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Evaluating Red Blood Cell Transfusions for Blood Cancers

This study is looking at how different levels of hemoglobin (a protein in red blood cells) affect the quality of life and daily activities of people with certain blood cancers, including acute myeloid leukemia (AML) or B acute lymphoblastic lymphoma/leukemia (B-ALL). After receiving chemotherapy or a stem cell transplant, some patients need transfusions of packed red blood cells (PRBC). This trial compares two different approaches to when PRBC transfusions are given: one where transfusions happen when hemoglobin is 7 gm/dL or less, and another when it's 9 gm/dL or less. The goal is to find the best balance between safety and effectiveness, especially given blood supply challenges. You may be able to join if you are 18 or older and have one of these specific blood cancers.

Study design
This is an interventional study where participants are randomly assigned to one of two groups. The study plans to enroll 50 participants.
What's involved
You would undergo packed red blood cell transfusions based on your assigned group and have blood samples collected. Some participants may also have activity tracking, cognitive assessments, and electronic health record reviews.
Compensation
Not stated in the trial record.
Follow-up
After the main study intervention, you will be followed for 7 days and then periodically for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
NAAges 18+InterventionalSupportive care
University of Washington
~50 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Activity TrackingBiospecimen CollectionCognitive AssessmentElectronic Health Record ReviewPacked Red Blood Cell TransfusionQuality-of-Life Assessment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of eligible patients that consent (feasibility)
Measured over Up to 30 months
+2 more outcomes measured

Conditions

Acute Myeloid Leukemia
B Acute Lymphoblastic Leukemia
B Lymphoblastic Lymphoma
Myeloid Neoplasm

Explore related trials

Acute Myeloid LeukemiaB Acute Lymphoblastic LeukemiaB Lymphoblastic LymphomaMyeloid Neoplasm

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Anna Halpern, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Anna Halpern, MD
[email protected]
206-606-1978
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of eligible patients that consent (feasibility)Up to 30 months

    Randomizing patients to two different transfusion thresholds will be considered feasible if greater than 50% of eligible patients consent.

  • Percentage of patients randomized to the restrictive 7 gm/dL threshold that tolerate this transfusion trigger (feasibility)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.

  • Indication for early termination based on interim analyses of safety (feasibility)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.