Myelodysplastic Syndromes Clinical Trial
— GREFFEOfficial title:
Multicenter Prospective Observational Study of the Outcome of Patients With Acute Myeloblastic Leukemia (AML) and Myelodysplastic Syndrome (MDS) Receiving Iron Chelation Therapy (Exjade) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
NCT number | NCT03659084 |
Other study ID # | 2013.812 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | April 2020 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | April 2020 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adults older than 18 years old - Patients with AML or MDS in complete remission receiving CSH transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning. - Patients with iron overload defined by at least one ferritinemia> 1000 µg / L in the 6th month after CSH allograft - Creatinine less than 1.5 x ULN; ALAT and ASAT <2 x ULN - Patients giving their informed consent (prior to performing any study procedure) Exclusion Criteria: - Hypersensitivity to the Exjade - Association with another iron chelator - Proteinuria> 1g / 24h - Acute and chronic hepatitis (B and C viruses); HIV - Extended corrected QT - History of ocular toxicity related to iron chelation treatment - Gastrointestinal Abnormal Absorption of Oral Medications - Pregnancy and lactation |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Lyon Sud | Pierre-Bénite |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Cumulative incidence of GVHD | Acute and chronic GVHD date and maximum grade using international classification | 3 months, 1 and 2 years | |
Secondary | Rate of infection | during the observation period | Through study completion, an average of 4 years | |
Secondary | Hematological toxicity during administration of Exjade | Hemoglobin level; Current average frequency of transfusions | Through study completion, an average of 4 years | |
Secondary | Non-hematological toxicity during administration of Exjade | Ferritinemia | Through study completion, an average of 4 years | |
Secondary | Non-hematological toxicity during administration of Exjade | Transferrin | Through study completion, an average of 4 years |
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