Triple therapy for primary immune thrombocytopenia

Efficacy, safety and tolerability of combination therapy with high dose dexamethasone, low dose rituximab and cyclosporine in patients with primary immune thrombocytopenic purpura (ITP)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000015943

Enrollment

Registered

2011-01-06

Start date

2011-01-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

As the major immune cell types involved in initiating and sustaining the ITP disease are antigent presenting cells (APC), B cells and T cells (Chong 2009, Kuwana 2009), it is reasonable to expect better long-term response rates by using drugs targeting all three cell types: namely an anti-B cell agent (rituximab), an anti-APC drug (high dose dexamethasone) and an anti-T cell treatment (cyclosporine). By combining these drugs together over a short period of time (4 weeks), we hope to maximise the efficacy while minimising anticipated toxicities associated with longer-term use of these drugs.

Interventions

triple therapy: 1. high dose dexamethasone (40mg orally days 1-4) 2. low dose rituximab (fixed 100mg intravenous days 7, 14, 21, 28) 3. cyclosporine (2.5-3mg/kg/day orally in 2 divided doses days 1-28) overall duration of treatment is 1 cycle of therapy.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Primary ITP as diagnosed according to IWG guidelines (Provan et, 2010) Platelet count <30x10^9/L or 30-50x10^9/L with either 1. evidence of ongoing bleeding secondary to thrombocytopenia or 2. treatment dependence including corticosteroids, IVIG, second-line immunosuppressants and TPO-agonists. Fully informed written consent

Exclusion criteria

Treatment in the last 6 months with combination therapy of high dose corticosteroids (methylprednisolone >30mg/kg/day for 3 days or high dose dexamethasone 40mg/day for 4 days) and either anti-CD 20 antibody (rituximab) or anti-T cell therapy with cyclosporine or mycophenolate mofetil Active malignant disease - except BCC or SCC of skin Untreated hepatitis B infection Active opportunistic infection or untreated tuberculosis Life expectancy of less than 12 months Moderate-severe renal impairment (eGFR<50mL/min) Poorly controlled hypertension (BP>140/80) Pregnancy in females of child-bearing age

Outcome results