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Iron chelation, mostly associated with multiple red blood cell transfusion, is relatively common in patients with hematological malignancies receiving allo-HSCT.
This multicenter prospective observational study is designed to establish the impact of iron chelation on relapse after allo-HSCT in patients with acute myeloid leukemia and myelodysplastic syndrome. The investigators will compare the results obtained in the prospective study to those observed in a historical retrospective cohort of paired patients who did not receive chelation. Given our clinical experience and literature results, the investigators will evaluate the Exjade chelator. Although not demonstrated, the presence of mutations of the HFE gene could play an indirect role on leukemogenesis by promoting overload. It is therefore important to evaluate the status in this patient population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXJADE | Drug | The patient having given his consent, will begin the Exjade at 10 mg / kg per day if the ferritin level reached 1000 ng / ml at 6 months after allograft, for a minimum duration of three months and up to 6 months. The iron parameters will be evaluated at 3, 6, 9, 12, 18 and 24 months after the beginning of the exjade treatment. The evaluation of the disease will be carried out according to the practices of the center. It is recommended to have a washout period of one week between stopping the ciclosporin and the beginning of treatment by exjade. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of iron chelation on relapse-free survival rate | Relapse-free survival will be defined as the number of days between the date of diagnosis and the date of death and / or relapse (or censored at the end of follow-up). | At 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of relapse-free survival after allograft of chelated patients to allografted patients not receiving chelation. | Matching variables will include disease type (AML or MDS), prognostic factors (cytogenetics, molecular biology, age), donor type / matching, and type of conditioning. | At 2-year |
| Cumulative incidence of GVHD |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute leukemia (AML) or Myelodysplastic Syndrome (MDS) and iron overload with ferritinemia ≥ 1000 μg / l, 6 months after CSH allograft.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mauricette MICHALLET, MD, PhD | Contact | 33(0)478862220 | mauricette.michallet@lyon.unicancer.fr | |
| Mohamed ELHAMRI, PhD | Contact | 33 (0) 478 86 22 20 | mohamed.el-hamri@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mauricette MICHALLET, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | France |
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Acute and chronic GVHD date and maximum grade using international classification |
| 3 months, 1 and 2 years |
| Rate of infection | during the observation period | Through study completion, an average of 4 years |
| Hematological toxicity during administration of Exjade | Hemoglobin level; Current average frequency of transfusions | Through study completion, an average of 4 years |
| Non-hematological toxicity during administration of Exjade | Ferritinemia | Through study completion, an average of 4 years |
| Non-hematological toxicity during administration of Exjade | Transferrin | Through study completion, an average of 4 years |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D000077588 | Deferasirox |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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