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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best method for administering red blood cell transfusions to individuals with certain types of leukemia or lymphoma who have undergone chemotherapy or a stem cell transplant. The primary goal is to determine if using a lower hemoglobin level for transfusions can maintain patients' well-being and functionality while conserving blood supplies. Two groups will be compared: one receives transfusions when hemoglobin is 7 or lower, and the other when it is 9 or lower. This trial suits those diagnosed with high-grade myeloid neoplasm, acute myeloid leukemia, or B-cell acute lymphoblastic lymphoma/leukemia who are planning intense treatment that leads to anemia. As an unphased trial, this study provides a unique opportunity to optimize transfusion practices and potentially enhance patient care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that transfusions of packed red blood cells (PRBCs) are usually well-tolerated by patients. One study found that processing red blood cells with low oxygen levels using a special system was both effective and safe. This finding suggests that similar PRBC transfusions might also be safe for people with leukemia.

Other studies have shown that PRBC transfusions can improve blood counts and survival rates in patients with anemia, which is common after chemotherapy or stem cell transplants. While transfusions can cause side effects, such as allergic reactions or fever, using red blood cells with fewer white blood cells can help reduce these risks.

Overall, research supports the safety of PRBC transfusions, but patients should discuss any concerns with their healthcare team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different transfusion strategies for leukemia patients, which could optimize care and improve patient outcomes. The trial investigates two approaches: a restrictive threshold, where patients receive red blood cell transfusions if hemoglobin falls to 7 gm/dL, and a liberal threshold, with transfusions starting at 9 gm/dL. This comparison aims to determine which strategy better supports patient recovery after chemotherapy or stem cell infusion, potentially leading to more personalized and effective treatment protocols.

What evidence suggests that this trial's treatments could be effective for leukemia?

This trial will compare two strategies for red blood cell transfusions in patients with leukemia. One group will receive transfusions when hemoglobin levels drop to 7 gm/dL or lower, while the other group will receive them at 9 gm/dL or lower. Studies have shown that administering transfusions only when hemoglobin levels fall to 7 gm/dL or lower can be as effective as doing so at 9 gm/dL or lower. This more cautious approach might even be preferable, as it can reduce the risks associated with excessive transfusions. Research indicates that transfusions raise blood counts, which is crucial because low blood counts are linked to lower survival rates in leukemia patients. While the effect on quality of life can vary, transfusions generally improve patients' energy levels. Overall, the cautious transfusion strategy conserves blood supplies while maintaining patient health. ^{1 2 3 6 7}

Who Is on the Research Team?

Anna Halpern

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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

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

Exclusion Criteria

Pregnancy or lactation

I am on dialysis.

I refuse blood transfusions due to my beliefs.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4986514/

Red blood cell transfusion triggers in acute leukemia These studies have mainly shown that a restrictive strategy of RBC transfusion is at least as effective as and possibly superior to a liberal transfusion ...

2. nature.com nature.com/articles/s41598-022-26309-5

Label-free testing strategy to evaluate packed red blood ... PRBCs transfusion helps to increase blood counts which results in higher survival rates since anemia is associated with lower survival in ...

3. aob.amegroups.org aob.amegroups.org/article/view/11039/html

Impact of red blood cell transfusion on patient's quality of life The impact of RBC transfusion on QoL has been extensively studied, with varying results depending on the patient population and specific ...

4. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15289.evaluating-the-effects-of-hemoglobin-threshold-specific-packed-red-blood-cell-transfusions-on-quality-of-life-and-functional-outcomes-in-patients.html

Clinical Trial Details This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6410443/

Leukodepleted Packed Red Blood Cells Transfusion in ... In this systematic review, we appraise the clinical effectiveness of allogeneic leukodepleted (LD) PRBC transfusion for preventing infections ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753523/

Evaluation of leukocyte depletion of packed red blood cells ... The study aimed to reveal whether the use of leukocyte-poor red blood cells (LPRBCs) can reduce the incidence of transfusion reactions to promote patient ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1473050223001398

Safety of hypoxic red blood cell administration in patients ... This interim analysis showed that transfusion with hypoxic RBCs processed with the CPD/PAGGSM LR, O 2 /CO 2 reduced system was effective and well tolerated.