Red blood cell transfusion in dose intensive chemotherapy of acute myeloid leukemia

A Prospective, Randomized, Pilot Study for Optimal Use of Red Cells in Transfusion in Patients with Acute Myeloid Leukemia Receiving Dose Intensive Chemotherapy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007596

Enrollment

Registered

2022-08-03

Start date

2018-09-20

Completion date

Unknown

Last updated

2022-09-20

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

Conditions

None listed

Interventions

Others(Red blood cell transfusion) : Patients are randomized into 4 groups using 2 by 2 factorial design, according to trigger (Hb 7 vs 8g/dL) and quantity (single-unit vs double-unit) and be trasfuse

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Number of RBC units per case accross the groups	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJa Min Byun

Seoul National University Hospital

jaminbyun@naver.com+82-2-2072-3383

Outcome results