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

NCT02229422 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-30

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Kipps Thomas, MD · University of California, San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2025-10-30
Completion
2025-12-25

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT02229422 on ClinicalTrials.gov