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

Sponsor
University College, London
Study ID
NCT03630042
Phase
PHASE2
Status
Completed

Conditions

  • Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 6, 2019
Status verified
Nov 2024
Primary completion
Sep 21, 2021
Completion
Feb 14, 2024

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab and Rituximab

Primary Outcome Measure

Percentage of Patients Achieving at Least a Major Response Rate at 24 Weeks Post Commencing Treatment [ Time Frame: 24 weeks ]

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