CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03630042
NCT03630042Phase 2Completed

A Phase II Trial to Investigate the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia

University College, London·interventional·Posted Aug 14, 2018·Updated Nov 7, 2024

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Rituximab for Waldenstrom Macroglobulinemia. Completed, enrolled 17 participants across 9 sites.

Detailed Summary

This study is for patients who have previously been treated for Waldenström's macroglobulinaemia (WM) and their disease has either not responded (known as refractory disease) or has returned (known as relapsed disease). Through this study, the researchers would like to find out whether treating these patients with drugs called rituximab and pembrolizumab is a safe and effective combination for this disease. In this study, pembrolizumab and rituximab will be given together. In other studies pembrolizumab has been shown to be effective at treating diseases similar to WM. The researchers want to test whether giving pembrolizumab and rituximab together is safe and effective.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartSep 6, 2019
Primary CompletionSep 21, 2021
Study CompletionFeb 14, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.9 years ago

Interventions

Pembrolizumabdrug

200 mg IV dose given on day 1 of a three week cycle

Rituximabdrug

375 mg/m2 IV dose given up to 8 times in the trial