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

August 12, 2021 updated by: Gilead Sciences

A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital/Cornell Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University Hospital of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose level 1
120 mg/m2
Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • IMMU-106
  • hA20
  • veltuzumab
Experimental: Dose level 2
200 mg/m2
Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • IMMU-106
  • hA20
  • veltuzumab
Experimental: Dose Level 3
375 mg/m2
Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • IMMU-106
  • hA20
  • veltuzumab
Experimental: Dose level 1B
80 mg/m2
Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • IMMU-106
  • hA20
  • veltuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerance of different dose levels
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Lack of immunogenicity
Time Frame: 8 and 12 weeks
8 and 12 weeks
Pharmacodynamics
Time Frame: over 12 weeks
over 12 weeks
Pharmacokinetics
Time Frame: over 12 weeks
over 12 weeks
Efficacy
Time Frame: 4, 8 and 12 wks, every 3 months
4, 8 and 12 wks, every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 2, 2006

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM-T-hA20-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Hodgkin's Lymphoma

Clinical Trials on hA20-humanized anti-CD20 antibody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe