This study will investigate the effects of sertraline in people with low-risk myelodysplastic syndrome (MDS). It is hoped that sertraline will decrease disease progression and reduce the need for blood transfusions.
This pilot study investigates clinical benefit of four 28-day cycles of sertraline in low-risk MDS patients. Participants will receive 100mg of oral sertraline daily. The study will also evaluate potential associated biological mechanisms of action.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Baylor College of Medicine
Houston, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Hematological Improvement - minor (HI-minor)
Improvement in erythroid, neutrophil or platelet
Time frame: 16 weeks
HI-minor response rate
HI-minor response rate Cycle 1
Time frame: 4 weeks
HI-minor response rate
HI-minor response rate Cycle 2
Time frame: 8 weeks
HI-minor response rate
HI-minor response rate Cycle 3
Time frame: 12 weeks
HI-minor response rate
HI-minor response rate Cycle 4
Time frame: 16 weeks
Individual rates of HI minor measurements: erythroid, neutrophil and platelet
Individual rates of HI minor measurements at Cycle 1: erythroid, neutrophil and platelet
Time frame: 4 weeks
Individual rates of HI minor measurements: erythroid, neutrophil and platelet
Individual rates of HI minor measurements at Cycle 2: erythroid, neutrophil and platelet
Time frame: 8 weeks
Individual rates of HI minor measurements: erythroid, neutrophil and platelet
Individual rates of HI minor measurements at Cycle 3: erythroid, neutrophil and platelet
Time frame: 12 weeks
Individual rates of HI minor measurements: erythroid, neutrophil and platelet
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Individual rates of HI minor measurements at Cycle 4: erythroid, neutrophil and platelet
Time frame: 16 weeks
Hematological Improvement - major (HI-major) response rate
HI-major response rate at Cycle 1
Time frame: 4 weeks
Hematological Improvement - major (HI-major) response rate
HI-major response rate at Cycle 2
Time frame: 8 weeks
Hematological Improvement - major (HI-major) response rate
HI-major response rate at Cycle 3
Time frame: 12 weeks
Hematological Improvement - major (HI-major) response rate
HI-major response rate at Cycle 4
Time frame: 16 weeks
Individual rates of HI major measurements: erythroid, neutrophil and platelet
Individual rates of HI major measurements at Cycle 1: erythroid, neutrophil and platelet
Time frame: 4 weeks
Individual rates of HI major measurements: erythroid, neutrophil and platelet
Individual rates of HI major measurements at Cycle 2: erythroid, neutrophil and platelet
Time frame: 8 weeks
Individual rates of HI major measurements: erythroid, neutrophil and platelet
Individual rates of HI major measurements at Cycle 3: erythroid, neutrophil and platelet
Time frame: 12 weeks
Individual rates of HI major measurements: erythroid, neutrophil and platelet
Individual rates of HI major measurements at Cycle 4: erythroid, neutrophil and platelet
Time frame: 16 weeks
Serum cytokine level modifications
Measured as the difference between Week 4 and pre-treatment levels
Time frame: 4 weeks
Serum cytokine level modifications
Measured as the difference between Week 8 and pre-treatment levels
Time frame: 8 weeks
Serum cytokine level modifications
Measured as the difference between Week 12 and pre-treatment levels
Time frame: 12 weeks
Serum cytokine level modifications
Measured as the difference between Week 16 and pre-treatment levels
Time frame: 16 weeks
Changes in the Gene Expression Profile
Measured as the difference between Day 14 and Baseline
Time frame: Between Baseline and Day 14