Myelodysplastic SyndromesPhase 2MYELO-CAN:TXANCT06599762
Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia
A Phase 2 study testing Tranexamic acid in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic/Myeloproliferative Neoplasm
- What is being tested?
- Tranexamic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2025to 1 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- Active ischemic heart disease
- Gross hematuria
- Stage V chronic kidney disease
- Clinically suspected disseminated intravascular coagulation (DIC)
- Pregnancy and/or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Brett Houston, MD, 204-787-1103, bhouston@cancercare.mb.ca
About this study
Official title: Evaluation of Tranexamic Acid Among Outpatients With Myelodysplastic Syndromes and Acute Myeloid Leukemia: a Multicenter Pilot 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.
Read the 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.
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic/Myeloproliferative Neoplasm
- Being tested
- Tranexamic acid, Placebo
- Keywords
- Tranexamic Acid, Randomized Controlled Trial, Myelodysplastic Syndrome, Acute Myeloid Leukemia, Thrombocytopenia, myelodysplastic/myeloproliferative neoplasm, myeloproliferative neoplasm
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Myelodysplastic-Myeloproliferative Diseases, Thrombocytopenia, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Tranexamic acid 1000mg orally two or three times daily
PlaceboDrug
Placebo orally two or three times daily
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Not described Receives: Drug: Tranexamic acid |
| Matching Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient enrollment feasibility
The ability to enroll a median of 1 patient per site per month (10 patients / month when all sites are active)
Measured: 2 months
Secondary outcomes (7)
Venous or arterial thromboembolism incidence
The incidence of venous or arterial thromboembolism will be measured as a safety outcome.
Measured: 2 months
Catheter-associated thrombosis incidence
The incidence of catheter-associated thrombosis will be measured as a safety outcome.
Measured: 2 months
Study drug discontinuation
Study drug discontinuation due to adverse events will be measured as a safety outcome.
Measured: 2 months
Ability to consent 30% of eligible patients
The ability to consent 30% of eligible patients will be measured as a feasibility outcome.
Measured: 2 months
Grade 3 and 4 nausea/vomiting
The incidence of grade 3 and 4 nausea/vomiting (CTCAE) will be measured as a safety outcome.
Measured: 2 months
Visual disturbance incidence
The incidence of new visual disturbances will be measured as a safety outcome.
Measured: 2 months
Medication adherence
Protocol adherence of 80% of all intended medication doses per patient will be measured as a feasibility outcome.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled pilot trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Houston, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599762
- Sponsor's protocol ID
- CHI-001-1
- Acronym
- MYELO-CAN:TXA
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tranexamic Acid Among Outpatients With Myelodysplastic Syndromes and Acute Myeloid Leukemia: a Multicenter Pilot Trial
- ClinicalTrials.gov ID
- NCT06599762
- Acronym / sponsor ID
- MYELO-CAN:TXA / CHI-001-1
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic acid |
| Matching Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidTranexamic acid 1000mg orally two or three times daily | Drug | Tranexamic Acid |
| PlaceboPlacebo orally two or three times daily | Drug | Matching Placebo |
Primary outcome
Patient enrollment feasibility
Time frame: 2 months
The ability to enroll a median of 1 patient per site per month (10 patients / month when all sites are active)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic acid in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Houston, MD, PhD (204-787-8552, bhouston@cancercare.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient enrollment feasibility (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.