NCT00547066

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_1

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

August 16, 2021

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

October 17, 2007

Last Update Submit

August 12, 2021

Conditions

Purpura, Thrombocytopenic, IdiopathicAutoimmune Thrombocytopenic PurpuraPurpura, Thrombocytopenic, Autoimmune

Keywords

ITPhA20Treatment

Outcome Measures

Primary Outcomes (2)

  • Primary - Safety

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

    1 year

  • Secondary - Efficacy

    Platelet responses will be followed for up to 5 years.

    5 years

Study Arms (1)

veltuzumab

EXPERIMENTAL

veltuzumab is a humanized CD20 antibody administered subcutaneously.

Biological: veltuzumab

Interventions

veltuzumabBIOLOGICAL

hA20 will be administered intravenously in two doses over two weeks

Also known as: IMMU-106, hA20, humanized anti-CD20
veltuzumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Southern California- Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Center of Hope for Cancer and Blood Disorders

Riverdale, Georgia, 30274, United States

Location

Georgia Cancer Specialtists

Tucker, Georgia, 30084, United States

Location

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

Hematology Oncology Specialists

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

Denville, New Jersey, 07834, United States

Location

Hematology/Oncology Specialists

Buffalo, New York, 14215, United States

Location

New York Presbyterian Hospital Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Related Publications (2)

  • 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.

    PMID: 27515248DERIVED

  • 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.

    PMID: 23829485DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

veltuzumab

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • William Wegener, MD, PHD

    Gilead Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

November 1, 2007

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

August 16, 2021

Record last verified: 2020-03

Locations

US(8)