The Use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura (TTP)

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT00937131
• Date of registration: 09/07/2009
• Prospective Registration: No
• Primary sponsor: University College, London
• Public title: The Use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura (TTP)
• Scientific title: A Study to Assess the Safety, Efficacy and Tolerability of Rituximab (Mabthera) in Combination With Plasma Exchange (PEX) in Patients With Acute Thrombotic Thrombocytopenic Purpura (TTP)
• Date of first enrolment: March 2006
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00937131
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Marie A Scully, MBBS, BSc, MRCPath
• Affiliation: University College London, University College London Hosptials NHS Trust

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients > 18 years and < 65 years who present with an acute episode of TTP

- Evidence of microangiopathic haemolytic anaemia

- Thrombocytopenia with a normal clotting screen

- Raised Lactate Dehydrogenase (one and a half time above upper normal)

- Patients without neurological dysfunction able to give informed consent

- Patients of reproductive age (must avoid pregnancy for 12 months and/or normalised B
cell function after receiving Rituximab. Oestrogen containing oral contraceptive pills
and the morning after pills should be avoided in female TTP patients)

- Patients with an acute deterioration in neurological function which may include
encephalopathy, such as altered personality, problems with short term memory and coma
can be included when consent has been given by next of kin or from the appropriate
legal representative.

Exclusion Criteria:

- All female subjects who are knowingly pregnant or breast feeding or do not use an
adequate form of contraception (the effect on the foetus and newborn have not yet been
fully established so Rituximab should be avoided in these groups. Male patients
receiving Rituximab should ensure adequate contraception for 12 months following
treatment).

- Patients who are HIV positive (which does not appear to be antibody mediated, would be
unlikely to benefit from Rituximab)

- Patients with childhood TTP

- Patients who have Haemolytic Uraemic Syndrome (HUS) (which is not associated with
reduced ADAMTS 13 levels)

- Patients who are post bone marrow transplant - either autologous or allogeneic

- Patients wiht a medical or long term psychiatric condition which, in the opinion of
the investigator, contraindicates the patients' participation into the trial

- Previous or concurrent malignancies at other sites, with exception of appropriately
treated localized epithelial or cervical cancer. Patients with a history of cured
tumours may be entered (> 5 years).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Thrombotic Thrombocytopenic Purpura (TTP)

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

The primary objective of this study is to investigate whether Rituximab and PEX decreases the time to remission of TTP patients. [Time Frame: One year]

Secondary Outcome(s)

Improved mortality ot TTP patients [Time Frame: 3 months]

Safety and toxicity of Rituximab in conjunction with standard therapy for acute TTP [Time Frame: 3 months]

Effect of Rituximab on B lymphocyte function [Time Frame: One year]

Effect of Rituximab on ADAMTS 13 activity and antibody production and time to relapse [Time Frame: One year]

Secondary ID(s)

BRD/05/011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors