Myeloproliferative NeoplasmBioPredictorNCT05440838
Identification of Factors Associated With Treatment Response in Patients With Polycythemia Vera, Essential Thrombocythemia, and Pre-myelofibrosis.
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Angers at 6 sites in France.
Trial summary
First-line treatment for patients with polycythemia vera, essential thrombocythemia, and pre-myelofibrosis is based on hydroxyurea or pegylated interferon. The objective of treatment is to prevent thrombotic complications and leukemic transformation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- Next-generation sequencing
- How many people
- 120 participants
- Where
- 6 sitesFrance
- Study dates
- 17 May 2023to 17 Feb 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis requiring first-line treatment with hydroxyurea or pegylated interferon.
Who may be able to join
- Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis.
- Indication for first-line treatment with hydroxyurea or pegylated interferon.
- Consent to participate.
- Affiliated to social security.
Who cannot join
- Previous treatment.
- Other on-going malignancy, including overt myelofibrosis.
- Other treatment such as phlebotomy solely, ruxolitinib, anagrelide, or pipobroman.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Chu Angers
Angers
CORENTIN ORVAIN, DOCTOR, +3302 41 35 44 75, Corentin.Orvain@chu-angers.fr
- Recruiting
Chu Brest
Brest, 29606
JEAN-CHRISTOPHE IANOTTO, +3302 98 22 37 86, jean-christophe.ianotto@chu-brest.fr
- Recruiting
Chu Nantes
Nantes, 44093
VIVIANE DUBRUILLE, +3302 40 08 32 71, viviane.dubruille@chu-nantes.fr
- Recruiting
Chu Poitiers
Poitiers, 86021
Jose-Miguel TORREGROSA-DIAZ, +3305 49 44 44 44, jose-miguel.torregrosa-diaz@inserm.eu
- Recruiting
Chu Rennes
Rennes, 35033
MARC BERNARD, +3302 99 28 42 91, marc.bernard@chu-rennes.fr
- Recruiting
Chu Tours
Tours, 37044
ANTOINE MACHET, +3302 47 47 37 12, a.machet@chu-tours.fr
About this study
First-line treatment for patients with polycythemia vera, essential thrombocythemia, and pre-myelofibrosis is based on hydroxyurea or pegylated interferon. The objective of treatment is to prevent thrombotic complications and leukemic transformation. Despite overall good response rates, some patients do not respond to treatment and others lose their response over time. Both situations are associated with worse survival and there are to date no clear predictive factors for response although the existence of additional mutations seems unfavorable.
In this exploratory study, we hypothesize that biological factors at diagnosis are associated with hematological response at 12 months. We will more specifically study the association between mutational profile, assessed by next-generation sequencing, and cytokine profile with hematological response.
This study will help in identifying patients who will not respond to hydroxyurea or pegylated interferon and give the opportunity to try other treatments upfront, in the perspective of precision medicine. On the basic science side, this study will help in understanding the molecular and immunological factors involved in resistance to treatment.
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- Next-generation sequencing
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next-generation sequencingDiagnostic test
Also called Cytokines
Next-generation sequencing and cytokine profile will be established in all patients before the start of treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete hematological response
ELN-2013 criteria by meeting all of the following:
- Durable resolution of disease-related signs including palpable hepatosplenomegaly, large symptoms improvement, AND
- Durable peripheral blood count remission, defined as: platelet count ≤400 ×109/L, WBC count <10 × 109/L, Ht lower than 45% without phlebotomies (for PV patients), absence of leukoerythroblastosis, AND
- Without signs of progressive disease, and absence of any hemorrhagic or thrombotic events.
Measured: 12 months
Secondary outcomes (2)
Complete hematological response
ELN-2013 criteria by meeting all of the following:
- Durable resolution of disease-related signs including palpable hepatosplenomegaly, large symptoms improvement, AND
- Durable peripheral blood count remission, defined as: platelet count ≤400 ×109/L, WBC count <10 × 109/L, Ht lower than 45% without phlebotomies (for PV patients), absence of leukoerythroblastosis, AND
- Without signs of progressive disease, and absence of any hemorrhagic or thrombotic events.
Measured: 24, 36, 48, and 60 months
Molecular response
ELN-2013 criteria: Complete response is defined as eradication of a preexisting abnormality (CALR, JAK2, or MPL mutations) by quantitative PCR. Partial response applies only to patients with at least 20% mutant allele burden at baseline. Partial response is defined as ≥50% decrease in allele burden by quantitative PCR.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start17 May 2023
- Primary completion17 Feb 2027 (estimated)
- Study completion17 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- University Hospital, Brest, Nantes University Hospital, Poitiers University Hospital, Rennes University Hospital, University Hospital, Tours
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440838
- Sponsor's protocol ID
- 2022-A01044-39
- Acronym
- BioPredictor
- Status last verified
- Mar 2026
- First submitted
- 10 Jun 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors Associated With Treatment Response in Patients With Polycythemia Vera, Essential Thrombocythemia, and Pre-myelofibrosis.
- ClinicalTrials.gov ID
- NCT05440838
- Acronym / sponsor ID
- BioPredictor / 2022-A01044-39
- Conditions
- Myeloproliferative Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- University Hospital, Brest, Nantes University Hospital, Poitiers University Hospital, Rennes University Hospital, University Hospital, Tours
- Study start
- 17 May 2023 (actual)
- Primary completion
- 17 Feb 2027 (estimated)
- Study completion
- 17 Feb 2032 (estimated)
- First posted
- 1 Jul 2022 (actual)
- 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.
First-line treatment for patients with polycythemia vera, essential thrombocythemia, and pre-myelofibrosis is based on hydroxyurea or pegylated interferon. The objective of treatment is to prevent thrombotic complications and leukemic transformation. Despite overall good response rates, some patients do not respond to treatment and others lose their response over time. Both situations are associated with worse survival and there are to date no clear predictive factors for response although the existence of additional mutations seems unfavorable.
In this exploratory study, we hypothesize that biological factors at diagnosis are associated with hematological response at 12 months. We will more specifically study the association between mutational profile, assessed by next-generation sequencing, and cytokine profile with hematological response.
This study will help in identifying patients who will not respond to hydroxyurea or pegylated interferon and give the opportunity to try other treatments upfront, in the perspective of precision medicine. On the basic science side, this study will help in understanding the molecular and immunological factors involved in resistance to treatment.
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
- Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis requiring first-line treatment with hydroxyurea or pegylated interferon.
Key inclusion criteria (4 listed)
- Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis.
- Indication for first-line treatment with hydroxyurea or pegylated interferon.
- Consent to participate.
- Affiliated to social security.
Key exclusion criteria (3 listed)
- Previous treatment.
- Other on-going malignancy, including overt myelofibrosis.
- Other treatment such as phlebotomy solely, ruxolitinib, anagrelide, or pipobroman.
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 |
|---|---|---|
| Next-generation sequencingAlso: CytokinesNext-generation sequencing and cytokine profile will be established in all patients before the start of treatment. | Diagnostic test | – |
Primary outcome
Complete hematological response
Time frame: 12 months
ELN-2013 criteria by meeting all of the following: * Durable resolution of disease-related signs including palpable hepatosplenomegaly, large symptoms improvement, AND * Durable peripheral blood count remission, defined as: platelet count ≤400 ×109/L, WBC count <10 × 109/L, Ht lower than 45% without phlebotomies (for PV patients), absence of leukoerythroblastosis, AND * Without signs of progressive disease, and absence of any hemorrhagic or thrombotic events.
2 secondary outcomes
Complete hematological response
Time frame: 24, 36, 48, and 60 months
Molecular response
Time frame: 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Angers at 6 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 4 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CORENTIN ORVAIN, DOCTOR (+3302 41 35 44 75, Corentin.Orvain@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete hematological response (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2026.