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

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 you cannot participate if you are on certain blood thinners like anticoagulants, aspirin, or nonsteroidal anti-inflammatory drugs.

What data supports the effectiveness of the RBC transfusion strategy treatment for leukemia?

Research suggests that a restrictive RBC transfusion strategy is safe and can reduce the amount of blood used without negatively affecting clinical outcomes in patients with blood-related cancers, including leukemia. This approach may also lower costs associated with transfusions. ^{1 2 3 4 5}

Is red blood cell transfusion generally safe for people with leukemia?

Research suggests that a restrictive red blood cell transfusion strategy is generally safe for people with leukemia, as it does not increase the risk of complications like infections or affect the response to chemotherapy. This approach also reduces the number of transfusions needed, which can lower costs and potential risks associated with transfusions. ^{1 5 6 7 8}

How does the RBC transfusion strategy treatment for leukemia differ from other treatments?

The RBC transfusion strategy for leukemia is unique because it involves choosing between restrictive and liberal transfusion approaches, which differ in the hemoglobin levels they aim to maintain before giving a transfusion. This strategy is focused on optimizing the use of blood resources and ensuring patient safety, unlike other treatments that may not specifically address transfusion thresholds. ^{1 2 7 9 10}

What is the purpose of this trial?

This pilot study aims to gather preliminary evidence on how different hemoglobin levels impact blood biomarkers related to bleeding. The feasibility of conducting a future larger clinical trial will also be assessed. Red blood cell transfusions are part of the standard of care for patients with leukemia. This study evaluates two transfusion strategies: one that maintains hemoglobin levels above the standard-of-care threshold, reflecting current routine practice; and another that maintains hemoglobin levels above 110 g/L, which is closer to the normal hemoglobin range. The normal hemoglobin range is 120-160 g/L for females and 140-180 g/L for males. Raising hemoglobin levels closer to normal values may reduce bleeding risk.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Restrictive versus liberal transfusion strategies in patients with malignant neoplasm -a meta-analysis of randomized controlled trials. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

RBC Transfusion Strategy in Oncological Patients with Chronic RBC Transfusion Therapy. [2023]

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

Transfusion support in acute leukemias. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Impact of red blood cell transfusion strategies in haemato-oncological patients: a systematic review and meta-analysis. [2018]

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

Feasibility of a restrictive red-cell transfusion policy for patients treated with intensive chemotherapy for acute myeloid leukaemia. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. [2023]

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

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

9. Thailand pubmed.ncbi.nlm.nih.gov

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

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

Can we transfuse wisely in patients undergoing chemotherapy for acute leukemia or autologous stem cell transplantation? [2020]