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

Launched by UNIVERSITY OF WASHINGTON · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different levels of hemoglobin, a protein in red blood cells that carries oxygen, affect the quality of life and daily functioning of patients with certain blood cancers, like acute myeloid leukemia and B-cell acute lymphoblastic leukemia. The researchers are comparing two approaches to blood transfusions: one that gives transfusions when hemoglobin levels drop below 9 grams per deciliter (a more liberal approach) and another that allows transfusions only when levels drop below 7 grams per deciliter (a more restrictive approach). The goal is to see if the more restrictive approach can still maintain patients' quality of life while also reducing the side effects of transfusions and conserving blood supplies.

To be eligible for this trial, participants need to be at least 18 years old and have a diagnosis of a high-grade myeloid neoplasm or one of the specified types of leukemia. They should be planning to receive intensive chemotherapy or a stem cell transplant that is likely to cause anemia and low platelet counts. Participants must also be able to understand the study and agree to be part of it by signing a consent form. The trial is not yet recruiting, but once it starts, participants can expect close monitoring and care at the University of Washington and Fred Hutchinson Cancer Center, where they will receive treatments and evaluations throughout the study.

Gender

ALL

Eligibility 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 (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