Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

Trial Title: Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

NCT ID: NCT06599762

Condition: Myelodysplastic Syndromes
Acute Myeloid Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Tranexamic Acid

Conditions: Keywords:
Tranexamic Acid
Randomized Controlled Trial
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Thrombocytopenia

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized controlled pilot trial

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Tranexamic acid
Description: Tranexamic acid 1 gram orally twice daily
Arm group label: Tranexamic Acid

Intervention type: Drug
Intervention name: Placebo
Description: Placebo orally twice daily
Arm group label: Matching Placebo

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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 and relapsed/refractory setting) 2. Severe thrombocytopenia (platelets ≤ 30x10^9/L or platelets ≤ 50x10^9/L prior to chemotherapy initiation) 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 1, 2024

Completion date: November 1, 2027

Lead sponsor:
Agency: University of Manitoba
Agency class: Other

Source: University of Manitoba

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06599762