NCT03399513

Ibrutinib and Standard Immuno-Chemotherapy in Younger, High-Risk Patients With Diffuse Large B-Cell Lymphoma

Ibrutinib and Standard Immuno-Chemotherapy (R-CHOEP-14) in Younger, High-Risk Patients With Diffuse Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate if treatment results obtained with R-CHOEP in young high-risk patients with diffuse large B-cell lymphoma can be further improved by the addition of ibrutinib to this regimen.

Detailed description

Encouraging results have been achieved in younger high-risk patients with newly diagnosed diffuse large B-cell lymphoma treated with R-CHOEP. However, more than one fourth of patients still relapse or show primary progressive disease. The outcome of such patients is poor, in particular if first-line therapy contained rituximab. In order to avoid such detrimental situations, we seek to further improve progression-free survival and overall survival by combining R-CHOEP with ibrutinib. Ibrutinib is a first-in-class, orally administered, potent, small-molecule inhibitor of Bruton's tyrosine kinase, a mediator of critical B-cell signaling pathways implicated in the pathogenesis of B-cell cancers.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib Oral Capsule [Imbruvica]	Imbruvica 140 mg hard capsules (Active substance: Ibrutinib)
DRUG	R-CHOEP chemotherapy	Immunochemotherapy

Timeline

• Start date: 2018-05-03
• Primary completion: 2023-12-23
• Completion: 2023-12-23
• First posted: 2018-01-16
• Last updated: 2024-01-05

Locations

12 sites across 1 country: Germany