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
- Conditions
- 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.
- Registration Number
- EUCTR2006-006516-30-DE
- Lead Sponsor
- Charité-Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
-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
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);
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br>-toxicity of the induction chemotherapy and the highly dose chemotherapy<br>-the overall survival <br>;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).<br>2. Response rate of the induction chemotherapy.<br>3. Toxicity of the induction chemotherapy and the highly dose chemotherapy.<br>4. The overall survival.<br>
- Secondary Outcome Measures
Name Time Method