Main info

Identifier:

HOVON 64 ITP

Sponsor:

HOVON

Included patients:

156

Active sites:

34

(of 35)

Title:

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

Timeline

Flow

Details

Phase:

Prospective randomized Phase II study

Monitoring Type:

Objectives:

• The main objective of the current study is to investigate the effectiveness of three different dosing schedules rituximab in refractory or relapsed ITP patients, whether or not already splenectomized.
• Furthermore, stratification for splenectomy will be performed to reliably assess whether treatment of non-splenectomized patients with rituximab results in avoidance of splenectomy after 1 year follow up.

Eligibility

Inclusion Criteria:

• Age minimal 18 years
• Subjects with relapsed or refractory ITP (fulfilling the diagnostic criteria given in appendix A) and platelet numbers <30 x 10^9/l
• Having completed first line treatment with corticosteroids
• Written informed consent
• WHO performance status <= 2

Exclusion Criteria:

• The presence of an accessory spleen in splenectomized patients.
• 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).
• Pulsed or high dose corticosteroids, IVIG or splenectomy within 3 weeks prior to randomization. Maintenance corticosteroid therapy is allowed.
• Prior therapy with rituximab.
• 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.
• Inadequate renal and liver function, i.e. creatinin or bilirubin >2.5 x the upper normal value
• Neutrophil count <1.5 x 10^9/l and hemoglobin level <6.2 mmol/l.
• Active bleeding (defined by grade 3 or 4 according to NCI CTCAE v3.0)
• Pregnant or lactating
• Systemic infections: active viral infections, including HIV
• Seriously immunocompromised patients
• Systemic autoimmune disorders (e.g. Systemic lupus erythematosus (SLE))
• Current malignant disease
• Any experimental therapy within 30 days prior to randomization.

Participating Sites

= Active hospitals

= Inactive hospitals