Sequential Analysis in Patients With an Hemopathy

Study Overview
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Brief Summary
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Recent advances in hematology clearly illustrate that the simple clonal nature of various hematological malignancies may not really reflect the reality of malignant cells natural expansion. This has been nicely illustrated in recent works in AML for example where subclones coexists in the same patient at the same time, but could also differentially expand over time because of effects of therapeutics intervention, but also by oncogenic spontaneous events (1). These observations have been done recently because of next generation sequencing that allows to discriminate in the same tumor samples, different subclones and to analyse the clonal architecture. Sequential analyses could help us to identify the first oncogenic event and to correlate disease progression to the emergence of subclones. For all these reasons it is of a major interest to precisely understand the architecture of the clone in MPNs, especially to understand which is the initiating event and how from this initial event the clone develops. In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN, but may favor the development of other malignant hemopathies.

Official Title
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Sequential Analysis in Patients With an Hemopathy

Conditions
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Hemopathy

Intervention / Treatment
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* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a malignant hematological disease. Signed written informed consent Age and Sex : men and women aged 18 years or older Patients affiliated to a social security system Exclusion Criteria: - Patients protected by law, in accordance with Articles L1121-L1121-5 to 8 of the Code of Public Health.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: chronic myelomonocytic leukemia<br>Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia) | Other: Blood samples<br> <br> |
| Other: essential thrombocytemia<br>Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia) | Other: Blood samples<br> <br> |
| Other: myelofibrosis<br>Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia) | Other: Blood samples<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of new genetic alterations | Identification of new genetic alterations in patients with hematological malignancies by next generation sequencing using blood samples | At baseline and then every 6 months up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential analysis of the malignant clones | Sequential analysis of the malignant clones for each patient included in the trial using genetic markers | At baseline and 12 months after inclusion |