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TerminatedNCT02050581Dex/RituxanUpdated Jul 16, 2018

A Chart Review of Rituximab Plus Repeated Cycles of Dexamethasone

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

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
72
Ages
3 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Idiopathic Thrombocytopenia Purpura

Keywords

  • Platelets are a part of the blood hat helps with clotting
  • ITP idiopathic thrombocytopenia purpura low platelet count
03

In context

Thrombocytopenia

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have received more than one course of dexamethasone together with rituximab for relapsed or refractory ITP.

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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
72 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. An increase in Platelet count

    An increase in Platelet count after 8 weeks on treatment

    Time frame: 8 weeks

Secondary outcomes

  1. 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

07

Study locations

1 site
  • New York Presbyterian Hospital Weill Cornell Medical College
    New York, New York 10065, United States
08

References and documents

Publications

  • Bussel JB, Lee CS, Seery C, Imahiyerobo AA, Thompson MV, Catellier D, Turenne IG, Patel VL, Basciano PA, Elstrom RL, Ghanima W. Rituximab and three dexamethasone cycles provide responses similar to splenectomy in women and those with immune thrombocytopenia of less than two years duration. Haematologica. 2014 Jul;99(7):1264-71. doi: 10.3324/haematol.2013.103291. Epub 2014 Apr 18. PubMed 24747949 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02050581
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Jan 31, 2014
Start date
Jan 2011
Primary completion
Apr 12, 2017
Last update
Jul 16, 2018

Study contacts

James B Bussel, M.D.
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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