BENITIONSClinical Trial Intelligence

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

Фаза 2 Прекращено NCT04268277

ЗаболеваниеMarginal Zone Lymphoma
ФазаФаза 2
СпонсорUniversity of Ulm
СтатусПрекращено
Участники22 участн.
ВмешательствоRituximab, Pembrolizumab
Дата начала1.03.2022
Дата завершения6.12.2024
Публикация результатов27.02.2026

Кратко

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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