NCT06710418

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

Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and functional outcomes in patients who have undergone chemotherapy or an allogeneic hematopoietic stem cell transplant for a high-grade myeloid neoplasm, acute myeloid leukemia, or B acute lymphoblastic lymphoma/leukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and/or anemia that requires PRBC transfusions. Given critical shortages in blood supply, and risks associated with transfusion of PRBC, there has been much investigation into the "minimum" hemoglobin level that effectively balances safety and toxicity in patients. This clinical trial evaluates the effects of giving PRBC transfusions based on a more restrictive hemoglobin threshold (\> 7 gm/dL) compared to a more liberal hemoglobin threshold (\> 9 gm/dL) on quality of life and functional outcomes. A more restrictive threshold may be just as effective at maintaining patient quality of life and function while decreasing side effects from blood transfusions and helping to conserve blood supply resources.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo PRBC transfusion if at any point their hemoglobin level is 7 gm/dL or less, starting the day after standard of care (SOC) chemotherapy/stem cell infusion is complete and continuing for up to 42 days. Patients also undergo collection of blood samples on study. ARM II: Patients undergo PRBC transfusion if at any point their hemoglobin level is 9 gm/dL or less, starting the day after SOC chemotherapy/stem cell infusion is complete and continuing for up to 42 days. Patients also undergo collection of blood samples on study. After completion of study intervention, patients are followed up for 7 days and then periodically for up to 5 years.

Conditions

• Acute Myeloid Leukemia
• B Acute Lymphoblastic Leukemia
• B Lymphoblastic Lymphoma
• Myeloid Neoplasm

Interventions

Type	Name	Description
OTHER	Activity Tracking	Ancillary studies
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Cognitive Assessment	Ancillary studies
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Packed Red Blood Cell Transfusion	Undergo PRBC transfusion
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2024-11-29
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States