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

NCT03659084 | Unknown

• 1 other identifier: 2013.812
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloid Leukemia; Myelodysplastic Syndromes

Keywords

Acute myeloid leukaemia; Myelodysplastic syndrome; Iron Chelation Therapy (Exjade); allogeneic Hematopoietic Stem Cell transplantation (Allo-HSCT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Comparison of relapse-free survival after allograft of chelated patients to allografted patients not receiving chelation.

  At 2-year

• Cumulative incidence of GVHD

  3 months, 1 and 2 years

• Rate of infection

  Through study completion, an average of 4 years

• Hematological toxicity during administration of Exjade

  Through study completion, an average of 4 years

• Non-hematological toxicity during administration of Exjade

  Through study completion, an average of 4 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute leukemia (AML) or Myelodysplastic Syndrome (MDS) and iron overload with ferritinemia ≥ 1000 μg / l, 6 months after CSH allograft.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Interventions

Deferasirox

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mauricette MICHALLET, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 6, 2018
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2020
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

FR (1)