Study Comparing Two Hemoglobin Levels for Red Blood Cell Transfusions in Adults With High-Grade Myeloid Neoplasms, Acute Myeloid Leukemia, or B-Cell Acute Lymphoblastic Leukemia Assessing Quality of Life and Function After Chemotherapy or Stem Cell Transplant

What this Trial Is About

Researchers are studying how different hemoglobin levels for packed red blood cell PRBC transfusions affect quality of life and function in patients treated for high-grade myeloid neoplasms, acute myeloid leukemia, or B acute lymphoblastic lymphomaleukemia. These conditions often require chemotherapy or stem cell transplants that can cause anemia and low platelet counts, leading to the need for PRBC transfusions. The trial aims to balance transfusion safety and risks while considering blood supply shortages by comparing two hemoglobin thresholds. Participants are randomly assigned to one of two groups one group receives PRBC transfusions when hemoglobin drops to 7 gmdL or less, and the other group receives transfusions when hemoglobin is 9 gmdL or less. Transfusions start the day after standard chemotherapy or stem cell transplant completion and continue for up to 42 days. Blood samples are collected during the study. After treatment, patients are followed for 7 days and then monitored periodically for up to 5 years. During the trial, participants undergo assessments including blood sample collections and quality-of-life and cognitive evaluations. Researchers track how well patients tolerate the transfusion thresholds, collect data on safety, and measure quality of life and function. The main outcomes are the percentage of patients who consent and tolerate the assigned transfusion threshold and safety analyses over up to 30 months. The study is sponsored by the University of Washington and involves long-term follow-up to evaluate lasting effects.

Evaluating the Effects of Hemoglobin Threshold-specific Packed Red Blood Cell Transfusions on Quality of Life and Functional Outcomes in Patients With High-grade Myeloid Neoplasms, Acute Myeloid Leukemia, or B Acute Lymphoblastic Lymphoma/Leukemia