MedTrace Logo

GOAL: GA101 Plus Pixantrone for Relapsed Aggressive Lymphoma

NCT02499003 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

DRUG

Obinutuzumab and Pixantrone

Obinutuzumab: 1000 mg flat dose on day 1, 8, 15 of cycle one and day 1 of subsequent cycles, Pixantrone: 50 mg/m² Pixantrone on day 1,8,15 of each 28 d cycle

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Servier

    collaborator INDUSTRY

  • Johannes Gutenberg University Mainz

    lead OTHER

Principal Investigators

  • Georg Hess, MD · Johannes Gutenberg University Mainz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-14
Primary Completion
2019-01-02
Completion
2022-01-02

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02499003 on ClinicalTrials.gov