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

This study has been completed.
Sponsor:
Information provided by:
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00285428
First received: January 31, 2006
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: hA20-humanized anti-CD20 antibody
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • Safety and tolerance of different dose levels [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lack of immunogenicity [ Time Frame: 8 and 12 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]
  • Efficacy [ Time Frame: 4, 8 and 12 wks, every 3 months ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: September 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose level 1
120 mg/m2
Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • veltuzumab
  • IMMU-106
  • hA20
Experimental: Dose level 2
200 mg/m2
Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • veltuzumab
  • IMMU-106
  • hA20
Experimental: Dose Level 3
375 mg/m2
Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • veltuzumab
  • IMMU-106
  • hA20
Experimental: Dose level 1B
80 mg/m2
Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • veltuzumab
  • IMMU-106
  • hA20

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285428

Locations
United States, New York
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, United States, 10021
United States, Pennsylvania
University Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.
  More Information

Publications:
Responsible Party: William Wegener, MD, PhD, Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT00285428     History of Changes
Obsolete Identifiers: NCT00112970
Other Study ID Numbers: IM-T-hA20-01
Study First Received: January 31, 2006
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:
treatment
NHL
CD20+ B-cell NHL
Lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014