Purpura, Thrombocytopenic, IdiopathicPhase 2NCT00372892
Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)
A Phase 2 study testing Rituximab in people with Purpura, Thrombocytopenic, Idiopathic, run by Hamilton Health Sciences Corporation at 7 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 7 sitesCanada
- Study dates
- Sep 2006to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 21Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
McMaster Univerisity
Hamilton, Ontario, L8N3Z5
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3
London Health Sciences Centre
London, Ontario, N6A 4S2
Ottawa Health Research Institute
Ottawa, Ontario, K1H 8L6
University Health Network
Toronto, Ontario, M5G 2C4
St. Paul's Hospital
Vancouver, British Columbia, V6Z 2A5
About this study
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)
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).
Read the 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.
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Being tested
- Rituximab, Placebo
- Keywords
- Idiopathic Thrombocytopenic Purpura, Rituximab, Feasibility study
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan, Mabthera
375mg/m2 per week for 4 consecutive weeks
PlaceboDrug
Saline IV placebo once per week for 4 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Rituximab Receives: Drug: Rituximab |
| B | Placebo comparator | Saline placebo iv infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Measured: 3 years
Degree of adherence to the study protocol
Measured: 3 years
Event free survival in controls
Measured: 6 months
Bleeding
Measured: 6 months
rescue therapy
Measured: 6 months
Secondary outcomes (4)
Platelet count response
Measured: 6 months
Quality of life
Measured: 6 months
Circulating CD-20 positive lymphocytes
Measured: 6 months
Platelet associated IgG
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Purpura, Thrombocytopenic, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Donald Arnold, McMaster University
- Investigators
- Donald M Arnold, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372892
- Sponsor's protocol ID
- 06-105
- Other IDs
- HC-104634
- Status last verified
- Jun 2012
- First submitted
- 6 Sep 2006
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22223819Arnold 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.
PubMed 20576011
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00372892
- Acronym / sponsor ID
- 06-105
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Keywords
- Idiopathic Thrombocytopenic Purpura, Rituximab, Feasibility study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Sep 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: RituximabRituximab |
| B | Placebo comparator | Drug: PlaceboSaline placebo iv infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: Rituxan, Mabthera375mg/m2 per week for 4 consecutive weeks | Drug | A |
| PlaceboSaline IV placebo once per week for 4 consecutive weeks | Drug | B |
Primary outcome
Feasibility of recruitment
Time frame: 3 years
Degree of adherence to the study protocol
Time frame: 3 years
Event free survival in controls
Time frame: 6 months
Bleeding
Time frame: 6 months
rescue therapy
Time frame: 6 months
4 secondary outcomes
Platelet count response
Time frame: 6 months
Quality of life
Time frame: 6 months
Circulating CD-20 positive lymphocytes
Time frame: 6 months
Platelet associated IgG
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- Derived from this study: PubMed 22223819Arnold 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.
- Derived from this study: PubMed 20576011Arnold 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald M Arnold, MD principal investigator
McMaster University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with Purpura, Thrombocytopenic, Idiopathic, run by Hamilton Health Sciences Corporation at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00372892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.