Red blood cell transfusion in dose intensive chemotherapy of acute myeloid leukemia
- Conditions
- Neoplasms
- Registration Number
- KCT0007596
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Newly diagnosed non-acute promyelocytic leukemia acute myeloid leukemia (AML) aged between 19 to 70 years old, undergoing cytarabine ± anthracycline chemotherapy were considered eligible for enrollment. The diagnosis of AML was made according to the World Health Organization (WHO) Classification of Hematopoietic Neoplasms, which requires identification of 20% or more leukemic blasts in the bone marrow. For induction therapy, either idarubicin 12mg/m2 for 3 days plus cytarabine 100mg/m2 for 7 days or daunorubicin 60 to 90mg/m2 for 3 days plus cytarabine 100mg/m2 for 7 days were used. For FMS-related tyrosine kinase 3 (FLT3) positive patients, midostaurin use was allowed. For consolidation therapy, high dose cytarabine (HDAC, 3g/m2 twice daily over 3 days) and intermediate dose cytarabine (IDAC 2g/m2 twice daily over 3 days) were used. Patients were stratified according to chemotherapy (i.e. induction versus HDAC versus IDAC).
Patients with biphenotypic leukemias, relapsed/refractory disease or treatment history for previous hematologic disease were excluded. Those (1) with history of transfusion related adverse events, (2) on anticoagulation or antiplatelet therapy, (3) active bleeding, (4) with history of major bleeding events according to International Society on Thrombosis and Hemostasis (ISTH)20 and (5) with cardio-pulmonary disease requiring higher Hb target levels per attending physician’s decision were also excluded.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of RBC units per case accross the groups
- Secondary Outcome Measures
Name Time Method Major bleeding per case accross the groups;Clinical relevant non-major bleeding (CRNM) according to ISTH20 per case accross the groups;AML treatment response according to International Working Group accross the groups;Number of platelet units per case accross the groups;Transfusion related adverse events accross the groups