Know Cancer

or
forgot password

A Phase I/II Study of Immunotherapy With Humanized Anti-CD20 Antibody, IMMU-106 (hA20), in Adult Patients With Chronic Immune Thrombocytopenic Purpura


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Autoimmune

Thank you

Trial Information

A Phase I/II Study of Immunotherapy With Humanized Anti-CD20 Antibody, IMMU-106 (hA20), in Adult Patients With Chronic Immune Thrombocytopenic Purpura


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

Hematology laboratory results and adverse events will be followed closely for one year.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

William Wegener, MD, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

IM-T-hA20-07

NCT ID:

NCT00547066

Start Date:

November 2007

Completion Date:

June 2016

Related Keywords:

  • Purpura, Thrombocytopenic, Idiopathic
  • Autoimmune Thrombocytopenic Purpura
  • Purpura, Thrombocytopenic, Autoimmune
  • ITP
  • hA20
  • Treatment
  • Purpura
  • Purpura, Thrombocytopenic
  • Purpura, Thrombocytopenic, Idiopathic

Name

Location

Hackensack, New Jersey  07601
Georgetown University Medical CenterWashington, District of Columbia  20007
Goshen Center for Cancer CareGoshen, Indiana  46526
Center of Hope for Cancer and Blood DisordersRiverdale, Georgia  30274
University of Southern California- Keck School of MedicineLos Angeles, California  90033
Georgia Cancer SpecialtistsTucker, Georgia  30084
Hematology Oncology SpecialistsMetairie, Louisiana  70006
Hematology/Oncology SpecialistsBuffalo, New York  14215
New York Presbyterian Hospital Weill Cornell Medical CenterNew York City, New York  10021
Thurston Arthritis Research CenterChapel Hill, North Carolina  27599