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

Primary Purpose

Purpura, Thrombocytopenic, Idiopathic

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Rituximab

Placebo

About this trial

This is an interventional prevention trial for Purpura, Thrombocytopenic, Idiopathic focused on measuring Idiopathic Thrombocytopenic Purpura, Rituximab, Feasibility study

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Pregnancy or breastfeeding.
Known sensitivity to murine proteins, Chinese Hamster Ovary (CHO) cell proteins or to any component of rituximab.
Participation in another clinical trial.
Geographic inaccessibility.
Failure to provide written informed consent.
Any additional laboratory test result, health related illness or other diagnosis which, in the opinion of the treating physician, may put the subject's health or safety at risk.

Sites / Locations

St. Paul's Hospital
Queen Elizabeth II Health Sciences Centre
McMaster Univerisity
Grand River Regional Cancer Centre
London Health Sciences Centre
Ottawa Health Research Institute
University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Rituximab

Saline placebo iv infusion

Outcomes

Primary Outcome Measures

Feasibility of recruitment

Degree of adherence to the study protocol

Event free survival in controls

Bleeding

rescue therapy

Secondary Outcome Measures

Platelet count response

Quality of life

Circulating CD-20 positive lymphocytes

Platelet associated IgG

Full Information

NCT ID

NCT00372892

First Posted

September 6, 2006

Last Updated

June 6, 2012

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00372892

Brief Title

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

Official Title

A Randomized, Double Blind, Placebo Controlled Pilot Trial of Rituximab for Non-splenectomized Adults With Acute Immune Thrombocytopenic Purpura Receiving Standard Treatment (R-ITP)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hamilton Health Sciences Corporation

Collaborators

Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

Immune thrombocytopenic purpura (ITP) is an autoimmune disease characterized by severe thrombocytopenia and bleeding. With current standard therapies, adult-onset ITP tends to recur thus exposing patients to prolonged risks of hemorrhage and toxicities of standard treatments. Rituximab, a chimeric anti-CD20 monoclonal antibody, has been shown to be effectively raise the platelet count in some patients with ITP and there is clinical and biological evidence to suggest that, if given early, rituximab may prevent ITP relapses. We have designed a randomized, double blind, placebo controlled pilot trial of rituximab for the treatment of non-splenectomized adults with acute ITP who are receiving standard treatments. The primary objectives of this trial are to determine the feasibility of recruitment, randomization and blinding; the safety of rituximab in ITP; and the event rate in the control group which will be used to calculate the sample size for a larger trial. Secondary objectives are to determine rates of 6-month event free survival where an event is defined as any of: a platelet count <50; the need for rescue treatment; or significant bleeding. Data from this pilot trial will inform the design of a larger phase III trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Purpura, Thrombocytopenic, Idiopathic

Keywords

Idiopathic Thrombocytopenic Purpura, Rituximab, Feasibility study

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Rituximab

Arm Title

Arm Type

Placebo Comparator

Arm Description

Saline placebo iv infusion

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Rituxan, Mabthera

Intervention Description

375mg/m2 per week for 4 consecutive weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Saline IV placebo once per week for 4 consecutive weeks

Primary Outcome Measure Information:

Title

Feasibility of recruitment

Time Frame

3 years

Title

Degree of adherence to the study protocol

Time Frame

3 years

Title

Event free survival in controls

Time Frame

6 months

Title

Bleeding

Time Frame

6 months

Title

rescue therapy

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Platelet count response

Time Frame

6 months

Title

Quality of life

Time Frame

6 months

Title

Circulating CD-20 positive lymphocytes

Time Frame

6 months

Title

Platelet associated IgG

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Pregnancy or breastfeeding. Known sensitivity to murine proteins, Chinese Hamster Ovary (CHO) cell proteins or to any component of rituximab. Participation in another clinical trial. Geographic inaccessibility. Failure to provide written informed consent. Any additional laboratory test result, health related illness or other diagnosis which, in the opinion of the treating physician, may put the subject's health or safety at risk.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald M Arnold, MD

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Paul's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2A5

Country

Canada

Facility Name

Queen Elizabeth II Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

McMaster Univerisity

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N3Z5

Country

Canada

Facility Name

Grand River Regional Cancer Centre

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2G 1G3

Country

Canada

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4S2

Country

Canada

Facility Name

Ottawa Health Research Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

22223819

Citation

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.

Results Reference

derived

PubMed Identifier

20576011

Citation

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.

Results Reference

derived

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

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