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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06710418
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (restrictive threshold)
    Patients undergo PRBC transfusion if at any point their hemoglobin level is 7 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.
  • Experimental: Arm II (liberal threshold)
    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.

Primary Outcome Measure

Percentage of eligible patients that consent (feasibility) [ Time Frame: Up to 30 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Anna Halpern, MD
[email protected]
206-606-1978
Anna Halpern, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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