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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Purpura, Thrombocytopenic, Idiopathic Autoimmune Thrombocytopenic Purpura Purpura, Thrombocytopenic, Autoimmune

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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veltuzumab

veltuzumab is a humanized CD20 antibody administered subcutaneously.

Group Type EXPERIMENTAL

veltuzumab

Intervention Type BIOLOGICAL

hA20 will be administered intravenously in two doses over two weeks

Interventions

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veltuzumab

hA20 will be administered intravenously in two doses over two weeks

Intervention Type BIOLOGICAL

Other Intervention Names

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IMMU-106 hA20 humanized anti-CD20

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No