Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)

Summary

Thrombotic thrombocytopenic purpura (TTP) is a rare disorder that causes blood clots to form in blood vessels. The main treatment for TTP is plasma exchange, in which affected patients receive transfusions of plasma, the liquid part of blood, from healthy donors. This study will examine the effectiveness of an antibody, rituximab, in combination with plasma exchange, at improving the immune response in people with TTP and decreasing the recurrence of TTP.

Conditions

• Thrombotic Thrombocytopenic Purpura

Interventions

DRUG

Rituximab

Dose of 375 mg/m2, given intravenously, repeated at 1-week intervals for a total of four doses

PROCEDURE

Plasma exchange

Target volume of 1.25 plasma volume replacement; fresh frozen plasma (FFP) is the required replacement fluid; provided daily until platelet counts are normal and signs of tissue damage have improved.

DRUG

Corticosteroids

1 mg/kg of prednisone (or equivalent) each day until plasma exchange is stopped

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Genentech, Inc.

  collaborator INDUSTRY

• Carelon Research

  lead OTHER

Principal Investigators

• Susan F. Assmann, PhD · New England Research Institutes, Inc.

• Jan McFarland, MD · Froedtert Hospital

• Eliot Williams, MD, PhD · University of Wisconsin, Madison

• Keith McCrae, MD · University Hospitals Cleveland Medical Center

• Ellis Neufeld, MD · Boston Children's Hospital

• James Bussel, MD · Weill Medical Colllege, Cornell University

• Thomas Ortel, MD · Duke University

• Christopher Hillyer, MD · Emory University

• Paul Ness, MD · Johns Hopkins University

• David Kuter, MD · Massachusetts General Hospital

• Sherrill Slichter, MD · University of Washington Medical Center/Fred Hutchinson Cancer Research Center (FHCRC)

• Cindy Leissinger, MD · Tulane University

• Ronald Strauss, MD · University of Iowa

• John Hess, MD · University of Maryland

• Mark Brecher, MD · University of North Carolina, Chapel Hill

• James George, MD · University of Oklahoma

• Barbara Konkle, MD · University of Pennsylvania

• Darrell Triulzi, MD · University of Pittsburgh Presbyterian and Shadyside/Children's Hospital Pittsburgh

• Joseph Kiss, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2010-02-28

Completion

2010-02-28

Countries

• United States

Study Locations