MyelofibrosisCLONEMFNCT05710211
Clonal Architecture of ASXL1-mutated Myelofibrosis
A study testing Clonal architecture determination in people with Myelofibrosis, run by University Hospital, Angers at 13 sites in France.
Trial summary
Prospective study to decipher the clonal architecture of ASXL1-mutated primary and secondary myelofibrosis and its impact on prognosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- Clonal architecture determination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 13 sitesFrance
- Study dates
- 24 Apr 2023to 23 Apr 2031
- Phase
- Interventional
- 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
Who may be able to join
- Adults (age ≥18 years),
- Affiliated to the national social security system,
- ASXL1 mutated primary or secondary myelofibrosis,
- Signed the consent to participate in the study,
- Included, or consenting to be included, in the national clinical-biological database of France Intergroupe Syndrome Myéloprolifératifs (FIM).
Who cannot join
- Patient with another active hematological disease or cancer at the time of diagnosis,
- Person subject to legal protection scheme or incapable of giving consent.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Recruiting
CHU Angers
Angers
Corentin ORVAIN, Dr
Corentin ORVAIN, Dr
- Not yet recruiting
CHRU Brest
Brest
Jean-Christophe IANOTTO, Pr
Jean-Christophe IANOTTO, Pr
- Not yet recruiting
CH Cholet
Cholet
Charles BESCOND, Dr
Charles BESCOND, Dr
- Recruiting
CHU Henri MONDOR
Créteil, 94010
Lydia ROY, 01 49 81 20 57 ext. +33, lydia.roy@aphp.fr
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
Jérôme REY, 04 91 22 36 95 ext. +33, reyj@ipc.unicancer.fr
- Not yet recruiting
CHU Nantes
Nantes
Viviane DUBRUILLE, Dr
Viviane DUBRUILLE, Dr
- Not yet recruiting
AP-HP Hôpital Saint Louis
Paris, 75010
Juliette SORET-DULPHY, 04 42 49 47 87 ext. +33, Juliette.soret@aphp.fr
- Recruiting
Hôpital Bicêtre
Paris
Laurence Laurence, Dr
Laurence Laurence, Dr
- Recruiting
CHU de Bordeaux
Pessac, 33604
Clémence MEDIAVILLA, 05 57 65 65 11 ext. +33, clemence.mediavilla@chu-bordeaux.fr
- Recruiting
CHU Lyon
Pierre-Bénite, 69495
Vincent ALCAZER, 04 78 86 43 12 ext. +33, vincent.alcazer@chu-lyon.fr
- Not yet recruiting
CH de Cornouaille
Quimper
Lenaïg LE CLECH, Dr
Lenaïg LE CLECH, Dr
- Recruiting
CHRU Tours - Hôpital Bretonneau
Tours
Antoine MACHET, Dr
Antoine MACHET, Dr
- Not yet recruiting
CH de Vannes
Vannes
Mélanie MERCIER, 02 97 01 48 45 ext. +33, melanie.mercier@ch-bretagne-atlantique.fr
About this study
Prospective study to decipher the clonal architecture of ASXL1-mutated primary and secondary myelofibrosis and its impact on prognosis
Read the detailed description
The clonal architecture of myelofibrosis patients is still little described. Inconsistent results in terms of the prognostic value of some mutations are observed in the literature, in particular concerning ASXL1 mutations. We assume that a better understanding of the clonal architecture of ASXL1-mutated myelofibrosis could help refining the prognostic impact of ASXL1 mutations.
This study aims to evaluate a multicenter cohort of 50 patients. Blood of patients will be collected within 18 months of diagnosis. After 4 years of follow-up of the patient as part of his usual care, data on survival and leukemic transformation will be collected.
- Conditions
- Myelofibrosis
- Being tested
- Clonal architecture determination
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonal architecture determinationBiological
Biological:
- Determination of clonal architecture by sorting of circulating CD34 positive cells followed by cell culture and colony genotyping and/or single-cell DNA-sequencing
- Secondary outcome: transcriptomic study by RNA-sequencing
| Study group | Role | What they receive |
|---|---|---|
| CLONEMF cohort | Experimental | Not described Receives: Biological: Clonal architecture determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify subgroups of ASXL1-mutated myelofibrosis based on clonal architecture data
The clonal architecture is defined by the number of mutations (numerical), the order of acquisition of the mutations (categorial, pre/post/separated), the mutational branching (categorial, yes/no), the presence of distinct clones (categorial, yes/no) and the transition towards homozygosity of each clone (categorial, yes/no). All parameters of clonal architecture will be analyzed together using a multivariate classification (Factor Analysis for Mixed Data) followed by a clustering which allow us to identify homogeneous cluster of patients.
Measured: 24 months
Secondary outcomes (10)
Description of previously constituted prognostic genomic groups (according to Luque Paz et al. 2021) within identified clusters of clonal architecture
The repartition of patients onto genomic groups will be reported for each clusters of clonal architecture (number and percentage).
Measured: 24 months
Studying the functional characteristics of each subtype of clonal architecture by transcriptomics
Gene Set Enrichment Analysis (GSEA) will be performed for each cluster of clonal architecture
Measured: 24 months
Comparison of male proportion within the subtypes of clonal architecture
Repartition of gender will be compared
Measured: 24 months
Comparison of age at the time of diagnosis within the subtypes of clonal architecture
Age at the time (years) of diagnosis will be compared
Measured: 24 months
Comparison of blood counts within the subtypes of clonal architecture
Blood counts (g/dL or G/L) at the time of diagnosis will be compared
Measured: 24 months
Comparison of LDH levels within the subtypes of clonal architecture
LDH levels (UI/L) at the time of diagnosis will be compared
Measured: 24 months
Comparison of splenomegaly proportion within the subtypes of clonal architecture
Proportion of patients with splenomegaly will be compared
Measured: 24 months
Comparison of constitutional symptoms proportion within the subtypes of clonal architecture
Proportion of patients with constitutional symptoms will be compared
Measured: 24 months
Evaluation of overall survival of the patients at 4 years according to their clonal architecture profile
Overall survival will be evaluated by Cox models
Measured: 72 months
Evaluation of the leukemia-free survival of the patients at 4 years according to their clonal architecture profile
Leukemia-free survival will be evaluated by Cox models
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start24 Apr 2023
- Primary completion23 Apr 2027 (estimated)
- Study completion23 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- POUILLART, Study director, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710211
- Sponsor's protocol ID
- 2022-A02497-36
- Acronym
- CLONEMF
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2022
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonal Architecture of ASXL1-mutated Myelofibrosis
- ClinicalTrials.gov ID
- NCT05710211
- Acronym / sponsor ID
- CLONEMF / 2022-A02497-36
- Conditions
- Myelofibrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 23 Apr 2031 (estimated)
- First posted
- 2 Feb 2023 (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.
Prospective study to decipher the clonal architecture of ASXL1-mutated primary and secondary myelofibrosis and its impact on prognosis
Detailed description
The clonal architecture of myelofibrosis patients is still little described. Inconsistent results in terms of the prognostic value of some mutations are observed in the literature, in particular concerning ASXL1 mutations. We assume that a better understanding of the clonal architecture of ASXL1-mutated myelofibrosis could help refining the prognostic impact of ASXL1 mutations.
This study aims to evaluate a multicenter cohort of 50 patients. Blood of patients will be collected within 18 months of diagnosis. After 4 years of follow-up of the patient as part of his usual care, data on survival and leukemic transformation will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLONEMF cohort | Experimental | Biological: Clonal architecture determination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (age ≥18 years),
- Affiliated to the national social security system,
- ASXL1 mutated primary or secondary myelofibrosis,
- Signed the consent to participate in the study,
- Included, or consenting to be included, in the national clinical-biological database of France Intergroupe Syndrome Myéloprolifératifs (FIM).
Key exclusion criteria (2 listed)
- Patient with another active hematological disease or cancer at the time of diagnosis,
- Person subject to legal protection scheme or incapable of giving consent.
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 |
|---|---|---|
| Clonal architecture determinationBiological: * Determination of clonal architecture by sorting of circulating CD34 positive cells followed by cell culture and colony genotyping and/or single-cell DNA-sequencing * Secondary outcome: transcriptomic study by RNA-sequencing | Biological | CLONEMF cohort |
Primary outcome
Identify subgroups of ASXL1-mutated myelofibrosis based on clonal architecture data
Time frame: 24 months
The clonal architecture is defined by the number of mutations (numerical), the order of acquisition of the mutations (categorial, pre/post/separated), the mutational branching (categorial, yes/no), the presence of distinct clones (categorial, yes/no) and the transition towards homozygosity of each clone (categorial, yes/no). All parameters of clonal architecture will be analyzed together using a multivariate classification (Factor Analysis for Mixed Data) followed by a clustering which allow us to identify homogeneous cluster of patients.
10 secondary outcomes
Description of previously constituted prognostic genomic groups (according to Luque Paz et al. 2021) within identified clusters of clonal architecture
Time frame: 24 months
Studying the functional characteristics of each subtype of clonal architecture by transcriptomics
Time frame: 24 months
Comparison of male proportion within the subtypes of clonal architecture
Time frame: 24 months
Comparison of age at the time of diagnosis within the subtypes of clonal architecture
Time frame: 24 months
Comparison of blood counts within the subtypes of clonal architecture
Time frame: 24 months
Comparison of LDH levels within the subtypes of clonal architecture
Time frame: 24 months
Comparison of splenomegaly proportion within the subtypes of clonal architecture
Time frame: 24 months
Comparison of constitutional symptoms proportion within the subtypes of clonal architecture
Time frame: 24 months
Evaluation of overall survival of the patients at 4 years according to their clonal architecture profile
Time frame: 72 months
Evaluation of the leukemia-free survival of the patients at 4 years according to their clonal architecture profile
Time frame: 72 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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
POUILLART study director
University Hospital, Angers
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clonal architecture determination in people with Myelofibrosis, run by University Hospital, Angers at 13 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 5 inclusion and 2 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 9 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 13 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 Margaux Wiber, PharmD. (0033241355553, margaux.wiber@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify subgroups of ASXL1-mutated myelofibrosis based on clonal architecture data (time frame: 24 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 9 Mar 2026.