Lower versus higher hemoglobin thresholds for red blood cell transfusions in adults with high-grade myeloid cancers or B-cell ALL/lymphoma
Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study
This will see if giving transfusions only when hemoglobin drops to 7 g/dL instead of 9 g/dL affects quality of life and physical functioning for adults receiving intensive chemotherapy or allogeneic stem cell transplant for high-grade myeloid cancers or B-cell ALL/lymphoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06710418 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with high-grade myeloid neoplasms, AML (excluding APL), or B-cell ALL/lymphoma who plan to receive intensive induction or post-remission chemotherapy or allogeneic HSCT expected to cause anemia and prolonged low platelets, who will get post-treatment care at UW/Fred Hutch and can give informed consent, are ideal candidates.
Not a fit: Patients not receiving intensive chemotherapy or allogeneic HSCT, those with APL, those unable to receive post-treatment care at UW/Fred Hutch, or those with immediate symptomatic anemia or active bleeding requiring urgent transfusion may not benefit from this protocol.
Why it matters
Potential benefit: If successful, a more restrictive transfusion threshold could reduce the number of transfusions and related risks while preserving quality of life and function, and help conserve limited blood supplies.
How similar studies have performed: Restrictive transfusion thresholds (around 7 g/dL) have been shown to be safe and reduce transfusion use in ICU and some cancer populations, but randomized evidence specifically addressing quality of life and functional outcomes in high-grade myeloid malignancies is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seattle, Washington
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.