunocytological analysis of cerebrospinal fluid or by radiology,
•with and without systemic NHL-infestation;
•-ECOG performance score ?2
•-no active infection
•-negative HIV-serology
•-age: 18-65
•-adequate renal function with a creatinine-clearance > 50 ml/min
•-adequate bone marrow reserve with a peripheral number of granulocytes >1500/µl
•and number of thrombocytes > 80000/µl
•-bilirubin at standard range, GOT < threefold of the upper standard-range
•-negative pregnancy test
•-accomplished patient information, and written informed consent of the patient
•-accessibility of the patient (geographical proximity) with regard to the treatment
•and Follow-upexamination
•-patients compliance
•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

•-first diagnosed NHL with primary CNS-participation;
•-low malignant NHL, lymphoblastic NHL, Burkitt`s lymphoma;
•-preceding CNS-radiation;
•-pretreatment of the CNS-relapse except corticosteroid therapy;
•-preceding immunsuppression treatment; simultaneous immunsuppressive
•treatment with regard to organ transplantation and allogenic stem cell
•transplantation;
•-simultaneous participation in another clinical study;
•-simultaneous or preceding malignant illness in the last 5 years with exception of an
•adequately treated basal cell carzinoma or a cervix carzinoma in situ;
•-Treatment with salicylate, non-steroidal antirheumatics, within one week before
•beginning of the MTX-containing therapy;
•-Comorbidities, which can not be handled with an intensive chemotherapy and its
•the execution;
•-Contraindication for treatment with Ifosfamid, Depocyte, Cytarabin, Thiotepa, BCNU
•or Etoposid;
•-missing compliance fore the pseudonymised storage and transfer of pseudonymised
•disease data in the context of the clinical trial;
•-preceding high dose chemotherapy using the same conditioning pattern within the
•-preceding irradiation of the mediastinum;
•-pregnant or nursing women;
•-Women of childbearing age without highly effective contraception (defined as
•PEARL-Index < 1 %);
•-Persons who are detained officially or legally to an official institute (e.g. psychiatric
•institute or prison) (according to AMG §40 (1) 4);

发起方