search
Back to results

Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

Primary Purpose

Myelodysplastic Syndromes

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tamibarotene
Placebo
Azacitidine
Sponsored by
Syros Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Higher-Risk, Retinoic Acid Receptor Alpha (RARA) positive, Newly Diagnosed, Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of ArizonaRecruiting
  • UC IrvineRecruiting
  • University of Southern CaliforniaRecruiting
  • University of California, Los AngelasRecruiting
  • Yale Cancer CenterRecruiting
  • Cancer specialists of North FloridaRecruiting
  • Comprehensive Hematology and OncologyRecruiting
  • University of Illinois Cancer CenterRecruiting
  • Orchard Healthcare Research Inc.Recruiting
  • University of IowaRecruiting
  • Tulane Cancer CenterRecruiting
  • Johns Hopkins UniversityRecruiting
  • American Oncology Partners of Maryland, PARecruiting
  • SCL Health Research Institute, Inc. (St. Vincent Frontier Cancer Center)Recruiting
  • Morristown Medical Center- Atlantic Hematology OncologyRecruiting
  • Montefiore Medical Center & Albert Einstein College of MedicineRecruiting
  • Northwell HealthRecruiting
  • Novant Health IncRecruiting
  • Novant Health Cancer Institute - ForsythRecruiting
  • Wake Forest Baptist HealthRecruiting
  • Cleveland ClinicRecruiting
  • The Ohio State University Comprehensive Cancer CenterRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Texas Oncology - Baylor Charles A. Sammons Cancer CenterRecruiting
  • University of Utah Huntsman Cancer InstituteRecruiting
  • Medical University of GrazRecruiting
  • Salzburg Cancer Research Institute (SCRI)Recruiting
  • Klinik HietzingRecruiting
  • ZNA MiddelheimRecruiting
  • Institut Jules BordetRecruiting
  • Hospital De JolimontRecruiting
  • CHU de LiègeRecruiting
  • AZ DeltaRecruiting
  • CHU-UCL NamurRecruiting
  • Juravinski Cancer CentreRecruiting
  • London Health Sciences CenterRecruiting
  • McGill University Health Centre (MUHC)Recruiting
  • University Hospital OstravaRecruiting
  • Nemocnice PelhrimovRecruiting
  • General University Hospital PragueRecruiting
  • CHU Amiens-PicardieRecruiting
  • CHU d'AngersRecruiting
  • Centre Hospitalier de la Côte Basque Hématologie CliniqueRecruiting
  • Hôpital AvicenneRecruiting
  • CHRU de BREST - Hôpital MorvanRecruiting
  • CHU Clermont Ferrand / CHU EstaingRecruiting
  • CHU Grenoble Alpes Hôpital Nord MichallonRecruiting
  • Hopital MignotRecruiting
  • CHU de LimogesRecruiting
  • Centre Léon BérardRecruiting
  • CHU Nantes - Hotel DieuRecruiting
  • CHU de Nice - Hopital L'ArchetRecruiting
  • Hôpital Saint LouisRecruiting
  • Centre Hospitalier de PerpignanRecruiting
  • CHU BordeauxRecruiting
  • CHU Lyon SudRecruiting
  • CHU PoitersRecruiting
  • ICANS StrasbourgRecruiting
  • Institut Gustave RoussyRecruiting
  • Helios Klinikum Berlin Buch GmbHRecruiting
  • Universitätsklinikum FreiburgRecruiting
  • Universitätsklinikum Halle (Saale)Recruiting
  • Universitätsklinikum MarburgRecruiting
  • Universitätsklinikum MünsterRecruiting
  • Semmelweis Egyetem
  • Debrecen University Medical and Health Science CentreRecruiting
  • Petz Aladar County Teaching HospitalRecruiting
  • Josa Andras Teaching HospitalRecruiting
  • Barzilai Medical Center of AshkelonRecruiting
  • Bnai Zion Medical centerRecruiting
  • Carmel Medical CenterRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Sheba Medical CenterRecruiting
  • Kaplan Medical CenterRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting
  • ASST Spedali Civili di BresciaRecruiting
  • Azienda Ospedaliero-Universitaria di FerraraRecruiting
  • AOU CareggiRecruiting
  • Ospedale Policlinico San MartinoRecruiting
  • Romagnolo Institute to Study Tumors "Dino Amadori "/ MeldonaRecruiting
  • A.O.U. Maggiore della CaritàRecruiting
  • Ospedale S.Maria delle CrociRecruiting
  • Ospedale Infermi di RiminiRecruiting
  • Ospedale S. Eugenio - ASL Roma 2Recruiting
  • Fondazione Policlinico Tor VergataRecruiting
  • AOUI di VeronaRecruiting
  • University Clinic GdanskRecruiting
  • Pomeranian Hospital GdyniaRecruiting
  • Wojewodzki Szpital Specjalistyczny w LegnicyRecruiting
  • University Clinic WarsawRecruiting
  • H. Santa Creu i Sant PauRecruiting
  • Fundación Privada Instituto de Investigación Oncológica Vall d'HebronRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario de BurgosRecruiting
  • Hospital San Pedro de AlcántaraRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Hospital Universitario Fundacion Jimenez DiazRecruiting
  • H. Universitario La PazRecruiting
  • Hospital Universitario Central de AsturiaRecruiting
  • Hospital Son LlatzerRecruiting
  • Clinica Universidad NavarraRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Universitario Marqués de ValdecillaRecruiting
  • Hospital Universitario Virgen Del RocioRecruiting
  • Hospital Universitario y Politécnico La FeRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Western General Hospital in NHS Lothian Edinburgh ScotlandRecruiting
  • Clatterbridge Cancer Centre NHS Foundation TrustRecruiting
  • King's College Hospital NHS Foundation TrustRecruiting
  • Sandwell and West Birmingham Hospital NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tamibarotene + Azacitidine

Tamibarotene Matched Placebo + Azacitidine

Arm Description

Tamibarotene: 6 mg administered orally twice per day (BID) on Days 8 through 28 of each 28-day treatment cycle. Azacitidine: 75 mg/m^2 administered intravenously or subcutaneously each day on Days 1 through 7 of each 28-day treatment cycle.

Placebo: Tamibarotene-matching tablets administered orally BID on Days 8 through 28 of each 28-day treatment cycle. Azacitidine: 75 mg/m^2 administered intravenously or subcutaneously each day on Days 1 through 7 of each 28-day treatment cycle.

Outcomes

Primary Outcome Measures

Proportion of Participants with Complete Remission

Secondary Outcome Measures

Duration of Overall Survival
Proportion of Participants Who Achieve Transfusion Independence
Proportion of Participants Who Achieve Objective Response
Duration of Complete Response
Duration of Overall Response
Time to Complete Remission
Time to Initial Response
Duration of Event Free Survival
Change in Health-Related Quality of Life (HRQOL) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 Scale (EORTC QLQ-30)
Change in HRQOL as assessed by the European Quality of Life 5 dimensions Scale (EuroQoL-5D)
Proportion of participants with Adverse Events and Serious Adverse Events

Full Information

First Posted
March 11, 2021
Last Updated
August 7, 2023
Sponsor
Syros Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT04797780
Brief Title
Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 8, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syros Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 newly diagnosed with higher-risk myelodysplastic syndrome (HR-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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Higher-Risk, Retinoic Acid Receptor Alpha (RARA) positive, Newly Diagnosed, Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamibarotene + Azacitidine
Arm Type
Experimental
Arm Description
Tamibarotene: 6 mg administered orally twice per day (BID) on Days 8 through 28 of each 28-day treatment cycle. Azacitidine: 75 mg/m^2 administered intravenously or subcutaneously each day on Days 1 through 7 of each 28-day treatment cycle.
Arm Title
Tamibarotene Matched Placebo + Azacitidine
Arm Type
Placebo Comparator
Arm Description
Placebo: Tamibarotene-matching tablets administered orally BID on Days 8 through 28 of each 28-day treatment cycle. Azacitidine: 75 mg/m^2 administered intravenously or subcutaneously each day on Days 1 through 7 of each 28-day treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Tamibarotene
Other Intervention Name(s)
SY-1425
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Administered as specified in the treatment arm
Primary Outcome Measure Information:
Title
Proportion of Participants with Complete Remission
Time Frame
Up to 5 Years
Secondary Outcome Measure Information:
Title
Duration of Overall Survival
Time Frame
Up to 5 Years
Title
Proportion of Participants Who Achieve Transfusion Independence
Time Frame
Up to 5 Years
Title
Proportion of Participants Who Achieve Objective Response
Time Frame
Up to 5 Years
Title
Duration of Complete Response
Time Frame
Up to 5 Years
Title
Duration of Overall Response
Time Frame
Up to 5 Years
Title
Time to Complete Remission
Time Frame
Up to 5 Years
Title
Time to Initial Response
Time Frame
Up to 5 Years
Title
Duration of Event Free Survival
Time Frame
Up to 5 Years
Title
Change in Health-Related Quality of Life (HRQOL) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 Scale (EORTC QLQ-30)
Time Frame
Up to 5 Years
Title
Change in HRQOL as assessed by the European Quality of Life 5 dimensions Scale (EuroQoL-5D)
Time Frame
Up to 5 Years
Title
Proportion of participants with Adverse Events and Serious Adverse Events
Time Frame
Up to 5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Manager
Phone
617-674-9069
Email
SELECTMDS1@syros.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Syros Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Argentina Morales
Email
argentinamorales@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Sharad Khurana
Facility Name
UC Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Grace
Email
magi@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Deepa Jeyakumar
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey O'Connell
Facility Name
University of California, Los Angelas
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruck Habtemarium
Email
BHabtemariam@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Wanxing Chai Ho
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amer Zeidan
Facility Name
Cancer specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Kobrinski
Facility Name
Comprehensive Hematology and Oncology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Archana Pathak
Phone
727-384-4388
Email
apathak@comphemonc.com
First Name & Middle Initial & Last Name & Degree
Pratibha Desai, MD
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irum Khan, MD
Facility Name
Orchard Healthcare Research Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Jardinico
Email
jjardinico@orchardhr.com
First Name & Middle Initial & Last Name & Degree
Ira Oliff
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Parrott
Email
Karen-parrott@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Grerk Sutamtewagul
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hana Safah
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Huck
Phone
410-614-3725
First Name & Middle Initial & Last Name & Degree
Amy DeZern
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Stutzman
Email
Taylor.Stutzman@aoncology.com
First Name & Middle Initial & Last Name & Degree
Ralph Vincent Boccia
Facility Name
SCL Health Research Institute, Inc. (St. Vincent Frontier Cancer Center)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Cobb, MD
Facility Name
Morristown Medical Center- Atlantic Hematology Oncology
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
02140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen Nowakowski
Email
Maureen.Nowakowski@atlantichealth.org
First Name & Middle Initial & Last Name & Degree
Mohamad Cherry
Facility Name
Montefiore Medical Center & Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
11102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Victor
Email
jovictor@montefiore.org
First Name & Middle Initial & Last Name & Degree
Aditi Shastri
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Allen, MD
Facility Name
Novant Health Inc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Dugan
Facility Name
Novant Health Cancer Institute - Forsyth
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Dugan
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupali Roy Bhave
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melina Sharif
Email
sharifm@ccf.org
First Name & Middle Initial & Last Name & Degree
Jenna Thomas
Email
thomasj21@ccf.org
First Name & Middle Initial & Last Name & Degree
Hetty Carraway
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uma Borate
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Cook
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moshe Levy
Facility Name
University of Utah Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afaf Osman
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armin Zebisch
Facility Name
Salzburg Cancer Research Institute (SCRI)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Greil
Facility Name
Klinik Hietzing
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Geissler
Facility Name
ZNA Middelheim
City
Antwerp
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bert Heyrman
Facility Name
Institut Jules Bordet
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Costantini
Phone
+32 25 41 36 47
Email
sabrina.costantini@bordet.be
First Name & Middle Initial & Last Name & Degree
Chloe Spilleboudt
Facility Name
Hospital De Jolimont
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Van Obbergh
Facility Name
CHU de Liège
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline Faccinetto
Email
cfaccinetto@chuliege.be
First Name & Middle Initial & Last Name & Degree
Marie Lejeune
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Demeersseman
Phone
+32 2 51237560
First Name & Middle Initial & Last Name & Degree
Dries Deeren
Facility Name
CHU-UCL Namur
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Marcin
Phone
+32 81423837
Email
catherine.marcin@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Carlos Graux
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
ON L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Leber
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lalit Saini
Facility Name
McGill University Health Centre (MUHC)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Storring
Facility Name
University Hospital Ostrava
City
Ostrava
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zdenek Koreistek
Facility Name
Nemocnice Pelhrimov
City
Pelhřimov
ZIP/Postal Code
39338
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Kessler
Facility Name
General University Hospital Prague
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Jonášová
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine Hubert
Phone
+ 33 3 22 45 54 23
Email
hubert.amandine@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Delphine Lebon
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Le Van Suu
Phone
+33(0)2 41 35 67 26
Email
Melanie.levansuu@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Sylvain Thepot
Facility Name
Centre Hospitalier de la Côte Basque Hématologie Clinique
City
Bayonne
ZIP/Postal Code
64109
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Séverine Labarrere
Phone
+33 5 59 44 38 28
Email
slabarrere@ch-cotebasque.fr
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste Robin
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey Edouart
Phone
+33-1-48-95-75-05 or +33-1-48
Email
geoffrey.edouart@aphp.fr
First Name & Middle Initial & Last Name & Degree
Thorsten Braun
Facility Name
CHRU de BREST - Hôpital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romuald Kerdoncuff
Phone
33.2.29.02.01.00
Email
romuald.kerdoncuff@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Gaëlle Guillerm
Facility Name
CHU Clermont Ferrand / CHU Estaing
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaspar Aspas-Requena
Facility Name
CHU Grenoble Alpes Hôpital Nord Michallon
City
La Tronche
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Park
Facility Name
Hopital Mignot
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine Constant
Phone
+33 1 39 23 97 83
Email
cconstant@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
Philippe Rousselot
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre Gourin
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amine Belhhabri
Facility Name
CHU Nantes - Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bettina Viel
Phone
+33 2 40 08 32 60
Email
bettina.viel@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Léa Robert
Phone
+33 2 40 08 32 60
Email
Lea.robet@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Alice Garnier
Facility Name
CHU de Nice - Hopital L'Archet
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Lechardeur
Email
lechardeur.j@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Thomas Cluzeau
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hajer Chehimi
Phone
+33 1 71 20 70 10
Email
hajer.chehimi@aphp.fr
First Name & Middle Initial & Last Name & Degree
Pierre Fenaux
Facility Name
Centre Hospitalier de Perpignan
City
Perpignan
ZIP/Postal Code
66046
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Quesada
Phone
+33 (0)4 68 61 89 01
Email
kevin.quesada@ch-perpignan.fr
First Name & Middle Initial & Last Name & Degree
Laurence Sanhes
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corentin Rouvray
Phone
+33(0)5 24 54 91 69
Email
corentin.rouvray@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Sophie Dimicoli-Salazar
Facility Name
CHU Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Leclercq
Phone
+33 4 78 86 22 69
Email
sophie.leclercq@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Gaëlle Fossard
Facility Name
CHU Poiters
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Achiath Lassissi
Phone
+33 549443115
Email
achiath.lassissi@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Jose Torregrosa
Facility Name
ICANS Strasbourg
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Collin
Phone
+33(0)3 68 76 72 03
Email
c.collin@icans.eu
First Name & Middle Initial & Last Name & Degree
Shanti Natarajan-Ame
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louiza Bennane
Email
Louiza.BENNANE@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Stéphane De Botton
Facility Name
Helios Klinikum Berlin Buch GmbH
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Snjezana Janjetovic
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Lübbert
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haifa Kathrin Al-Ali
Facility Name
Universitätsklinikum Marburg
City
Marburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Metzelder
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Schliemann
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Nagy
Facility Name
Debrecen University Medical and Health Science Centre
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Árpád Illes
Facility Name
Petz Aladar County Teaching Hospital
City
Győr
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Lázár
Facility Name
Josa Andras Teaching Hospital
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laszlo Rejto
Facility Name
Barzilai Medical Center of Ashkelon
City
Ashkelon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anatoly Nemets
Facility Name
Bnai Zion Medical center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar Tadmor
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meir Preis
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yishai Ofran
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drorit Merkel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalman Filanovsky
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moshe Yakir
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Fatica
Phone
39.051.214.4177
Email
sofia.fatica@aosp.bo.it
First Name & Middle Initial & Last Name & Degree
Cristina Papayannidis
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Borlenghi
Facility Name
Azienda Ospedaliero-Universitaria di Ferrara
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Cuneo
Facility Name
AOU Careggi
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Santini
Facility Name
Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulia Rivoli
Facility Name
Romagnolo Institute to Study Tumors "Dino Amadori "/ Meldona
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federica Frabetti
Email
federica.frabetti@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Giovanni Marconi
Facility Name
A.O.U. Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clara Deambrogi
Phone
+39 0321 3732094
Email
clara.deambrogi@med.uniupo.it
First Name & Middle Initial & Last Name & Degree
Andrea Patriarca
Facility Name
Ospedale S.Maria delle Croci
City
Ravenna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Lanza
Facility Name
Ospedale Infermi di Rimini
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dora Prota
Phone
+39 0541 705866
Email
dora.prota@auslromagna.it
First Name & Middle Initial & Last Name & Degree
Patrizia Tosi
Facility Name
Ospedale S. Eugenio - ASL Roma 2
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo De Fabritiis
Facility Name
Fondazione Policlinico Tor Vergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Maurillo
Facility Name
AOUI di Verona
City
Verona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilaria Tanasi
Facility Name
University Clinic Gdansk
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Zaucha
Facility Name
Pomeranian Hospital Gdynia
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanda Knopinska-Posluszny
Facility Name
Wojewodzki Szpital Specjalistyczny w Legnicy
City
Legnica
ZIP/Postal Code
59-220
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jadwiga Holojda
Facility Name
University Clinic Warsaw
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Basak
Facility Name
H. Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio de la Riva
Phone
+34 93 556 5520
First Name & Middle Initial & Last Name & Degree
Ana Garido
Facility Name
Fundación Privada Instituto de Investigación Oncológica Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Valcarcel-Ferreiras
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio De la Riva Buissen
Phone
+34 93 556 5520
Email
ARiva@santpau.cat
First Name & Middle Initial & Last Name & Degree
Ana Garrido
Facility Name
Hospital Universitario de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Labrador Gomes
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Bergua
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirian Sanchez
Phone
+34 917878600
Ext
2883-2884
Email
mirian.delgado@fundacionmdanderson.es
First Name & Middle Initial & Last Name & Degree
Adolfo de la Fuente
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belen Veldhuizen Vaquero
Phone
+34 91 550 48 00
Ext
3750
Email
belen.veldhuizen@quironsalud.es
First Name & Middle Initial & Last Name & Degree
Arantxa Garcia Raso
Phone
+34 91 550 48 00
Ext
3719
Email
argarciar@quironsalud.es
First Name & Middle Initial & Last Name & Degree
Teresa Arquero
Facility Name
H. Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Gil Ortega
Phone
+34 91 207 12 47
Email
raquelhematologia@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Raquel De Paz Arias
Facility Name
Hospital Universitario Central de Asturia
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Garcia
Phone
'+34 669 204 799
Email
neohem@ispasturias.es
First Name & Middle Initial & Last Name & Degree
Teresa Bernal
Facility Name
Hospital Son Llatzer
City
Palma De Mallorca
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Flexas Morey
Phone
+34871202158
Email
m.flexas@ssib.es
First Name & Middle Initial & Last Name & Degree
Juan José Bargay
Facility Name
Clinica Universidad Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Alfonso
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Garcia
Phone
+34 923291100
Ext
55974
Email
mgarcia.ibsal@saludcastillayleon.es
First Name & Middle Initial & Last Name & Degree
Maria Diez Campelo
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanca Sánchez
Email
mblanca.sanchezs@scsalud.es
First Name & Middle Initial & Last Name & Degree
Noemi Fernandez Escalada
Facility Name
Hospital Universitario Virgen Del Rocio
City
Seville
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Francisco Falantes Gonzalez
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pau Montesinos Fernandez
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria del Mar Tormo Díaz
Facility Name
Western General Hospital in NHS Lothian Edinburgh Scotland
City
Edinburgh
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Campbell
Facility Name
Clatterbridge Cancer Centre NHS Foundation Trust
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arpad Toth
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pramila Krishnamurthy
Facility Name
Sandwell and West Birmingham Hospital NHS Trust
City
West Bromwich
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farooq Wandroo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

We'll reach out to this number within 24 hrs