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- Essai clinique NCT02899767
Transfusion in Adult Acute Myeloid Leukemia
Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukemia
Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.
Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.
Based on these data, we retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patient > 15 years old
- Newly diagnosed AML or post myelodysplastic syndrome (MDS)
Exclusion Criteria:
- Patients with M3 AML of FAB classification (APL, Acute Promyelocytic Leukemia)
- World Health Organization (WHO) performance status >2;
- Left ventricular systolic ejection fraction below the normal range
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Serum creatinine concentration > 2x ULN (Upper Limit of Normal laboratory ranges),
- AST or ALT levels > 2.0 x ULN, except if AML-related
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall survival (OS)
Délai: 3 year OS
|
Overall survival (OS) is defined as the time elapsed between induction chemotherapy regimen and death for any cause.
Patients not known to have this event are censored on the date they were last examined
|
3 year OS
|
|
Overall survival (OS)
Délai: 7 year OS
|
Overall survival (OS) is defined as the time elapsed between induction chemotherapy regimen and death for any cause.
Patients not known to have this event are censored on the date they were last examined
|
7 year OS
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Complete remission (CR) rate
Délai: Up to 10 weeks
|
Response to induction therapy was assessed after one or two courses of chemotherapy.
CR was defined according to standard criteria as less than 5 % blasts in bone marrow aspirates with evidence of maturation of cell lines and restoration of peripheral blood counts
|
Up to 10 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 69HCL16_0562
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