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

Phase 2

Completed

• Conditions: Waldenstrom Macroglobulinemia
• Interventions: Drug: Pembrolizumab; Drug: Rituximab

• Registration Number: NCT03630042
• Lead Sponsor: University College, London

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-14
• Study Start: 2019-09-06
• Primary Completion: 2021-09-21
• Study Completion: 2024-02-14
• Results First Submitted: 2024-05-21
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Results First Posted: 2024-11-07
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pembrolizumab and Rituximab	Rituximab	-
Pembrolizumab and Rituximab	Pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving at Least a Major Response Rate at 24 Weeks Post Commencing Treatment	24 weeks	The primary outcome is the percentage of patients achieving at least a major response rate at 24 weeks post commencing treatment. A major response rate is defined as a greater than 50% reduction in paraprotein measurement - this is in line with international recognised response criteria for the disease under investigation. In this single arm study all patients receiving treatment were considered applicable for endpoint analysis. There is no comparison as there is only one arm.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability of Pembrolizumab and Rituximab as Assessed by the Frequency of Serious and Non-serious Adverse Events, According to CTCAE v5.0	until 5 months post last IMP administration	As assessed by the number and grade of serious and non-serious adverse events, graded according to CTCAE v5.0
Complete Response Rate at 24 Weeks Post Commencing Treatment	24 weeks
Very Good Partial Response Rate at 24 Weeks Post Commencing Treatment	24 weeks
Time to Maximal Response as Determined by the Time of Registration to the Maximal Disease Response	Assessed at 12 weeks, 24 weeks and 1 year after commencing treatment
Time to Next Treatment	Assessed once per year after completing treatment (average of 1 year)	as determined by the time from registration to the next line of therapy
Progression Free Survival (PFS) at 1 and 2 Years	1 and 2 years post commencing treatment
Overall Survival (OS) at 1 and 2 Years	1 and 2 years post commencing treatment
Quality of Life - Change in Quality of Life (QoL) at 24 Weeks Post Commencing Treatment as Assessed by EORTC QLQ-C30 Questionnaire	24 weeks	Change in quality of life (QoL) at 24 weeks post commencing treatment as assessed by EORTC QLQ-C30 questionnaire. Daily activities and thoughts/feelings experienced by the patient over the week preceding questionnaire completion are graded on a scale from '1-not at all' to '4-very much'. Also rating of overall health and quality of life from '1-very poor' to '7-excellent'

Trial Locations

Locations (9)

Derriford Hospital, Univeristy Hospitals Plymouth NHS Trust; 🇬🇧 Plymouth, Devon, United Kingdom

Churchill Hospital, Oxford Univeristy NHS Foundation Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom

UCLH, Univeristy College London Hospitals NHS Foundation Trust; 🇬🇧 London, Greater London, United Kingdom

Bristol Haematology & Oncology Medical Centre, University Hospitals Bristol and Weston NHS Foundation Trust; 🇬🇧 Bristol, United Kingdom

Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, United Kingdom

St Bartholomew's Hospital, Barts Health NHS Trust; 🇬🇧 London, Greater London, United Kingdom

The Christie Hospital, The Christie NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom

Royal Bournemouth Hospital, University Hospitals Dorset NHS Foundation Trust; 🇬🇧 Bournemouth, Dorset, United Kingdom

Torbay and South Devon NHS Foundation Trust; 🇬🇧 Torquay, Devon, United Kingdom