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Red Blood Cell Transfusions for Leukemia

N/A

Waitlist Available

Led By Anna Halpern, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Patients requiring renal replacement therapy at the time of randomization

Patients who decline transfusion for personal or religious beliefs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effects of giving different levels of red blood cell transfusions to patients who have had chemotherapy or a stem cell transplant for certain types of blood cancers. The trial compares giving transfusions

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to the blood transfusion such as fever, allergic reactions, lung injury, iron overload in long-term cases, and rarely transmission of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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

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I plan to receive all my care after chemotherapy or stem cell transplant at UW/FHCC.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on dialysis.

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I refuse blood transfusions due to my beliefs.

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I do not have significant bleeding issues.

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I need a platelet transfusion only if my count drops below 10,000/uL.

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I haven't had a heart attack or blood clot in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Indication for early termination based on interim analyses of safety (feasibility)

Percentage of eligible patients that consent (feasibility)

Percentage of patients randomized to the restrictive 7 gm/dL threshold that tolerate this transfusion trigger (feasibility)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (liberal threshold)Experimental Treatment6 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 Treatment6 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Assessment

2011

Completed Phase 2

~1420

Biospecimen Collection

2004

Completed Phase 3

~2030