Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma
Phase 1
Completed
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT00285428
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
Inclusion Criteria
- CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose level 1 hA20-humanized anti-CD20 antibody 120 mg/m2 Dose level 2 hA20-humanized anti-CD20 antibody 200 mg/m2 Dose Level 3 hA20-humanized anti-CD20 antibody 375 mg/m2 Dose level 1B hA20-humanized anti-CD20 antibody 80 mg/m2
- Primary Outcome Measures
Name Time Method Safety and tolerance of different dose levels 12 weeks
- Secondary Outcome Measures
Name Time Method Lack of immunogenicity 8 and 12 weeks Pharmacodynamics over 12 weeks Pharmacokinetics over 12 weeks Efficacy 4, 8 and 12 wks, every 3 months
Trial Locations
- Locations (3)
New York Presbyterian Hospital/Cornell Medical Center
🇺🇸New York, New York, United States
University Hospital of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States