Purpura, Thrombocytopenic, IdiopathicITP-RITUXNCT01101295
The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.
An observational study of Purpura, Thrombocytopenic, Idiopathic and Autoimmune Thrombocytopenia, run by Henri Mondor University Hospital at 2 sites in France.
Trial summary
The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenia
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2010to Apr 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Immune ThrombocytoPenia (ITP) patients according to the American Society of Hematology (ASH).
Who may be able to join
- ITP diagnosis according to the American Society of Hematology society
- Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)
Who cannot join
- Previous treatment by rituximab
- Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia, Hodgkin Disease...)
- Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Henri Mondor University Hospital
Créteil, Val de Marne, 94010
Mehdi KHELLAF, MD, 0033149812076, mehdi.khellaf@hmn.aphp.fr
Mehdi KHELLAF, MD
- Recruiting
National Reference Center for the Study of Auto Immune Cytopenia
Créteil, Val de Marne, 94010
Mehdi KHELLAF, MD, 0033149812076, mehdi.khellaf@hmn.aphp.fr
About this study
Official title: The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.
The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia.
Read the detailed description
Rituximab (RTX) is used in the treatment of malignant non-Hodgkin's indication for which it has been authorized since 1997 and why it is considered effective and well tolerated. Rituximab is also effective and well tolerated in combination with methotrexate in severe rheumatoid arthritis (RA) refractory to anti-TNF. To date, the RA is the only autoimmune disease in which rituximab has proven efficacy in randomized trials and has obtained authorization in this indication. There are also data from the literature, for the benefit of rituximab in other autoimmune diseases like Lupus, cryoglobulinemia associated to Hepatitis C or Sjogren's disease.
Immune Thrombocytopenia (ITP) is an autoimmune disease in which there is thrombocytopenia due in part to destruction of platelets by autoantibodies. In adults, the disease is most often chronic and in the most severe forms, the treatment of choice is splenectomy. Rituximab was suggested during chronic ITP when used with 4 weekly infusions of 375 mg/m2, 60% of patients achieve an immediate response and 30 to 40% a prolonged response. These encouraging results and the apparent good tolerance advocate for using rituximab as first-line treatment for patients refractory to splenectomy. In France, Afssaps - French Health Products Safety Agency has recently issued a temporary protocol processing to authorize rituximab in this indication. Nevertheless, many questions remain unresolved, including the tolerance of long-term treatment and the risk of late relapse in responders. This justifies the creation of this register, whose establishment is recommended by Afssaps - French Health Products Safety Agency.
- Keywords
- Immune Thrombocytopenia, Rituximab, side effects, tolerance, safety, splenectomy, serum sickness
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Serum Sickness
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a serious adverse events (clinical or biological events)
reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...
Measured: 5 years
Secondary outcomes (5)
Impact of rituximab on the natural history of ITP
Number of patients in complete response (platelet count>100G/L), in partial response (platelet count>50G/L and at least doubling the baseline platelet count)or in failure. Rate of diminution for the concomittant therapies for ITP.
Use of emergencies treatment for ITP.
Measured: 5 years
Modality of the administration of rituximab
number of perfusions, dosage, retreatment.
Measured: 5 years
Characteristics of the patients receiving Rituximab
age, sex, duration of ITP, previous used treatment
Measured: 5 years
Evaluation of the Platelet count evolution
Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.
Measured: 5 years
Rate of splenectomy in the cohort
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Khellaf Mehdi, Henri Mondor University Hospital
- Investigators
- Bertrand GODEAU, MD, Principal investigator, National Reference Center for Study of Cytopenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101295
- Sponsor's protocol ID
- GECAI
- Acronym
- ITP-RITUX
- Status last verified
- Mar 2012
- First submitted
- 5 Apr 2010
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khellaf M, Charles-Nelson A, Fain O, Terriou L, Viallard JF, Cheze S, Graveleau J, Slama B, Audia S, Ebbo M, Le Guenno G, Cliquennois M, Salles G, Bonmati C, Teillet F, Galicier L, Hot A, Lambotte O, Lefrere F, Sacko S, Kengue DK, Bierling P, Roudot-Thoraval F, Michel M, Godeau B. Safety and efficacy of rituximab in adult immune thrombocytopenia: results from a prospective registry including 248 patients. Blood. 2014 Nov 20;124(22):3228-36. doi: 10.1182/blood-2014-06-582346. Epub 2014 Oct 7.
PubMed 25293768
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.
- ClinicalTrials.gov ID
- NCT01101295
- Acronym / sponsor ID
- ITP-RITUX / GECAI
- Keywords
- Immune Thrombocytopenia, Rituximab, side effects, tolerance, safety, splenectomy, serum sickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 9 Apr 2010 (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 primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia.
Detailed description
Rituximab (RTX) is used in the treatment of malignant non-Hodgkin's indication for which it has been authorized since 1997 and why it is considered effective and well tolerated. Rituximab is also effective and well tolerated in combination with methotrexate in severe rheumatoid arthritis (RA) refractory to anti-TNF. To date, the RA is the only autoimmune disease in which rituximab has proven efficacy in randomized trials and has obtained authorization in this indication. There are also data from the literature, for the benefit of rituximab in other autoimmune diseases like Lupus, cryoglobulinemia associated to Hepatitis C or Sjogren's disease.
Immune Thrombocytopenia (ITP) is an autoimmune disease in which there is thrombocytopenia due in part to destruction of platelets by autoantibodies. In adults, the disease is most often chronic and in the most severe forms, the treatment of choice is splenectomy. Rituximab was suggested during chronic ITP when used with 4 weekly infusions of 375 mg/m2, 60% of patients achieve an immediate response and 30 to 40% a prolonged response. These encouraging results and the apparent good tolerance advocate for using rituximab as first-line treatment for patients refractory to splenectomy. In France, Afssaps - French Health Products Safety Agency has recently issued a temporary protocol processing to authorize rituximab in this indication. Nevertheless, many questions remain unresolved, including the tolerance of long-term treatment and the risk of late relapse in responders. This justifies the creation of this register, whose establishment is recommended by Afssaps - French Health Products Safety Agency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Immune ThrombocytoPenia (ITP) patients according to the American Society of Hematology (ASH).
Key inclusion criteria (2 listed)
- ITP diagnosis according to the American Society of Hematology society
- Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)
Key exclusion criteria (3 listed)
- Previous treatment by rituximab
- Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia, Hodgkin Disease...)
- Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of a serious adverse events (clinical or biological events)
Time frame: 5 years
reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...
5 secondary outcomes
Impact of rituximab on the natural history of ITP
Time frame: 5 years
Modality of the administration of rituximab
Time frame: 5 years
Characteristics of the patients receiving Rituximab
Time frame: 5 years
Evaluation of the Platelet count evolution
Time frame: 5 years
Rate of splenectomy in the cohort
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Derived from this study: PubMed 25293768Khellaf M, Charles-Nelson A, Fain O, Terriou L, Viallard JF, Cheze S, Graveleau J, Slama B, Audia S, Ebbo M, Le Guenno G, Cliquennois M, Salles G, Bonmati C, Teillet F, Galicier L, Hot A, Lambotte O, Lefrere F, Sacko S, Kengue DK, Bierling P, Roudot-Thoraval F, Michel M, Godeau B. Safety and efficacy of rituximab in adult immune thrombocytopenia: results from a prospective registry including 248 patients. Blood. 2014 Nov 20;124(22):3228-36. doi: 10.1182/blood-2014-06-582346. Epub 2014 Oct 7.
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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.
Bertrand GODEAU, MD principal investigator
National Reference Center for Study of Cytopenia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Purpura, Thrombocytopenic, Idiopathic and Autoimmune Thrombocytopenia, run by Henri Mondor University Hospital at 2 sites in France.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand GODEAU, MD (0033149812900, bertrand.godeau@hmn.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a serious adverse events (clinical or biological events) (time frame: 5 years). 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 NCT01101295, which also lists 1 linked publication.
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 21 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.