Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome

NCT02452983 | Terminated Phase 1 DMC

• 1 other identifier: H-36160
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Myelodysplastic Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hematological Improvement - minor (HI-minor)

  Improvement in erythroid, neutrophil or platelet

  16 weeks

Secondary Outcomes (21)

• HI-minor response rate

  4 weeks

• HI-minor response rate

  8 weeks

• HI-minor response rate

  12 weeks

• HI-minor response rate

  16 weeks

• Individual rates of HI minor measurements: erythroid, neutrophil and platelet

  4 weeks

Study Arms (1)

Sertraline

EXPERIMENTAL

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

Drug: Sertraline; Procedure: Bone Marrow Aspirate/Biopsy

Interventions

Sertraline DRUG

Also known as: Zoloft

Sertraline

Bone Marrow Aspirate/Biopsy PROCEDURE

Sertraline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gustavo Rivero: lead
• Baylor College of Medicine: collaborator

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia; Leukemia; Hematologic Diseases; Cytopenia; Bone Marrow Diseases; Preleukemia

Interventions

Sertraline; Biopsy

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Precancerous Conditions

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gustavo A Rivero, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 25, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

US (2)