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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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Patients with low-risk MDS verifying the eligibility criteria may be included in the study.
Patients will receive the number of DFX tablets (Exjade, cp film-coated, 90mg or 360mg), in relation to their body weight to be closer to 3.5mg / kg / d for 12 months.
At one month and six months of treatment, the residual plasma levels of DFX will be measured in patients (sent to the Bordeaux laboratory of Biochemistry, Pr Molimard) to allow the dosage to be adjusted (plasma objective of 3 μM).
At inclusion (J1) and at 6 months of treatment, a dosage of NTBI and hepcidine will be performed.
If patients become transfusion-dependent (≥) 2 packed red cells (RBP) per 2-month period evaluated over 6 months, they will stop low-dose DFX and go out of protocol to receive DFX at 20mg / kg (according to EMEA authorization) for iron chelation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferasirox | Experimental | efficacy of 3.5mg/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferasirox | Drug | iron chelation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients without transfusion-dependence at 12 months. | Percentage of patients without transfusion-dependence at 12 months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Park | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de GRENOBLE ALPES | Grenoble | 38043 | France |
e crf
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| ID | Term |
|---|---|
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077588 | Deferasirox |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |