RBC Transfusion Strategy for Leukemia

(BAIT Trial)

Overseen By Dimpy Modi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Donald Arnold

Must not be taking: Anticoagulants, Aspirin, NSAIDs

Disqualifiers: Palliative chemotherapy, Coagulopathies, Iron overload, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different red blood cell (RBC) transfusion strategies for people with leukemia. The researchers aim to determine if maintaining higher hemoglobin levels (the protein in red blood cells that carries oxygen) can reduce bleeding risk. Participants will receive either standard transfusions or transfusions to keep their hemoglobin levels closer to normal. This study includes individuals diagnosed with acute myeloid leukemia or acute lymphocytic leukemia who have started chemotherapy within the last five days. As an unphased trial, it offers participants the opportunity to contribute to important research that could enhance future leukemia treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain blood thinners like anticoagulants, aspirin, or nonsteroidal anti-inflammatory drugs.

What prior data suggests that this RBC transfusion strategy is safe for leukemia patients?

Research has shown that both restrictive and liberal red blood cell (RBC) transfusion methods are generally safe for patients. Studies have found that a liberal transfusion method, which maintains higher hemoglobin levels, does not increase the risk of death compared to more restrictive methods. This is significant because, in this trial, the liberal method aims to keep hemoglobin levels at least at 110 g/L, closer to normal levels.

In past studies, patients who received liberal transfusions did not experience more negative side effects than those with lower hemoglobin targets. This suggests that increasing hemoglobin levels might be safe for patients with leukemia. Overall, both transfusion methods have demonstrated similar safety, reassuring their use in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different strategies for red blood cell (RBC) transfusions in leukemia patients. Unlike the standard restrictive transfusion strategy that maintains hemoglobin levels at 70-80 g/L, this trial also examines a more liberal approach, aiming for 110 g/L. By comparing these two methods, researchers hope to find out which strategy better supports patient health and recovery, potentially leading to improved treatment guidelines for leukemia.

What evidence suggests that this trial's RBC transfusion strategies could be effective for leukemia?

Research shows that red blood cell (RBC) transfusions commonly treat anemia and reduce symptoms like tiredness in people with leukemia. Studies have found that the risk of death remains largely unchanged whether doctors use fewer or more transfusions. However, maintaining higher hemoglobin levels might lower the risk of bleeding, which is crucial for leukemia patients. Although few large studies focus solely on leukemia, the goal is to determine if keeping hemoglobin levels closer to normal can improve health outcomes. This trial will compare two RBC transfusion strategies: one arm will follow a standard-of-care restrictive strategy to maintain a hemoglobin level of at least 70-80 g/L, while the other arm will use a liberal strategy to maintain a hemoglobin level of at least 110 g/L. The aim is to assess whether using more transfusions to keep hemoglobin levels higher could be beneficial. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with certain types of leukemia (like T-Lymphoblastic Leukemia/Lymphoma, Acute Myeloid Leukemia) who are experiencing anemia-induced bleeding. Participants must require red blood cell transfusions as part of their standard care.

Inclusion Criteria

I have been diagnosed with acute leukemia.

I am currently hospitalized.

I started chemotherapy less than 5 days ago.

Exclusion Criteria

Life expectancy <72 hours

My white blood cell count is over 100,000.

I do not want to receive blood transfusions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive red blood cell transfusions according to assigned transfusion strategy

4 weeks

Weekly visits for biomarker testing and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RBC transfusion strategy

Trial Overview The study tests two red blood cell transfusion strategies to manage hemoglobin levels in leukemia patients: one maintains the usual care threshold, and the other aims for a higher level closer to normal ranges.

How Is the Trial Designed?

Group I: RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/LL Experimental Treatment 1 Intervention

Participants randomized to this arm will be assigned to a liberal RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.

Group II: Standard-of-care RBC transfusion strategy Active Control 1 Intervention

Participants randomized to this arm will be assigned to a restrictive RBC transfusion strategy of standard-of-care, which is typically to maintain a hemoglobin level of at least 70-80 g/L.

Who Is Running the Clinical Trial?

Donald Arnold

Lead Sponsor

Published Research Related to This Trial

A study analyzing 732 cases of red blood cell alloimmunization in patients with oncological malignancies found that transfusion significantly increases the risk of developing antibodies against Rh blood group antigens, particularly the E antigen.

To minimize the risk of alloimmunization in these high-risk patients, the study recommends implementing a policy for extended RBC phenotyping and providing antigen-matched blood, especially for the E antigen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RBC Transfusion Strategy in Oncological Patients with Chronic RBC Transfusion Therapy. Fang, W., Pang, C., Zhang, F., 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 Red blood cell (RBC) transfusion thresholds have yet to be examined in large randomized trials in hematologic malignancies. This pilot study in acute leukemia ...

2. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/5573/506194/Restrictive-Versus-Liberal-Red-Blood-Cell

Restrictive Versus Liberal Red Blood Cell Transfusion ... Overall, a restrictive RBC transfusion strategy may result in little to no difference in the risk of death at 31 to 100 days compared to a ...

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

Impact of red blood cell transfusion on patient's quality of life Red blood cell (RBC) transfusion is a widely used intervention to manage anemia, aiming to relieve symptoms such as fatigue and dyspnea and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S088779632400049X

Single-Unit Transfusion Policy in Autologous ... Single-unit red blood cell (1-RBC) transfusion policy has shown to effectively reduce transfusion burden while maintaining comparable clinical outcomes.

5. haematologica.org haematologica.org/article/view/6173

Significant reduction of red blood cell transfusion ... This is the first study indicating that a change to a single-unit transfusion policy can safely reduce the RBC transfusion requirements by approximately 25% ...

6. haematologica.org haematologica.org/article/view/haematol.2021.279867

Do liberal thresholds for red cell transfusion result in ... Primary outcomes were: i) percentage pretransfusion hemoglobins below threshold of the assigned strategy (predefined compliance ≥70%); and ii) ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123121732

Restrictive Versus Liberal Red Blood Cell Transfusion ... Overall, a restrictive RBC transfusion strategy may result in little to no difference in the risk of death at 31 to 100 days compared to a ...