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OpenTrials
Completed

NCT Number: NCT00285428

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

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

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New York Presbyterian Hospital/Cornell Medical Center, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease

Treatment and study plan

hA20-humanized anti-CD20 antibody

Drug

once weekly iv dosing for 4 weeks

Other names: veltuzumab, IMMU-106, hA20

Primary outcomes

  1. Safety and tolerance of different dose levels

    Time frame: 12 weeks

Secondary outcomes

  1. Lack of immunogenicity

    Time frame: 8 and 12 weeks

  2. Pharmacodynamics

    Time frame: over 12 weeks

  3. Pharmacokinetics

    Time frame: over 12 weeks

  4. Efficacy

    Time frame: 4, 8 and 12 wks, every 3 months

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Feb 2, 2006
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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