BENITIONSClinical Trial Intelligence

Pembrolizumab in MarginalzoneLymphoma A MULTICENTER OPEN LABEL SINGLE-ARM PHASE II STUDY

Phase 2 Terminated NCT04268277

ConditionMarginal Zone Lymphoma
PhasePhase 2
SponsorUniversity of Ulm
StatusTerminated
Enrollment22 participants
InterventionsRituximab, Pembrolizumab
Start dateMar 1, 2022
Completion dateDec 6, 2024
Results postedFeb 27, 2026

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 does 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 55.8% vs. 78.8%, respectively (P \< 0.001). Thus, it is the major aim to develop chemotherapy-free approaches for MZL, which approach or surpass efficacy of rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities. Checkpoint inhibitors such as Pembrolizumab have revolutionized cancer treatment and have also shown first encouraging results in Non-Hodgkin lymphomas. Based on these observations it is the aim of this study to test the tox

CR Rate

4 weeks after end of treatment (18 cycles), approx. 58 weeks · Participants

Rituximab & Pembrolizumab3 Participants
p-value1.0
CRR value14

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