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NCT06104566RecruitingPhase 3

Global Trial in APG2575 for Patients With CLL/SLL

A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA Study)

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
400 (estimated)
First submitted
23 Oct 2023
Start date
20 Dec 2023
Primary completion date
31 Dec 2026
Lead sponsor
Ascentage Pharma Group Inc.
NCT number
NCT06104566
EU CT number
2023-508005-24-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 400
  • From 20 Dec 2023 to the primary completion date, 31 Dec 2026
  • 143 sites in 20 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.

Who the study is looking for

  • Age ≥ 18 years.
  • Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months
  • ECOG Performance Status grade 0-2
  • Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:
    • Absolute neutrophil count ≥ 1.0 × 109/L
    • Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia
    • Total hemoglobin ≥ 9 g/dL,
  • Adequate renal function
    • Creatinine clearance must be \> 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method.
    • For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is \> 50 ml/min.
  • Adequate liver function as indicated by:
    • Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome
    • Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value
    • Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value,
    • International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN.
  • Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (143)

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

SiteCityCountrySite status
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GosfordAustraliaCompleted
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PerthAustraliaCompleted
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WestmeadAustraliaCompleted
Antwerp University Hospital
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EdegemBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Chu Helora
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La LouvièreBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Clinique Saint Pierre
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Ottignies-Louvain-la-NeuveBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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YvoirBelgiumRecruiting
Dr. Pencho Georgiev Ambulatory For Individual Practice For Medical Aid For Clinical Hematology EOOD
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PlovdivBulgariaRecruiting
Medical Center Pulmovision Ltd.
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SofiaBulgariaRecruiting
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
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SofiaBulgariaRecruiting
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
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SofiyaBulgariaRecruiting
Acibadem City Clinic Tokuda University Hospital EAD
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SofiyaBulgariaRecruiting
Umbal - Prof. D-R Stoyan Kirkovich AD
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Stara ZagoraBulgariaRecruiting
MBAL Sveta Marina EAD
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VarnaBulgariaRecruiting
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HalifaxCanadaRecruiting
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BeijingChinaRecruiting
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BinzhouChinaRecruiting
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ChenzhouChinaRecruiting
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FoshanChinaRecruiting
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FuzhouChinaRecruiting
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GuangzhouChinaRecruiting
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HefeiChinaRecruiting
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LuzhouChinaRecruiting
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NanchangChinaRecruiting
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NanjingChinaRecruiting
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NanningChinaRecruiting
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SuzhouChinaRecruiting
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TaiyuanChinaRecruiting
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WuhanChinaRecruiting
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WuxiChinaRecruiting
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Xi'anChinaRecruiting
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YibinChinaRecruiting
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ZhengzhouChinaRecruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaRecruiting
Gemeinschaftspraxis Haematologie Onkologie
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DresdenGermanyRecruiting
Onkozentrum Dresden Freiberg Meissen
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DresdenGermanyRecruiting
Klinische Forschung Karlsruhe GmbH
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KarlsruheGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Sana Klinikum Offenbach GmbH
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Offenbach Am MainGermanyRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario de la Princesa
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MadridSpainRecruiting
University Hospital Son Espases
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PalmaSpainRecruiting
Hospital Son Llatzer
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PalmaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Hospital Arnau de Vilanova de Valencia
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ValenciaSpainRecruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceRecruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
L'Hopital Prive Du Confluent
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Nantes Cedex 2FranceRecruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceRecruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceRecruiting
Centre Hospitalier Universitaire D Orleans
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Orleans Cedex 2FranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Hôpital NOVO
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PontoiseFranceRecruiting
Groupe Hospitalier Saint Vincent
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StrasbourgFranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceRecruiting
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BirminghamUnited KingdomRecruiting
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BournemouthUnited KingdomRecruiting
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LiverpoolUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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ManchesterUnited KingdomRecruiting
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Stoke-on-TrentUnited KingdomRecruiting
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SwanseaUnited KingdomRecruiting
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West BromwichUnited KingdomRecruiting
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WolverhamptonUnited KingdomRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryRecruiting
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HaifaIsraelRecruiting
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JerusalemIsraelRecruiting
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Kfar SabaIsraelRecruiting
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Tel AvivIsraelRecruiting
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BangaloreIndiaRecruiting
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DelhiIndiaRecruiting
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GandhinagarIndiaRecruiting
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GurugramamIndiaRecruiting
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HyderabadIndiaRecruiting
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JhajjarIndiaRecruiting
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KolkataIndiaRecruiting
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MaduraiIndiaRecruiting
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MysuruIndiaRecruiting
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Navi MumbaiIndiaRecruiting
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New DelhiIndiaRecruiting
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PuducherryIndiaRecruiting
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PuneIndiaRecruiting
Centro di Riferimento Oncologico di Aviano
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AvianoItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
University Hospital Of Ferrara
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FerraraItalyRecruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyRecruiting
Ospedale Vito Fazzi Lecce
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LecceItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyRecruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedale Universita Padova
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PadovaItalyRecruiting
Hospital Santa Maria Della Misericordia
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PerugiaItalyRecruiting
Azienda Unita Sanitaria Locale Di Piacenza
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PiacenzaItalyRecruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyRecruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyRecruiting
Azienda Unita Sanitaria Locale Della Romagna
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RiminiItalyRecruiting
Università Campus Bio-Medico di Roma
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
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VareseItalyRecruiting
In- Vivo Sp. z o. o.
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BydgoszczPolandRecruiting
Pratia S.A.
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CracowPolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Aidport sp z o.o.
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SkorzewoPolandRecruiting
Institutul Clinic Fundeni
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BucharestRomaniaRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaRecruiting
Spitalul Clinic Municipal De Urgenta Timisoara
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TimisoaraRomaniaRecruiting
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KalugaRussiaActive, not recruiting
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Kazan'RussiaActive, not recruiting
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KirovRussiaActive, not recruiting
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MoscowRussiaActive, not recruiting
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PetrozavodskRussiaActive, not recruiting
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Saint PetersburgRussiaActive, not recruiting
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SochiRussiaActive, not recruiting
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SyktyvkarRussiaActive, not recruiting
National Oncology Institute
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BratislavaSlovakiaRecruiting
Univerzitna nemocnica Martin
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MartinSlovakiaRecruiting
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AnaheimUnited StatesRecruiting
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Ann ArborUnited StatesRecruiting
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BostonUnited StatesRecruiting
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GreenvilleUnited StatesRecruiting
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HoustonUnited StatesRecruiting
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JacksonvilleUnited StatesRecruiting
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KingswoodUnited StatesRecruiting
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Miami BeachUnited StatesRecruiting
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PeoriaUnited StatesRecruiting
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RichmondUnited StatesRecruiting
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TusconUnited StatesRecruiting
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KepezTurkey (Türkiye)Recruiting
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TrabzonTurkey (Türkiye)Recruiting

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