CNS Prophylaxis in Diffuse Large B-cell Lymphoma (CLSG-CNS-001)
Diffuse Large B-cell Lymphoma
About this trial
This is an interventional prevention trial for Diffuse Large B-cell Lymphoma focused on measuring Lymphoma, B cell, Central nervous system relapse, Methotrexate, Intrathecal chemotherapy
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed DLBCL
- age 18-72 years
- signed informed consent with the study
- first-line treatment 6 cycles of R CHOP +2x R or 6 cycles of DA EPOCH R+ 2xR
Exclusion Criteria:
- DLBCL and concomitant initial CNS involvement
- PMBL (primary mediastinal B-cell lymphoma)
- treatment with another chemotherapy than R CHOP or DA EPOCH R
- HIV positive, or active hepatitis B or C
- other concomitant serious disease (based on the decision of the physician-investigator)
- non-compliance of a patient
- any contraindication for application of anthracycline based chemotherapy or high dose methotrexate
- pregnancy or breast-feeding
Sites / Locations
- University Hospital Brno-BohuniceRecruiting
- University Hospital Hradec KrálovéRecruiting
- University Hospital OstravaRecruiting
- University Hospital PilsenRecruiting
- University Hospital Kralovske VinohradyRecruiting
- General University Hospital PragueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Arm A - Methotrexate i.v.
Arm B - Methotrexate i.t.
Arm C - no Methotrexate
Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive 2 cycles of methotrexate 3g/m2 i.v. after the 3rd and 6th cycle of systemic chemotherapy (R CHOP or DA EPOCH R).
Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive intrathecal methotrexate 12mg in each cycle of systemic chemotherapy (6x).
Patients with 0-1 risk factor for CNS relapse will not receive CNS prophylaxis.