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Brief Title: Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP
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)
Study ID: NCT02983097
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Diakonie Krankenhaus Bremen, Bremen, , Germany
Klinikum Chemnitz, Chemnitz, , Germany
Universitätsklinikum Essen, Essen, , Germany
Klinikum Frankfurt/Oder, Frankfurt/Oder, , Germany
Universitätsklinikum Göttingen, Göttingen, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Universitätsklinikum des Saarlandes, Homburg, , Germany
Westpfalz Klinikum, Kaiserslautern, , Germany
Städtisches Klinikum Karlsruhe, Karlsruhe, , Germany
LMU Klinikum München-Großhadern, München, , Germany
Name: Bertram Glaß, MD
Affiliation: AK St.Georg
Role: PRINCIPAL_INVESTIGATOR