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.
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
Drug | Synonyms | Arms |
---|
Sertraline | Zoloft | Sertraline |
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
Name | Type | Description | Interventions |
---|
Sertraline | Experimental | Sertraline tablets 100mg daily for 4 (28-day) cycles | |
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: | Measured as the difference between Day 14 and Baseline |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Gustavo Rivero |
Trial Keywords
- Anemia
- Leukemia
- Hematologic diseases
- Cytopenias
- Bone marrow diseases
- Preleukemia
Last Updated
November 27, 2020