Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for ITP
The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab and high-dose dexamethasone in the treatment of adult immune thrombocytopenic purpura.
Immune Thrombocytopenic Purpura
Drug: Rituximab and dexamethasone
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for Adult Patients With Immune Thrombocytopenic Purpura.|
- Number of patients with sustained response after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of patients with partial and complete response after 6 months.
- Number of patients with complete response at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]Number of patients with platelet count at least 150x109/L, 6 months after therapy
- Bleeding [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]Number of patients with bleeding complication after therapy
|Study Start Date:||April 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
only one arm receive four doses weekly rituximab and four dosis daily dexamethasona
Drug: Rituximab and dexamethasone
Rituximab 100mg IV days 1,8,15,22.
Dexamethasone 40mg PO days 1-4 (four days)
Other Name: Mabthera
ITP is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction and bleeding. Corticosteroids increase the platelet count in about 80 percent of patients.However, many patients have a relapse when the dose of corticosteroid is reduced. Debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count. Rituximab, a chimeric anti-CD20 monoclonal antibody, has been shown to be effectively raise the platelet count in some patients with ITP and there is clinical and biological evidence to suggest that, if given early, rituximab may prevent ITP relapses. Rituximab 375 mg/m2 weekly for four weeks has significant activity in patients with immune thrombocytopenia. Furthermore, using lower dose rituximab the level of B-cell depletion and the response rates appear similar to those previously observed with standard dosages in a population of ITP.
The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab (100mg IV days 1,8, 15 and 22) and high-dose dexamethasone (40mg PO days 1,2,3,4) in untreated adult patients immune thrombocytopenic purpura.
A complete platelet response is defined as an increase in platelet counts to >150×109/L on two consecutive occasions. A partial response is defined as an increase in the platelet count to between 50 and 150×109/L on two consecutive occasions, 1 week apart. Duration of response is considered from the day of the initial infusion to the first time of relapse (platelet count <30×109/L)or to time of analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107951
|Hospital Universitario Dr. Jose E Gonzalez UANL|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Principal Investigator:||David Gomez-Almaguer, MD||Hospital Universitario|