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

Gustavo Rivero

Status and phase

Terminated

Phase 1

Conditions

Myelodysplastic Syndromes

Treatments

Drug: Sertraline

Procedure: Bone Marrow Aspirate/Biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02452983

H-36160

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.