Recruiting
Phase 2

Rituximab

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT00531089

Conditions

Thrombotic Thrombocytopenic Purpura

Hemolytic Uremic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rituximab

Study Details

Brief summary:

The general objective of this study is to assess the efficacy and safety of Rituximab in the management of patients with refractory or relapsed thrombotic thrombocytopenic purpura-hemolytic uremic syndrome (TTP-HUS). There have been several case reports and case series describing the use of Rituximab in patients with TTP-HUS; however its use has not been studied in a large trial. It is hypothesized that Rituximab may ameliorate the severity of certain cases of TTP-HUS by decreasing the number of activity of B-cells which may result in decreased production of the ADAMTS13 protease inhibitor. Patients with TTP-HUS not responding to standard therapy or patients with relapsed disease may have particular benefit. Treatments that decrease the frequency of relapse or shorten the time to remission of TTP-HUS will be of benefit by decreasing the need for blood product support.

Conditions

Thrombotic Thrombocytopenic Purpura

Hemolytic Uremic Syndrome

Study ID

NCT00531089

Start date

Dec, 2007

Status verified date

Sep, 2007

Completion date

Jan, 2011

Anticipated

Primary completion date

Jan, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • any patient 18 years or older diagnosed with relapsed or refractory TTP-HUS requiring therapy

Exclusion Criteria:

  • alternate cause of hemolytic microangiopathy (evidence of DIC, malignant hypertension, vasculitis, anti-phospholipid antibody syndrome, post-partum acute renal failure)
  • congenital or familial TTP
  • TTP occuring post-stem cell, bone marrow, or solid organ transplant
  • drug-induced TTP
  • pregnancy or breast-feeding
  • history of hepatitis B or C infection
  • prior rituximab treatment
  • active or metastatic cancer
  • other causes of thrombocytopenia such as ITP, myelodysplastic syndrome, confirmed or suspected drug-induced thrombocytopenia
  • refusal to receive blood products
  • hypersensitivity to blood products, plasma products, murine proteins, or any component of the Rituximab formulation
  • geographic inaccessibility
  • co-morbid illness limiting life expectancy to less than 2 months independent of TTP
  • failure to provide written informed consent

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study group

All patients in the study will be in the study group and will receive rituximab. There is no "control" arm.

Interventions

Rituximab

Rituximab will be administered on weeks 1, 2, 3, and 4 at a dose of 375 mg/m2 per infusion. Premedications (prednisone 50 mg, diphenhydramine 50 mg, acetaminophen) will be administered prior to study infusion. Patients will also be treated with plasma exchange as per institution/apheresis centre.

Primary outcome measure

  • The proportion of patients achieving all: (1) platelet count >150x109/L; (2) LDH < 1.5 x normal; (3) no requirement for plasma exchange therapy; (4) asymptomatic. [ Time Frame: 8 weeks after initiation of therapy ]

Central Contacts and Locations

Central contacts

Kathryn E Webert, MD

905-521-2100webertk@mcmaster.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contacts

Paul Yenson, Dr.

604-875-4863pyenson@bccancer.bc.ca

Lisa Basque

604-875-4111lbasque@bccancer.bc.ca

Principal Investigator:

Paul Yenson, Dr

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Julie Carruthers

905-525-9140carrutj@mcmaster.ca

Principal Investigator:

Kathryn E Webert, MD

London Health Sciences Centre, Westminister Campus

Recruiting

London, Ontario, Canada, N6A4G5

Contacts

Clark F William, MD

519-685-8500william.clark@lhsc.on.ca

Principal Investigator:

William F Clark, MD

Princess Margaret Hospital, ABMT/Apheresis Unit

Recruiting

Toronto, Ontario, Canada, M5G2M9

Contacts

David Barth, MD

416-946-4688david.barth@uhn.on.ca

Principal Investigator:

David Barth, MD

St. Paul's Hospital Apheresis Unit

Recruiting

Saskatoon, Saskatchewan, Canada, S7M 0Z9

Contacts

Ahmed Shoker, MD

306-655-5934ahmed.shoker@usask.ca

Principal Investigator:

Ahmed Shoker, MD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

May 19, 2010

Last verified

Sep, 2007

Keywords

  • TTP
  • thrombotic thrombocytopenic purpura
  • HUS
  • hemolytic uremic syndrome
  • plasma exchange

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2010-05-19.