Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for ITP
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01107951|
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : March 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenic Purpura||Drug: Rituximab and dexamethasone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for Adult Patients With Immune Thrombocytopenic Purpura.|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||January 2013|
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
- Number of patients with sustained response after 6 months [ Time Frame: 6 months ]Number of patients with partial and complete response after 6 months.
- Number of patients with complete response at month 6 [ Time Frame: month 6 ]Number of patients with platelet count at least 150x109/L, 6 months after therapy
- Bleeding [ Time Frame: month 6 ]Number of patients with bleeding complication after therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107951
|Hospital Universitario Dr. Jose E Gonzalez UANL|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Principal Investigator:||David Gomez-Almaguer, MD||Hospital Universitario|