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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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There are 2 possible treatments for the treatment of Acute Myelogenous Leukemia (AML), high-risk myelodysplastic syndromes (HR-MDS) or chronic myelomonocytic leukemia (CMML): intensive curative chemotherapy , and for over-aged or co-morbid patients , non-intensive palliative chemotherapy with a hypomethylating agent (Azacytidine) associated or not with venetoclax.
Pro-inflammatory cytokines and in particular IL-6 (Interleukin 6) seem to play a key role in the chemoresistance of solid cancers and AML : it would be associated with a poor prognosis of AML , would promote the proliferation of leukemic blasts , and would promote the progression of MDS to AML .
In AML treated with intensive chemotherapy, researchers demonstrated that a particular kinetic profile of the FLT3 ligand and IL6 at day 22 could very significantly predict the survival of patients with AML .
It therefore seems interesting to study the plasma cytokine profiles in patients with AML, HR-MDS or CMML treated non-intensively, and to see if researchers observe the same prognostic correlation as during intensive chemotherapy.
Patients will be divided into 2 groups treated according to a non-intensive chemotherapy :
Group 1 : 40 patients treated with Azacytidine and Venetoclax +/- another molecule according to the following schedule:
Group 2 : 20 patients treated with Azacytidine +/- another molecule according to the following schedule:
• Azacytidine 75 mg/m² D1 to D7 SC The cycles will be 28 days long and will be carried out until relapse or death. The cytokine assays will be carried out on D1, D8, D15 and D22 of each cycle for 3 cycles.
The duration of follow-up for a patient is 12 months from day 1 of the first cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacytidine and Venetoclax | 40 patients treated with Azacytidine and Venetoclax +/- another molecule according to the following schedule:
| ||
| Azacytidine | 20 patients treated with Azacytidine +/- another molecule according to the following schedule: • Azacytidine 75 mg/m² D1 to D7 SC The cycles will be 28 days long and will be carried out until relapse or death. The cytokine assays will be carried out on D1, D8, D15 and D22 of each cycle for 3 cycles. The duration of follow-up for a patient is 12 months from day 1 of the first cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of cytokine profiles (Flt3-L, IL (Interleukin) 1beta, IL6, IL8/CXCL8, IL10, IL15, IL17A, IL17E, IL17-F, IL18, GM-CSF, TNFalpha) in patients treated non-intensively for AML, SMD-HR or an LMMC. | Determination of plasma cytokines (Flt3-L, IL1beta, IL6, IL8/CXCL8, IL10, IL15, IL17A, IL17E, IL17-F, IL18, GM-CSF (granulocyte-monocyte colony-stimulating factor, TNFalpha) by Luminex at diagnosis and during treatment of adult patients with of AML, SMD-HR (High risk myelodysplastic syndrome) or CMML(Chronic myelomonocytic leukemia) treated non-intensively | 2 years |
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Inclusion Criteria :
Exclusion Criteria :
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40 patients treated with Azacytidine and Venetoclax +/- another molecule and 20 patients treated with Azacytidine +/- another molecule.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice GARNIER, PH | Contact | 33 2 44 76 80 81 | alice.garnier@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Recruiting | Nantes | Loire-Atlantique | 44093 | France |
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During the weekly blood samples taken in the day hospital as part of the treatment, an additional 9 ml EDTA tube will be taken, during the first 2 cycles for group 1 and during the first 3 cycles for group 2.This additional tube will be used to supply this biocollection and to promote the development of knowledge in the field of acute myeloidblastic leukemia, myelodysplasia and chronic myelomonocytic leukemia.
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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