NCT03293173

Biomarker Driven Intensified ChemoImmunotherapy With Early CNS Prophylaxis

Biomarker Driven and Dose Intensified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk Diffuse Large B-Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Nordic Lymphoma Group · Network
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study is testing whether stratification of the patients according to biological risk factors for different treatment groups will improve the outcome of patients with clinically high diffuse large B-cell lymphoma (DLBCL).

Detailed description

For young clinically high-risk diffuse large B-cell lymphoma (DLBCL) patients the optimal therapy has not been established. Previous Nordic phase II studies, where dose-dense chemoimmunotherapy (R-CHOEP-14) with systemic CNS prophylaxis (HD-Mtx and HD-AraC) was given, demonstrated favorable outcome in comparison to historical controls. However, the patients with biological risk factors, such as translocation of bcl2 and myc oncogenes or and/or high BCL2 and MYC expression or deletion 17p and/or high P53 expression had significantly higher risk of death, as compared to patients without aberrations. The figures provide evidence for an unmet clinical need for the patients with biological risk factors, and underscore the importance of a clinical trial, where both biological and clinical risk factors play a role in the treatment planning. In this trial treatment intensity varies according to presence or absence of biological risk factors. All patients receive a prephase medication consisting of prednisone and vincristine and two cycles of R-CHOP and high dose (HD) methotrexate. Subsequently, depending on the biological risk factors either four additional cycles of R-CHOEP (standard arm with no risk factors) or four dose adjusted R-EPOCH courses (experimental arm with risk factors) are given, followed by one course of high dose cytarabine (Ara-C) and R. R-CHOEP courses should be given with a two-week and R-EPOCH with a three-week interval.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
COMBINATION_PRODUCT	R-CHOEP	rituximab, cyclophosphamide, doxorubicin, etoposide, vincristine, prednisone
COMBINATION_PRODUCT	DA-EPOCH-R	dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab

Timeline

• Start date: 2017-08-04
• Primary completion: 2021-01-31
• Completion: 2024-12-31
• First posted: 2017-09-26
• Last updated: 2024-06-21

Locations

16 sites across 4 countries: Denmark, Finland, Norway, Sweden