None listed
Conditions
Brief summary
Rituximab's efficacy in causing profound B cell depletion when treating non hodgkin lymphoma has led to interest in its application in B cell mediated auto immune disease. Rituximab at conventional dose is expensive and not without side effects, in particular infection. There is evidence to suggest abbreviated courses may be sufficient in this scenario to achieve disease control whilst minimising potential risks of therapy.
Interventions
Eligible subjects who consent to participate will receive one dose of intravenous rituximab 375mg/m2 at study entry. Response to the initial study treatment will be assessed within 2 - 8 weeks. Response assessment is disease specific, but those achieving at least a partial response will then be observed. Participants achieving minimal or no response would then receive a second intravenous dose. Patients who fail to acheive at least a partial response to two doses would come off study. Those
Eligible subjects who consent to participate will receive one dose of intravenous rituximab 375mg/m2 at study entry. Response to the initial study treatment will be assessed within 2 - 8 weeks. Response assessment is disease specific, but those achieving at least a partial response will then be observed. Participants achieving minimal or no response would then receive a second intravenous dose. Patients who fail to acheive at least a partial response to two doses would come off study. Those with a partial response or better, are observed. If relapsing after at least a 3 month response, up to two further doses may be administered at two week intervals. Total duration of intervention will depend on individual response but could be from 3 to 4 years. If further doses are indicated, they will also be at 375mg/m2 I.V.
Sponsors
Melbourne Health - The Royal Melbourne Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Auto-immune disease refractory to or intolerant of conventional immunosuppressive therapy, Informed consent.
Exclusion criteria
Hepatitis B or C positivity.
Outcome results
None listed