Red Blood Cell Transfusions for Leukemia

Overseen By Anna Halpern, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anticoagulants, Antiplatelets, Antifibrinolytics

Disqualifiers: Thrombosis, Renal therapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who need certain blood-thinning medications that can't be paused. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Packed Red Blood Cell Transfusion for leukemia?

Red blood cell transfusions are essential for patients with acute leukemia, as they help manage anemia (a condition where you don't have enough healthy red blood cells) during treatment. This is supported by research showing their use is common and necessary in these patients. ^{1 2 3 4 5}

Is red blood cell transfusion generally safe for humans?

Red blood cell transfusions are generally considered safe, but they can have risks such as increasing the chance of lung problems in critically ill patients and causing iron overload, which may lead to heart and liver issues. They can also have proinflammatory effects, potentially leading to infections and other complications. ^{1 2 3 5 6}

How is red blood cell transfusion unique for treating leukemia?

Red blood cell transfusions for leukemia are unique because they provide essential support for patients with anemia (low red blood cell count) caused by the disease or its treatment. Unlike other treatments, transfusions directly increase red blood cell levels, but they can lead to complications like iron overload and immune reactions, which require careful management. ^{1 2 5 7 8}

What is the purpose of this trial?

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.

Research Team

Anna Halpern

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

This trial is for patients with high-grade myeloid neoplasms, acute myeloid leukemia, or B acute lymphoblastic lymphoma/leukemia who have had chemotherapy or a stem cell transplant. It's important that they need packed red blood cell transfusions due to low hemoglobin from treatment.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

I am set to receive strong chemotherapy or a stem cell transplant that will likely cause severe anemia and low platelet counts.

I have been diagnosed with a specific type of blood cancer, not including APL.

Exclusion Criteria

Pregnancy or lactation

I am on dialysis.

I refuse blood transfusions due to my beliefs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PRBC transfusion based on hemoglobin thresholds after SOC chemotherapy/stem cell infusion, continuing for up to 42 days

6 weeks

Regular visits for transfusion and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days initially, then periodically for up to 5 years

Treatment Details

Interventions

• Packed Red Blood Cell Transfusion

Trial Overview The study tests if giving blood transfusions at a lower hemoglobin level (>7 gm/dL) is as good for patient quality of life and function as doing it at a higher level (>9 gm/dL), which could reduce side effects and save blood resources.

Participant Groups

Group I: Arm II (liberal threshold) Experimental Treatment 6 Interventions

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 II: Arm I (restrictive threshold) Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Findings from Research

In a study of 360 children who underwent surgery for solid tumors, those who received packed red blood cell (PRBC) transfusions had a higher risk of postoperative infections and tumor recurrence, indicating potential risks associated with transfusions in this population.

Each additional unit of PRBC transfused increased the odds of postoperative infection by nearly four times, suggesting that if transfusions are necessary, they should be given in single unit increments to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Transfusion is Associated With Adverse Outcomes in Pediatric Solid Tumor Oncology Patients Following Tumor Resection. Acker, SN., Nolan, MM., Prendergast, C., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Number of erythrocyte transfusions is more predictive than serum ferritin in estimation of cardiac iron loading in pediatric patients with acute lymphoblastic leukemia. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Audit of red blood cell transfusion in patients with acute leukemia at a tertiary care university hospital. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Blood Transfusion is Associated With Adverse Outcomes in Pediatric Solid Tumor Oncology Patients Following Tumor Resection. [2023]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The therapeutic efficacy of transfusions of erythrocyte mass in anemia in patients with internal diseases]. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Red blood cell transfusion triggers in acute leukemia: a randomized pilot study. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Red blood cell transfusions and the risk of acute respiratory distress syndrome among the critically ill: a cohort study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Transfusion support in acute leukemias. [2007]

8. Thailand pubmed.ncbi.nlm.nih.gov

Red Cell Alloimmunization in Repeatedly Transfused Sudanese Patients with leukemia in Northern Sudan. [2023]