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A Study of Obinutuzumab(GA101) in Combination With High-Dose Methylprednisolone(HDMP) in Chronic Lymphocytic Leukemia(CLL) Patients (GA101 & HDMP) — GA101 & HDMP  

CLL Clinical Trial

Official title:
A Study of Obinutuzumab in Combination With High-Dose Methylprednisolone in Chronic Lymphocytic Leukemia Patients

Clinical Trial Summary

We hypothesize that GA101 - Obinutuzumab in combination with HDMP is well tolerated and will induce similar if not higher response rates than the ones observed in Rituximab plus HDMP studies (Castro et al., 2009, Castro et al., 2008).

Clinical Trial Description

This is an open label phase Ib/II clinical trial to determine the safety and clinical activity of the GA101 - Obinutuzumab in combination with high-dose methylprednisone (HDMP). We will evaluate dose-limiting toxicities (DLTs) during the first month of therapy as part of the phase Ib of this study. In the phase II we will determine response rate in an intention to treat analysis. In this study we will include CLL patients that have never received treatment as well as patients that have failed previous treatments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02229422
Study type Interventional
Source University of California, San Diego
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date September 2014
Completion date December 25, 2025
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