Status:
TERMINATED
Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
Lead Sponsor:
Syros Pharmaceuticals
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and ne...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- Key
- Participants must be RARA-positive based on the investigational assay.
- Participants must be newly diagnosed with HR-MDS as follows:
- Diagnosis of MDS according to the World Health Organization (WHO) classification and classified by the Revised International Prognostic Scoring System (IPSS R) risk category as very high, high, or intermediate risk.
- Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Key
Exclusion
- Participants are suitable for and agree to undergo allogeneic hematopoietic stem cell transplant (HSCT) at the time of screening.
- Participants who need treatment prior to stem cell transplant can receive treatment on this study and stop the study treatment when they are ready to proceed to transplant.
- Participants who received prior treatment for MDS with any hypomethylating agent, lenalidomide, chemotherapy or allogeneic HSCT.
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2024
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT04797780
Start Date
February 8 2021
End Date
November 13 2024
Last Update
April 10 2025
Active Locations (128)
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1
University of Arizona
Tucson, Arizona, United States, 85719
2
University of Southern California
Los Angeles, California, United States, 90033
3
University of California, Los Angelas
Los Angeles, California, United States, 90095
4
Yale Cancer Center
New Haven, Connecticut, United States, 06510