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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02899767

Enrollment

1067

Registered

2016-09-14

Start date

2014-01-31

Completion date

2015-07-31

Last updated

2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

transfusion dependency, transfusion intensity, prognosis, chemotherapy

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival (OS)	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

Secondary

Measure	Time frame	Description
Complete remission (CR) rate	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

Outcome results