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

May 31, 2022 updated by: Gustavo Rivero

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sertraline
Sertraline tablets 100mg daily for 4 (28-day) cycles
Drug: Sertraline
Other Names:
  • Zoloft
Procedure: Bone Marrow Aspirate/Biopsy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hematological Improvement - minor (HI-minor)
Time Frame: 16 weeks
Improvement in erythroid, neutrophil or platelet
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HI-minor response rate
Time Frame: 4 weeks
HI-minor response rate Cycle 1
4 weeks
HI-minor response rate
Time Frame: 8 weeks
HI-minor response rate Cycle 2
8 weeks
HI-minor response rate
Time Frame: 12 weeks
HI-minor response rate Cycle 3
12 weeks
HI-minor response rate
Time Frame: 16 weeks
HI-minor response rate Cycle 4
16 weeks
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
4 weeks
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
8 weeks
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
12 weeks
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
16 weeks
Hematological Improvement - major (HI-major) response rate
Time Frame: 4 weeks
HI-major response rate at Cycle 1
4 weeks
Hematological Improvement - major (HI-major) response rate
Time Frame: 8 weeks
HI-major response rate at Cycle 2
8 weeks
Hematological Improvement - major (HI-major) response rate
Time Frame: 12 weeks
HI-major response rate at Cycle 3
12 weeks
Hematological Improvement - major (HI-major) response rate
Time Frame: 16 weeks
HI-major response rate at Cycle 4
16 weeks
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
4 weeks
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
8 weeks
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
12 weeks
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
16 weeks
Serum cytokine level modifications
Time Frame: 4 weeks
Measured as the difference between Week 4 and pre-treatment levels
4 weeks
Serum cytokine level modifications
Time Frame: 8 weeks
Measured as the difference between Week 8 and pre-treatment levels
8 weeks
Serum cytokine level modifications
Time Frame: 12 weeks
Measured as the difference between Week 12 and pre-treatment levels
12 weeks
Serum cytokine level modifications
Time Frame: 16 weeks
Measured as the difference between Week 16 and pre-treatment levels
16 weeks
Changes in the Gene Expression Profile
Time Frame: Between Baseline and Day 14
Measured as the difference between Day 14 and Baseline
Between Baseline and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gustavo Rivero

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baylor College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gustavo A Rivero, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-36160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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