The aim of the study is the prospective verification of effectiveness and compatibility of a systemic therapy with CNS passable cytostatics (high-dose Methotrexat and Ifosfamide, and high-dose Cytarabine and Thiothepa) combined with an intrathecal Depocyte therapy, followed by a High-dose dose chemotherapy with Carmustine, Thiothepa and Etoposid and an autologous stem cell transplantation.
Conditions
Interventions
Trade Name: Carmubris (Durchstechflasche)
Product Name: Carmubris
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: CARMUSTINE
CAS Number: 154938
Other descriptive name: BCNU
Sponsors
Charité-Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -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 last year; -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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is the improved therapy of patients with NHL with high dose chemotherapy and stem cell transplantation, determined by the increased time to treatment failure, TTF).;Secondary Objective: -response rate of the induction chemotherapy; -toxicity of the induction chemotherapy and the highly dose chemotherapy -the overall survival ;Primary end point(s): 1. The improvement of the therapy of patients with NHL with high dose chemotherapy and stem cell transplantation, determined by the increased time to treatment failure, TTF). 2. Response rate of the induction chemotherapy. 3. Toxicity of the induction chemotherapy and the highly dose chemotherapy. 4. The overall survival. | — |
Countries
Germany
Outcome results
None listed