Study of Veltuzumab (hA20) at Different Doses in Patients With ITP
This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and effective for treating ITP.
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Thrombocytopenic Purpura
Purpura, Thrombocytopenic, Autoimmune
|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|
- 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.
|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)|
veltuzumab is a humanized CD20 antibody administered subcutaneously.
hA20 will be administered intravenously in two doses over two weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Buffalo, New York, United States, 14215|
|New York Presbyterian Hospital Weill Cornell Medical Center|
|New York City, New York, United States, 10021|
|Study Chair:||William Wegener, MD, PHD||Immunomedics, Inc.|