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

NCT06710418 | Recruiting DMC

• 3 other identifiers: RG1124891NCI-2024-0901820807
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Percentage of eligible patients that consent (feasibility)

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

  Up to 30 months

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

  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.

  Up to 7 days after completion of study intervention

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

  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.

  Up to 30 months

Study Arms (2)

Arm I (restrictive threshold)

EXPERIMENTAL

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.

Other: Activity Tracking; Procedure: Biospecimen Collection; Procedure: Cognitive Assessment; Other: Electronic Health Record Review; Other: Packed Red Blood Cell Transfusion; Other: Quality-of-Life Assessment

Arm II (liberal threshold)

EXPERIMENTAL

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.

Other: Activity Tracking; Procedure: Biospecimen Collection; Procedure: Cognitive Assessment; Other: Electronic Health Record Review; Other: Packed Red Blood Cell Transfusion; Other: Quality-of-Life Assessment

Interventions

Activity Tracking OTHER

Ancillary studies

Arm I (restrictive threshold); Arm II (liberal threshold)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (restrictive threshold); Arm II (liberal threshold)

Cognitive Assessment PROCEDURE

Ancillary studies

Arm I (restrictive threshold); Arm II (liberal threshold)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (restrictive threshold); Arm II (liberal threshold)

Packed Red Blood Cell Transfusion OTHER

Undergo PRBC transfusion

Also known as: PRBC Transfusion

Arm I (restrictive threshold); Arm II (liberal threshold)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (restrictive threshold); Arm II (liberal threshold)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Burkitt Lymphoma; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Specimen Handling; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Anna Halpern, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Halpern, MD

CONTACT

206-606-1978; halpern2@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 29, 2024
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)