Study of the Outcome of Patients With Acute Myeloblastic Leukemia and Myelodysplastic Syndrome Receiving Iron Chelation Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (GREFFE)

Civil Hospices of Lyon

Status: Unknown

Conditions: Myeloid Leukemia; Myelodysplastic Syndromes

Treatments: Drug: EXJADE

Study type: Observational

Funder types: Other

Identifiers

NCT03659084

2013.812

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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