NCT05710211

Brief Summary

Prospective study to decipher the clonal architecture of ASXL1-mutated primary and secondary myelofibrosis and its impact on prognosis

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
57mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Apr 2023Apr 2031

First Submitted

Initial submission to the registry

December 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 24, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2027

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2031

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

December 28, 2022

Last Update Submit

March 6, 2026

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    24 months

  • Studying the functional characteristics of each subtype of clonal architecture by transcriptomics

    24 months

  • Comparison of male proportion within the subtypes of clonal architecture

    24 months

  • Comparison of age at the time of diagnosis within the subtypes of clonal architecture

    24 months

  • Comparison of blood counts within the subtypes of clonal architecture

    24 months

  • +5 more secondary outcomes

Study Arms (1)

CLONEMF cohort

EXPERIMENTAL
Biological: Clonal architecture determination

Interventions

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

CLONEMF cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Patient with another active hematological disease or cancer at the time of diagnosis,
  • Person subject to legal protection scheme or incapable of giving consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CHU Angers

Angers, France

RECRUITING

CHRU Brest

Brest, France

NOT YET RECRUITING

CH Cholet

Cholet, France

NOT YET RECRUITING

CHU Henri MONDOR

Créteil, 94010, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

CHU Nantes

Nantes, France

NOT YET RECRUITING

AP-HP Hôpital Saint Louis

Paris, 75010, France

NOT YET RECRUITING

Hôpital Bicêtre

Paris, France

RECRUITING

CHU de Bordeaux

Pessac, 33604, France

RECRUITING

CHU Lyon

Pierre-Bénite, 69495, France

RECRUITING

CH de Cornouaille

Quimper, France

NOT YET RECRUITING

CHRU Tours - Hôpital Bretonneau

Tours, France

RECRUITING

CH de Vannes

Vannes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • POUILLART

    University Hospital, Angers

    STUDY DIRECTOR

Central Study Contacts

Margaux Wiber, PharmD.

CONTACT

0033241355553margaux.wiber@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2022

First Posted

February 2, 2023

Study Start

April 24, 2023

Primary Completion (Estimated)

April 23, 2027

Study Completion (Estimated)

April 23, 2031

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)