Last updated on February 2018

OPTIMAL>60 / DR. CHOP Improvement of Therapy of Elderly Patients With CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine

Brief description of study

The purpose of this study is to improve the outcome of elderly patients with CD20+ Aggressive B-Cell Lymphoma and to reduce the toxicity of standard used Immuno-Chemotherapy by using an optimised schedule of the monoclonal antibody Rituximab, substituting conventional by Liposomal Vincristine and by a PET-guided reduction of therapy in Combination with Vitamin D Substitution.

Detailed Study Description

Primary objective of study:

"OPTIMAL>60 Less Favourable" Patients with less favourable prognosis:

To test whether progression-free survival (PFS) can be improved by substituting conventional by liposomal vincristine;

To test whether PFS can be improved by 12 optimised applications instead of 8 2-week applications of rituximab.

"OPTIMAL>60 Favourable": Patients with favourable prognosis:

Comparison of neurotoxicity of conventional and liposomal vincristine;

Determination of PFS for the treatment strategy of reducing treatment in patients with negative FDG-PET after 4 x R-CHOP/CHLIP-14 (PET-4) and comparison with the corresponding patient population in RICOVER-60.

Secondary objectives: "OPTIMAL>60 Favourable" and "OPTIMAL>60 Less Favourable":

Comparison of the prognostic value of a pre-treatment FDG-PET (PET-0) with conventional CT/MRT.

Investigation of the prognostic value of different FDG-PET derived imaging biomarkers for lymphoma load (SUV, MTV, TLG).

Comparison of the FDG-PET-based individualised treatment strategy in OPTIMAL>60 with the fixed (pre-defined) treatment strategy in RICOVER>60.

Estimation of the vincristine-related neurotoxicity ("OPTIMAL>60 Less Favourable only, since vincristine related neurotoxicity is primary objective of the study in favourable patients) and other toxicities (all patients).

Determination of the therapeutic efficacy of a Vitamin D substitution by comparing the first patients without Vitamin D substitution with patients with Vitamin D substitution.

Clinical Study Identifier: NCT01478542

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DSHNHL Central Study Office

Prosper-Hospital Recklinghausen, Med. Klinik I
Recklinghausen, Germany
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DSHNHL Central Study Office

St. Josef-Hospital Gelsenkirchen, Onkologie und H matologie
Gelsenkirchen, Germany
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DSHNHL Central Study Office

Knappschaftskrankenhaus Bochum
Bochum, Germany
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