Adjuvant Low Dose Rituximab for Acquired TTP With Severe ADAMTS13 Deficiency

Status: Completed
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Thrombotic thrombocytopenic purpura (TTP) is a disease characterized by small blood clots throughout the body that can damage major organs and cause death. TTP is treated with plasma exchange (also called plasmapheresis). Patients who do not respond initially to plasma exchange often are helped by later treatment with rituximab. The purpose of this study is to see whether combining low doses of rituximab with plasma exchange will help patients get better sooner and reduce the chance of getting TTP again.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Age 18 or greater

• Diagnosis of suspected thrombotic thrombocytopenic purpura (TTP)

• Platelet count of < 80,000 for newly diagnosed patients and < 120,000 for relapsed patients

• Microangiopathic hemolytic anemia with RBC fragmentation

• LDH >1 x ULN

• Subjects who will receive treatment for TTP with plasma exchange

• Subjects who have not started the 5th plasma exchange

• Plasma ADAMTS13 activity <10%

Locations
United States
Georgia
Emory University
Atlanta
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Missouri
Washington University
Saint Louis
North Carolina
Duke University Medical Center
Durham
Time Frame
Start Date: August 2012
Completion Date: February 14, 2020
Participants
Target number of participants: 19
Treatments
Experimental: low dose rituximab
this is a single-arm trial
Authors
Martha Arellano, Morey Blinder, Timothy Ley, Amelia Langston, Erik Uhlmann, Tanner Johanns, Gowthami Arepally, Thomas L Ortel, Douglas Tollefsen, Elaine Majerus, Suresh Vedantham, Lingling Du, Nirmish Shah, Ana Antun, Matthew Weinstock, Charles Eby, Kenneth Bauer, Stephen Oh, Ara Metjian, Manila Gaddh, Pavan Bhamidipati, Daniel Link, Theodore Thomas, Jacques Galipeau, Anand P Jillella, Siddhartha Devarakonda, Brenda Grossman, George Broze, Leonard T Heffner, Thomas Regenbogen, H Jean Khoury, Zaid Al-Kadhimi, Vamsi Kota, Chih Yi Liao, Kristin Sanfilippo, Toyosi Onwuemene, Jeffrey Zwicker, Zhou Amy, J E Sadler, Joshua Muia, Sana Saif Ur Rehman, Ayad Hamdan
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov

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