Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic acid, Placebo.
- Who it may be relevant to
- Registry conditions: Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic/Myeloproliferative Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Tranexamic Acid Among Outpatients With Myelodysplastic Syndromes and Acute Myeloid Leukemia: a Multicenter Pilot Trial
Overview
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), myelodysplastic/myeloproliferative neoplasm (MDS/MPN) 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.
Interventions
- Drug Tranexamic acid
Tranexamic acid 1000mg orally two or three times daily - Drug Placebo
Placebo orally two or three times daily
Primary outcome measures
- Patient enrollment feasibility [Time frame: 2 months]
Secondary outcome measures (7)
- Venous or arterial thromboembolism incidence [Time frame: 2 months]
- Catheter-associated thrombosis incidence [Time frame: 2 months]
- Study drug discontinuation [Time frame: 2 months]
- Ability to consent 30% of eligible patients [Time frame: 2 months]
- Grade 3 and 4 nausea/vomiting [Time frame: 2 months]
- Visual disturbance incidence [Time frame: 2 months]
- Medication adherence [Time frame: 2 months]
Eligibility criteria
Inclusion criteria
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)
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- CancerCare Manitoba — Winnipeg
Identifiers
NCT: NCT06599762 · CHI-001-1