Clinical Trials /

Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome

NCT02452983

Description:

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.

Related Conditions:
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome
  • Official Title: SS1: Pilot Study of Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome (MDS)

Clinical Trial IDs

  • ORG STUDY ID: H-36160
  • NCT ID: NCT02452983

Conditions

  • Myelodysplastic Syndromes

Interventions

DrugSynonymsArms
SertralineZoloftSertraline

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
SertralineExperimentalSertraline tablets 100mg daily for 4 (28-day) cycles
  • Sertraline

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Hematological Improvement - minor (HI-minor)
Time Frame:16 weeks
Safety Issue:
Description:Improvement in erythroid, neutrophil or platelet

Secondary Outcome Measures

Measure:HI-minor response rate
Time Frame:4 weeks
Safety Issue:
Description:HI-minor response rate Cycle 1
Measure:HI-minor response rate
Time Frame:8 weeks
Safety Issue:
Description:HI-minor response rate Cycle 2
Measure:HI-minor response rate
Time Frame:12 weeks
Safety Issue:
Description:HI-minor response rate Cycle 3
Measure:HI-minor response rate
Time Frame:16 weeks
Safety Issue:
Description:HI-minor response rate Cycle 4
Measure:Individual rates of HI minor measurements: erythroid, neutrophil and platelet
Time Frame:4 weeks
Safety Issue:
Description:Individual rates of HI minor measurements at Cycle 1: erythroid, neutrophil and platelet
Measure:Individual rates of HI minor measurements: erythroid, neutrophil and platelet
Time Frame:8 weeks
Safety Issue:
Description:Individual rates of HI minor measurements at Cycle 2: erythroid, neutrophil and platelet
Measure:Individual rates of HI minor measurements: erythroid, neutrophil and platelet
Time Frame:12 weeks
Safety Issue:
Description:Individual rates of HI minor measurements at Cycle 3: erythroid, neutrophil and platelet
Measure:Individual rates of HI minor measurements: erythroid, neutrophil and platelet
Time Frame:16 weeks
Safety Issue:
Description:Individual rates of HI minor measurements at Cycle 4: erythroid, neutrophil and platelet
Measure:Hematological Improvement - major (HI-major) response rate
Time Frame:4 weeks
Safety Issue:
Description:HI-major response rate at Cycle 1
Measure:Hematological Improvement - major (HI-major) response rate
Time Frame:8 weeks
Safety Issue:
Description:HI-major response rate at Cycle 2
Measure:Hematological Improvement - major (HI-major) response rate
Time Frame:12 weeks
Safety Issue:
Description:HI-major response rate at Cycle 3
Measure:Hematological Improvement - major (HI-major) response rate
Time Frame:16 weeks
Safety Issue:
Description:HI-major response rate at Cycle 4
Measure:Individual rates of HI major measurements: erythroid, neutrophil and platelet
Time Frame:4 weeks
Safety Issue:
Description:Individual rates of HI major measurements at Cycle 1: erythroid, neutrophil and platelet
Measure:Individual rates of HI major measurements: erythroid, neutrophil and platelet
Time Frame:8 weeks
Safety Issue:
Description:Individual rates of HI major measurements at Cycle 2: erythroid, neutrophil and platelet
Measure:Individual rates of HI major measurements: erythroid, neutrophil and platelet
Time Frame:12 weeks
Safety Issue:
Description:Individual rates of HI major measurements at Cycle 3: erythroid, neutrophil and platelet
Measure:Individual rates of HI major measurements: erythroid, neutrophil and platelet
Time Frame:16 weeks
Safety Issue:
Description:Individual rates of HI major measurements at Cycle 4: erythroid, neutrophil and platelet
Measure:Serum cytokine level modifications
Time Frame:4 weeks
Safety Issue:
Description:Measured as the difference between Week 4 and pre-treatment levels
Measure:Serum cytokine level modifications
Time Frame:8 weeks
Safety Issue:
Description:Measured as the difference between Week 8 and pre-treatment levels
Measure:Serum cytokine level modifications
Time Frame:12 weeks
Safety Issue:
Description:Measured as the difference between Week 12 and pre-treatment levels
Measure:Serum cytokine level modifications
Time Frame:16 weeks
Safety Issue:
Description:Measured as the difference between Week 16 and pre-treatment levels
Measure:Changes in the Gene Expression Profile
Time Frame:Between Baseline and Day 14
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Gustavo Rivero

Trial Keywords

  • Anemia
  • Leukemia
  • Hematologic diseases
  • Cytopenias
  • Bone marrow diseases
  • Preleukemia

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