CNS Prophylaxis in Diffuse Large B-cell Lymphoma

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS prophylaxis (arm C).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Czech Lymphoma Study Group
• Treatments: Methotrexate

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