Prophylaxis of CNS relapse in adult patients with aggressive Non-Hodgkin-Lymphomas at risk for CNS metastasis MedDRA version: 7.0 Level: LLT Classification code 10029547
Conditions
Interventions
Trade Name: DepoCyte
Product Name: DepoCyte
Product Code: ----
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Cytarabin
CAS Number: ---
Current Sponsor code: ---
Other descriptive na
Sponsors
Mundipharma Research Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent - Male and female, age = 18 years - Histological proven aggressive Non-Hodgkin-Lymphoma at risk and eligible for R-CHOP therapy (newly diagnosed patients) respectively R-ICE therapy (systemically relapsed patients) and A. ONE of the following extranodal sites: * Testis involvement * High cervical involvement (nasal/paranasal sinuses, orbita, epidural space, parotid and submandibular glands, ear, throat region) * Bone marrow involvement AND ONE of the following risk factors: * Extranodal sites > 1 * LDH > 450 U/l OR B. BOTH of the following risk factors: * Extranodal sites > 1 * LDH > 450 U/l - Negative CSF-cytology - Karnofsky = 60% - Females of child-bearing potential must have a negative (urine or serum) pregnancy test and effective methods to prevent pregnancy. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Histology of lymphoma not eligible for R-CHOP or R-ICE treatment - Uncontrolled infection including HIV infection - Any previous CNS tumor therapy - Known or suspected CNS metastasis - Previous history of any CNS disease or present condition which is regarded as contraindication for intrathecal chemotherapy - Patients unable to comply with trial procedures - Pregnancy and lactation - Any other investigational drug within 21 days prior to trial entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Incidence of confirmed leptomeningeal metastasis (CNS relapse) during the post treatment observation period of one year verified by CNS cytology ;Secondary Objective: - Overall safety profile (adverse events, laboratory, vital signs) - Survival (all cause) - Time to confirmed CNS relapse;Primary end point(s): Incidence of confirmed leptomeningeal metastasis (CNS relapse) during the post treatment observation period of one year verified by CNS cytology | — |
Countries
Austria
Outcome results
None listed