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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00547066
First received: October 17, 2007
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Thrombocytopenic Purpura
Purpura, Thrombocytopenic, Autoimmune
Biological: veltuzumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

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

  • Efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Platelet responses will be followed for up to 5 years.


Estimated Enrollment: 66
Study Start Date: November 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547066

Locations
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.
Investigators
Study Chair: William Wegener, MD, PHD Immunomedics, Inc.
  More Information

No publications provided by Immunomedics, Inc.

Additional 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
Study First Received: October 17, 2007
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:
ITP
hA20
Treatment

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on November 20, 2014