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NCT00285428 Clinical Trial

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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00285428
Other study ID # IM-T-hA20-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 2004
Est. completion date October 2007

Study information
Verified date February 2012
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.

Other known NCT identifiers
  • NCT00112970

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks

Locations
Country Name City State
United States MD Anderson Cancer Center Houston Texas
United States New York Presbyterian Hospital/Cornell Medical Center New York New York
United States University Hospital of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (2)

Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123. Review. — View Citation

Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerance of different dose levels 12 weeks
Secondary Lack of immunogenicity 8 and 12 weeks
Secondary Pharmacodynamics over 12 weeks
Secondary Pharmacokinetics over 12 weeks
Secondary Efficacy 4, 8 and 12 wks, every 3 months
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