A Chart Review of Rituximab Plus Repeated Cycles of Dexamethasone

NCT02050581 | Terminated

• 1 other identifier: 1012011459
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Thrombocytopenia Purpura

Keywords

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

Outcome Measures

Primary Outcomes (1)

• An increase in Platelet count

  An increase in Platelet count after 8 weeks on treatment

  8 weeks

Secondary Outcomes (1)

• Achieve a complete or partial response to treatment

  Within an average of 12 weeks

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York Presbyterian Hospital Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 24747949 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• James B Bussel, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 31, 2014
• Study Start: January 1, 2011
• Primary Completion: April 12, 2017
• Last Updated: July 16, 2018

Record last verified: 2018-07

Locations

US (1)