An observational study in Acute Myeloid Leukemia, sponsored by Hospices Civils de Lyon. Completed. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-09-14.
Sponsored by Hospices Civils de Lyon · Observational
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 1,067 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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An observational, longitudinal, and retrospective study was conducted in 1067 patients (>15 years of age) fulfilling the clinical and laboratory criteria for diagnosis of AML. Patients were admitted at the Lyon University Hospital over two decades (fromMarch 1985 to December 2006) and enrolled onto 12 successive therapeutic trials according to age and time of enrollment. Diagnosis of AML was based on smears of bone marrow aspirates. Leukemic cells were classified according to the French-American-British (FAB) criteria. FAB M3 AMLs were not included in the study. AML with 20 % or more myeloid marrow blasts, either de novo or evolving from a MDS, was eligible in the absence of (i)World Health Organization (WHO) performance status >2; (ii) left ventricular systolic ejection fraction below the normal range; (iii) a creatinine or hepatic enzyme levels >2 ULN, except ifAML-related; and (iv) uncontrolled severe infection. All participants gave their written informed consent
Exclusion Criteria:
Overall survival (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
Time frame: 3 year OS
Overall survival (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
Time frame: 7 year OS
Complete remission (CR) rate
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
Time frame: Up to 10 weeks
No study locations are listed for this record.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon