Copanlisib and Rituximab in Marginal Zone Lymphoma Patients
Status:
Recruiting
Trial end date:
2029-12-31
Target enrollment:
Participant gender:
Summary
For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy is
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 PI3K inhibitor Copanlisib has shown high
clinical activity in indolent B - cell lymphomas among them MZL. Based on these observations
it is the aim of this study to test the toxicity and efficacy of Copanlisib in combination
with the anti-CD20 antibody Rituximab in patients with newly diagnosed or relapsed MZL in
need of treatment, who are not eligible or failed local therapy, following the assumption
that this novel chemotherapy - free combination is significantly more effective than
Rituximab single agent therapy and at least as efficient as Rituximab/chemotherapy, but
avoids chemotherapy - related toxicity.
Phase:
Phase 2
Details
Lead Sponsor:
Christian Buske
Collaborators:
Bayer Healthcare LTD Celltrion Healthcare Co., LTD SSS International Clinical Research GmbH University of Ulm X-act Cologne Clinical Research GmbH Zentrum für Klinische Studien Ulm