A Phase 2 interventional study of Rituximab and dexamethasone in Immune Thrombocytopenic Purpura, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-03-22.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Phase 2, Interventional, and Treatment
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.
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.
263 studies on the registry are indexed under Purpura; 27 are open to participants now.
This study's enrollment of 21 is below the median of 50 across 171 interventional studies indexed under Purpura.
Browse Purpura studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 79 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Also known as: Mabthera
Number of patients with sustained response after 6 months
Number of patients with partial and complete response after 6 months.
Time frame: 6 months
Number of patients with complete response at month 6
Number of patients with platelet count at least 150x109/L, 6 months after therapy
Time frame: month 6
Bleeding
Number of patients with bleeding complication after therapy
Time frame: month 6
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Dr. Jose E. Gonzalez