Rituximab in Patients With Relapsed or Refractory TTP-HUS

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00531089
• Date of registration: 17/09/2007
• Prospective Registration: Yes
• Primary sponsor: Hamilton Health Sciences Corporation
• Public title: Rituximab in Patients With Relapsed or Refractory TTP-HUS
• Scientific title: A Phase II Study Evaluating the Efficacy of Rituximab in the Management of Patients With Relapsed/Refractory Thrombotic Thrombocytopenic Purpura (TTP) - Hemolytic Uremic Syndrome (HUS)
• Date of first enrolment: December 2007
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00531089
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Kathryn E Webert, MD

• Name: Kathryn E Webert, E
• Affiliation: Hamilton Health Sciences Corporation

• Name: David Barth, MD
• Affiliation: University of Toronto

• Name: Gail Rock, MD
• Affiliation: Canadian Apheresis Group

• Name: Ronan Foley, MD
• Affiliation: Hamilton Health Sciences Corporation

• Name: William Clark, MD
• Affiliation: University of Western Ontario/London Health Sciences

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hemolytic Uremic Syndrome

Thrombotic Thrombocytopenic Purpura

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

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]

Secondary Outcome(s)

mortality [Time Frame: 52 weeks]

proportion of patients with no requirement for plasma exchange therapy [Time Frame: 8 weeks]

changes from baseline in platelet counts, LDH, ADAMTS13 protease level, ADAMTS13 inhibitor level [Time Frame: 8, 12, 24, 52 weeks]

clinical response (CR, PR, non-response) [Time Frame: 52 weeks]

frequency of relapse [Time Frame: 52 weeks]

proportion of patients who are asymptomatic (no new neurological symptoms ans stabilization of previous neurological symptoms [Time Frame: 8 weeks]

toxicity and clinical safety as assessed by monitoring of adverse events, laboratory parameters, vital signs during infusion, and immediate tolerability [Time Frame: 8 weeks]

proportion of patients with LDH < 1.5 X normal [Time Frame: 8 weeks]

proportion of patients with platelet count greater than 150 x 109/L [Time Frame: 8 weeks]

Secondary ID(s)

CAG-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Canadian Apheresis Group

Hoffmann-La Roche

McMaster University