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Prospective phase 1/2 study of rituximab in childhood and adolescent chronic immune thrombocytopenic purpura.
- Source :
-
Blood [Blood] 2006 Apr 01; Vol. 107 (7), pp. 2639-42. Date of Electronic Publication: 2005 Dec 13. - Publication Year :
- 2006
-
Abstract
- We assessed safety and efficacy of rituximab in a prospective study of 36 patients, age 2.6 to 18.3 years, with severe chronic immune thrombocytopenic purpura (ITP). The primary outcome of sustained platelets above 50 x 10(9)/L (50,000/mm3) during 4 consecutive weeks, starting in weeks 9 to 12, was achieved by 11 of 36 patients (31%, confidence interval [CI], 16% to 48%). Median response time was 1 week (range, 1 to 7 weeks). Attainment of the primary outcome was not associated with age, prior pharmacologic responses, prior splenectomy, ITP duration, screening platelet count, refractoriness, or IgM reduction. First-dose, infusion-related toxicity was common (47%) despite premedication. Significant drug-related toxicities included third-dose hypotension (n = 1) and serum sickness (n = 2). Peripheral B cells were depleted in all subjects. IgM decreased 3.4% per week, but IgG did not significantly decrease. Rituximab was well tolerated, with manageable infusion-related side effects, but 6% of subjects developed serum sickness. Rituximab is beneficial for some pediatric patients with severe, chronic ITP.
- Subjects :
- Adolescent
Antibodies, Monoclonal, Murine-Derived
Child
Child, Preschool
Humans
Hypotension chemically induced
Patient Selection
Prospective Studies
Rituximab
Serum Sickness chemically induced
Treatment Outcome
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal toxicity
Immunologic Factors therapeutic use
Immunologic Factors toxicity
Purpura, Thrombocytopenic, Idiopathic drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0006-4971
- Volume :
- 107
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Blood
- Publication Type :
- Academic Journal
- Accession number :
- 16352811
- Full Text :
- https://doi.org/10.1182/blood-2005-08-3518