Dex/Rituxan: A Chart Review of Rituximab Plus Repeated Cycles of Dexamethasone

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Terminated

CT.gov ID

NCT02050581

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Thrombocytopenia Purpura

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

72 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Apr 12, 2017

Outcome Measures

Primary Outcome Measures

An increase in Platelet count [8 weeks]
An increase in Platelet count after 8 weeks on treatment

Secondary Outcome Measures

Achieve a complete or partial response to treatment [Within an average of 12 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects must be diagnosed with ITP.
Subjects must be 3 years old or older
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:

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