An open-label, multicentre, randomised phase II Pembrolizumab in combination with R-ICE chemotherapy in relapsed/refractory diffuse large B-cell lymphoma.
The study has two treatment arms to which participants will be randomised on a 3:1 basis to the experimental arm.
The control arm (Arm A) will be R-ICE for 3 cycles followed by an autologous stem cell transplant (for patients in a CR or PR on the post treatment PET-CT scan). The experimental arm (Arm B) will consist of P+R-ICE for 3 cycles followed by an autologous stem cell transplant (for patients in a CR or PR on the post treatment PET-CT scan) and maintenance Pembrolizumab every 3 weeks for one year. All patients will be randomised at study entry and will be stratified by relapse within 12 months or > 12 months of first line therapy.
Primary:
An event is defined as any of the following:
Secondary:
Tertiary:
Open to recruitment.
Population over 18 years old with relapsed/refractory diffuse large B-cell lymphoma.
This trial is funded by Merck Sharp & Dohme (MSD) known as Merck & Co.
Any additional costs will be covered by SCTU.
Senior Trial Manager:
Josh Caddy
Trial Manager:
Amber Cole
Trial Monitors:
Parys Hatchard
Aleksandra Kusinska
Data Manager:
Zoe Konn
Clinical Trials Data Coordinator:
Oli Seymour
Email: [email protected]
Phone: 023 8120 5154
Email: [email protected]
P+R-ICE - Main Patient Information Sheet _v3 26Jan2022
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