Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)
This study has been completed.
Sponsor:
Hamilton Health Sciences Corporation
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Donald Arnold, McMaster University
ClinicalTrials.gov Identifier:
NCT00372892
First received: September 6, 2006
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Purpura, Thrombocytopenic, Idiopathic |
Drug: Rituximab Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
thrombotic thrombocytopenic purpura
Drug Information available for:
Rituximab
U.S. FDA Resources
Further study details as provided by McMaster University:
Primary Outcome Measures:
- Feasibility of recruitment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Degree of adherence to the study protocol [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Event free survival in controls [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Bleeding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- rescue therapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Platelet count response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Circulating CD-20 positive lymphocytes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Platelet associated IgG [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | September 2006 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Rituximab
|
Drug: Rituximab
375mg/m2 per week for 4 consecutive weeks
Other Name: Rituxan, Mabthera
|
|
Placebo Comparator: B
Saline placebo iv infusion
|
Drug: Placebo
Saline IV placebo once per week for 4 consecutive weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372892
Locations
| Canada, British Columbia | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z 2A5 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| McMaster Univerisity | |
| Hamilton, Ontario, Canada, L8N3Z5 | |
| Grand River Regional Cancer Centre | |
| Kitchener, Ontario, Canada, N2G 1G3 | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4S2 | |
| Ottawa Health Research Institute | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Hoffmann-La Roche
Investigators
| Principal Investigator: | Donald M Arnold, MD | McMaster University |
More Information
No publications provided by McMaster University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Donald Arnold, MD, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00372892 History of Changes |
| Other Study ID Numbers: | 06-105, HC-104634 |
| Study First Received: | September 6, 2006 |
| Last Updated: | June 6, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McMaster University:
|
Idiopathic Thrombocytopenic Purpura Rituximab Feasibility study |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia |
Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013