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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

550

Study ID:

NCT04797780

Recruitment Status:

Recruiting

Sponsor:

Syros Pharmaceuticals

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There are 86 Locations for this study

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University of Arizona
Tucson Arizona, 85719, United States More Info
Argentina Morales
Contact
[email protected]
Sharad Khurana
Principal Investigator
UC Irvine
Irvine California, 92697, United States More Info
Ma Grace
Contact
[email protected]
Deepa Jeyakumar
Principal Investigator
University of Southern California
Los Angeles California, 90033, United States More Info
Casey O'Connell
Principal Investigator
University of California, Los Angelas
Los Angeles California, 90095, United States More Info
Bruck Habtemarium
Contact
[email protected]
Wanxing Chai Ho
Principal Investigator
Yale Cancer Center
New Haven Connecticut, 06510, United States More Info
Amer Zeidan
Principal Investigator
Cancer specialists of North Florida
Jacksonville Florida, 32256, United States More Info
Daniel Kobrinski
Principal Investigator
Comprehensive Hematology and Oncology
Saint Petersburg Florida, 33709, United States More Info
Archana Pathak
Contact
727-384-4388
[email protected]
Pratibha Desai, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
David Sallman
Principal Investigator
University of Illinois Cancer Center
Chicago Illinois, 60612, United States More Info
John Quigley, MD
Principal Investigator
Orchard Healthcare Research Inc.
Skokie Illinois, 60077, United States More Info
Joy Jardinico
Contact
[email protected]
Ira Oliff
Principal Investigator
University of Iowa
Iowa City Iowa, 52242, United States More Info
Karen Parrott
Contact
[email protected]
Grerk Sutamtewagul
Principal Investigator
Tulane Cancer Center
New Orleans Louisiana, 70112, United States More Info
Hana Safah
Principal Investigator
Johns Hopkins University
Baltimore Maryland, 21287, United States More Info
Colin Huck
Contact
410-614-3725
Amy DeZern
Principal Investigator
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States More Info
Taylor Stutzman
Contact
[email protected]
Ralph Vincent Boccia
Principal Investigator
SCL Health Research Institute, Inc. (St. Vincent Frontier Cancer Center)
Billings Montana, 59102, United States More Info
Patrick Cobb, MD
Principal Investigator
Morristown Medical Center- Atlantic Hematology Oncology
Morristown New Jersey, 02140, United States More Info
Maureen Nowakowski
Contact
[email protected]
Mohamad Cherry
Principal Investigator
Montefiore Medical Center & Albert Einstein College of Medicine
Bronx New York, 11102, United States More Info
Joel Victor
Contact
[email protected]
Aditi Shastri
Principal Investigator
Northwell Health
Lake Success New York, 11042, United States More Info
Steven Allen, MD
Principal Investigator
Novant Health Inc
Charlotte North Carolina, 28204, United States More Info
James Dugan
Principal Investigator
Novant Health Cancer Institute - Forsyth
Winston-Salem North Carolina, 27103, United States More Info
James Dugan
Principal Investigator
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States More Info
Rupali Roy Bhave
Principal Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Melina Sharif
Contact
[email protected]
Jenna Thomas
Contact
[email protected]
Hetty Carraway
Principal Investigator
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Uma Borate
Principal Investigator
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Rachel Cook
Principal Investigator
TriStar - Sarah Cannon BMT
Nashville Tennessee, 37203, United States More Info
Stephen Strickland
Principal Investigator
University of Utah Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Afaf Osman
Principal Investigator
Swedish Cancer Institute
Seattle Washington, 98104, United States More Info
Daniel Egan
Principal Investigator
Medical University of Graz
Graz , 8036, Austria More Info
Armin Zebisch
Principal Investigator
Salzburg Cancer Research Institute (SCRI)
Salzburg , 5020, Austria More Info
Richard Greil
Principal Investigator
Klinik Hietzing
Vienna , , Austria More Info
Klaus Geissler
Principal Investigator
ZNA Middelheim
Antwerp , , Belgium More Info
Bert Heyrman
Principal Investigator
Institut Jules Bordet
Brussels , , Belgium More Info
Sarah Buntinx
Principal Investigator
Ghent University Hospital
Gent , , Belgium More Info
Dominiek Mazure
Principal Investigator
Hospital De Jolimont
La Louvière , 7100, Belgium More Info
Florence Van Obbergh
Principal Investigator
CHU de Liège
Liège , , Belgium More Info
Céline Faccinetto
Contact
[email protected]
Marie Lejeune
Principal Investigator
AZ Delta
Roeselare , 8800, Belgium More Info
Ruth Demeersseman
Contact
+32 2 51237560
Dries Deeren
Principal Investigator
CHU-UCL Namur
Yvoir , 5530, Belgium More Info
Catherine Marcin
Contact
+32 81423837
[email protected]
Carlos Graux
Principal Investigator
CancerCare Manitoba
Winnipeg Manitoba, , Canada More Info
Brett Houston
Principal Investigator
Juravinski Cancer Centre
Hamilton Ontario, ON L8, Canada More Info
Brian Leber
Principal Investigator
London Health Sciences Center
London Ontario, N6A 5, Canada More Info
Lalit Saini
Principal Investigator
Princess Margaret Cancer Centre - University Health Network
Toronto Ontario, , Canada More Info
Andre Schuh
Principal Investigator
McGill University Health Centre (MUHC)
Montréal Quebec, H4A 3, Canada More Info
John Storring
Principal Investigator
Tom Baker Cancer Centre
Calgary , , Canada More Info
Michelle Geddes
Principal Investigator
London Health Sciences Centre
London , ON, Canada More Info
Lalit Saini
Principal Investigator
Fakultni nemocnice Olomouc (University Hospital Olomouc)
Olomouc , , Czechia More Info
Renata Machova
Principal Investigator
University Hospital Ostrava
Ostrava , , Czechia More Info
Zdenek Koreistek
Principal Investigator
Nemocnice Pelhrimov
Pelhřimov , 39338, Czechia More Info
Petr Kessler
Principal Investigator
General University Hospital Prague
Prague , , Czechia More Info
Anna Jonášová
Principal Investigator
CHU Amiens-Picardie
Amiens , 80054, France More Info
Amandine Hubert
Contact
+ 33 3 22 45 54 23
[email protected]
Delphine Lebon
Principal Investigator
CHU d'Angers
Angers , 49933, France More Info
Melanie Le Van Suu
Contact
+33(0)2 41 35 67 26
[email protected]
Sylvain Thepot
Principal Investigator
Centre Hospitalier de la Côte Basque Hématologie Clinique
Bayonne , 64109, France More Info
Séverine Labarrere
Contact
+33 5 59 44 38 28
[email protected]
Jean-Baptiste Robin
Principal Investigator
Hôpital Avicenne
Bobigny , 93000, France More Info
Thorsten Braun
Principal Investigator
CHRU de BREST - Hôpital Morvan
Brest , 29200, France More Info
Romuald Kerdoncuff
Contact
33.2.29.02.01.00
[email protected]
Gaëlle Guillerm
Principal Investigator
CHU Clermont Ferrand / CHU Estaing
Clermont-Ferrand , , France More Info
Benoit de Renzis
Principal Investigator
CHU Grenoble Alpes Hôpital Nord Michallon
La Tronche , , France More Info
Sophie Park
Principal Investigator
Hopital Mignot
Le Chesnay , 78150, France More Info
Celine Constant
Contact
+33 1 39 23 97 83
[email protected]
Philippe Rousselot
Principal Investigator
CHU de Limoges
Limoges , 87000, France More Info
Marie-Pierre Gourin
Principal Investigator
Centre Léon Bérard
Lyon , 69373, France More Info
Clémence Santana
Principal Investigator
CHU la Conception
Marseille , , France More Info
Regis Costello
Principal Investigator
CHU Nantes - Hotel Dieu
Nantes , 44093, France More Info
Alice Garnier
Principal Investigator
CHU de Nice - Hopital L'Archet
Nice , 06200, France More Info
Jessica Lechardeur
Contact
[email protected]
Thomas Cluzeau
Principal Investigator
Hôpital Saint Louis
Paris , 75475, France More Info
Hajer Chehimi
Contact
+33 1 71 20 70 10
[email protected]
Pierre Fenaux
Principal Investigator
Centre Hospitalier de Perpignan
Perpignan , 66046, France More Info
Laurence Sanhes
Principal Investigator
CHU Bordeaux
Pessac , 33604, France More Info
Corentin Rouvray
Contact
+33(0)5 24 54 91 69
[email protected]
Sophie Dimicoli-Salazar
Principal Investigator
CHU Lyon Sud
Pierre-Bénite , 69495, France More Info
Sophie Leclercq
Contact
+33 4 78 86 22 69
[email protected]
Gaëlle Fossard
Principal Investigator
CHU Poiters
Poitiers , 86021, France More Info
Achiath Lassissi
Contact
+33 549443115
[email protected]
Jose Torregrosa
Principal Investigator
CHU Saint Etienne
Saint-Priest-en-Jarez , , France More Info
Emmanuelle Tavernier
Principal Investigator
ICANS Strasbourg
Strasbourg , 67033, France More Info
Camille Collin
Contact
+33(0)3 68 76 72 03
[email protected]
Amé Shanti
Principal Investigator
Institut Gustave Roussy
Villejuif , 94805, France More Info
Louiza Bennane
Contact
[email protected]
Stéphane De Botton
Principal Investigator
Universitätsklinikum Augsburg
Augsburg , , Germany More Info
Andreas Rank
Principal Investigator
Helios Klinikum Berlin Buch GmbH
Berlin , , Germany More Info
Snjezana Janjetovic
Principal Investigator
Universitätsklinikum Freiburg
Freiburg , , Germany More Info
Michael Lübbert
Principal Investigator
Universitätsmedizin Göttingen
Göttingen , , Germany More Info
Raphael Koch
Principal Investigator
Universitätsklinikum Halle (Saale)
Halle , , Germany More Info
Haifa Kathrin Al-Ali
Principal Investigator
Universitätsklinikum Marburg
Marburg , , Germany More Info
Stephan Metzelder
Principal Investigator
Universitätsklinikum Münster
Münster , , Germany More Info
Christoph Schliemann
Principal Investigator
Semmelweis Egyetem
Budapest , 1083, Hungary More Info
Zsolt Nagy
Principal Investigator
Debrecen University Medical and Health Science Centre
Debrecen , H-401, Hungary More Info
Árpád Illes
Principal Investigator
Markhot Ferenc Oktatókórház és Rendelőintézet, Belgyógyászati- és Infektológiai Centrum
Eger , , Hungary More Info
Tajti Balazs
Principal Investigator
Petz Aladar County Teaching Hospital
Győr , , Hungary More Info
Zsolt Lázár
Principal Investigator
Josa Andras Teaching Hospital
Nyíregyháza , 4400, Hungary More Info
Laszlo Rejto
Principal Investigator
Barzilai Medical Center of Ashkelon
Ashkelon , , Israel More Info
Anatoly Nemets
Principal Investigator
Bnai Zion Medical center
Haifa , 31048, Israel More Info
Tamar Tadmor
Principal Investigator
Carmel Medical Center
Haifa , , Israel More Info
Meir Preis
Principal Investigator
Shaare Zedek Medical Center
Jerusalem , 91031, Israel More Info
Yishai Ofran
Principal Investigator
Sheba Medical Center
Ramat Gan , , Israel More Info
Drorit Merkel
Principal Investigator
Kaplan Medical Center
Rehovot , 76610, Israel More Info
Kalman Filanovsky
Principal Investigator
Tel Aviv Sourasky Medical Center
Tel Aviv , , Israel More Info
Moshe Yakir
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna , 40138, Italy More Info
Sofia Fatica
Contact
39.051.214.4177
[email protected]
Cristina Papayannidis
Principal Investigator
ASST Spedali Civili di Brescia
Brescia , , Italy More Info
Erika Borlenghi
Principal Investigator
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara , 44124, Italy More Info
Antonio Cuneo
Principal Investigator
AOU Careggi
Firenze , , Italy More Info
Valeria Santini
Principal Investigator
Ospedale Policlinico San Martino
Genova , 16132, Italy More Info
Giulia Rivoli
Principal Investigator
Romagnolo Institute to Study Tumors "Dino Amadori "/ Meldona
Meldola , 47014, Italy More Info
Federica Frabetti
Contact
[email protected]
Giovanni Marconi
Principal Investigator
A.O.U. Maggiore della Carità
Novara , 28100, Italy More Info
Clara Deambrogi
Contact
+39 0321 3732094
[email protected]
Andrea Patriarca
Principal Investigator
Ospedali Marche Nord Centro Ematologia e Trapianti
Pesaro , 61122, Italy More Info
Alessandro Isidori
Principal Investigator
Ospedale S.Maria delle Croci
Ravenna , , Italy More Info
Francesco Lanza
Principal Investigator
Ospedale Infermi di Rimini
Rimini , 47923, Italy More Info
Giulia Tolomelli
Principal Investigator
Ospedale S. Eugenio - ASL Roma 2
Roma , , Italy More Info
Paolo De Fabritiis
Principal Investigator
Fondazione Policlinico Tor Vergata
Rome , 00133, Italy More Info
Luca Maurillo
Principal Investigator
AOUI di Verona
Verona , , Italy More Info
Ilaria Tanasi
Principal Investigator
University Clinic Gdansk
Gdańsk , 80-95, Poland More Info
Jan Zaucha
Principal Investigator
Pomeranian Hospital Gdynia
Gdynia , 81-51, Poland More Info
Wanda Knopinska-Posluszny
Principal Investigator
Wojewodzki Szpital Specjalistyczny w Legnicy
Legnica , 59-22, Poland More Info
Jadwiga Holojda
Principal Investigator
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Warszawa , , Poland More Info
Bozena Budziszewska
Principal Investigator
University Clinic Warsaw
Warszawa , , Poland More Info
Grzegorz Basak
Principal Investigator
Alfred Sokołowski Hospital Wałbrzych
Wałbrzych , , Poland More Info
Aleksandra Butrym
Principal Investigator
Institut Catala d'Oncologia - Hospital Duran i Reynals Location
Badalona , , Spain More Info
Helena Pomares
Principal Investigator
Hospital del Mar
Barcelona , 08003, Spain More Info
Sarah García Ávila
Principal Investigator
H. Santa Creu i Sant Pau
Barcelona , 08025, Spain More Info
Antonio de la Riva
Contact
+34 93 556 5520
Ana Garido
Principal Investigator
Fundación Privada Instituto de Investigación Oncológica Vall d'Hebron
Barcelona , 08035, Spain More Info
David Valcarcel-Ferreiras
Principal Investigator
Hospital de la Santa Creu i Sant Pau
Barcelona , 08041, Spain More Info
Antonio De la Riva Buissen
Contact
+34 93 556 5520
[email protected]
Ana Garrido
Principal Investigator
Hospital del Mar Secretaria d'Hematologia Clínica
Barcelona , , Spain More Info
Sarah García Ávila
Principal Investigator
Hospital Universitario de Burgos
Burgos , 09006, Spain More Info
Jorge Labrador Gomes
Principal Investigator
Hospital San Pedro de Alcántara
Cáceres , , Spain More Info
Juan Bergua
Principal Investigator
MD Anderson Cancer Center
Madrid , 28033, Spain More Info
Mirian Sanchez
Contact
+34 917878600
[email protected]
Adolfo de la Fuente
Principal Investigator
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain More Info
Belen Veldhuizen Vaquero
Contact
+34 91 550 48 00
[email protected]
Arantxa Garcia Raso
Contact
+34 91 550 48 00
[email protected]
Teresa Arquero
Principal Investigator
H. Universitario La Paz
Madrid , 28046, Spain More Info
Raquel Gil Ortega
Contact
+34 91 207 12 47
[email protected]
Maria Raquel De Paz Arias
Principal Investigator
Hospital Universitario de La Princesa
Madrid , , Spain More Info
Maria Valle Gomez Garcia de Soria
Principal Investigator
Hospital General Universitario J.M. Morales Meseguer
Murcia , , Spain More Info
Tzua-Hua Chen-Liang
Principal Investigator
Hospital Universitario Central de Asturia
Oviedo , 33011, Spain More Info
Teresa Bernal
Principal Investigator
Hospital Son Llatzer
Palma De Mallorca , 07198, Spain More Info
Magdalena Flexas Morey
Contact
+34871202158
[email protected]
Juan José Bargay
Principal Investigator
Clinica Universidad Navarra
Pamplona , 31008, Spain More Info
Ana Alfonso
Principal Investigator
Hospital Universitario de Salamanca
Salamanca , 37007, Spain More Info
Magdalena Garcia
Contact
+34 923291100
[email protected]
Maria Diez Campelo
Principal Investigator
Hospital Universitario Donostia
San Sebastián , , Spain More Info
Carlos Manuel Panizo Santos
Principal Investigator
Hospital Universitario Marqués de Valdecilla
Santander , 39008, Spain More Info
Blanca Sánchez
Contact
[email protected]
Noemi Fernandez Escalada
Principal Investigator
Hospital Universitario Virgen Del Rocio
Seville , 41013, Spain More Info
Jose Francisco Falantes Gonzalez
Principal Investigator
Hospital Universitario y Politécnico La Fe
Valencia , 46026, Spain More Info
Pau Montesinos Fernandez
Principal Investigator
Hospital Clinico Universitario de Valencia
Valencia , , Spain More Info
Maria del Mar Tormo Díaz
Principal Investigator
Castle Hill Hospital, Cottingham
Cottingham , , United Kingdom More Info
Simone Green
Principal Investigator
Ninewells Hospital
Dundee , , United Kingdom More Info
Tauro Sudhir
Principal Investigator
Western General Hospital in NHS Lothian Edinburgh Scotland
Edinburgh , , United Kingdom More Info
Victoria Campbell
Principal Investigator
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool , , United Kingdom More Info
Arpad Toth
Principal Investigator
King's College Hospital NHS Foundation Trust
London , , United Kingdom More Info
Pramila Krishnamurthy
Principal Investigator
The Royal Marsden Foundation Trust
London , , United Kingdom More Info
David Taussig
Principal Investigator
University Hospital Southampton NHS Foundation Trust
Southampton , , United Kingdom More Info
Srinivas Narayanan
Principal Investigator
Sandwell and West Birmingham Hospital NHS Trust
West Bromwich , , United Kingdom More Info
Farooq Wandroo
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

550

Study ID:

NCT04797780

Recruitment Status:

Recruiting

Sponsor:


Syros Pharmaceuticals

How clear is this clinincal trial information?

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