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Nucleoside Analog

Tamibarotene + Azacitidine for Myelodysplastic Syndrome

Phase 3
Recruiting
Research Sponsored by Syros Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
Diagnosis of MDS according to the World Health Organization (WHO) classification (Arber 2016) and classified by the Revised International Prognostic Scoring System (IPSS R) risk category as very high, high, or intermediate risk.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial compares two treatments for MDS patients who are positive for the RARA gene. The goal is to see if one treatment results in more complete remissions than the other.

Who is the study for?
This trial is for adults over 18 with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) who test positive for RARA and haven't been treated before. They should be able to perform daily activities with some limitations (ECOG ≤2). Those planning a stem cell transplant or who've had certain MDS treatments can't join.Check my eligibility
What is being tested?
The study tests Tamibarotene combined with Azacitidine against Azacitidine plus a placebo in patients with HR-MDS. The main focus is to see which group has more complete remission of the disease.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, blood abnormalities, gastrointestinal issues, fatigue, and skin changes. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My MDS is classified as very high, high, or intermediate risk according to WHO.
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I am 18 years or older.
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My cancer is RARA-positive according to a specific test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants with Complete Remission
Secondary outcome measures
Change in HRQOL as assessed by the European Quality of Life 5 dimensions Scale (EuroQoL-5D)
Change in Health-Related Quality of Life (HRQOL) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 Scale (EORTC QLQ-30)
Duration of Complete Response
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tamibarotene + AzacitidineExperimental Treatment2 Interventions
Tamibarotene: 6 mg administered orally twice per day (BID) on Days 8 through 28 of each 28-day treatment cycle. Azacitidine: 75 mg/m^2 administered intravenously or subcutaneously each day on Days 1 through 7 of each 28-day treatment cycle.
Group II: Tamibarotene Matched Placebo + AzacitidinePlacebo Group2 Interventions
Placebo: Tamibarotene-matching tablets administered orally BID on Days 8 through 28 of each 28-day treatment cycle. Azacitidine: 75 mg/m^2 administered intravenously or subcutaneously each day on Days 1 through 7 of each 28-day treatment cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamibarotene
2016
Completed Phase 2
~160
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

Syros PharmaceuticalsLead Sponsor
5 Previous Clinical Trials
478 Total Patients Enrolled
Medical Director, MDStudy DirectorSyros Pharmaceuticals
76 Previous Clinical Trials
15,694 Total Patients Enrolled
Medical DirectorStudy DirectorSyros Pharmaceuticals Inc.
2,777 Previous Clinical Trials
8,063,314 Total Patients Enrolled

Media Library

Azacitidine (Nucleoside Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04797780 — Phase 3
Myelodysplastic Syndrome Research Study Groups: Tamibarotene + Azacitidine, Tamibarotene Matched Placebo + Azacitidine
Myelodysplastic Syndrome Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04797780 — Phase 3
Azacitidine (Nucleoside Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04797780 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current status of SY-1425 + Azacitidine in terms of FDA approval?

"Phase 3 trials have evidenced both efficacy and safety, so our team rates SY-1425 + Azacitidine as a 3 on our 1 to 3 scale."

Answered by AI

Are there any other instances where SY-1425 and Azacitidine have been studied together?

"Currently, there are a total of 180 research studies being conducted that involve SY-1425 + Azacitidine. Out of those, 33 trials are in the third and final stage. Although the majority of these clinical trials take place in Saint Louis, Missouri; 5706 different locations worldwide are running similar research projects."

Answered by AI

Are we currently able to sign people up for this experiment?

"The clinical trial is recruiting patients at this time, as indicated by the listing on clinicaltrials.gov. This page was created on 2/8/2021 and updated last on 11/8/2022."

Answered by AI

What are the typical indications for SY-1425 + Azacitidine?

"SY-1425 + Azacitidine is normally given to cancer patients. Additionally, this treatment can be used for conditions such as 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia."

Answered by AI

How many people are given the opportunity to participate in this test case?

"The clinicaltrials.gov website does show that this particular trial is actively looking for patients at the moment. It was first posted on February 8th 2021 and the most recent update was on November 8th 2022. In total, they are hoping to enroll 190 participants from 49 different locations."

Answered by AI

Are there any other places in Canada where this clinical trial is being conducted?

"You can find a list of the 49 sites participating in this trial on our website. The locations are situated in Atlanta, New Orleans, Waltham and other places across the nation. To limit travel requirements, please choose the location nearest you."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Comprehensive Hematology and Oncology
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
2021. "Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04797780.
All > Mds > Myelodysplastic Syndrome
~73 spots leftby Nov 2024
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