Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic/Myeloproliferative Neoplasm

In brief

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.

Key facts

Study ID

NCT06599762

Run by

University of Manitoba

People needed

75

Starts

2025-09-10

Expected to finish

2027-04-01

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Master platform inclusion criteria:
• Age ≥ 18 years
• Diagnosis of myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm or acute myeloid leukemia
• MYELO-CAN TXA inclusion criteria:
• Receipt of less-intensive chemotherapy (includes both frontline and relapsed/refractory setting)
• Severe thrombocytopenia (platelets ≤ 30x10\^9/L or platelets ≤ 50x10\^9/L prior to chemotherapy initiation)

You may not qualify if…

• Master platform exclusion criteria:
• Participant is deemed unlikely to survive >30 days (as determined by clinical team)
• Participant unable to provide informed consent
• MYELO-CAN TXA exclusion criteria:
• Known allergy to tranexamic acid
• Active thromboembolic disease
• Active ischemic heart disease
• Gross hematuria
• Stage V chronic kidney disease
• Clinically suspected disseminated intravascular coagulation (DIC)
• Pregnancy and/or breastfeeding

Where it is running

• CancerCare Manitoba — Winnipeg, Manitoba, Canada (enrolling)

Full record on ClinicalTrials.gov

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