NCT03630042

Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg IV dose given on day 1 of a three week cycle
DRUG	Rituximab	375 mg/m2 IV dose given up to 8 times in the trial

Timeline

• Start date: 2019-09-06
• Primary completion: 2021-09-21
• Completion: 2024-02-14
• First posted: 2018-08-14
• Last updated: 2024-11-07
• Results posted: 2024-11-07

Locations

9 sites across 1 country: United Kingdom