A Chart Review of Rituximab Plus Repeated Cycles of Dexamethasone

Idiopathic Thrombocytopenia Purpura Clinical Trial

— Dex/Rituxan  

Official title:

"A Chart Review of Rituximab Plus Repeated Cycles of Dexamethasone for the Treatment of Relapsed/Refractory ITP:"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02050581
• Other study ID #: 1012011459
• Status: Terminated
• Start date: January 2011

Study information

• Verified date: July 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

1. Subjects must be diagnosed with ITP.

2. Subjects must be 3 years old or older

3. Subjects must have a platelet count less than 40,000/uL at initiation of treatment regimen or inability to discontinue maintenance treatments such as intravenous immunoglobulin (IVIG), corticosteroids, azathioprine, and/or a thrombopoietin receptor agonist.

Exclusion Criteria:

1. Subjects who have not been diagnosed with ITP. 2 Subjects who are younger than 3 years old 3. Subjects who have a medical condition that would be adversely affected by high dose steroids

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenia Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An increase in Platelet count	An increase in Platelet count after 8 weeks on treatment	8 weeks
Secondary	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	Within an average of 12 weeks