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NCT04603495Active, not recruitingPhase 3

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
430 (actual)
First submitted
20 Oct 2020
Start date
9 Apr 2021
Primary completion date
23 Aug 2023
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT04603495
EU CT number
2023-507954-34-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 430
  • From 9 Apr 2021 to the primary completion date, 23 Aug 2023
  • 156 sites in 22 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Splenectomy or splenic irradiation in the previous 6 months
  • Chronic or active conditions and/or concomitant medication use that would prohibit treatment
  • Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm

Who the study is looking for

  • Aged ≥ 18 years
  • Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
  • Adequate hematologic, renal, and hepatic function
  • Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0
  • Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
  • Spleen volume of ≥ 450 cm\^3
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (156)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
LKH - Universitätsklinikum Graz; Abteilung für Hämatologie
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GrazAustriaUnknown status
Kepler University Hospital
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LinzAustriaUnknown status
Krankenhaus der Elisabethinen Linz
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LinzAustriaUnknown status
University Hospital Salzburg
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SalzburgAustriaUnknown status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
Icon Cancer Centre
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BrisbaneAustraliaUnknown status
USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic
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BuderimAustraliaUnknown status
Monash Health
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ClaytonAustraliaUnknown status
Peninsula Private Hospital Clinical Trials Unit
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FrankstonAustraliaUnknown status
One Clinical Research Pty Ltd
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NedlandsAustraliaUnknown status
ZNA
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AntwerpBelgiumUnknown status
Cliniques universitaires Saint-Luc
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BrusselsBelgiumUnknown status
Hôpital de Jolimont
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La LouvièreBelgiumUnknown status
UZ Leuven
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LeuvenBelgiumUnknown status
Domaine Universitaire du Sart Tilman
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LiègeBelgiumUnknown status
Tom Baker Cancer Centre
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CalgaryCanadaUnknown status
University of Alberta Hospital
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EdmontonCanadaUnknown status
London Health Sciences Center - Victoria Hospital
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LondonCanadaUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
Princess Margaret Cancer Center
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TorontoCanadaUnknown status
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaUnknown status
University Hospital Olomouc
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OlomoucCzechiaUnknown status
Hämatologisch-Onkologische Praxis Augsburg
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AugsburgGermanyUnknown status
Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH)
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HalleGermanyUnknown status
University hospital Hamburg Eppendorf
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HamburgGermanyUnknown status
Universitätsklinikum Jena, Klinik für Innere Medizin II
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JenaGermanyUnknown status
Universitätsklinikum Ulm
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UlmGermanyUnknown status
ICO Badalona - Hospital Universitari Germans Trias i Pujol
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BadalonaSpainUnknown status
Vall d'Hebron Institute of Oncology
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BarcelonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital San Pedro De Alcántara
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CáceresSpainUnknown status
Hospital Universitario de Gran Canaria Dr Negrín
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Las Palmas de Gran CanariaSpainUnknown status
Quirónsalud Madrid University Hospital
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MadridSpainUnknown status
Morales Meseguer General University Hospital
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MurciaSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Universitario de Salamanc
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SalamancaSpainUnknown status
Hospital Virgen Macarena
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SevilleSpainUnknown status
University Hospital of Toledo
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ToledoSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Amiens South Hospital univerisy - Hopital Sud
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AmiensFranceUnknown status
Centre Hospitalier
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Le MansFranceUnknown status
Hôpital l'Archet 1
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NiceFranceUnknown status
Gard Cancer Institute
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NîmesFranceUnknown status
Centre Hospitalier Lyon Sud Secteur 1G
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Pierre-BéniteFranceUnknown status
Chu Pontchaillou - Service Hematologie
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RennesFranceUnknown status
Institut de Cancérologie Lucien Neuwirth
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Saint-Priest-en-JarezFranceUnknown status
Hopital Bretonneau
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ToursFranceUnknown status
Chru Brabois
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Vandœuvre-lès-NancyFranceUnknown status
Pilgrim Hospital
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BostonUnited KingdomUnknown status
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomUnknown status
University Hospital of Wales
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CardiffUnited KingdomUnknown status
Western General Hospital
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EdinburghUnited KingdomUnknown status
The Clatterbridge Cancer Centre
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LiverpoolUnited KingdomUnknown status
University College London Hospitals
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LondonUnited KingdomUnknown status
Guy's & St Thomas' NHS Foundation Trust
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LondonUnited KingdomUnknown status
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
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LondonUnited KingdomUnknown status
Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital
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OxfordUnited KingdomUnknown status
Laiko General Hospital
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AthensGreeceUnknown status
UGH of Ioannina
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IoanninaGreeceUnknown status
University General Hospital of Patras
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RioGreeceUnknown status
Princess Margaret Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia
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NyíregyházaHungaryUnknown status
: Pecs University, 1st Department of Medicine
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PécsHungaryUnknown status
Soroka Medical Center
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BeershebaIsraelUnknown status
Shamir Medical Center
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Be’er Ya‘aqovIsraelUnknown status
Lady Davis Carmel Medical Center
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HaifaIsraelUnknown status
Rambam Health Corporation
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HaifaIsraelUnknown status
Wolfson Medical Center
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HolonIsraelUnknown status
Hadassah University Hospital - Ein Kerem
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JerusalemIsraelUnknown status
Shaarei Zedek
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NahariyaIsraelUnknown status
Rabin Medical Center-Beilinson Campus
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Petah TikvaIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyUnknown status
A.O.U. Policlinico S.Orsola Malpighi
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BolognaItalyUnknown status
Regional Hospital Spedali Civili di Brescia
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BresciaItalyUnknown status
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
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FerraraItalyUnknown status
Azienda Ospedaliera Universitaria Careggi
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FlorenceItalyUnknown status
IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori
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MeldolaItalyUnknown status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyUnknown status
Azienda Ospedaliera San Gerardo di Monza
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MonzaItalyUnknown status
University Hospital Maggiore della Carita
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NovaraItalyUnknown status
AOU S. Luigi Gonzaga
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OrbassanoItalyUnknown status
University Hospital of Padova
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PadovaItalyUnknown status
University Hospital 'Paolo Giaccone' Polyclinic
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PalermoItalyUnknown status
Ospedale Sant'Eugenio
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RomeItalyUnknown status
Hospital Ordine Mauriziano of Turin
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TurinItalyUnknown status
Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi
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VareseItalyUnknown status
Inje University Busan Paik Hospital
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BusanSouth KoreaUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Inje University Haeundae Paik Hospital
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BusanSouth KoreaUnknown status
Daegu Catholic University Medical Center
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DaeguSouth KoreaUnknown status
Kyungpook National University Hospital
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DaeguSouth KoreaUnknown status
The Catholic University Of Korea St. Vincent Hospital
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Gyeonggi-doSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
jeonbuk National University Hospital
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JeonjuSouth KoreaUnknown status
Gyeongsang National University Hospital
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JinjuSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea
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SeoulSouth KoreaUnknown status
The Catholic University of South Korea Seoul St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Hospital Sultanah Bahiyah
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Alor StarMalaysiaUnknown status
Hospital Ampang
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AmpangMalaysiaUnknown status
Hospital Pulau Pinang
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George TownMalaysiaUnknown status
Hospital Sultanah Aminah
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Johor BahruMalaysiaUnknown status
Hospital Queen Elizabeth
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Kota KinabaluMalaysiaUnknown status
Sunway Medical Centre
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Petaling JayaMalaysiaUnknown status
Amsterdam UMC
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AmsterdamNetherlandsUnknown status
Maastricht University Medical Center
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MaastrichtNetherlandsUnknown status
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
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Biała PodlaskaPolandUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandUnknown status
Pratia Onkologia Katowice
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KatowicePolandUnknown status
Centrum Medyczne Pratia
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SkorzewoPolandUnknown status
Nasz Lekarz Przychodnie Medyczne
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TorunPolandUnknown status
King Chulalongkorn Memorial Hospital
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BangkokThailandUnknown status
Chulabhorn Hospital
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BangkokThailandUnknown status
Rajavithi Hospital
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BangkokThailandUnknown status
Srinagarind Hospital, Khon Kaen University
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Khon KaenThailandUnknown status
Songklanagarind Hospital
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SongkhlaThailandUnknown status
Chang-Gung Memorial Hospital - Chiayi
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Chiayi CityTaiwanUnknown status
China Medical University Hospital
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Chiayi CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
University of Michigan Medical Center
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Ann ArborUnited StatesUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
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ChandlerUnited StatesUnknown status
Cleveland Clinic Taussig Cancer Center
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ClevelandUnited StatesUnknown status
Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL
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DecaturUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Franciscan Health/Indiana blood and Marrow Transplantation
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IndianapolisUnited StatesUnknown status
Mayo Clinic
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JacksonvilleUnited StatesUnknown status
UC San Diego Moores Cancer Center
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La JollaUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
UCLA Medical Center
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Los AngelesUnited StatesUnknown status
Norton Cancer Institute, St. Matthews Campus
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LouisvilleUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Weill Cornell Medical College-New York Presbyterian Hospital
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
University of Texas Health Science Center San Antonio
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San AntonioUnited StatesUnknown status
Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute
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SeattleUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Dr. Abdurrahman Yurtaslan Oncology Health Application and Research Center
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AnkaraTurkey (Türkiye)Unknown status
Ankara University Faculty of Medicine Cebeci Research and Application Hospital
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AnkaraTurkey (Türkiye)Unknown status
Antalya Medstar Hospital
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AntalyaTurkey (Türkiye)Unknown status
Edirne Trakya University Faculty of Medicine Hospital
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EdirneTurkey (Türkiye)Unknown status
Gaziantep University Sahinbey Research and Application Center Hospital
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GaziantepTurkey (Türkiye)Unknown status
Izmir Ege University Faculty of Medicine Hospital
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IzmirTurkey (Türkiye)Unknown status
Erciyes University Faculty of Medicine Hospital
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KayseriTurkey (Türkiye)Unknown status
Kocaeli University Application
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KocaeliTurkey (Türkiye)Unknown status
Mersin University
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MersinTurkey (Türkiye)Unknown status
Samsun 19 Mayıs University Health Application Research Hospital
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SamsunTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.