Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Walde… (NCT03630042) | Clinical Trial Compass
CompletedPhase 2
Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia
United Kingdom17 participantsStarted 2019-09-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients ≥18 years old
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✓. Presence of measurable disease, (defined as a serum IgM level of \>0.5g/L) and fulfils other World Health Organisation (WHO) diagnostic criteria for WM
✓. Relapsed or refractory WM who have received ≥1 prior lines of therapy
✓. Adequate renal function: estimated creatinine clearance ≥ 30ml/min as calculated using the Cockroft-Gault equation
✓. Adequate liver function, including:
✓. Adequate organ and bone marrow function:
✓. Willing to comply with the contraceptive requirements of the trial
Exclusion criteria
✕. Refractory to rituximab as defined by progression on/within 6 months of finishing a rituximab based regimen
✕
What they're measuring
1
Percentage of Patients Achieving at Least a Major Response Rate at 24 Weeks Post Commencing Treatment
. Women who are pregnant or breastfeeding, or males expecting to conceive or father children at any point from the start of treatment until 4 months after the last administration of pembrolizumab
✕. Clinically significant cardiac disease within 6 months prior to registration including unstable angina or myocardial infarction, uncontrolled congestive heart failure (NYHA class III-IV), and unstable arrhythmias requiring therapy, with the exception of extra systoles or minor conduction abnormalities. Stable and controlled atrial fibrillation is not an exclusion.
✕. History of significant cerebrovascular disease in last 6 months
✕. Known central nervous system involvement of WM
✕. Clinically significant active infection requiring antibiotic or antiretroviral therapy (including Hepatitis B, C or human immunodeficiency virus (HIV))
✕. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
✕. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy