Tranexamic Acid (TXA) Trial
Protocol #: CHI-001-1
Title: Evaluation of tranexamic acid among outpatients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML): a multicenter pilot trial (MYELO-CAN TXA)
Description: Patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) commonly experience complications related to bleeding, despite the best efforts of their care team. 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.
Tranexamic acid (TXA) reduces clinically relevant bleeding events in a variety of settings. However, the efficacy and safety of TXA in outpatients with MDS and AML is unknown; clinical trials are needed to inform best practice.
Aim: To evaluate trial feasibility to inform our larger phase III trial of TXA among at-risk patients. Ultimately, we will evaluate the efficacy and safety of TXA to minimize bleeding in patients with MDS and AML treated in the outpatient setting.
Patient population: Patients with MDS and AML receiving less-intensive chemotherapy with severe thrombocytopenia (platelet count <30×109/L).
Target sample size: 75 patients, across 10-15 Canadian sites.
Intervention: Tranexamic acid 1 gram orally 2-3 times per day for 60 days.
Comparator: Placebo orally 2-3 times per day for 60 days.
Primary outcome: Ability to enroll a median of 1 patient / site / month.
Antibiotic Prophylaxis (ABX) Trial
Protocol #: CHI-001-2
Title: Evaluation of antibiotic prophylaxis in myelodysplastic syndrome and acute myeloid leukemia: a multicenter pilot trial (MYELO-CAN ABX)
Description: Patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) commonly experience complications related to infection, despite the best efforts of their care team. These complications affect patient quality-of-life and can sometimes lead to hospitalization or death. Evaluation of affordable and widely available treatments to minimize infection complications among patients with MDS and AML is needed.
Levofloxacin (antibiotic) prophylaxis is shown to minimize febrile neutropenia and infectious complications in a variety of settings. However, the efficacy and safety of levofloxacin in outpatients with MDS and AML is unknown; clinical trials are needed to inform best practice.
Aim: To evaluate trial feasibility to inform our larger phase III trial of levofloxacin among at-risk patients. Ultimately, we will evaluate the efficacy and safety of levofloxacin prophylaxis to minimize infection in patients with MDS and AML treated in the outpatient setting.
Patient population: Patients with MDS and AML receiving less-intensive chemotherapy who are at-risk for infection.
Target sample size: 75 patients across 10-15 Canadian sites.
Intervention: Levofloxacin 500mg orally once daily for 90 days.
Comparator: Standard of care (no antibiotic prophylaxis).
Primary outcome: Ability to enroll a median of 1 patient / site / month.