Clinical trial NCT00547066: Study of Veltuzumab (hA20) at Different Doses in Patients With ITP
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Purpura, Thrombocytopenic, Idiopathic
Autoimmune Thrombocytopenic Purpura
Purpura, Thrombocytopenic, Autoimmune
Keywords: ITP
hA20
Treatment
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Primary - Safety
timeFrame: 1 year
measure: Secondary - Efficacy
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California- Keck School of Medicine
state: California
city: Riverdale
country: United States
facility: Center of Hope for Cancer and Blood Disorders
state: Georgia
city: Tucker
country: United States
facility: Georgia Cancer Specialtists
state: Georgia
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Metairie
country: United States
facility: Hematology Oncology Specialists
state: Louisiana
city: Denville
country: United States
state: New Jersey
city: Buffalo
country: United States
facility: Hematology/Oncology Specialists
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Gilead Sciences
name: William Wegener, MD, PHD
role: STUDY_CHAIR
References:
citation: Liebman HA, Saleh MN, Bussel JB, Negrea OG, Horne H, Wegener WA, Goldenberg DM. Comparison of two dosing schedules for subcutaneous injections of low-dose anti-CD20 veltuzumab in relapsed immune thrombocytopenia. Haematologica. 2016 Nov;101(11):1327-1332. doi: 10.3324/haematol.2016.146738. Epub 2016 Aug 11.
citation: 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.