Overview

Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide for Refractory or Relapsed Aggressive B-Cell Lymphomas

Status:
Active, not recruiting

Trial end date:
2021-10-01

Target enrollment:

Participant gender:

Summary

The Phase I part of the study will apply to identify dose-limiting toxicities (DLT) and to define maximum-tolerated dose (MTD) for a new chemoimmunotherapy combination of bendamustine, ofatumumab, carboplatin, and etoposide in patients with Non Hodgkin's lymphoma whose disease has progressed or has recurred after prior chemotherapy. The Phase II part of the study will be a single-arm, open-label study in which all patients will receive combination bendamustine, ofatumumab, carboplatin and etoposide at the MTD dose defined in phase I. This study hopes to identify a life-prolonging therapy for patients with Non-Hodgkin's Lymphoma whose disease has progressed or has recurred after prior chemotherapy. The hypothesis is that the proposed combination of chemotherapy is well-tolerated and is efficacious for the treatment of relapsed/refractory aggressive B cell lymphomas.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators:

GlaxoSmithKline
Novartis

Treatments:

Antibodies, Monoclonal
Bendamustine Hydrochloride
Carboplatin
Etoposide
Etoposide phosphate
Ofatumumab