An observational study in Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by Hospices Civils de Lyon · Observational
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 150 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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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.
Exclusion Criteria:
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.
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).
Time frame: At 2 years
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.
Time frame: At 2-year
Cumulative incidence of GVHD
Acute and chronic GVHD date and maximum grade using international classification
Time frame: 3 months, 1 and 2 years
Rate of infection
during the observation period
Time frame: Through study completion, an average of 4 years
Hematological toxicity during administration of Exjade
Hemoglobin level; Current average frequency of transfusions
Time frame: Through study completion, an average of 4 years
Non-hematological toxicity during administration of Exjade
Ferritinemia
Time frame: Through study completion, an average of 4 years
Non-hematological toxicity during administration of Exjade
Transferrin
Time frame: Through study completion, an average of 4 years
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon