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

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ClinicalTrials.gov Identifier: NCT00547066
Recruitment Status : Unknown
Verified March 2016 by Immunomedics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 19, 2007
Last Update Posted : March 21, 2016
Information provided by (Responsible Party):
Immunomedics, Inc.

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
Purpura, Thrombocytopenic, Idiopathic Autoimmune Thrombocytopenic Purpura Purpura, Thrombocytopenic, Autoimmune 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
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 : November 2007
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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

Primary Outcome Measures :
  1. Safety [ Time Frame: 1 year ]
    Hematology laboratory results and adverse events will be followed closely for one year.

  2. Efficacy [ Time Frame: 5 years ]
    Platelet responses will be followed for up to 5 years.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547066

United States, California
University of Southern California- Keck School of Medicine
Los Angeles, California, United States, 90033
United States, Georgia
Center of Hope for Cancer and Blood Disorders
Riverdale, Georgia, United States, 30274
Georgia Cancer Specialtists
Tucker, Georgia, United States, 30084
United States, Indiana
Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
United States, Louisiana
Hematology Oncology Specialists
Metairie, Louisiana, United States, 70006
United States, New Jersey
Denville, New Jersey, United States, 07834
United States, New York
Hematology/Oncology Specialists
Buffalo, New York, United States, 14215
New York Presbyterian Hospital Weill Cornell Medical Center
New York City, New York, United States, 10021
Sponsors and Collaborators
Immunomedics, Inc.
Study Chair: William Wegener, MD, PHD Immunomedics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT00547066     History of Changes
Other Study ID Numbers: IM-T-hA20-07
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016

Keywords provided by Immunomedics, Inc.:

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents