For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy are
widely used for those patients who fail local therapy or do not qualify for such. Depending
on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but do
not prevent relapse later on. In addition, chemotherapy associated toxicity is often
problematic in MZL patients, who are mostly of advanced age. Thus, chemotherapy - free
approaches are highly attractive for this patient group. Rituximab single agent is a widely
used chemotherapy - free approach in MZL, but was significantly inferior compared to
Rituximab/chlorambucil in a large randomized prospective clinical trial in treatment naïve
MZL with a CR rate of 56 % vs. 80%, respectively (P<0.001).Thus, it is the major aim to
develop chemotherapy - free approaches for MZL, which approach efficacy of
rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities. This in
particular important in MZL as many physicians are reluctant to treat these often elderly
patients with more intense treatments and prefer single agent therapies in these very often
well and long responding lymphoma subtype. The type II anti-CD20 antibody Obinutuzumab
(OBINUTUZUMAB) has demonstrated remarkable activity in follicular lymphoma and superiority to
Rituximab in combination with chemotherapy in treatment naïve (Gallium trial) and rituximab
refractory follicular lymphoma (Gadolin trial) as well as in CLL in combination with
chlorambucil. Based on these observations it is the aim of this study to test the toxicity
and efficacy of the anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) in patients with newly
diagnosed MZL in need of treatment, who are not eligible or failed local therapy, following
the assumption that this novel anti-CD20 antibody is significantly more effective than
Rituximab single agent therapy, and avoids chemotherapy - related toxicity.
Phase:
Phase 2
Details
Lead Sponsor:
Christian Buske
Collaborators:
Roche Pharma AG SSS International Clinical Research GmbH University of Ulm X-act Cologne Clinical Research GmbH Zentrum für Klinische Studien Ulm