Non-Hodgkin's Lymphoma
Conditions
Keywords
treatment, NHL, CD20+ B-cell NHL, Lymphoma
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.
Interventions
DRUGhA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance of different dose levels | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Lack of immunogenicity | 8 and 12 weeks |
| Pharmacodynamics | over 12 weeks |
| Pharmacokinetics | over 12 weeks |
| Efficacy | 4, 8 and 12 wks, every 3 months |
Countries
United States
Outcome results
None listed