Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

NCT06599762 | Recruiting Phase 2 DMC

• 1 other identifier: CHI-001-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myelodysplastic Syndromes; Acute Myeloid Leukemia; Myelodysplastic/Myeloproliferative Neoplasm

Keywords

Tranexamic Acid; Randomized Controlled Trial; Myelodysplastic Syndrome; Acute Myeloid Leukemia; Thrombocytopenia; myelodysplastic/myeloproliferative neoplasm; myeloproliferative neoplasm

Outcome Measures

Primary Outcomes (1)

• Patient enrollment feasibility

  The ability to enroll a median of 1 patient per site per month (10 patients / month when all sites are active)

  2 months

Secondary Outcomes (7)

• Venous or arterial thromboembolism incidence

  2 months

• Catheter-associated thrombosis incidence

  2 months

• Study drug discontinuation

  2 months

• Ability to consent 30% of eligible patients

  2 months

• Grade 3 and 4 nausea/vomiting

  2 months

Other Outcomes (8)

• Quality of life evaluation using PROMIS questionnaire

  2 months

• Quality of life evaluation using EORTC questionnaire

  2 months

• Grade 2 to 5 bleeding incidence

  2 months

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Drug: Tranexamic acid

Matching Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tranexamic acid DRUG

Tranexamic acid 1000mg orally two or three times daily

Tranexamic Acid

Placebo DRUG

Placebo orally two or three times daily

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm or acute myeloid leukemia
• 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:

• Participant is deemed unlikely to survive \>30 days (as determined by clinical team)
• Participant unable to provide informed consent
• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Myelodysplastic-Myeloproliferative Diseases; Thrombocytopenia; Myeloproliferative Disorders

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Blood Platelet Disorders; Cytopenia

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Brett Houston, MD, PhD

CONTACT

204-787-8552; bhouston@cancercare.mb.ca

Nora Choi, MSc

CONTACT

204-787-8552; nchoi@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled pilot trial

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2025-09

Locations

CA (1)