NCT05221645

Pembrolizumab in Combination With R-ICE Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: University of Southampton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicentre, randomised phase II trial in relapsed or refractory diffuse large B-cell lymphoma.

Detailed description

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.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD 1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Based on preclinical in vitro data, pembrolizumab has high affinity and potent receptor blocking activity for PD 1. Pembrolizumab has an acceptable preclinical safety profile and is in clinical development as an intravenous (IV) immunotherapy for advanced malignancies. Keytruda® (pembrolizumab) is indicated for the treatment of patients across a number of indications because of its mechanism of action to bind the PD-1 receptor on the T cell.
DRUG	Rituximab	Rituximab is a chimeric mouse/human monoclonal antibody that binds to CD20, on pre-B and mature B lymphocytes and eliminates these cells potentially via a number of different mechanisms. Anti-CD20 mAbs, like rituximab, are classified by their CD20-binding characteristics, ability to induce complement-dependent cytotoxicity (CDC), and immune effector cell effects.
DRUG	Ifosfamide	Ifosfamide, Carboplatin and Etoposide (ICE) is proven to be an effective regimen in the relapsed refractory NHL population. In a study of 163 transplant eligible patients with relapsed/refractory disease, 66.3% of patients obtained CR/PR after 3 cycles of ICE chemotherapy at two weekly intervals.
DRUG	Carboplatin	Ifosfamide, Carboplatin and Etoposide (ICE) is proven to be an effective regimen in the relapsed refractory NHL population. In a study of 163 transplant eligible patients with relapsed/refractory disease, 66.3% of patients obtained CR/PR after 3 cycles of ICE chemotherapy at two weekly intervals.
DRUG	Etoposide	Ifosfamide, Carboplatin and Etoposide (ICE) is proven to be an effective regimen in the relapsed refractory NHL population. In a study of 163 transplant eligible patients with relapsed/refractory disease, 66.3% of patients obtained CR/PR after 3 cycles of ICE chemotherapy at two weekly intervals.

Timeline

• Start date: 2022-06-27
• Primary completion: 2026-05-30
• Completion: 2026-12-31
• First posted: 2022-02-03
• Last updated: 2024-12-05

Locations

2 sites across 1 country: United Kingdom