Study of Veltuzumab (hA20) at Different Doses in Patients With ITP

Sponsor
Gilead Sciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT00547066
Collaborator
(none)
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Study Details

Study Description

Brief Summary

This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and effective for treating ITP.

Condition or Disease Intervention/Treatment Phase
  • Biological: veltuzumab
Phase 1/Phase 2

Detailed Description

The goal of current treatment guidelines for most patients with chronic adult ITP is to maintain platelet levels above 30 x 109/L. The conventional first-line therapy is corticosteroids with or without intravenous immunoglobulins, but many patients relapse when steroids are tapered. Standard therapy then is splenectomy, but patients with refractory ITP who do not respond require further therapy. Unfortunately, immunosuppressive agents or other available treatments typically produce only short-term responses. Because of the lack of medical options after first-line therapy, the target population for this first study of anti-CD20 immunotherapy with hA20 are adult patients with chronic ITP who failed at least one standard ITP therapy (i.e., received at least one standard ITP therapy and now present with platelet levels below 30 x 109/L).

In autoimmune disease, rituximab as well as other anti-CD20 antibodies currently being considered for commercialization have focused on a different dosing schedule in rheumatoid arthritis, and use fixed dosages rather than variable doses based on body surface area. In addition, recent studies of these newer anti-CD20 antibodies in rheumatoid arthritis have reported that lower doses indeed appear effective when administered twice, 2 weeks apart. Based upon these considerations, patients in this study will receive hA20 twice, 2 weeks apart, and administered at one of 3 dose levels.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Study of Immunotherapy With Humanized Anti-CD20 Antibody, IMMU-106 (hA20), in Adult Patients With Chronic Immune Thrombocytopenic Purpura
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: veltuzumab

veltuzumab is a humanized CD20 antibody administered subcutaneously.

Biological: veltuzumab
hA20 will be administered intravenously in two doses over two weeks
Other Names:
  • IMMU-106
  • hA20
  • humanized anti-CD20
  • Outcome Measures

    Primary Outcome Measures

    1. Primary - Safety [1 year]

      Hematology laboratory results and adverse events will be followed closely for one year.

    2. Secondary - Efficacy [5 years]

      Platelet responses will be followed for up to 5 years.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male or female, >18 years old, with or without prior splenectomy

    • Signed written informed consent obtained prior to study entry

    • ITP according to ASH guidelines, with other potential causes of thrombocytopenia excluded

    • Platelet levels < 150 x 109/L for more than 6 months

    • Received an adequate course of at least one standard ITP treatment (an inadequate course of standard ITP therapy does not qualify as meeting this requirement)

    • Platelet count < 30 x 109/L at study entry and on at least one other occasion at least 1 week apart within the past month. (Phase I only: platelet count also > 10 x 109/L at study entry).

    • Bleeding assessment score of Grade 0 or 1. See full protocol for all inclusion criteria

    Exclusion Criteria:

    See full protocol for exclusion criteria or contact study staff for details

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Southern California- Keck School of Medicine Los Angeles California United States 90033
    2 Center of Hope for Cancer and Blood Disorders Riverdale Georgia United States 30274
    3 Georgia Cancer Specialtists Tucker Georgia United States 30084
    4 Goshen Center for Cancer Care Goshen Indiana United States 46526
    5 Hematology Oncology Specialists Metairie Louisiana United States 70006
    6 Denville New Jersey United States 07834
    7 Hematology/Oncology Specialists Buffalo New York United States 14215
    8 New York Presbyterian Hospital Weill Cornell Medical Center New York New York United States 10021

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Chair: William Wegener, MD, PHD, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT00547066
    Other Study ID Numbers:
    • IM-T-hA20-07
    First Posted:
    Oct 19, 2007
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Mar 1, 2020
    Keywords provided by Gilead Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2021