Actively Recruiting
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
Led by University of Washington · Updated on 2026-02-12
50
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of high-grade myeloid neoplasm (≥ 10% blasts in blood or bone marrow), acute myeloid leukemia (AML) (excluding acute promyelocytic leukemia), or B-cell acute lymphoblastic lymphoma/leukemia (ALL) per 2022 WHO classification
- Plan to undergo intensive chemotherapy induction or post-remission therapy or allogeneic hematopoietic stem cell transplant expected to cause anemia requiring PRBC transfusion and platelet counts ≤ 30,000/uL for at least 5 days after therapy
- Plan to receive all post-chemotherapy or post-transplant care at the University of Washington/Fred Hutchinson Cancer Center
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Need for prophylactic platelet transfusion at thresholds above 10,000/uL
- Requirement for systemic anticoagulation, anti-platelet, or antifibrinolytic therapy that will not be stopped once platelets are below 50,000/uL
- Grade 2 or higher bleeding at randomization
- Arterial or venous thrombotic event, including myocardial infarction, within 6 months before chemotherapy or transplant
- Need for renal replacement therapy at randomization
- Decline of transfusion due to personal or religious beliefs
- Pregnancy or lactation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
A
Anna Halpern, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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