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
1 other identifier
interventional
82
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2004
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedAugust 17, 2021
February 1, 2012
3.1 years
January 31, 2006
August 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerance of different dose levels
12 weeks
Secondary Outcomes (4)
Lack of immunogenicity
8 and 12 weeks
Pharmacodynamics
over 12 weeks
Pharmacokinetics
over 12 weeks
Efficacy
4, 8 and 12 wks, every 3 months
Study Arms (4)
Dose level 1
EXPERIMENTAL120 mg/m2
Dose level 2
EXPERIMENTAL200 mg/m2
Dose Level 3
EXPERIMENTAL375 mg/m2
Dose level 1B
EXPERIMENTAL80 mg/m2
Interventions
once weekly iv dosing for 4 weeks
Eligibility Criteria
You may qualify if:
- CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (3)
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, 10021, United States
University Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related 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.
PMID: 20214444BACKGROUNDMorschhauser 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 Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18.
PMID: 19451441RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William Wegener, MD, PhD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 31, 2006
First Posted
February 2, 2006
Study Start
September 1, 2004
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
August 17, 2021
Record last verified: 2012-02