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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

October 17, 2007
May 23, 2014
November 2007
January 2016   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00547066 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Veltuzumab (hA20) at Different Doses in Patients With ITP
A Phase I/II Study of Immunotherapy With Humanized Anti-CD20 Antibody, IMMU-106 (hA20), in Adult Patients With Chronic Immune Thrombocytopenic Purpura

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

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Purpura, Thrombocytopenic, Idiopathic
  • Autoimmune Thrombocytopenic Purpura
  • Purpura, Thrombocytopenic, Autoimmune
Biological: veltuzumab
hA20 will be administered intravenously in two doses over two weeks
Other Names:
  • IMMU-106
  • hA20
  • humanized anti-CD20
Experimental: veltuzumab
veltuzumab is a humanized CD20 antibody administered subcutaneously.
Intervention: Biological: veltuzumab
Liebman HA, Saleh MN, Bussel JB, Negrea OG, Horne H, Wegener WA, Goldenberg DM. Low-dose anti-CD20 veltuzumab given intravenously or subcutaneously is active in relapsed immune thrombocytopenia: a phase I study. Br J Haematol. 2013 Sep;162(5):693-701. doi: 10.1111/bjh.12448. Epub 2013 Jul 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
June 2016
January 2016   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547066
IM-T-hA20-07
No
Immunomedics, Inc.
Immunomedics, Inc.
Not Provided
Study Chair: William Wegener, MD, PHD Immunomedics, Inc.
Immunomedics, Inc.
May 2014

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