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

NCT ID: NCT06710418

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (restrictive threshold)

Patients undergo PRBC transfusion if at any point their hemoglobin level is 7 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.

Group Type: EXPERIMENTAL

Activity Tracking

Intervention Type: OTHER

Ancillary studies

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Cognitive Assessment

Intervention Type: PROCEDURE

Ancillary studies

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Packed Red Blood Cell Transfusion

Intervention Type: OTHER

Undergo PRBC transfusion

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Arm II (liberal threshold)

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.

Group Type: EXPERIMENTAL

Activity Tracking

Intervention Type: OTHER

Ancillary studies

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Cognitive Assessment

Intervention Type: PROCEDURE

Ancillary studies

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Packed Red Blood Cell Transfusion

Intervention Type: OTHER

Undergo PRBC transfusion

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Activity Tracking

Ancillary studies

Intervention Type: OTHER

Biospecimen Collection

Undergo blood sample collection

Intervention Type: PROCEDURE

Cognitive Assessment

Ancillary studies

Intervention Type: PROCEDURE

Electronic Health Record Review

Ancillary studies

Intervention Type: OTHER

Packed Red Blood Cell Transfusion

Undergo PRBC transfusion

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Biological Sample Collection; Biospecimen Collected; Specimen Collection; PRBC Transfusion; Quality of Life Assessment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Halpern, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anna Halpern, MD

Role: CONTACT

halpern2@uw.edu

206-606-1978

Facility Contacts

Anna Halpern, MD

Role: primary

halpern2@uw.edu

206-606-1978

Other Identifiers

NCI-2024-09018

Identifier Type: REGISTRY

Identifier Source: secondary_id

20807

Identifier Type: OTHER

Identifier Source: secondary_id

RG1124891

Identifier Type: -

Identifier Source: org_study_id