RECRUITINGPhase 2INTERVENTIONAL

Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

Evaluation of Tranexamic Acid Among Outpatients With Myelodysplastic Syndromes and Acute Myeloid Leukemia: a Multicenter Pilot Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: Master platform Who May Qualify: 1. Age ≥ 18 years 2. Diagnosis of myelodysplastic syndromes or acute myeloid leukemia MYELO-CAN TXA Who May Qualify: 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) Who Should NOT Join This Trial: Master platform Who Should NOT Join This Trial: 1. Participant is deemed unlikely to survive \>30 days (as determined by clinical team) 2. Participant unable to provide willing to sign a consent form MYELO-CAN TXA Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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) 7. Pregnancy and/or breastfeeding

Treatments Being Tested

DRUG

Tranexamic acid

Tranexamic acid 1000mg orally two or three times daily

DRUG

Placebo

Placebo orally two or three times daily

Locations (1)

CancerCare Manitoba

Winnipeg, Manitoba, Canada