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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

Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 42 days, 7 days, 5 years
  • Procedures mentioned: Infusions, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "After completion of study intervention, patients are followed up for 7 days and then periodically for up to 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two blood test levels used to decide when to give red blood cell transfusions. It looks at quality of life and ability to do daily tasks in adults with certain blood cancers who receive strong chemotherapy or a stem cell transplant from a donor.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have a high-grade myeloid cancer with at least 10% immature cells in blood or bone marrow, acute myeloid leukemia (not the APL type), or B-cell acute lymphoblastic lymphoma/leukemia.
  • You plan to receive one of the study's allowed strong chemotherapy treatments or a stem cell transplant from a donor.
  • Your treatment is expected to cause low red blood cells needing transfusions and low platelets for at least 5 days. Platelets help blood clot; the required count is 30,000 or less per microliter.
  • You plan to get all care after chemotherapy or transplant at the University of Washington/Fred Hutchinson Cancer Center.
  • You can understand the study and are willing to sign a consent form.

Who can't join

  • You need platelet transfusions to prevent bleeding when your platelet count is above 10,000 per microliter.
  • You need blood thinners, medicines that keep platelets from sticking together, or medicines that prevent clots from breaking down, and cannot stop them when platelets fall below 50,000 per microliter.
  • You have bleeding rated grade 2 or higher on the study's bleeding scale when assigned to a study group.
  • You had a blood clot in an artery or vein, including a heart attack, within 6 months before starting chemotherapy or transplant.
  • You need dialysis or another treatment to replace kidney function when assigned to a study group.
  • You do not accept blood transfusions because of personal or religious beliefs.
  • You are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (1)

WA