Lower versus higher hemoglobin thresholds for red blood cell transfusions in adults with high-grade myeloid cancers or B-cell ALL/lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with high-grade myeloid neoplasms, acute myeloid leukemia (non-APL), or B-cell acute lymphoblastic leukemia/lymphoma who are undergoing intensive chemotherapy or allogeneic hematopoietic stem cell transplant are randomized to receive packed red blood cell transfusions at either a restrictive hemoglobin threshold (≤7 g/dL) or a liberal threshold (≤9 g/dL). Transfusions are managed from the day after completion of chemotherapy/transplant for up to 42 days, with biospecimen collection, activity tracking, cognitive assessments, and medical record review included. The trial's primary focus is on patient-reported quality of life and functional outcomes, with safety and transfusion frequency also recorded. Participants are followed for 7 days after intervention completion and then periodically for up to five years to capture longer-term effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Fred Hutch/University of Washington Cancer Consortium
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Anna Halpern, MD — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Anna Halpern, MD
• Email: halpern2@uw.edu
• Phone: 206-606-1978

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.