Lymphoma, Large B-Cell, Diffuse Clinical Trial
Official title:
Biomarker Driven and Dose Intensified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk Diffuse Large B-Cell Lymphoma
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).
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.
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|---|---|---|---|
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