Tranexamic Acid for Blood Cancers

(MYELO-CAN:TXA Trial)

Overseen By Nora Choi, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Manitoba

Disqualifiers: Thromboembolic disease, Ischemic heart disease, Kidney disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if tranexamic acid, a medicine that prevents blood clots from breaking down, can reduce bleeding in people with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). These blood cancers often cause bleeding problems, affecting life quality and sometimes leading to serious health issues. Participants will be divided into two groups: one will receive the medication, and the other will receive a placebo (a harmless pill with no active ingredient). This trial is suitable for individuals with MDS or AML who are receiving less-intensive chemotherapy and experience severe bleeding issues. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that tranexamic acid is likely to be safe for humans?

Previous studies have shown that tranexamic acid (TXA) is safe. Research indicates that TXA does not significantly increase the risk of blood clots, a common concern with medications that stop bleeding. In cancer surgery patients, TXA did not cause more clotting problems than expected, despite their higher risk for such issues. This suggests that TXA is generally well-tolerated. However, TXA did not significantly reduce the risk of serious bleeding or the need for blood transfusions in patients with blood cancers. Overall, while TXA appears safe, its effectiveness in preventing bleeding in blood cancer patients remains under study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tranexamic Acid is unique because it targets excessive bleeding, which is a significant concern in blood cancers, by helping to stabilize blood clots. While most treatments for blood cancers focus on killing cancer cells through chemotherapy or radiation, Tranexamic Acid offers a supportive approach by reducing the risk of bleeding complications. Researchers are excited about this treatment because it could enhance patients' quality of life by minimizing bleeding risks, potentially making it a valuable adjunct therapy alongside traditional cancer treatments.

What evidence suggests that tranexamic acid might be an effective treatment for blood cancers?

This trial will compare Tranexamic Acid (TXA) with a matching placebo to evaluate its effectiveness in patients with blood cancers. Research has shown that TXA, a drug that helps prevent blood clots from breaking down too quickly, does not significantly lower the risk of bleeding in patients with blood cancers like myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Several studies have found that TXA does not reduce the chances of moderate or severe bleeding compared to a placebo. It also does not decrease the need for platelet transfusions, which are often required to control bleeding in these conditions. While TXA has proven useful in reducing certain infections after surgery, its ability to prevent bleeding in blood cancer patients remains unproven. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with myelodysplastic syndromes or acute myeloid leukemia, who are receiving less-intensive chemotherapy and have severe thrombocytopenia (very low platelet counts). It's not for those outside these criteria.

Inclusion Criteria

My platelet count is very low.

I have been diagnosed with myelodysplastic syndromes or acute myeloid leukemia.

I have received milder forms of chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tranexamic acid or placebo to evaluate the effectiveness and safety in preventing bleeding in MDS and AML patients

2 months

Monthly visits for monitoring and quality of life evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of visual disturbances and thromboembolism

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The trial is testing if tranexamic acid, a medication that prevents blood clots from breaking down, can reduce bleeding in patients. Half will receive the drug and half a placebo to compare effectiveness.

How Is the Trial Designed?

Group I: Tranexamic Acid Experimental Treatment 1 Intervention

Group II: Matching Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Citations

1. ashpublications.org ashpublications.org/blood/article/140/11/1254/485476/Prophylactic-tranexamic-acid-in-patients-with

Prophylactic tranexamic acid in patients with hematologic ... Prophylactic TXA did not decrease WHO grade 2+ bleeding incidence compared with placebo in thrombocytopenia related to malignancy. Prophylactic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9479029/

Prophylactic tranexamic acid in patients with hematologic ... The authors confirm that TXA does not significantly reduce the risk of WHO grade 2 or higher bleeding, nor does it decrease the need for platelet transfusions.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S235230262400317X

Tranexamic acid versus placebo to prevent bleeding in ... We found that tranexamic acid did not reduce the risk of death or grade 2 or higher bleeding compared with placebo among patients with haematological ...

4. ash.confex.com ash.confex.com/ash/2023/webprogram/Paper180720.html

Paper: Tranexamic Acid to Prevent Bleeding in Patients ... Conclusions: Prophylactic TXA had no effect on the incidence of WHO Grade ≥2 bleeding or death when given in addition to prophylactic platelet ...

5. rpthjournal.org rpthjournal.org/article/S2475-0379(24)00047-5/fulltext

Fewer severe infections with tranexamic acid in patients ... Tranexamic acid has been shown to reduce the risk of some surgical site infections. Patients with hematologic malignancies received either tranexamic acid or a ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666548425000332

Safety and efficacy of tranexamic acid in oncologic surgery ... TXA demonstrated a reassuring safety profile, with no significant increase in thromboembolic complications despite the inherently higher thrombotic risk in ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03136445

NCT03136445 | TRial to EvaluAte Tranexamic Acid ... The purpose of this study is to test whether giving tranexamic acid to patients receiving treatment for blood cancers reduces the risk of bleeding or death.