NCT02594163

Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-cell Lymphoma

A Randomized, Open Label, Phase 2 Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for Relapsed or Refractory CD30-Positive Diffuse Large B-Cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in patients ineligible for autologous stem cell transplant (ASCT).

Detailed description

Patients will be randomized in a 1:1 manner to receive rituximab plus bendamustine with or without brentuximab vedotin. Patients who respond to combination treatment containing brentuximab vedotin and do not experience excessive toxicity may receive additional single-agent brentuximab vedotin following combination treatment, for up to an additional 10 cycles (up to 16 total cycles of treatment).

Conditions

• Diffuse Large B-cell Lymphoma Refractory
• Follicular B-cell Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin
DRUG	Rituximab
DRUG	Bendamustine

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-11-02
• Last updated: 2018-10-16
• Results posted: 2018-10-16

Locations

50 sites across 7 countries: United States, Czechia, France, Italy, Poland, Spain, United Kingdom