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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00285428
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : February 6, 2012
Sponsor:
Information provided by:
Immunomedics, Inc.

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 2, 2006
Last Update Posted Date February 6, 2012
Study Start Date  ICMJE September 2004
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2008)
Safety and tolerance of different dose levels [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
Safety and tolerance of different dose levels
Change History Complete list of historical versions of study NCT00285428 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2008)
  • Lack of immunogenicity [ Time Frame: 8 and 12 weeks ]
  • Pharmacodynamics [ Time Frame: over 12 weeks ]
  • Pharmacokinetics [ Time Frame: over 12 weeks ]
  • Efficacy [ Time Frame: 4, 8 and 12 wks, every 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
  • Lack of immunogenicity
  • Pharmacodynamics
  • Pharmacokinetics
  • Efficacy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma
Official Title  ICMJE A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkin's Lymphoma
Intervention  ICMJE Drug: hA20-humanized anti-CD20 antibody
once weekly iv dosing for 4 weeks
Other Names:
  • veltuzumab
  • IMMU-106
  • hA20
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2008)
82
Original Enrollment  ICMJE
 (submitted: January 31, 2006)
40
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285428
Other Study ID Numbers  ICMJE IM-T-hA20-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Wegener, MD, PhD, Immunomedics, Inc.
Study Sponsor  ICMJE Immunomedics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.
PRS Account Immunomedics, Inc.
Verification Date February 2012

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