NCT02436707

Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma

A Multi-Stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.

Detailed description

This research is being done to try to find new combinations of treatment that may be better for treating patients with this disease. It is not clear however if these treatments can offer better results than standard treatment. The study uses a "pick the winner" design to facilitate efficient screening of novel combination treatment regimens and select those meeting pre-specified criteria for testing in the phase III setting. All novel treatment options will be compared against the standard treatment for this disease: rituximab plus gemcitabine, dexemthasone, and cisplatin (R-GDP).

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib
DRUG	Rituximab
DRUG	Gemcitabine
DRUG	Dexamethasone
DRUG	Cisplatin
DRUG	Mesna
DRUG	Cyclophosphamide
DRUG	Etoposide
DRUG	G-CSF
DRUG	Selinexor

Timeline

• Start date: 2015-10-27
• Primary completion: 2026-03-31
• Completion: 2026-12-31
• First posted: 2015-05-07
• Last updated: 2026-03-27

Locations

11 sites across 1 country: Canada