MPNPhase 3FASTNCT02611973
Hydroxyurea Versus Aspirin and Hydroxyurea in Essential Thrombocythemia
A Phase 3 study testing Aspirin therapy interruption, Usual treatment by aspirin 100 mg/d in the active comparator arm and No interruption of aspirin in the Observational arm in people with MPN and Essential Thrombocythemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes less useful once patients have achieved a hematologic response (HR) (modified by amendment 1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially in elderly patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MPN, Essential Thrombocythemia
- What is being tested?
- Aspirin therapy interruption, Usual treatment by aspirin 100 mg/d in the active comparator arm and No interruption of aspirin in the Observational arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,250 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2016to Nov 2022
- Phase
- Phase 3
- 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
Who may be able to join
- > 18 years and older (modified by amendment 01/03/2017)
- Contraception considered effective by the investigator: for women of childbearing and for men whose partner is likely to procreate (added by amendment 01/03/2017)
- Diagnosis of ET performed within the last 10 years (modified by amendment 01/03/2017) : with or without Janus kinase 2V617F (JAK2V617F) mutation according to the WHO 2008 criteria (TEFFERI,2007)
- ET patients currently treated with hydroxyurea in first line, who have achieved a complete or partial hematologic response according to the ELN 2009 (BAROSI, 2009) modified (at least three month apart and at inclusion) (modified by amendment 01/03/2017)
- Signed Written Informed Consent
- Health insurance coverage.
Who cannot join
- Other myeloproliferative disorder than ET.
- Contra-indication to hydroxyurea.
- Other uncontrolled malignancies at the time of diagnosis or inclusion.
- History of haemostasis perturbation not related to ET, associated with a significant risk of hemorrhage or thrombosis (modified by amendment 01/03/2017)
- -.• Pregnancy or breastfeeding (added by amendment 01/03/2017)
- Inability to freely provide consent through judiciary or administrative condition.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Henri Mondor Hospital
Créteil, 94010
Stéphane Giraudier, MD, PhD, (0)149812880 ext. +33, stephane.giraudier@aphp.fr
Onja Rarison, CRA, (0)149813387 ext. +33, onja.rarison@aphp.fr
About this study
Official title: French Aspirin Study in Essential Thrombocythemia: an Open and Randomized Study
The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes less useful once patients have achieved a hematologic response (HR) (modified by amendment 1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially in elderly patients.
Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in hematological response (modified by amendment 1/03/2017) on Hydroxyurea.
Read the detailed description
ET is a myeloproliferative neoplasm (MPN) characterized by a high platelet level. Increased occurrence of thrombosis and hemorrhages are the main complications in ET. In this regard, the key factors defining high risk ET include age over 60 years, past history of thrombosis, platelet > 1500 109/L and to a lesser degree cardiovascular risk factors. These criteria currently serve as therapeutic guidelines for the use of cytoreductive therapy, with hydroxyurea (HU) being the treatment of choice in the first line setting.
The use of antiplatelet agent i.e. low-dose aspirin is also generally recommended. However, the benefit of aspirin has never been formally demonstrated in ET. Only indirect evidence come from the ECLAP study that enrolled patients with polycythemia vera (PV). Of note in the ECLAP study, the efficacy of aspirin was assessed only at diagnosis but not correlated thereafter with the hematological response on cytoreductive therapy.
In general non-MPN population studies, primary prophylaxis with aspirin has been associated with a risk reduction of major vascular events, but an increased risk of hemorrhage, especially considering age and prior gastrointestinal history. In a recent retrospective study, the combination of aspirin and cytoreduction was reported to prevent thrombosis but concomitantly increase the bleeding risk when compared to HU alone , especially in patients older than 60 years, thus questioning the benefits of long term use of aspirin therapy. These data raise the question of the actual benefit of aspirin maintenance, once patients have been efficiently treated with cytoreductive therapy.
Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio of aspirin maintenance in high risk ET patients, in hematological response (modified by amendment 1/03/2017) on Hydroxyurea. Patients for which Aspirin interruption will not be possible because of extra-ET indications will be enrolled in the control observational arm.
- Conditions
- MPN, Essential Thrombocythemia
- Being tested
- Aspirin therapy interruption, Usual treatment by aspirin 100 mg/d in the active comparator arm, No interruption of aspirin in the Observational arm, Hydroxyurea treatment (HU)
- Keywords
- Essential Thrombocythemia, Aspirin
- Medical subject headings
- Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin therapy interruptionOther
Stop the treatment by aspirin 100mg/d in the experimental arm.
Usual treatment by aspirin 100 mg/d in the active comparator armOther
HU+ aspirin maintenance
No interruption of aspirin in the Observational armOther
patient with Contre indication to aspirin or required antithrombotic therapy
Hydroxyurea treatment (HU)Drug
HU maintenance
| Study group | Role | What they receive |
|---|---|---|
| HU without aspirin | Experimental | Not described Receives: Other: Aspirin therapy interruption; Drug: Hydroxyurea treatment (HU) |
| HU + aspirin maintenance | Active comparator | Not described Receives: Other: Usual treatment by aspirin 100 mg/d in the active comparator arm; Drug: Hydroxyurea treatment (HU) |
| HU + AAG | Other | Observational arm Receives: Other: No interruption of aspirin in the Observational arm; Drug: Hydroxyurea treatment (HU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of death from vascular origin and other thrombotic and hemorrhagic events (combined endpoint)
Definition of vascular events:
Thrombotic events: Myocardial infarction, unstable angina, stroke, transient ischemic attack, peripheral arterial thrombosis, splanchnic or limb deep vein thrombosis, pulmonary embolism, and erythromelalgia
Hemorrhagic events:
Intracranial or retroperitoneal bleed, overt hemorrhage associated with a decrease in hemoglobin ≥20 g/l or overt hemorrhage requiring a blood transfusion of two red blood cell (RBC) units or more, and hemorrhage of grade >=2 according to the NCI Common Toxicity criteria (CTC) V.4.0 scale.
Deaths will be included as a death from thrombosis or hemorrhage if they satisfied criteria for one of the above diagnoses immediately ANTE-MORTEM or if they had a POST-MORTEM examination confirming the diagnosis. Sudden death of presumed vascular origin without a POST-MORTEM examination will be included as a thrombotic death.
Measured: at 2-years follow-up
Secondary outcomes (19)
Cumulative incidence and characteristics of vascular complications: thrombosis and hemorrhage, (grade, site, recurrence), assessed yearly over a 5-year follow-up period.
Measured: at 5 years
Rate of hematological response every 6 months
Hematological response as assessed by European Leukemia Net (ELN) criteria, revised ELN International Working Group on Myeloproliferative Neoplasms Research and Treatment (ELN -IWG MRT).
Measured: at 5 years
Adverse event (AE) frequency and incidence, comparison in the two arms
Measured: at 5 years
Number of HU-related nonhematologic toxicities
Measured: at 5 years
Cumulative incidence of thrombosis
Measured: at 5 years
Cumulative incidence of hemorrhagic complications
Measured: at 5 years
Estimation of the progression-free survival
Measured: at 5 years
Estimation of overall survival
Measured: at 5 years
Short Form 36 (SF36) Health Survey
Evaluation of quality of life by using SF36
Measured: through study completion, an average of 1 year
Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
Evaluation of quality of life by using (MPN-SAF)
Measured: through study completion, an average of 1 year
Number of mortality cause.
Measured: at 5 years
Cumulative incidence of progression to polyglobulia
Measured: at 5 years
Cumulative incidence of progression to myelofibrosis (MF)
Measured: at 5 years
Cumulative incidence of progression to myelodysplastic syndrome (MDS)
Measured: at 5 years
Cumulative incidence of progression AML
Measured: at 5 years
Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden (in blood DNA) in patients presenting thrombosis or not .
Measured: at 5 years
Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patients in persistent hematological response (modified by amendment 1/03/2017).
responses and intolerance define according to ELN criteria
Measured: at 5 years
Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patient who will lose their hematological response (modified by amendment 1/03/2017).
responses and intolerance define according to ELN criteria
Measured: at 5 years
Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patients presenting intolerance to treatment.
responses and intolerance define according to ELN criteria
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study start10 Mar 2016
- Primary completionNov 2019 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MPNStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Giraudier, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611973
- Sponsor's protocol ID
- P140933
- Acronym
- FAST
- Status last verified
- Jul 2017
- First submitted
- 13 Oct 2015
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alvarez-Larran A, Pereira A, Arellano-Rodrigo E, Hernandez-Boluda JC, Cervantes F, Besses C. Cytoreduction plus low-dose aspirin versus cytoreduction alone as primary prophylaxis of thrombosis in patients with high-risk essential thrombocythaemia: an observational study. Br J Haematol. 2013 Jun;161(6):865-71. doi: 10.1111/bjh.12321. Epub 2013 Apr 12.
PubMed 23577924Barbui T, Barosi G, Birgegard G, Cervantes F, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Hehlmann R, Hoffman R, Kiladjian JJ, Kroger N, Mesa R, McMullin MF, Pardanani A, Passamonti F, Vannucchi AM, Reiter A, Silver RT, Verstovsek S, Tefferi A; European LeukemiaNet. Philadelphia-negative classical myeloproliferative neoplasms: critical concepts and management recommendations from European LeukemiaNet. J Clin Oncol. 2011 Feb 20;29(6):761-70. doi: 10.1200/JCO.2010.31.8436. Epub 2011 Jan 4.
PubMed 21205761Barosi G, Birgegard G, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Kiladjian JJ, Lengfelder E, McMullin MF, Passamonti F, Reilly JT, Vannucchi AM, Barbui T. Response criteria for essential thrombocythemia and polycythemia vera: result of a European LeukemiaNet consensus conference. Blood. 2009 May 14;113(20):4829-33. doi: 10.1182/blood-2008-09-176818. Epub 2009 Mar 10.
PubMed 19278953Barosi G, Mesa R, Finazzi G, Harrison C, Kiladjian JJ, Lengfelder E, McMullin MF, Passamonti F, Vannucchi AM, Besses C, Gisslinger H, Samuelsson J, Verstovsek S, Hoffman R, Pardanani A, Cervantes F, Tefferi A, Barbui T. Revised response criteria for polycythemia vera and essential thrombocythemia: an ELN and IWG-MRT consensus project. Blood. 2013 Jun 6;121(23):4778-81. doi: 10.1182/blood-2013-01-478891. Epub 2013 Apr 16.
PubMed 23591792Barosi G, Birgegard G, Finazzi G, Griesshammer M, Harrison C, Hasselbalch H, Kiladijan JJ, Lengfelder E, Mesa R, Mc Mullin MF, Passamonti F, Reilly JT, Vannucchi AM, Barbui T. A unified definition of clinical resistance and intolerance to hydroxycarbamide in polycythaemia vera and primary myelofibrosis: results of a European LeukemiaNet (ELN) consensus process. Br J Haematol. 2010 Mar;148(6):961-3. doi: 10.1111/j.1365-2141.2009.08019.x. Epub 2009 Nov 23. No abstract available.
PubMed 19930182
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Aspirin Study in Essential Thrombocythemia: an Open and Randomized Study
- ClinicalTrials.gov ID
- NCT02611973
- Acronym / sponsor ID
- FAST / P140933
- Conditions
- MPN, Essential Thrombocythemia
- Keywords
- Essential Thrombocythemia, Aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 23 Nov 2015 (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 hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes less useful once patients have achieved a hematologic response (HR) (modified by amendment 1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially in elderly patients.
Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in hematological response (modified by amendment 1/03/2017) on Hydroxyurea.
Detailed description
ET is a myeloproliferative neoplasm (MPN) characterized by a high platelet level. Increased occurrence of thrombosis and hemorrhages are the main complications in ET. In this regard, the key factors defining high risk ET include age over 60 years, past history of thrombosis, platelet > 1500 109/L and to a lesser degree cardiovascular risk factors. These criteria currently serve as therapeutic guidelines for the use of cytoreductive therapy, with hydroxyurea (HU) being the treatment of choice in the first line setting.
The use of antiplatelet agent i.e. low-dose aspirin is also generally recommended. However, the benefit of aspirin has never been formally demonstrated in ET. Only indirect evidence come from the ECLAP study that enrolled patients with polycythemia vera (PV). Of note in the ECLAP study, the efficacy of aspirin was assessed only at diagnosis but not correlated thereafter with the hematological response on cytoreductive therapy.
In general non-MPN population studies, primary prophylaxis with aspirin has been associated with a risk reduction of major vascular events, but an increased risk of hemorrhage, especially considering age and prior gastrointestinal history. In a recent retrospective study, the combination of aspirin and cytoreduction was reported to prevent thrombosis but concomitantly increase the bleeding risk when compared to HU alone , especially in patients older than 60 years, thus questioning the benefits of long term use of aspirin therapy. These data raise the question of the actual benefit of aspirin maintenance, once patients have been efficiently treated with cytoreductive therapy.
Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio of aspirin maintenance in high risk ET patients, in hematological response (modified by amendment 1/03/2017) on Hydroxyurea. Patients for which Aspirin interruption will not be possible because of extra-ET indications will be enrolled in the control observational arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HU without aspirin | Experimental | Other: Aspirin therapy interruption, Drug: Hydroxyurea treatment (HU) |
| HU + aspirin maintenance | Active comparator | Other: Usual treatment by aspirin 100 mg/d in the active comparator arm, Drug: Hydroxyurea treatment (HU) |
| HU + AAG | Other | Other: No interruption of aspirin in the Observational arm, Drug: Hydroxyurea treatment (HU)Observational arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 18 years and older (modified by amendment 01/03/2017)
- Contraception considered effective by the investigator: for women of childbearing and for men whose partner is likely to procreate (added by amendment 01/03/2017)
Key exclusion criteria (6 listed)
- Other myeloproliferative disorder than ET.
- Contra-indication to hydroxyurea.
- Other uncontrolled malignancies at the time of diagnosis or inclusion.
- History of haemostasis perturbation not related to ET, associated with a significant risk of hemorrhage or thrombosis (modified by amendment 01/03/2017)
- -.• Pregnancy or breastfeeding (added by amendment 01/03/2017)
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 |
|---|---|---|
| Aspirin therapy interruptionStop the treatment by aspirin 100mg/d in the experimental arm. | Other | HU without aspirin |
| Usual treatment by aspirin 100 mg/d in the active comparator armHU+ aspirin maintenance | Other | HU + aspirin maintenance |
| No interruption of aspirin in the Observational armpatient with Contre indication to aspirin or required antithrombotic therapy | Other | HU + AAG |
| Hydroxyurea treatment (HU)HU maintenance | Drug | HU + AAG, HU + aspirin maintenance, HU without aspirin |
Primary outcome
Cumulative incidence of death from vascular origin and other thrombotic and hemorrhagic events (combined endpoint)
Time frame: at 2-years follow-up
Definition of vascular events: Thrombotic events: Myocardial infarction, unstable angina, stroke, transient ischemic attack, peripheral arterial thrombosis, splanchnic or limb deep vein thrombosis, pulmonary embolism, and erythromelalgia Hemorrhagic events: Intracranial or retroperitoneal bleed, overt hemorrhage associated with a decrease in hemoglobin ≥20 g/l or overt hemorrhage requiring a blood transfusion of two red blood cell (RBC) units or more, and hemorrhage of grade >=2 according to the NCI Common Toxicity criteria (CTC) V.4.0 scale. Deaths will be included as a death from thrombosis or hemorrhage if they satisfied criteria for one of the above diagnoses immediately ANTE-MORTEM or if they had a POST-MORTEM examination confirming the diagnosis. Sudden death of presumed vascular origin without a POST-MORTEM examination will be included as a thrombotic death.
19 secondary outcomes
Cumulative incidence and characteristics of vascular complications: thrombosis and hemorrhage, (grade, site, recurrence), assessed yearly over a 5-year follow-up period.
Time frame: at 5 years
Rate of hematological response every 6 months
Time frame: at 5 years
Adverse event (AE) frequency and incidence, comparison in the two arms
Time frame: at 5 years
Number of HU-related nonhematologic toxicities
Time frame: at 5 years
Cumulative incidence of thrombosis
Time frame: at 5 years
Cumulative incidence of hemorrhagic complications
Time frame: at 5 years
Estimation of the progression-free survival
Time frame: at 5 years
Estimation of overall survival
Time frame: at 5 years
Short Form 36 (SF36) Health Survey
Time frame: through study completion, an average of 1 year
Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
Time frame: through study completion, an average of 1 year
Number of mortality cause.
Time frame: at 5 years
Cumulative incidence of progression to polyglobulia
Time frame: at 5 years
Cumulative incidence of progression to myelofibrosis (MF)
Time frame: at 5 years
Cumulative incidence of progression to myelodysplastic syndrome (MDS)
Time frame: at 5 years
Cumulative incidence of progression AML
Time frame: at 5 years
Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden (in blood DNA) in patients presenting thrombosis or not .
Time frame: at 5 years
Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patients in persistent hematological response (modified by amendment 1/03/2017).
Time frame: at 5 years
Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patient who will lose their hematological response (modified by amendment 1/03/2017).
Time frame: at 5 years
Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patients presenting intolerance to treatment.
Time frame: at 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Background: PubMed 23577924Alvarez-Larran A, Pereira A, Arellano-Rodrigo E, Hernandez-Boluda JC, Cervantes F, Besses C. Cytoreduction plus low-dose aspirin versus cytoreduction alone as primary prophylaxis of thrombosis in patients with high-risk essential thrombocythaemia: an observational study. Br J Haematol. 2013 Jun;161(6):865-71. doi: 10.1111/bjh.12321. Epub 2013 Apr 12.
- Background: PubMed 21205761Barbui T, Barosi G, Birgegard G, Cervantes F, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Hehlmann R, Hoffman R, Kiladjian JJ, Kroger N, Mesa R, McMullin MF, Pardanani A, Passamonti F, Vannucchi AM, Reiter A, Silver RT, Verstovsek S, Tefferi A; European LeukemiaNet. Philadelphia-negative classical myeloproliferative neoplasms: critical concepts and management recommendations from European LeukemiaNet. J Clin Oncol. 2011 Feb 20;29(6):761-70. doi: 10.1200/JCO.2010.31.8436. Epub 2011 Jan 4.
- Background: PubMed 19278953Barosi G, Birgegard G, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Kiladjian JJ, Lengfelder E, McMullin MF, Passamonti F, Reilly JT, Vannucchi AM, Barbui T. Response criteria for essential thrombocythemia and polycythemia vera: result of a European LeukemiaNet consensus conference. Blood. 2009 May 14;113(20):4829-33. doi: 10.1182/blood-2008-09-176818. Epub 2009 Mar 10.
- Background: PubMed 23591792Barosi G, Mesa R, Finazzi G, Harrison C, Kiladjian JJ, Lengfelder E, McMullin MF, Passamonti F, Vannucchi AM, Besses C, Gisslinger H, Samuelsson J, Verstovsek S, Hoffman R, Pardanani A, Cervantes F, Tefferi A, Barbui T. Revised response criteria for polycythemia vera and essential thrombocythemia: an ELN and IWG-MRT consensus project. Blood. 2013 Jun 6;121(23):4778-81. doi: 10.1182/blood-2013-01-478891. Epub 2013 Apr 16.
- Background: PubMed 19930182Barosi G, Birgegard G, Finazzi G, Griesshammer M, Harrison C, Hasselbalch H, Kiladijan JJ, Lengfelder E, Mesa R, Mc Mullin MF, Passamonti F, Reilly JT, Vannucchi AM, Barbui T. A unified definition of clinical resistance and intolerance to hydroxycarbamide in polycythaemia vera and primary myelofibrosis: results of a European LeukemiaNet (ELN) consensus process. Br J Haematol. 2010 Mar;148(6):961-3. doi: 10.1111/j.1365-2141.2009.08019.x. Epub 2009 Nov 23. No abstract available.
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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.
Stéphane Giraudier, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin therapy interruption, Usual treatment by aspirin 100 mg/d in the active comparator arm and No interruption of aspirin in the Observational arm in people with MPN and Essential Thrombocythemia, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 6 inclusion and 6 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 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Stéphane Giraudier, MD, PhD ((0)149812880 ext. +33, stephane.giraudier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of death from vascular origin and other thrombotic and hemorrhagic events (combined endpoint) (time frame: at 2-years follow-up). 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 NCT02611973, which also lists 5 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 26 Jul 2017.