Anti-CD20 treatment of relapsed or refractory Immune Thrombocytopenic Purpura (ITP) after first line corticosteroid treatment.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23430

Enrollment

150

Registered

2005-08-31

Start date

2005-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

None listed

Interventions

All patients will be randomized between: - Arm A: conventional dose rituximab 375 mg/m^2, 4 weekly doses - Arm B: conventional dose rituximab 375 mg/m^2, 2 weekly + 2 weekly doses, dependent on resp

Eligibility

Inclusion criteria

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 <30 x 10^9/l; 3. Having completed first line treatment with corticosteroids; 4. Written informed consent; 5. WHO performance status <= 2.

Exclusion criteria

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 randomization date (tranexaminic acid (Cyklokapron®) treatment is allowed); 3. Pulsed or high dose corticosteroids, IVIG or splenectomy within 3 weeks prior to randomization. Maintenance corticosteroid therapy is allowed; 4. Prior therapy with rituximab; 5. ITP treatments (other than corticosteroids, IVIG or splenectomy) within 3 months prior to randomization (e.g. cyclosporine, vincristine). Stable treatment with non-immunosuppressive medication (i.e. danazol, dapson, vitamin C) is permitted; 6. Inadequate renal and liver function, i.e. creatinin or bilirubin >2.5 x the upper normal value; 7. Neutrophil count <1.5 x 10^9/l and hemoglobin level <6.2 mmol/l; 8. Active bleeding (defined by grade 3 or 4 according to NCI CTCAE v3.0); 9. Pregnant or lactating; 10. Systemic infections: active viral infections, including 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 randomization.

Design outcomes

Primary

Measure	Time frame
The response (CR/GR/MR/NR) to treatment.	—

Secondary

Measure	Time frame
1. Need for emergency treatment (platelet count <10 or hemorrhagic diathesis, hemorrhage/bleeding defined by grade 3 or 4 according to NCI CTCAE v3.0); 2. Time to treatment failure/relapse.	—

Contacts

Public ContactH.R. Koene

Academic Medical Center (AMC), Department of Hematology, P.O. Box 22660

h.r.koene@amc.uva.nl+31 (0)20 5669111

Outcome results