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NCT06588478RecruitingPhase 2

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
249 (estimated)
First submitted
6 Sept 2024
Start date
3 Jan 2025
Primary completion date
Jun 2028
Lead sponsor
Loxo Oncology, Inc.
NCT number
NCT06588478
EU CT number
2024-515689-15-01

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 249
  • From 3 Jan 2025 to the primary completion date, Jun 2028
  • 129 sites in 18 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

  • Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
  • Have a history of greater than or equal to (\>=) Grade 3 bleeding due to treatment with a BTK inhibitor
  • Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
    • nonmelanoma skin cancer or lentigo malignant melanoma
    • cervical carcinoma in situ
    • localized prostate cancer undergoing active surveillance, and
    • localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy

Other illness

  • Have known or suspected history of central nervous system involvement by CLL/SLL

Other

  • Have known or suspected Richter's transformation

Who the study is looking for

  • Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
  • Part 1: Have received prior CLL/SLL treatment
  • Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
  • Have received a covalent BTK inhibitor
  • Part 2: Have received no prior treatment for CLL/SLL
    • Part 1 - Known 17p deletion status (positive or negative)
    • Part 2 - Must have 17p deletion (positive)
  • Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
  • Capable of swallowing oral study medication.
  • Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.

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

Full criteria on ClinicalTrials.gov

Sites (129)

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

SiteCityCountrySite status
Flinders Medical Centre
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AdelaideAustraliaRecruiting
Bankstown-Lidcombe Hospital
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BankstownAustraliaRecruiting
Box Hill Hospital
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Box HillAustraliaRecruiting
Coffs Harbour Health Campus
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Coffs HarbourAustraliaRecruiting
Royal Hobart Hospital
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HobartAustraliaRecruiting
Icon Cancer Centre Kurralta Park
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Kurralta ParkAustraliaRecruiting
Latrobe Regional Health
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TraralgonAustraliaRecruiting
Calvary Mater Newcastle
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WaratahAustraliaRecruiting
The Perth Blood Institute - West Perth
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West PerthAustraliaRecruiting
Princess Alexandra Hospital
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WoolloongabbaAustraliaRecruiting
Institut Jules Bordet
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AnderlechtBelgiumRecruiting
AZ Sint-Jan Brugge-Oostende AV
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BrugesBelgiumRecruiting
UZ Gent
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GhentBelgiumRecruiting
Groupe Jolimont
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La LouvièreBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Clinique Saint Pierre
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OttigniesBelgiumRecruiting
AZ Delta vzw
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RoeselareBelgiumRecruiting
AZ Nikolaas
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Sint-NiklaasBelgiumRecruiting
CHR Verviers - La Tourelle
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VerviersBelgiumRecruiting
Royal Victoria Regional Health Centre
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BarrieCanadaRecruiting
Saskatoon Cancer Centre
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SaskatoonCanadaRecruiting
Fakultní nemocnice Brno Bohunice
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BrnoCzechiaActive, not recruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaCompleted
MV-Zentrum für Onkologie und Hämatologie
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CologneGermanyRecruiting
Centrum für Hämatologie und Onkologie Bethanien
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FrankfurtGermanyRecruiting
OSP Göttingen
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GöttingenGermanyRecruiting
Onkologisches Ambulanzzentrum Hannover
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HanoverGermanyRecruiting
Klinikum Aschaffenburg-Alzenau
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HösbachGermanyRecruiting
InVO Institut für Versorgungsforschung in der Onkologie
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KoblenzGermanyRecruiting
Aarhus Universitetshospital, Skejby
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AarhusDenmarkRecruiting
Odense Universitetshospital
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OdenseDenmarkRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Institut Català d'Oncologia - L'Hospitalet
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L'Hospitalet Del LlobregatSpainRecruiting
Clinica Universidad de Navarra
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
MD Anderson Cancer Center
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MadridSpainRecruiting
Hospital Universitario Infanta Leonor
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro - Majadahonda
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MajadahondaSpainRecruiting
Hospital Costa del Sol
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MarbellaSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
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SalamancaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Hospital Universitario Virgen del Rocio
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SevilleSpainRecruiting
Hospital Universitario Virgen Macarena
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SevilleSpainRecruiting
Centre Hospitalier d'Argenteuil Victor Dupouy
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ArgenteuilFranceRecruiting
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
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CaenFranceRecruiting
Centre Hospitalier du Mans
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Le MansFranceRecruiting
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace Hôpital Emile Muller
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MulhouseFranceRecruiting
Centre Antoine Lacassagne
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NiceFranceRecruiting
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
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ToursFranceRecruiting
Heartlands Hospital
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BirminghamUnited KingdomRecruiting
The Beatson West of Scotland Cancer Centre
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GlasgowUnited KingdomRecruiting
Northwick Park Hospital
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HarrowUnited KingdomRecruiting
St James's University Hospital
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LeedsUnited KingdomRecruiting
Lincoln County Hospital
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LincolnUnited KingdomRecruiting
Clatterbridge Cancer Centre - Liverpool
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LiverpoolUnited KingdomRecruiting
Hammersmith Hospital
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LondonUnited KingdomRecruiting
Singleton Hospital
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SwanseaUnited KingdomRecruiting
Evangelismos General Hospital of Athens
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AthensGreeceRecruiting
Attikon General University Hospital
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ChaïdáriGreeceRecruiting
G. Papanikolaou General Hospital
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ThessalonikiGreeceRecruiting
General Hospital of Athens "Laiko"
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ΑthensGreeceRecruiting
Semmelweis Egyetem
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BudapestHungaryRecruiting
Dél-Pesti Centrumkórház
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BudapestHungaryRecruiting
Pécsi Tudományegyetem Klinikai Központ
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PécsHungaryRecruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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SzegedHungaryRecruiting
A.O.U.C Policlinico di Bari
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BariItalyRecruiting
Azienda Ospedaliero Universitaria S.Anna
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ConaItalyRecruiting
Azienda Ospedaliera Universitaria Careggi
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FlorenceItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyRecruiting
Azienda Ospedale Universita Padova
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PadovaItalyRecruiting
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
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PalermoItalyRecruiting
AO Santa Maria della Misericordia
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PerugiaItalyRecruiting
AOU Policlinico Umberto I
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RomaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
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RomaItalyRecruiting
Pusan National University Hospital
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BusanSouth KoreaRecruiting
Chonnam National University Hwasun Hospital
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Hwasun-gunSouth KoreaRecruiting
The Catholic University of Korea Yeouido St. Mary's Hospital
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
IN VIVO
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BydgoszczPolandRecruiting
Pratia Onkologia Katowice
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KatowicePolandRecruiting
Pratia MCM Krakow
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KrakowPolandRecruiting
Aidport sp z o.o.
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SkorzewoPolandRecruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
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WroclawPolandRecruiting
Fundeni Clinical Institute
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BucharestRomaniaRecruiting
Spitalul Clinic Colțea
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BucharestRomaniaRecruiting
Institutul Oncologic Cluj
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Cluj-NapocaRomaniaRecruiting
Spitalul Clinic Municipal Filantropia Craiova
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CraiovaRomaniaRecruiting
Institutul Regional de Oncologie
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IașiRomaniaRecruiting
Ovidius Clinical Hospital OCH
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OvidiuRomaniaRecruiting
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
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Banská BystricaSlovakiaRecruiting
Narodny onkologicky ustav
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BratislavaSlovakiaRecruiting
Univerzitna nemocnica L. Pasteura Kosice
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KošiceSlovakiaRecruiting
Univerzitna nemocnica Martin
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MartinSlovakiaRecruiting
Rocky Mountain Cancer Center
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AuroraUnited StatesRecruiting
USO-Texas Oncology-Central/South Texas
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AustinUnited StatesRecruiting
American Oncology Partners, PA
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BethesdaUnited StatesRecruiting
Boston Medical Center
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BostonUnited StatesRecruiting
Ironwood Cancer & Research Centers
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ChandlerUnited StatesRecruiting
City of Hope National Medical Center
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DuarteUnited StatesRecruiting
Saint Elizabeth Medical Center Edgewood
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EdgewoodUnited StatesRecruiting
Williamette Valley Cancer Institute & Research Center
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EugeneUnited StatesRecruiting
East Carolina University
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GreenvilleUnited StatesRecruiting
Gulfport Memorial Hospital
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GulfportUnited StatesRecruiting
USO-Virginia Oncology Associates
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HamptonUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada
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HendersonUnited StatesRecruiting
City of Hope National Medical Center
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IrvineUnited StatesRecruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center
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MiamiUnited StatesRecruiting
City of Hope National Medical Center, Atlanta Cancer Center
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NewnanUnited StatesRecruiting
Palo Alto Medical Foundation Research Institute (PAMFRI)
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Palo AltoUnited StatesRecruiting
Stanford Cancer Center
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Palo AltoUnited StatesRecruiting
Sarah Cannon Research Institute/SCRI
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The WoodlandsUnited StatesRecruiting
Mission Cancer Blood
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WaukeeUnited StatesRecruiting
Cancer Care Associates of York
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YorkUnited StatesRecruiting
Sakarya University School of Medicine
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AdapazarıTurkey (Türkiye)Recruiting
Ankara University Health Practice and Research Hospitals
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AnkaraTurkey (Türkiye)Recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
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AnkaraTurkey (Türkiye)Recruiting
Memorial Antalya Hospital
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AntalyaTurkey (Türkiye)Recruiting
Yeditepe Üniversitesi Koşuyolu Hastanesi
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IstanbulTurkey (Türkiye)Recruiting
Ege Universitesi Hastanesi
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IzmirTurkey (Türkiye)Recruiting
Kocaeli Üniversitesi
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İzmitTurkey (Türkiye)Recruiting
VM Medical Park Mersin Hastanesi
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MersinTurkey (Türkiye)Recruiting
Ondokuz Mayıs Universitesi
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SamsunTurkey (Türkiye)Recruiting

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