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Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma

A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00285428
Enrollment
82
Registered
2006-02-02
Start date
2004-09-30
Completion date
2007-10-31
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

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
Lead SponsorINDUSTRY

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

MeasureTime frame
Safety and tolerance of different dose levels12 weeks

Secondary

MeasureTime frame
Lack of immunogenicity8 and 12 weeks
Pharmacodynamicsover 12 weeks
Pharmacokineticsover 12 weeks
Efficacy4, 8 and 12 wks, every 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026