SELECT-MDS-1, A Randomized, Double-blind, Placebo-controlled Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, RARA-positive Adult Patients With Higher-risk Myelodysplastic Syndrome | Aplastic Anemia & MDS International Foundation Return to top.

ClinicalTrials.gov Identifier:

NCT04797780

Contact Info

Sharada Chintakindi

schintakindi@syros.com

(888) 260-1599

Dates

Start: February 2021
End: July 2023

Official Title

SELECT-MDS-1, A Randomized, Double-blind, Placebo-controlled Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, RARA-positive Adult Patients With Higher-risk Myelodysplastic Syndrome

Purpose

This study compares the efficacy of tamibarotene (formerly SY-1425) in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms. A subset of participants have MDS characterized by an overexpression of the RARA gene. A blood test will be used to identify participants with RARA-positive MDS. Assessment of the RARA biomarker for study eligibility will be done by collection of blood samples from potential study participants at the pre-screening visit and testing at a central laboratory. Participants who meet eligibility requirements will be randomized 2:1 to receive either tamibarotene plus azacitidine or placebo plus azacitidine.

SELECT-MDS-1, A Randomized, Double-blind, Placebo-controlled Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, RARA-positive Adult Patients With Higher-risk Myelodysplastic Syndrome

Clinical Trial: NCT04797780

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Associated Drug(s): 
Phase: 
Phase 3
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  1. Participants must be at least 18 years old at the time of signing of an informed consent.
  2. Participants must be RARA-positive based on the investigational assay.
  3. Participants must be newly diagnosed with HR-MDS as follows:
    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.
  4. Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
Exclusion Criteria: 
  1. Participants are suitable for and agree to undergo allogeneic HSCT at the time of Screening.
  2. Participants who received prior treatment for MDS with any hypomethylating agent, chemotherapy or allogeneic HSCT.

Find Out More:

Disclaimer:

AAMDSIF does not recommend, endorse, or make any representation about the efficacy, appropriateness or suitability of any clinical trial listed on this website. Pharmaceutical company sponsored content is highlighted only to give additional information about the trial. All trials are listed on https://clinicaltrials.gov/. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a clinical trial, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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