The purpose is to test whether early central nervous system (CNS) prophylaxis given at the beginning of therapy for young high risk diffuse large B-cell lymphoma (DLBCL) patients is feasible and could reduce the risk of CNS relapses. Early CNS prophylaxis with two courses high dose methotrexate (HD-MTX) in combination with rituximab-cyclophosphamide-doxorubicin-vincristine-prednison (R-CHOP) is followed by four courses of R-CHOP14 and etoposide (E) and one course of HD-Ara-C. In addition the patients will receive three courses of liposomal cytarabine intrathecally. The results will be compared to a recent Nordic CRY-04 study. Shifting of CNS prophylaxis to the beginning of the therapy offers a potential to overcome the subclinical disease and thus reduce the risk of early clinical CNS recurrence. As flow cytometry (FCM) can improve the sensitivity for detecting occult leptomeningeal disease over cytology , FCM from cerebrospinal fluid will be incorporated into the staging procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
143
50 mg intrathecally three times
Department of Hematology, Århus University Hospital
Aarhus, Denmark
Department of Oncology, Helsinki University Central Hospital
Helsinki, Finland
Department of Oncology, Oslo University Hospital
Oslo, Norway
Department of Oncology, Lund University Hospital
Lund, Sweden
Time to treatment failure
Time frame: 3 and 5 years
Maximal hematological, gastrointestinal, neuronal and other toxicities
Time frame: Treatment period (5 years)
Clinical response rate
Time frame: Treatment period (5 years)
Incidence of central nervous system(CNS) relapse in cerebrospinal fluid (CSF )cytology neg/flow cytometry positive cases
Time frame: 3 and 5 years
Incidence of CNS relapse in a subgroup of patients with more than one extranodal site and elevated lactate dehydrogenase (LDH)
Time frame: 3 and 5 years
Progression free survival
Time frame: 3 and 5 years
Overall survival
Time frame: 3 and 5 years
Molecular predictors
Time frame: 3 years
CNS relapse rate
Time frame: 1,5 years
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