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

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)

Patrocinadores

Patrocinador principal: Hospices Civils de Lyon

Fuente Hospices Civils de Lyon
Resumen breve

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.

Estado general Recruiting
Fecha de inicio April 2016
Fecha de Terminación April 2020
Fecha de finalización primaria April 2018
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Impact of iron chelation on relapse-free survival rate At 2 years
Resultado secundario
Medida Periodo de tiempo
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
Non-hematological toxicity during administration of Exjade Through study completion, an average of 4 years
Inscripción 150
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: EXJADE

Descripción: 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.

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Mauricette MICHALLET, MD Principal Investigator Hospices Civils de Lyon
Contacto general

Apellido: Mauricette MICHALLET, MD, PhD

Teléfono: 33(0)478862220

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Investigador: Centre Hospitalier Lyon Sud Mauricette Michallet, MD 0 478 86 22 20 +33 [email protected] Mauricette Michallet, MD Principal Investigator
Ubicacion Paises

France

Fecha de verificación

September 2018

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Acrónimo GREFFE
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov