Anti-CD20 treatment of relapsed or refractory immune thrombocytopaenic purpura (ITP) after first line corticosteroid treatment

Completed

• Conditions: Immune thrombocytopaenic purpura (ITP); Haematological Disorders; Purpura and other haemorrhagic conditions

• Registration Number: ISRCTN16619820
• Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands) - Data Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age minimal 18 years
2. Subjects with relapsed or refractory ITP (fulfilling the diagnostic criteria given in appendix A) and platelet numbers less than 30 x 10^9/l
3. Having completed first line treatment with corticosteroids
4. Written informed consent
5. World Health Organization (WHO) performance status less than or equal to 2

Exclusion Criteria

1. The presence of an accessory spleen in splenectomized patients
2. Use of anticoagulants or chemotherapy or known other disorders and/or treatments influencing the platelet number within 3 months of randomisation date (tranexaminic acid [Cyklokapron®] treatment is allowed)
3. Pulsed or high dose corticosteroids, IVIG or splenectomy within 3 weeks prior to randomisation. Maintenance corticosteroid therapy is allowed.
4. Prior therapy with rituximab
5. ITP treatments (other than corticosteroids, IVIG or splenectomy) within 3 months prior to randomisation (e.g. cyclosporin, vincristine). Stable treatment with non-immunosuppressive medication (i.e. danazol, dapson, vitamin C) is permitted.
6. Inadequate renal and liver function, i.e. creatinine or bilirubin greater than 25 x the upper normal value
7. Neutrophil count less than 15 x 10^9/l and haemoglobin level less than 62 mmol/l
8. Active bleeding (defined by grade 3 or 4 according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3.0)
9. Pregnant or lactating
10. Systemic infections: active viral infections, including human immunodeficiency virus (HIV)
11. Seriously immunocompromised patients
12. Systemic autoimmune disorders (e.g. systemic lupus erythematosus [SLE])
13. Current malignant disease
14. Any experimental therapy within 30 days prior to randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The response (CR/GR/MR/NR) to treatment.<br>

Secondary Outcome Measures

Name	Time	Method
1. Need for emergency treatment (platelet count less than 10 or haemorrhagic diathesis, haemorrhage/bleeding defined by grade 3 or 4 according to NCI CTCAE v3.0)<br>2. Time to treatment failure/relapse