NCT02229422

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• CLL

Interventions

Type	Name	Description
DRUG	GA101/HDMP	All subjects will receive GA101 - Obinutuzumab by IV infusion for up to 6 cycles (28-day cycles) as follow: * On Cycle 1, Day 1, 100 mg GA101-obinutuzumab will be administered. * On Cycle 1, Day 2, 900 mg of GA101-obinutuzumab will be administered. * On Cycle 1, Days 8 and 15, 1,000 mg of GA101-obinutuzumab will be administered. * On Cycles 2-6, Day 1, 1,000 mg of GA101-obinutuzumab will be administered. All subjects will receive HDMP by IV infusion for up to 4 cycles (28-day cycles) as follow: •On Cycle 1-4, Days 1 to 3, 1,000 mg/m2 Methylprednisolone will be administered.

Timeline

• Start date: 2014-09-01
• Primary completion: 2025-10-30
• Completion: 2025-12-25
• First posted: 2014-09-01
• Last updated: 2023-08-30

Locations

1 site across 1 country: United States