Recruiting

PRBC Transfusions

Sponsor:

University of Washington

Code:

NCT06710418

Conditions

Acute Myeloid Leukemia

B Acute Lymphoblastic Leukemia

B Lymphoblastic Lymphoma

Myeloid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Activity Tracking

Biospecimen Collection

Cognitive Assessment

Electronic Health Record Review

Packed Red Blood Cell Transfusion

Study Details

Brief 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

Study ID

NCT06710418

Start date

Oct 15, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Activity Tracking

Ancillary studies

Biospecimen Collection

Undergo blood sample collection

Cognitive Assessment

Ancillary studies

Electronic Health Record Review

Ancillary studies

Packed Red Blood Cell Transfusion

Undergo PRBC transfusion

Quality-of-Life Assessment

Ancillary studies

Primary outcome measure

  • Percentage of eligible patients that consent (feasibility) [ Time Frame: 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 ]
  • Indication for early termination based on interim analyses of safety (feasibility) [ Time Frame: Up to 30 months ]

Central Contacts and Locations

Central contacts

Anna Halpern, MD

206-606-1978halpern2@uw.edu

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Anna Halpern, MD

206-606-1978halpern2@uw.edu

Principal Investigator:

Anna Halpern, MD

More Information

Sponsor

University of Washington

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Washington on 2026-08-19.