GOAL: GA101 Plus Pixantrone for Relapsed Aggressive Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title: The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the overall response rate of Obinutuzumab (GA101) in combination with Pixantrone in patients with relapsed aggressive B-cell lymphoma. 70 patients with diffuse large B-cell lymphoma, follicular lymphoma grade IIIB or transformed indolent lymphoma will receive up to 6 cycles of the described combination regimen. Follow up visits are scheduled for up to 3 years.

Clinical Trial Description

In patients with multiple relapsed aggressive lymphoma or refractory lymphoma life expectancy is short. Without potent treatment options the remaining life span can be measured in weeks to a few months.

Recently, an increasing number of reports have shown that either single agent use or the incorporation of potentially more potent agents or new approaches aiming at the inhibition of lymphoma specific pathways may help to overcome the current stagnation in the improvement of first and second line therapies. Surprisingly, little efforts have been undertaken to identify optimal standard dose backbone regimens based on currently available and novel drugs, which ideally would combine activity with reasonable safety and tolerability which allows the addition of targeted drugs in the future. Therefore this trial aims to test prospectively one potential combination to evaluate its potency in patients not suitable for intensive treatment.

Obinutuzumab is an anti-CD20 monoclonal antibody which has shown clinical efficacy even in patients failing Rituximab pre-treatment and therefore is an attractive combination partner within chemo-immunotherapy regimen. Pixantrone belongs to the most potent class of cytostatic drugs for the treatment of lymphoma. Given the proven efficacy of both drugs in relapsed aggressive lymphoma as well as the side effect profiles of both drugs, combination treatment seems sufficiently safe and promises significant efficacy.

This is a multicenter, prospective, open-label, non-randomized trial to evaluate the overall response rate of Obinutuzumab (GA101) in combination with Pixantrone in patients with relapsed aggressive B-cell lymphoma. The trial consists of a 28-days screening period, a treatment-period of up to 6 cycles of the combination regiment, including an interim staging prior to cycle 4 and an end of treatment visit 4-6 weeks after the last study-medication application. The response to treatment is measured by results of computer tomography (CT) after cycle 6 or at the individual end of treatment. Structured follow up visits are scheduled for 2 years, afterwards patients will be followed for survival and progression via a simplified survey until the end of the trial. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

• NCT number: NCT02499003
• Study type: Interventional
• Source: Johannes Gutenberg University Mainz
• Status: Completed
• Phase: Phase 2
• Start date: August 14, 2015
• Completion date: January 2, 2022