What side effects are associated with this type of intervention?

Common treatments for Myelodysplastic Syndrome (MDS) include erythropoiesis-stimulating agents (ESAs) and red blood cell (RBC) transfusions. ESAs can increase the risk of thrombosis, particularly in patients with a history of thromboembolic events or uncontrolled hypertension. RBC transfusions, while effective in alleviating anemia symptoms, carry risks such as alloimmunization, iron overload, and transfusion reactions. Chronic transfusion therapy can lead to iron overload, potentially causing damage to organs like the liver and heart.

What prior FDA approvals exist?

The FDA has approved several treatments for Myelodysplastic Syndrome (MDS), including hypomethylating agents such as azacitidine and decitabine, which are used to improve blood counts and reduce transfusion needs. Thrombopoietin mimetics like eltrombopag and romiplostim have also been approved to manage thrombocytopenia in MDS patients. These treatments aim to enhance hematologic function and minimize immune-mediated adverse effects, aligning with the goals of ensuring compatibility in transfusions, as studied in trials like the ABO Identical RBC Transfusion.

What other types of research exist?

Promising novel alternatives to ABO identical RBC transfusion for Myelodysplastic Syndrome patients include the use of erythropoiesis-stimulating agents (ESAs) to reduce the need for transfusions, and advancements in hematopoietic stem cell transplantation (HCT) techniques. Additionally, the development of safer transfusion practices and better matching algorithms may help minimize immune-mediated adverse effects.

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Blood Product

Non-Identical Blood Type Transfusions for Patient Outcomes (UD Trial)

N/A

Recruiting

Led By Donald Arnold

Research Sponsored by McMaster University

Eligibility Criteria Checklist

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

Must have

Diagnosis of MDS (Myelodysplastic syndrome ) without leukemia (IPSS-R classified or physician indicated either low-risk or intermediate-1)

Age ≥ 18 years of age

Must not have

Unable to provide informed consent

Blood group O

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-24 hours after transfusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving patients blood that exactly matches their own type can reduce complications and deaths. It focuses on patients who need transfusions and are at higher risk of problems when given non-matching blood. The goal is to prevent harmful immune reactions by using matching blood types.

Who is the study for?

This trial is for adults over 18 with Myelodysplastic Syndrome (MDS) who don't have leukemia. They must need regular blood transfusions every 6 weeks or less, be stable according to their doctor's assessment, and not require special blood products due to reactions. People with blood group O or those unable to consent are excluded.

What is being tested?

The study is examining if receiving Red Blood Cell (RBC) transfusions that aren't a perfect match for the patient's ABO blood type affects their health outcomes. It follows earlier research suggesting non-identical RBCs might increase in-hospital death risk.

What are the potential side effects?

While specific side effects are not detailed here, generally, risks from mismatched RBC transfusions can include allergic reactions, fever, iron overload, and rarely hemolytic transfusion reactions where the body attacks the new cells.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with MDS without leukemia, classified as low or intermediate-1 risk.

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I am 18 years old or older.

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I need blood transfusions of 2 units at least every 6 weeks.

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I am getting blood transfusions outside the hospital.

Exclusion Criteria

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

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I am unable to understand and give consent for treatment.

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My blood type is O.

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I need special blood products due to reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in the biomarkers of inflammation from baseline (C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1β, TNF-α, IL-8, CD40 Ligand)

Change in the biomarkers of inflammation(C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1β, TNF-α, IL-8, CD40 Ligand)

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

Active Control

Group I: ABO non-identical transfusionExperimental Treatment1 Intervention

All study patients will participate in the study for two consecutive transfusion episodes (a transfusion episode is defined as a clinic visit where 2 RBC units are transfused) and will receive an ABO identical product at one transfusion episode and an ABO non-identical product for the other episode. Randomization will dictate the order of the transfusion. The number of RBCs given for each study transfusion episode will be identical 2 RBC units.

Group II: ABO identical transfusionActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RBC transfusion

2013

Completed Phase 3

~290

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Myelodysplastic Syndrome (MDS) include erythropoiesis-stimulating agents (ESAs), thrombopoietin mimetics, and DNA methyltransferase inhibitors. ESAs, such as epoetin alfa, stimulate red blood cell production to alleviate anemia and reduce the need for transfusions. Thrombopoietin mimetics, like romiplostim, aim to increase platelet counts but are used cautiously due to potential risks of leukemic transformation. DNA methyltransferase inhibitors, such as azacitidine and decitabine, work by reversing abnormal DNA methylation patterns, thereby restoring normal gene function and inhibiting cancer cell growth. Ensuring compatibility in treatments, similar to the ABO Identical RBC Transfusion trial, is crucial to minimize immune-mediated adverse effects and improve patient outcomes.

Therapeutic modalities for patients with lower-risk myelodysplastic syndromes: current options and future directions.Combination therapy with DNA methyltransferase inhibitors in hematologic malignancies.