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Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome (SS1)

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ClinicalTrials.gov Identifier: NCT02452983
Recruitment Status : Terminated (This protocol is closed to further enrollment due to lack of study progress.)
First Posted : May 25, 2015
Last Update Posted : November 27, 2020
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Gustavo Rivero, Baylor College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: Sertraline Procedure: Bone Marrow Aspirate/Biopsy Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SS1: Pilot Study of Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome (MDS)
Study Start Date : May 2015
Actual Primary Completion Date : November 2020
Actual Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: Sertraline
Sertraline tablets 100mg daily for 4 (28-day) cycles
Drug: Sertraline
Other Name: Zoloft

Procedure: Bone Marrow Aspirate/Biopsy



Primary Outcome Measures :
  1. Hematological Improvement - minor (HI-minor) [ Time Frame: 16 weeks ]
    Improvement in erythroid, neutrophil or platelet


Secondary Outcome Measures :
  1. HI-minor response rate [ Time Frame: 4 weeks ]
    HI-minor response rate Cycle 1

  2. HI-minor response rate [ Time Frame: 8 weeks ]
    HI-minor response rate Cycle 2

  3. HI-minor response rate [ Time Frame: 12 weeks ]
    HI-minor response rate Cycle 3

  4. HI-minor response rate [ Time Frame: 16 weeks ]
    HI-minor response rate Cycle 4

  5. Individual rates of HI minor measurements: erythroid, neutrophil and platelet [ Time Frame: 4 weeks ]
    Individual rates of HI minor measurements at Cycle 1: erythroid, neutrophil and platelet

  6. Individual rates of HI minor measurements: erythroid, neutrophil and platelet [ Time Frame: 8 weeks ]
    Individual rates of HI minor measurements at Cycle 2: erythroid, neutrophil and platelet

  7. Individual rates of HI minor measurements: erythroid, neutrophil and platelet [ Time Frame: 12 weeks ]
    Individual rates of HI minor measurements at Cycle 3: erythroid, neutrophil and platelet

  8. Individual rates of HI minor measurements: erythroid, neutrophil and platelet [ Time Frame: 16 weeks ]
    Individual rates of HI minor measurements at Cycle 4: erythroid, neutrophil and platelet

  9. Hematological Improvement - major (HI-major) response rate [ Time Frame: 4 weeks ]
    HI-major response rate at Cycle 1

  10. Hematological Improvement - major (HI-major) response rate [ Time Frame: 8 weeks ]
    HI-major response rate at Cycle 2

  11. Hematological Improvement - major (HI-major) response rate [ Time Frame: 12 weeks ]
    HI-major response rate at Cycle 3

  12. Hematological Improvement - major (HI-major) response rate [ Time Frame: 16 weeks ]
    HI-major response rate at Cycle 4

  13. Individual rates of HI major measurements: erythroid, neutrophil and platelet [ Time Frame: 4 weeks ]
    Individual rates of HI major measurements at Cycle 1: erythroid, neutrophil and platelet

  14. Individual rates of HI major measurements: erythroid, neutrophil and platelet [ Time Frame: 8 weeks ]
    Individual rates of HI major measurements at Cycle 2: erythroid, neutrophil and platelet

  15. Individual rates of HI major measurements: erythroid, neutrophil and platelet [ Time Frame: 12 weeks ]
    Individual rates of HI major measurements at Cycle 3: erythroid, neutrophil and platelet

  16. Individual rates of HI major measurements: erythroid, neutrophil and platelet [ Time Frame: 16 weeks ]
    Individual rates of HI major measurements at Cycle 4: erythroid, neutrophil and platelet

  17. Serum cytokine level modifications [ Time Frame: 4 weeks ]
    Measured as the difference between Week 4 and pre-treatment levels

  18. Serum cytokine level modifications [ Time Frame: 8 weeks ]
    Measured as the difference between Week 8 and pre-treatment levels

  19. Serum cytokine level modifications [ Time Frame: 12 weeks ]
    Measured as the difference between Week 12 and pre-treatment levels

  20. Serum cytokine level modifications [ Time Frame: 16 weeks ]
    Measured as the difference between Week 16 and pre-treatment levels

  21. Changes in the Gene Expression Profile [ Time Frame: Between Baseline and Day 14 ]
    Measured as the difference between Day 14 and Baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452983


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Gustavo Rivero
Baylor College of Medicine
Investigators
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Principal Investigator: Gustavo A Rivero, MD Baylor College of Medicine
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Responsible Party: Gustavo Rivero, Assistant Professor, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02452983    
Other Study ID Numbers: H-36160
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Keywords provided by Gustavo Rivero, Baylor College of Medicine:
Anemia
Leukemia
Hematologic diseases
Cytopenias
Bone marrow diseases
Preleukemia
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs