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
NCT06710418 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-02-12
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.
Conditions
- Acute Myeloid Leukemia
- B Acute Lymphoblastic Leukemia
- B Lymphoblastic Lymphoma
- Myeloid Neoplasm
Interventions
- 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
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Anna Halpern, MD · Fred Hutch/University of Washington Cancer Consortium
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-15
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-31
Countries
- United States
Study Locations
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