Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

Last updated: May 5, 2025
Sponsor: University of Manitoba
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

White Cell Disorders

Acute Myeloid Leukemia

Treatment

Placebo

Tranexamic acid

Clinical Study ID

NCT06599762
CHI-001-1
  • Ages > 18
  • All Genders

Study Summary

Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life changing blood cancers. Patients with MDS and AML commonly experience complications related to bleeding, which affect patient quality-of-life and can sometimes lead to hospitalization or death. The investigators will conduct a randomized controlled trial to evaluate the effectiveness and safety of tranexamic acid (TXA; a medication that prevents clots from dissolving) to prevent bleeding. In this study, 50% of patients will be randomized (like the flip of a coin) to receive TXA; the other 50% of patients will receive placebo. The investigators will monitor both groups of patients to see if the medication improves the risk and/or severity of bleeding. If tranexamic acid were to safely reduced the frequency of bleeding, this would broadly influence how doctors provide care for patients with MDS and AML around the world.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Master platform inclusion criteria:

  1. Age ≥ 18 years

  2. Diagnosis of myelodysplastic syndromes or acute myeloid leukemia

MYELO-CAN TXA inclusion criteria:

  1. Receipt of less-intensive chemotherapy (includes both frontline andrelapsed/refractory setting)

  2. Severe thrombocytopenia (platelets ≤ 30x10^9/L or platelets ≤ 50x10^9/L prior tochemotherapy initiation)

Exclusion

Exclusion Criteria:

Master platform exclusion criteria:

  1. Participant is deemed unlikely to survive >30 days (as determined by clinical team)

  2. Participant unable to provide informed consent

MYELO-CAN TXA exclusion criteria:

  1. Known allergy to tranexamic acid

  2. Active thromboembolic disease

  3. Active ischemic heart disease

  4. Gross hematuria

  5. Stage V chronic kidney disease

  6. Clinically suspected disseminated intravascular coagulation (DIC)

  7. Pregnancy and/or breastfeeding

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
May 12, 2025
Estimated Completion Date:
April 01, 2027

Study Description

RATIONALE: Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life-changing blood cancers. Despite the best efforts of their care team, patients with MDS and AML commonly experience complications related to bleeding. These complications affect patient quality-of-life and can sometimes lead to hospitalization or death. Evaluation of affordable and widely available treatments to minimize bleeding complications among patients with MDS and AML is needed.

STUDY OBJECTIVES: To evaluate the feasibility of tranexamic acid (TXA) that will evaluate the efficacy and safety of treatments to minimize bleeding in patients with MDS and AML treated in the outpatient setting.

METHODOLOGY: The investigators will conduct a multicenter pilot randomized control trial (RCT) for outpatients ≥18 years of age with MDS and AML. Patients with MDS and AML with low platelet counts will receive TXA (a medication that prevents clots from dissolving). TXA is commonly used in other clinical settings but have not been studied in patients with MDS or AML receiving outpatient chemotherapy (ie, chemotherapy that can be given from clinic, rather than a hospital). In this study, 50% of patients will be randomized (like the flip of a coin) to receive the medication the investigators are studying. The other 50% of patients will receive a matching placebo.

OUTCOMES: The primary feasibility outcome is the ability to enroll a mean of 1 patient per site per month.

SITES AND DURATION: The investigators will initially enroll patients from 10-15 sites across Canada. The expected duration of enrollment is 2 years.

SIGNIFICANCE: With a broad range of stakeholders, including patient partners, the trial will address a broadly applicable patient-prioritized question. Tranexamic acid is readily available, inexpensive, and has an established side effect profile. Results of this trial are highly generalizable and will broadly impact the care of patients with MDS and AML.

Connect with a study center

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Active - Recruiting

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