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

• Conditions: Myelodysplastic Syndromes; Myeloid Leukemia

• Registration Number: NCT03659084
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2018-04
• Study First Submitted: 2018-08-27
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-03
• Last Update Submitted: 2018-09-03
• Study First Posted: 2018-09-06
• Last Update Posted: 2018-09-06
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of iron chelation on relapse-free survival rate	At 2 years	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).

Secondary Outcome Measures

Name	Time	Method
Comparison of relapse-free survival after allograft of chelated patients to allografted patients not receiving chelation.	At 2-year	Matching variables will include disease type (AML or MDS), prognostic factors (cytogenetics, molecular biology, age), donor type / matching, and type of conditioning.
Rate of infection	Through study completion, an average of 4 years	during the observation period
Non-hematological toxicity during administration of Exjade	Through study completion, an average of 4 years	Transferrin
Cumulative incidence of GVHD	3 months, 1 and 2 years	Acute and chronic GVHD date and maximum grade using international classification
Hematological toxicity during administration of Exjade	Through study completion, an average of 4 years	Hemoglobin level; Current average frequency of transfusions

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France