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Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL

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ClinicalTrials.gov Identifier: NCT00546793
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : March 27, 2013
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Tracking Information
First Submitted Date  ICMJE October 17, 2007
First Posted Date  ICMJE October 19, 2007
Last Update Posted Date March 27, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2012)
Safety/tolerability [ Time Frame: over 2 years after treatment ]
safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00546793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
Official Title  ICMJE Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Brief Summary The purpose of this study is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy of veltuzumab that was previously established when administered intravenously.
Detailed Description The first study of veltuzumab given IV weekly in NHL patients (IM-T-hA20-01) has shown excellent tolerability and even efficacy at weekly intravenous doses as low as 80-120 mg/m2 over 4 consecutive weeks. These clinical results confirm experiments laboratory studies. Laboratory studies using Veltuzumab administered subcutaneously showed potent activity based on B-cell depletion. The current study's goal is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in patients with NHL or CLL
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NHL
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Follicular
  • Lymphoma, Intermediate-Grade
  • Lymphoma, Large-Cell
  • Lymphoma, Low-Grade
  • Lymphoma, Mixed-Cell
  • Lymphoma, Small-Cell
  • Leukemia, Lymphocytic, Chronic
  • Leukemia, B-Cell, Chronic
  • Leukemia, Prolymphocytic
  • Leukemia, Small Lymphocytic
  • Lymphoma, Small Lymphocytic
  • Lymphoma, Lymphoplasmacytoid, CLL
  • Lymphoplasmacytoid Lymphoma, CLL
  • CLL
  • SLL
Intervention  ICMJE Biological: veltuzumab
veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
Other Names:
  • hA20
  • humanized anti-CD20
  • IMMU-106
Study Arms  ICMJE Experimental: veltuzumab
veltuzumab is a humanized CD20 antibody administered subcutaneously in this study.
Intervention: Biological: veltuzumab
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: March 25, 2013)
32
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2007)
72
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL)
  • Either previously untreated or relapsed
  • Measurable disease (at least one lesion > 1.5 cm for NHL, or ALC > 5,000 for CLL) see full protocol for additional criteria

Exclusion Criteria:

  • Previously untreated NHL patients with Stage I and II disease (Ann Arbor classification)
  • Previously untreated CLL patients with Stage 0-2 disease (Rai classification) unless specific treatment indications by NCCN guidelines exist (symptomatic, recurrent infections, end-organ function, cytopenias and steady disease progression).

see full protocol for additional criteria

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 NCT00546793
Other Study ID Numbers  ICMJE IM-T-hA20-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immunomedics, Inc.
Study Sponsor  ICMJE Immunomedics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Wegener, MD, PhD Immunomedics, Inc.
PRS Account Immunomedics, Inc.
Verification Date March 2013

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