Clinical study trying to answer the question if preventive treatment (prophylaxis) will lower the number of relapses (returns of the disease) in central nervous system in one of the aggressive form of lymph node cancer. The study is being performed in several centres, data will be collective prospectively and patients will be distributed to treatment groups by chance.
- Conditions
- Diffuse large B-cell lymphomaMedDRA version: 21.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2015-000591-97-CZ
- Lead Sponsor
- Kooperativní lymfomová skupina, o.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
1/histologically confirmed untreated DLBCL
2/age 18-72 years
3/signed informed consent with the study
4/planned first-line treatment 6 cycles of R CHOP +2x R or 6 cycles of DA EPOCH R+ 2xR
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1/ patients with DLBCL and concomitant initial CNS involvement
2/ patients with PMBL
3/ DLBCL patients with planned another chemotherapy than R CHOP or DA EPOCH R
4/ HIV positive, or active hepatitis B or C
5/ other serious disease (based on the decision of the physician-investigator)
6/ non-compliance of a patient
7/ every containdication for administration of antracyclin regimen or high dose methotrexat
8/ pregnancy or breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method