An observational study in Idiopathic Thrombocytopenia Purpura, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2018-07-16.
Sponsored by Weill Medical College of Cornell University · Observational
In this prospective and retrospective chart review, investigators will evaluate the response rates and duration of response for patients with relapsed and refractory idiopathic thrombocytopenic purpura (ITP) who have been treated with rituximab and repeated courses of dexamethasone. Investigators will also evaluate observed toxicities of the combination, and characteristics associated with response.
Patients with idiopathic thrombocytopenic purpura (ITP) usually respond with an increase in platelet count after treatment with steroids, but most patients will experience recurrence.Rituximab has been a useful treatment for patients with recurrent ITP; many hundreds of patients have been treated. 30-40% of patients will achieve a complete remission (CR: platelet count >150 x 109/l) with initial treatment. However, most patients will relapse between 1 and 3 years from initial treatment suggesting that long-term "cures" only occur in 20% of the initial patients. An increased rate of durable CRs is therefore a desirable goal. One approach would be to use rituximab maintenance; however, this strategy results in long term B cell suppression. Dexamethasone has also been used to achieve "cure" in ITP, especially in adults at or near diagnosis. An initial study suggested that approximately 50% of patients would achieve a long-term response with only one 4-day cycle of high dose (40 mg/day) dexamethasone. A follow up study suggested that 3-4 cycles of dexamethasone would be better than 1 cycle. Finally, a recent publication suggested that rituximab plus one cycle of dexamethasone was superior to dexamethasone alone, with a > 50% CR rate at 6 months. Based on the published activity of rituximab and dexamethasone in this disorder, some patients have received treatment with combined dexamethasone and rituximab. We will review the data of those patients who have received more than one course of dexamethasone together with rituximab for relapsed or refractory ITP in order to determine the response rate, duration of response, toxicity of the combination, and clinical predictors of response in this group.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's enrollment of 72 is below the median of 120 across 183 observational studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who have received more than one course of dexamethasone together with rituximab for relapsed or refractory ITP.
Exclusion Criteria:
An increase in Platelet count
An increase in Platelet count after 8 weeks on treatment
Time frame: 8 weeks
Achieve a complete or partial response to treatment
Investigators hope patients will achieve a complete response (a platelet count greater than or equal to 100,000/uL) or a partial response (a platelet count between 50,000/uL and 99,000/uL) not due to rescue medication within an average of 12 weeks
Time frame: Within an average of 12 weeks
Plan to share: Undecided
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University