- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 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)
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete remission (CR) rate
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0562
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