Evaluation of Tranexamic Acid Among Outpatients With Myelodysplastic Syndromes and Acute Myeloid Leukemia: a Multicenter Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Patient enrollment feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Matching Placebo
干预措施: Placebo (Drug)
Tranexamic Acid
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Patient enrollment feasibility
时间窗: 2 months
The ability to enroll a median of 1 patient per site per month (10 patients / month when all sites are active)
次要结局
- Visual disturbance incidence(2 months)
- Medication adherence(2 months)
- Venous or arterial thromboembolism incidence(2 months)
- Catheter-associated thrombosis incidence(2 months)
- Study drug discontinuation(2 months)
- Ability to consent 30% of eligible patients(2 months)
- Grade 3 and 4 nausea/vomiting(2 months)
研究者
Brett Houston
Principal Investigator
University of Manitoba