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Myelodysplastic SyndromesPhase 1SS1NCT02452983

Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome

A Phase 1 study testing Sertraline and Bone Marrow Aspirate/Biopsy in people with Myelodysplastic Syndromes, run by Gustavo Rivero at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
Sertraline and Bone Marrow Aspirate/Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesUnited States
Study dates
May 2015to Nov 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Sertraline, Bone Marrow Aspirate/Biopsy
Keywords
Anemia, Leukemia, Hematologic diseases, Cytopenias, Bone marrow diseases, Preleukemia
Medical subject headings
Myelodysplastic Syndromes, Anemia, Leukemia, Hematologic Diseases, Cytopenia, Bone Marrow Diseases, Preleukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SertralineDrug

    Also called Zoloft

  • Bone Marrow Aspirate/BiopsyProcedure or surgery

Study groups in NCT02452983
Study groupRoleWhat they receive
SertralineExperimentalSertraline tablets 100mg daily for 4 (28-day) cycles
Receives: Drug: Sertraline; Procedure: Bone Marrow Aspirate/Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematological Improvement - minor (HI-minor)

    Improvement in erythroid, neutrophil or platelet

    Measured: 16 weeks

Secondary outcomes (21)

  1. HI-minor response rate

    HI-minor response rate Cycle 1

    Measured: 4 weeks

  2. HI-minor response rate

    HI-minor response rate Cycle 2

    Measured: 8 weeks

  3. HI-minor response rate

    HI-minor response rate Cycle 3

    Measured: 12 weeks

  4. HI-minor response rate

    HI-minor response rate Cycle 4

    Measured: 16 weeks

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

    Individual rates of HI minor measurements at Cycle 1: erythroid, neutrophil and platelet

    Measured: 4 weeks

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

    Individual rates of HI minor measurements at Cycle 2: erythroid, neutrophil and platelet

    Measured: 8 weeks

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

    Individual rates of HI minor measurements at Cycle 3: erythroid, neutrophil and platelet

    Measured: 12 weeks

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

    Individual rates of HI minor measurements at Cycle 4: erythroid, neutrophil and platelet

    Measured: 16 weeks

  9. Hematological Improvement - major (HI-major) response rate

    HI-major response rate at Cycle 1

    Measured: 4 weeks

  10. Hematological Improvement - major (HI-major) response rate

    HI-major response rate at Cycle 2

    Measured: 8 weeks

  11. Hematological Improvement - major (HI-major) response rate

    HI-major response rate at Cycle 3

    Measured: 12 weeks

  12. Hematological Improvement - major (HI-major) response rate

    HI-major response rate at Cycle 4

    Measured: 16 weeks

  13. Individual rates of HI major measurements: erythroid, neutrophil and platelet

    Individual rates of HI major measurements at Cycle 1: erythroid, neutrophil and platelet

    Measured: 4 weeks

  14. Individual rates of HI major measurements: erythroid, neutrophil and platelet

    Individual rates of HI major measurements at Cycle 2: erythroid, neutrophil and platelet

    Measured: 8 weeks

  15. Individual rates of HI major measurements: erythroid, neutrophil and platelet

    Individual rates of HI major measurements at Cycle 3: erythroid, neutrophil and platelet

    Measured: 12 weeks

  16. Individual rates of HI major measurements: erythroid, neutrophil and platelet

    Individual rates of HI major measurements at Cycle 4: erythroid, neutrophil and platelet

    Measured: 16 weeks

  17. Serum cytokine level modifications

    Measured as the difference between Week 4 and pre-treatment levels

    Measured: 4 weeks

  18. Serum cytokine level modifications

    Measured as the difference between Week 8 and pre-treatment levels

    Measured: 8 weeks

  19. Serum cytokine level modifications

    Measured as the difference between Week 12 and pre-treatment levels

    Measured: 12 weeks

  20. Serum cytokine level modifications

    Measured as the difference between Week 16 and pre-treatment levels

    Measured: 16 weeks

  21. Changes in the Gene Expression Profile

    Measured as the difference between Day 14 and Baseline

    Measured: Between Baseline and Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionNov 2020
  4. Study completionNov 2020

Why it stopped: This protocol is closed to further enrollment due to lack of study progress.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452983
Sponsor's protocol ID
H-36160
Acronym
SS1
Status last verified
May 2022
First submitted
21 May 2015
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sertraline and Bone Marrow Aspirate/Biopsy in people with Myelodysplastic Syndromes, run by Gustavo Rivero at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This protocol is closed to further enrollment due to lack of study progress.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematological Improvement - minor (HI-minor) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02452983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.

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