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

January 31, 2006
February 2, 2012
September 2004
October 2007   (final data collection date for primary outcome measure)
Safety and tolerance of different dose levels [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerance of different dose levels
Complete list of historical versions of study NCT00285428 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Lack of immunogenicity
  • Pharmacodynamics
  • Pharmacokinetics
  • Efficacy
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • veltuzumab
  • IMMU-106
  • hA20
  • Experimental: Dose level 1
    120 mg/m2
    Intervention: Drug: hA20-humanized anti-CD20 antibody
  • Experimental: Dose level 2
    200 mg/m2
    Intervention: Drug: hA20-humanized anti-CD20 antibody
  • Experimental: Dose Level 3
    375 mg/m2
    Intervention: Drug: hA20-humanized anti-CD20 antibody
  • Experimental: Dose level 1B
    80 mg/m2
    Intervention: Drug: hA20-humanized anti-CD20 antibody

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00285428
IM-T-hA20-01
No
William Wegener, MD, PhD, Immunomedics, Inc.
Immunomedics, Inc.
Not Provided
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.
Immunomedics, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP