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NCT Number: NCT06710418

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity Tracking

Other

Ancillary studies

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

cognitive assessment

Procedure

Ancillary studies

Electronic Health Record Review

Other

Ancillary studies

packed red blood cell transfusion

Other

Undergo PRBC transfusion

Other names: PRBC Transfusion

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Halpern, MD

CONTACT

[email protected]

206-606-1978

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 29, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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