Diffuse Large B-cell Lymphoma (DLBCL) Clinical Trial
Official title:
Open-label, Multicenter Phase I/II Study: Salvage Therapy of Progressive and Relapsed Aggressive Non-Hodgkin-Lymphoma by Combination of Lenalidomide (Revlimid®) With Rituximab, Dexamethason, High-dose ARA-C and Cisplatinum (R²-DHAP)
The goal of this study is to evaluate efficacy and safety of the combination of lenalidomide, an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment, called R-DHAP. R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy consisting of Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based chemotherapy, either cisplatinum, or, if treatment with cisplatinum is contraindicated, carboplatinum.
This is a phase 1/2 study to evaluate the efficacy and safety of lenalidomide added to a
standard chemotherapy regime of R-DHAP (Rituximab, Dexamethasone, high-dose Cytarabine,
Cis/Carboplatinum) in the treatment of relapsed or refractory high-grade B-cell
non-hodgkin-lymphoma (NHL).
The study hypothesis is that the combination of lenalidomide with standard immunochemotherapy
will lead to an overall response rate of at least 60%. In this study, 3 rounds of
immunochemotherapy in combination with lenalidomide will be administered. After the first or
second round of therapy, peripheral hematopoetic stem cells will be harvested. Consolidation
treatment with autologous or allogenic peripheral blood stem cell transplantation is
recommended in all patients suitable, but is not part of the study.
In phase 1, up to six cohorts of at least 6 patients each will be treated with the study
therapy, with lenalidomide in increasing dosages, to determine the maximum tolerated dose
(MTD).
In phase 2, 50 patients will be treated with the MTD. Efficacy and safety will be evaluated.
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