A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, Adult Patients Selected for RARA-positive Higher-risk Myelodysplastic Syndrome (SELECT MDS-1) SELECT MDS-1

What's the purpose of this trial?

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 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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Key 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.

Key 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.

Additional Trial Information

Phase 3

Enrollment: 190 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

University of Arizona Cancer Center North Campus

Tucson, AZ

Open and Accepting

California

USC Norris Comprehensive Cancer Center University of Southern California

Los Angeles, CA

Open and Accepting

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles

Los Angeles, CA

Open and Accepting

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, CA

Open and Accepting

Florida

Cancer Specialists of North Florida

Jacksonville, FL

Open and Accepting

Boca Raton Clinical Research (BRCR) Medical Center

Plantation, FL

Open and Accepting

Comprehensive Hematology and Oncology

Saint Petersburg, FL

Open and Accepting

Illinois

University of Illinois at Chicago

Chicago, IL

Open and Accepting

Orchard Healthcare Research Inc. (Dr. Ira Oliff, MD)

Skokie, IL

Open and Accepting

Iowa

Holden Comprehensive Cancer Center University of Iowa Hospitals and Clinics

Iowa City, IA

Open and Accepting

Louisiana

Tulane Cancer Center Tulane University School of Medicine

New Orleans, LA

Open and Accepting

Maryland

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

American Oncology Partners of Maryland (Bethesda) The Center for Cancer & Blood Disorders - Bethesda

Bethesda, MD

Open and Accepting

Montana

SCL Health St. Vincent Healthcare SCL Health

Billings, MT

Open and Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Open and Accepting

New York

Montefiore Medical Center

Bronx, NY

Open and Accepting

Northwell Health Monter Cancer Center

Lake Success, NY

Open and Accepting

New York Medical College

Valhalla, NY

Open and Accepting

North Carolina

Wake Forest Baptist Atrium Health

Winston-Salem, NC

Open and Accepting

Ohio

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting
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