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| Name | Class |
|---|---|
| University Hospital, Brest | OTHER |
| Nantes University Hospital | OTHER |
| Poitiers University Hospital | OTHER |
| Rennes University Hospital |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next-generation sequencing | Diagnostic Test | Next-generation sequencing and cytokine profile will be established in all patients before the start of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete hematological response | ELN-2013 criteria by meeting all of the following:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete hematological response | ELN-2013 criteria by meeting all of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis requiring first-line treatment with hydroxyurea or pegylated interferon.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CORENTIN ORVAIN, DOCTOR | Contact | +3302 41 35 44 75 | Corentin.Orvain@chu-angers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Recruiting | Angers | France |
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| OTHER |
| University Hospital, Tours | OTHER |
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| 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. | 12 and 24 months |
| Chu Brest | Recruiting | Brest | 29606 | France |
|
| Chu Nantes | Recruiting | Nantes | 44093 | France |
|
| Chu Poitiers | Recruiting | Poitiers | 86021 | France |
|
| Chu Rennes | Recruiting | Rennes | 35033 | France |
|
| Chu Tours | Recruiting | Tours | 37044 | France |
|
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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