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

Gilead Sciences (Industry)
Overall Status
Completed ID

Study Details

Study Description

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 Design

Study Type:
Actual Enrollment :
32 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: veltuzumab

veltuzumab is a humanized CD20 antibody administered subcutaneously in this study.

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
  • Outcome Measures

    Primary Outcome Measures

    1. Safety/tolerability [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.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 Lewis Cancer Center and Research Pavilion Savannah Georgia United States 31405
    2 Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A. Denville New Jersey United States 07834
    3 Morristown Memorial Hospital Morristown New Jersey United States 07950
    4 New York Hospital Weill Cornell Medical Center New York New York United States 10021
    5 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • Gilead Sciences


    • Study Director: William Wegener, MD, PhD, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Gilead Sciences Identifier:
    Other Study ID Numbers:
    • IM-T-hA20-08
    First Posted:
    Oct 19, 2007
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Mar 1, 2013

    Study Results

    No Results Posted as of Aug 16, 2021