Myelodysplastic Syndrome Clinical Trial
Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
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 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.
Full 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 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.
Eligibility Criteria
Key Inclusion Criteria:
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 Criteria:
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 86 Locations for this study
Tucson Arizona, 85719, United States More Info
Principal Investigator
Los Angeles California, 90033, United States More Info
Principal Investigator
Los Angeles California, 90095, United States More Info
Principal Investigator
New Haven Connecticut, 06510, United States More Info
Principal Investigator
Jacksonville Florida, 32256, United States More Info
Principal Investigator
Saint Petersburg Florida, 33709, United States More Info
Principal Investigator
Tampa Florida, 33612, United States More Info
Principal Investigator
Chicago Illinois, 60612, United States More Info
Principal Investigator
Skokie Illinois, 60077, United States More Info
Principal Investigator
Iowa City Iowa, 52242, United States More Info
Principal Investigator
New Orleans Louisiana, 70112, United States More Info
Principal Investigator
Baltimore Maryland, 21287, United States More Info
Principal Investigator
Bethesda Maryland, 20817, United States More Info
Principal Investigator
Billings Montana, 59102, United States More Info
Principal Investigator
Morristown New Jersey, 02140, United States More Info
Principal Investigator
Bronx New York, 11102, United States More Info
Principal Investigator
Lake Success New York, 11042, United States More Info
Principal Investigator
Charlotte North Carolina, 28204, United States More Info
Principal Investigator
Winston-Salem North Carolina, 27103, United States More Info
Principal Investigator
Winston-Salem North Carolina, 27157, United States More Info
Principal Investigator
Cleveland Ohio, 44195, United States More Info
Principal Investigator
Columbus Ohio, 43210, United States More Info
Principal Investigator
Portland Oregon, 97239, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States More Info
Principal Investigator
Salt Lake City Utah, 84112, United States More Info
Principal Investigator
Seattle Washington, 98104, United States More Info
Principal Investigator
Salzburg , 5020, Austria More Info
Principal Investigator
La Louvière , 7100, Belgium More Info
Principal Investigator
Hamilton Ontario, ON L8, Canada More Info
Principal Investigator
London Ontario, N6A 5, Canada More Info
Principal Investigator
Toronto Ontario, , Canada More Info
Principal Investigator
Montréal Quebec, H4A 3, Canada More Info
Principal Investigator
Olomouc , , Czechia More Info
Principal Investigator
Prague , , Czechia More Info
Principal Investigator
Bayonne , 64109, France More Info
Principal Investigator
Brest , 29200, France More Info
Principal Investigator
Clermont-Ferrand , , France More Info
Principal Investigator
La Tronche , , France More Info
Principal Investigator
Perpignan , 66046, France More Info
Principal Investigator
Saint-Priest-en-Jarez , , France More Info
Principal Investigator
Villejuif , 94805, France More Info
Principal Investigator
Berlin , , Germany More Info
Principal Investigator
Halle , , Germany More Info
Principal Investigator
Münster , , Germany More Info
Principal Investigator
Debrecen , H-401, Hungary More Info
Principal Investigator
Eger , , Hungary More Info
Principal Investigator
Nyíregyháza , 4400, Hungary More Info
Principal Investigator
Ashkelon , , Israel More Info
Principal Investigator
Bologna , 40138, Italy More Info
Principal Investigator
Ferrara , 44124, Italy More Info
Principal Investigator
Genova , 16132, Italy More Info
Principal Investigator
Meldola , 47014, Italy More Info
Principal Investigator
Novara , 28100, Italy More Info
Principal Investigator
Pesaro , 61122, Italy More Info
Principal Investigator
Rome , 00133, Italy More Info
Principal Investigator
Gdynia , 81-51, Poland More Info
Principal Investigator
Legnica , 59-22, Poland More Info
Principal Investigator
Warszawa , , Poland More Info
Principal Investigator
Wałbrzych , , Poland More Info
Principal Investigator
Badalona , , Spain More Info
Principal Investigator
Barcelona , 08035, Spain More Info
Principal Investigator
Barcelona , 08041, Spain More Info
Principal Investigator
Barcelona , , Spain More Info
Principal Investigator
Burgos , 09006, Spain More Info
Principal Investigator
Madrid , 28033, Spain More Info
Principal Investigator
Madrid , 28040, Spain More Info
Principal Investigator
Madrid , 28046, Spain More Info
Principal Investigator
Madrid , , Spain More Info
Principal Investigator
Murcia , , Spain More Info
Principal Investigator
Oviedo , 33011, Spain More Info
Principal Investigator
Palma De Mallorca , 07198, Spain More Info
Principal Investigator
Salamanca , 37007, Spain More Info
Principal Investigator
San Sebastián , , Spain More Info
Principal Investigator
Santander , 39008, Spain More Info
Principal Investigator
Seville , 41013, Spain More Info
Principal Investigator
Valencia , 46026, Spain More Info
Principal Investigator
Valencia , , Spain More Info
Principal Investigator
Cottingham , , United Kingdom More Info
Principal Investigator
Edinburgh , , United Kingdom More Info
Principal Investigator
Liverpool , , United Kingdom More Info
Principal Investigator
London , , United Kingdom More Info
Principal Investigator
London , , United Kingdom More Info
Principal Investigator
Southampton , , United Kingdom More Info
Principal Investigator
West Bromwich , , United Kingdom More Info
Principal Investigator
How clear is this clinincal trial information?