Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)

NCT00372892 | Completed Phase 2 DMC

• 2 other identifiers: 06-105HC-104634
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to assess the feasibility of a randomized, double blind, placebo controlled trial of add-on rituximab for non-splenectomized adults with acute immune thrombocytopenic purpura (ITP).

Conditions

Purpura, Thrombocytopenic, Idiopathic

Keywords

Idiopathic Thrombocytopenic Purpura; Rituximab; Feasibility study

Outcome Measures

Primary Outcomes (5)

• Feasibility of recruitment

  3 years

• Degree of adherence to the study protocol

  3 years

• Event free survival in controls

  6 months

• Bleeding

  6 months

• rescue therapy

  6 months

Secondary Outcomes (4)

• Platelet count response

  6 months

• Quality of life

  6 months

• Circulating CD-20 positive lymphocytes

  6 months

• Platelet associated IgG

  6 months

Study Arms (2)

A

ACTIVE COMPARATOR

Rituximab

Drug: Rituximab

B

PLACEBO COMPARATOR

Saline placebo iv infusion

Drug: Placebo

Interventions

Rituximab DRUG

375mg/m2 per week for 4 consecutive weeks

Also known as: Rituxan, Mabthera

A

Placebo DRUG

Saline IV placebo once per week for 4 consecutive weeks

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-splenectomized patients with acute ITP, where "acute ITP" is defined as a platelet count below 30 at the time that standard treatment was recommended by a physician and for which no treatment had been received for the preceding 30 days.
• Must be receiving standard ITP treatment.

You may not qualify if:

• Cardiac arrhythmia.
• Uncontrolled hypertension or inability to hold antihypertensive medications for 12 hours prior to and throughout study drug infusions.
• Known coronary artery disease, angina pectoris or myocardial infarction within the last year.
• Significant pulmonary disease within the last year.
• Stroke, transient ischemic attack or venous thrombosis within the last year.
• Secondary causes of thrombocytopenia (splenomegaly \[palpable spleen or radiologically confirmed \>14 cm\], drug-induced thrombocytopenia, hereditary thrombocytopenia, microangiopathic hemolytic anemia, myelodysplastic syndrome).
• Chronic lymphocytic leukemia or lymphoma.
• Active or metastatic cancer.
• History of hepatitis B or C or HIV.
• Active infection in the 4 weeks before randomization.
• Inherited coagulation factor deficiency.
• Aspirin, aspirin-containing compounds, salicylates, non-steroidal anti-inflammatory medications (NSAIDS) medications, clopidogrel or ticlopidine in the 7 days preceding study drug infusions; vitamin K antagonists (warfarin) in the 3 days preceding study drug infusions; unfractionated heparin or low molecular weight heparin in the 24 hours preceding study drug infusions.
• Elevated INR or prolonged PTT; LDH, serum creatinine, liver function tests (AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin) increased more than 1.5 times upper limit of normal.
• Prior rituximab treatment.
• Unable to schedule 4 weekly study infusions.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Hoffmann-La Roche: collaborator

Study Sites (7)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2A5, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

McMaster Univerisity

Hamilton, Ontario, L8N3Z5, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4S2, Canada

Location

Ottawa Health Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• Arnold DM, Heddle NM, Carruthers J, Cook DJ, Crowther MA, Meyer RM, Liu Y, Cook RJ, McLeod A, MacEachern JA, Mangel J, Anderson D, Vickars L, Tinmouth A, Schuh AC, Kelton JG. A pilot randomized trial of adjuvant rituximab or placebo for nonsplenectomized patients with immune thrombocytopenia. Blood. 2012 Feb 9;119(6):1356-62. doi: 10.1182/blood-2011-08-374777. Epub 2012 Jan 5.

  PMID: 22223819 DERIVED

• Arnold DM, Crowther MA, Meyer RM, Carruthers J, Ditomasso J, Heddle NM, McLeod A, Kelton JG. Misleading hepatitis B test results due to intravenous immunoglobulin administration: implications for a clinical trial of rituximab in immune thrombocytopenia. Transfusion. 2010 Dec;50(12):2577-81. doi: 10.1111/j.1537-2995.2010.02766.x.

  PMID: 20576011 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Donald M Arnold, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 7, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

CA (7)