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

February 9, 2026 updated by: University of Washington

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutch/University of Washington Cancer Consortium
        • Principal Investigator:
          • Anna Halpern, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosis of "high-grade" myeloid neoplasm (≥ 10% blasts in blood or bone marrow) or acute myeloid leukemia (AML) (other than acute promyelocytic leukemia [APL]) or B-cell acute lymphoblastic lymphoma/leukemia (ALL) according to the 2022 WHO classification. Outside diagnostic material is acceptable to establish diagnosis
  • Plan to undergo intensive chemotherapy induction or post-remission therapy for their diagnosis (defined as "7+3," hyper-cyclophosphamide, vincristine, doxorubicin, and dexamethasone [CVAD], or regimen with cytarabine backbone ≥ 1,000mg/m^2), or allogeneic HSCT, expected to induce anemia requiring PRBC transfusion AND platelet counts of ≤ 30,000/uL for ≥ 5 days following the therapy (as determined by principal investigator)
  • Plan to get all post-chemotherapy/post-HSCT care at the University of Washington (UW)/Fred Hutchinson Cancer Center (FHCC)
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients requiring a prophylactic platelet transfusion at thresholds > 10,000/uL
  • Patients requiring systemic anticoagulation, anti-platelet agent, or antifibrinolytic therapy that will not be held once platelets reach a level of < 50,000/uL
  • Patients with grade ≥ 2 bleeding (as determined by the WHO Bleeding Criteria) at the time of randomization
  • Arterial or venous thrombotic event, including myocardial infarction within 6 months prior to initiation of the chemotherapy/HSCT
  • Patients requiring renal replacement therapy at the time of randomization
  • Patients who decline transfusion for personal or religious beliefs
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Cognitive Assessment
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Other: Activity Tracking
Ancillary studies
Other: Packed Red Blood Cell Transfusion
Undergo PRBC transfusion
Other Names:
  • PRBC Transfusion
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Cognitive Assessment
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Other: Activity Tracking
Ancillary studies
Other: Packed Red Blood Cell Transfusion
Undergo PRBC transfusion
Other Names:
  • PRBC Transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of eligible patients that consent (feasibility)
Time Frame: Up to 30 months
Randomizing patients to two different transfusion thresholds will be considered feasible if greater than 50% of eligible patients consent.
Up to 30 months
Percentage of patients randomized to the restrictive 7 gm/dL threshold that tolerate this transfusion trigger (feasibility)
Time Frame: Up to 7 days after completion of study intervention
Randomizing patients to two different transfusion thresholds will be considered feasible if greater than 75% of the patients randomized to the restrictive 7 gm/dL threshold tolerate this transfusion trigger. A patient will be defined as tolerant if the patient receives transfusions at a hemoglobin threshold higher than > 7gm/dL less than 3 times due to signs/symptoms of acute anemia.
Up to 7 days after completion of study intervention
Indication for early termination based on interim analyses of safety (feasibility)
Time Frame: Up to 30 months
Randomizing patients to two different transfusion thresholds will be considered feasible if there is no indication for early termination based on the interim safety analyses.
Up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Anna Halpern, MD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1124891
  • 20807 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • NCI-2024-09018 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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