Sertraline in Treating Participants with Low-Risk Myelodysplastic Syndrome

Inclusion Criteria

• Myelodysplastic syndromes: diagnosis of very low or low risk MDS (biologically defined as low-risk MDS) by Revised-International Prognostic Score (R-IPSS), pathologically confirmed by a bone marrow aspirate and biopsy prior to registration; blast count must be < 20% * Bone marrow aspirate can be obtained from the subject at any time after the subject has given consent; the subject must be registered to the study within 30 days of obtaining the aspirate; (Note: if diagnostic bone marrow is obtained within 30 days prior to registration, a portion of the bone marrow aspirate collected may be used for research baseline sample to alleviate a second biopsy)
• In addition to the pathologic diagnosis, at least ONE of the following cytopenias must be present: * Hemoglobin < 11 g/dL within 14 days of registration; this includes patients with transfusion dependency ** NOTE: transfusion dependency at screening is defined for this protocol as 1-8 disease-related units red blood cells (RBC) transfused in the previous 8 weeks; patients receiving more than 8 disease-related units of RBCs within 8 weeks of registration are excluded * Platelet count must be ≥ 20,000/mm^3 and < 100,000/mm^3 within 14 days of registration * Absolute neutrophil count (ANC) < 1000/mm^3 within 14 days of registration
• Life expectancy of 12 months or greater
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
• Women of child bearing potential (WOCBP) must be willing to use medically acceptable methods of birth control during the study treatment and for one month after discontinuing study treatment
• All subjects must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

• Previous exposure to 5-AC (azacitidine) or decitabine
• Use of antidepressants such as sertraline within 6 weeks OR use of paroxetine, fluoxetine, or citalopram within 3 months prior to registration
• Active cases (within the past 12 months) of depressive disorder, manic episodes, and/or anxiety requiring active treatment with a selective serotonin reuptake inhibitor (SSRI); patients being treated with an SSRI for non-psychiatric indications (such as hot flashes) are allowed and should go through the appropriate washout
• Previous or concurrent malignancy, except: (1) treated basal cell or squamous cell cancer of skin, (2) treated in situ cervical cancer, (3) treated lobular or ductal carcinoma in situ in one breast, (4) treated in situ bladder cancer (Bacillus Calmette-Guerin [BCG] as therapy only) with more than 2 years of remission or (5) any other cancer for which the patient has been disease-free for at least 5 years
• Actively receiving chemo-immunotherapy
• Evidence of active infection
• Treatment with steroids or immunosuppressive therapy such as cyclosporine, tacrolimus, anti-thymocyte globulin (ATG) within 6 months of registration
• Disease-related platelet transfusion within 8 weeks of registration
• Active treatment with growth factors such as erythropoietin stimulating agent (ESA), granulocyte colony-stimulating factor (GCSF), or thrombopoietin stimulating factor within 4 weeks of registration
• Treatment with an investigational agent within 4 weeks of registration
• History of autoimmune disease including rheumatoid arthritis, systemic lupus and sarcoidosis
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sertraline
• Known history of splenomegaly
• Pregnant or nursing women are excluded from this study, breast feeding should be discontinued
• Patients with known human immunodeficiency virus (HIV) are excluded
• Renal failure; exception: if GFR (glomerular filtration rate) is > 20%, a patient with renal failure can be included in the study
• Any condition or illness that, in the investigator’s opinion, would place the subject at unacceptable risk if he/she were to participate