Clinical trial · Interventional
Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome
SS1: Pilot Study of Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome (MDS)
NCT02452983CI-TRIAL-00058873SS1terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This protocol is closed to further enrollment due to lack of study progress.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone Marrow Aspirate/Biopsy | Procedure | — | UNRESOLVED |
| Sertraline | Drug | Sertraline | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sertraline
- description
- Sertraline tablets 100mg daily for 4 (28-day) cycles
- interventionNames
- Drug: Sertraline
- Procedure: Bone Marrow Aspirate/Biopsy
Primary outcomes (1)
- measure
- Hematological Improvement - minor (HI-minor)
- timeFrame
- 16 weeks
- description
- Improvement in erythroid, neutrophil or platelet
Secondary outcomes (21)
- measure
- HI-minor response rate
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Very Low or Low risk MDS defined by IPSS-R confirmed by a bone marrow aspirate and biopsy (Blast count must be \< 20%) * Hemoglobin \< 11 g/dL, or transfusion dependency. * Platelet count \<100,000/mm3 * Absolute Neutrophil Count (ANC) \< 1000/mm3 * Life expectancy of 12 months or greater * ECOG Performance status of 0 - 3 * Age ≥ 18 years * Willing to use medically acceptable methods of birth control during the study and for 28 days 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 * Both men and women and members of all races and ethnic groups 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 past 12 months) of depressive disorder, manic episodes, and/or anxiety requiring active treatment with an SSRI. Patients being treated with an SSRI for non-psychiatric indication are allowed, and should go through the appropriate washout. * Previous or concurrent malignancy, except treated basal cell or squamous cell cancer of skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in one breast, or 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 * Platelet transfusion within 8 weeks of registration. * Platelet count \< 20,000/mm3 within 14 days of registration. * Active treatment with growth factors such erythropoietin stimulating agent (ESA), granulocyte colony-stimulating factor (GCSF), thrombopoietin stimulating factor within 8 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 because Sertraline is a Class C agent with the potential for teratogenic or abortive effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sertraline, breast feeding should be discontinued. * HIV: Given high risk for Immune thrombocytopenic purpura, HIV associated neutropenia and combination antiretroviral therapy, patients with known HIV are excluded because of the potential for pharmacokinetic interactions with sertraline. * Any condition or illness that, in the Investigator's opinion, would place the subject at unacceptable risk if he/she were to participate.
References
Publications (0)
Data not yet available
No reference posted for this study.