New drug aims to keep AML away after transplant
NCT ID NCT05429632
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether mocravimod, taken as a pill, can prevent acute myeloid leukemia (AML) from returning after a stem cell transplant. About 366 adults with high-risk AML will receive either mocravimod or a placebo for up to two years. The main goal is to see if the drug improves relapse-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mocravimod
- What this could lead to
- If it works, mocravimod could help prevent AML from coming back after a stem cell transplant, improving long-term survival.
- What could go wrong
- This is still an experimental drug. Even in this large Phase 3 trial, it may not work better than placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 366 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and related precursor neoplasm, including AML with myelodysplasia-related gene mutations * European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \[CRi\] is also allowable * Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using PBSC graft * Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5 * Planned use of TAC-based GvHD prophylaxis * age ≥ 18 years and ≤ 75 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis * Diagnosis of macular edema during screening * Cardiac/pulmonary/hepatic/renal dysfunction * Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN); or total bilirubin \> 1.5 mg/dL * Renal dysfunction with estimated creatinine clearance \< 45 mL/min by the Cockcroft-Gault formula * Diabetes mellitus * History or presence of uveitis at screening * History or diagnosis of macular edema
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
68 sites in 14 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anjo-kosei Hospital
WITHDRAWNAnjo-shi, Aichi-ken, 446-8602, Japan
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Apteka NSSU
WITHDRAWNKrakow, 31-501, Poland
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Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
WITHDRAWNAlessandria, 15121, Italy
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Azienda Ospedaliera Ospedali Riuniti Marche Nord
RECRUITINGPesaro, 61122, Italy
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Azienda Ospedaliera San Gerardo - Monza
RECRUITINGMonza, 20900, Italy
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Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
ACTIVE_NOT_RECRUITINGAscoli Piceno, 63100, Italy
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Azienda Sanitaria Localedella provincia di Brindisi -
WITHDRAWNBrindisi, Brindisi, 72100, Italy
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Banner MD Anderson Cancer Center
WITHDRAWNGilbert, Arizona, 85234-2165, United States
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Baylor Charles A. Sammons Cancer Center
RECRUITINGDallas, Texas, 75246, United States
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CEPON - Centro de Pesquisas Oncologicas
WITHDRAWNFlorianópolis, Santa Catarina, 88034-000, Brazil
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CHRU Nancy Hopitaux de Brabois
RECRUITINGNancy, France
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CHU de Nantes - Hôtel Dieu
ACTIVE_NOT_RECRUITINGNantes, France
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Centralny Szpital Kliniczny Apteka Szpitalna
RECRUITINGWarsaw, 02-097, Poland
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Centre Hospitalier Lyon-Sud
RECRUITINGLyon, 69495, France
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Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -
ACTIVE_NOT_RECRUITINGLille, France
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Centre Hospitalier Universitaire (CHU) Angers
RECRUITINGAngers, France
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Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-Roussy
RECRUITINGVillejuif, France
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Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC
RECRUITINGBuenos Aires, Argentina
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Changhua Christian Hospital
WITHDRAWNChanghua, 500, Taiwan
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City of Hope Comprehensive Cancer Center - Duarte
RECRUITINGDuarte, California, 91010, United States
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Ehime Prefectural Centeral Hospital, Ehime
WITHDRAWNMatsuyama, 790-0024, Japan
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Emory University - Winship Cancer Institute (WCI)
RECRUITINGAtlanta, Georgia, 30322-1013, United States
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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
RECRUITINGMilan, Italy
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Fondazione IRCCS Policlinico San Matteo
RECRUITINGPavia, 27100, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITINGRoma, Roma, 00168, Italy
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Grande Ospedale Metropolitano Bianchi Melacrino Morelli
RECRUITINGReggio Calabria, Calabria, 89133, Italy
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Hadassah Medical Center
RECRUITINGJerusalem, Israel
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Henry Ford Cancer Institute
RECRUITINGDetroit, Michigan, 48202-2610, United States
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Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
ACTIVE_NOT_RECRUITINGHiroshima, 730-8619, Japan
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Hokkaido University Hospital
RECRUITINGSapporo, 060-8648, Japan
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Hospital Alemao Oswaldo Cruz (HAOC)
RECRUITINGSão Paulo, 01327-001, Brazil
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Hospital Amaral Carvalho
RECRUITINGSão Paulo, 17210-080, Brazil
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Hospital Clinico Universitario - Universidad de Salamanca
RECRUITINGSalamanca, Spain
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Hospital De La Princesa
WITHDRAWNMadrid, Spain
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Hospital El Cruce - Dr. Nestor Kirchner
RECRUITINGBuenos Aires, B1884LAD, Argentina
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Hospital Erasto Gaertner
RECRUITINGCuricica, 81520-060, Brazil
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Hospital Israelita Albert Einstein
ACTIVE_NOT_RECRUITINGSão Paulo, 05652-900, Brazil
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Hospital Italiano La Plata
RECRUITINGLa Plata, 1900, Argentina
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Hospital Saint Antoine
RECRUITINGParis, France
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Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitari i Politecnic La Fe
RECRUITINGValencia, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, Spain
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Hospital Universitario Ramon y Cajal
RECRUITINGMadrid, Spain
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Hospital Universitario Virgen de las Nieves
RECRUITINGGranada, Spain
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Hospital Universitario de Gran Canaria ""
RECRUITINGLas Palmas de Gran Canaria, Spain
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Hôpital Saint Louis
ACTIVE_NOT_RECRUITINGParis, France
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Imperial College, London
ACTIVE_NOT_RECRUITINGLondon, United Kingdom
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Institut Catala d'Oncologia (ICO)
RECRUITINGBarcelona, 8908, Spain
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Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
WITHDRAWNBarcelona, 8916, Spain
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Institut Universitaire du Cancer de Toulouse Oncopole
ACTIVE_NOT_RECRUITINGToulouse, 31059, France
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Institutul Clinic Fundeni
RECRUITINGBucharest, 022328, Romania
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Institutul Regional de Oncologie Iasi, - Haematology Department
WITHDRAWNIași, 700483, Romania
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Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
ACTIVE_NOT_RECRUITINGSan Giovanni Rotondo, Foggia, 71013, Italy
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Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)
RECRUITINGNagoya, Aichi-ken, 466-8550, Japan
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Jichi Medical University (JMU) Hospital
WITHDRAWNShimotsuke-shi, Tochigi, 329-0498, Japan
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Jichi Medical University Saitama Medical Center
WITHDRAWNSaitama, Saitama, 330-8503, Japan
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Kanazawa University Hospital
WITHDRAWNKanazawa, Ishikawa-ken, 920-8541, Japan
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Kobe City Medical Center General Hospital
ACTIVE_NOT_RECRUITINGKobe, 650-0047, Japan
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Kyoto University Hospital
ACTIVE_NOT_RECRUITINGKōtoku, 606-8507, Japan
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Kyushu University Hospital,
RECRUITINGFukuoka, 812-8582, Japan
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LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen
ACTIVE_NOT_RECRUITINGMunich, 81377, Germany
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Manchester Royal Infirmary;Manchester University
RECRUITINGManchester, M139WL, United Kingdom
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Massachusetts General Hospital
WITHDRAWNBoston, Massachusetts, 02114, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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National Cheng-Kung University Hospital
WITHDRAWNTainan, 70403, Taiwan
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National Taiwan University Cancer Center
RECRUITINGTaipei, 106, Taiwan
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National Taiwan University Hospital (NTUH)
RECRUITINGTaipei, 10002, Taiwan
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Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care
RECRUITINGNewcastle upon Tyne, NE7 7DN, United Kingdom
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Nottingham University Hospitals NHS Trust
ACTIVE_NOT_RECRUITINGNottingham, NG5 1PB, United Kingdom
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Ochsner Medical Center (OMC) - New Orleans
WITHDRAWNNew Orleans, Louisiana, 70121, United States
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Oita University (OU) Hospital
WITHDRAWNYufu, 875593, Japan
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Okayama University Hospital
ACTIVE_NOT_RECRUITINGOkayama, 700-8558, Japan
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Oregon Health & Science University (OHSU) - Knight Cancer Institute
RECRUITINGPortland, Oregon, 97239-3098, United States
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Osaka Metropolitan University Hospital
RECRUITINGOsaka, Osaka, 545-8589, Japan
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Ospedale Vito Fazzi Lecce
RECRUITINGLecce, Lecce, 73100, Italy
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Oxford University Hospitals
RECRUITINGOxford, United Kingdom
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Queen Elizabeth Hospital
RECRUITINGBirmingham, B152TH, United Kingdom
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Queen Elizabeth University Hospital
RECRUITINGGlasgow, G514TF, United Kingdom
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Rambam Health Care Campus
RECRUITINGHaifa, Israel
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Royal Hallamshire Hospital
RECRUITINGSheffield, S10 2JF, United Kingdom
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Sanatorio Allende (SA) - Nueva Cordoba
WITHDRAWNCórdoba, Argentina
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Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku
ACTIVE_NOT_RECRUITINGKatowice, Silesian Voivodeship, Silesia, Poland
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Sp Zoz Szpital Uniwersytecki W Krakowie
WITHDRAWNKrakow, Aichi-Ken, 30-688, Poland
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Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)
ACTIVE_NOT_RECRUITINGGrand Rapids, Michigan, 49503, United States
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Spitalul Clinic Coltea
WITHDRAWNBucharest, Romania
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Stony Brook University (SBU) - Cancer Center
ACTIVE_NOT_RECRUITINGStony Brook, New York, 11794-0001, United States
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Strasbourg (UIC d'onco-hématologie - Hôpital de Hautepierre)
NOT_YET_RECRUITINGStrasbourg, France
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The Chaim Sheba Medical Center
RECRUITINGTel Litwinsky, Israel
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The Ohio State University Comprehensive Cancer Center (OSUCCC)
RECRUITINGCleveland, Ohio, 44106-1716, United States
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The Tel Aviv Sourasky Medical Center
RECRUITINGTel Aviv, Israel
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Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital
ACTIVE_NOT_RECRUITINGTokyo, Japan
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UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
WITHDRAWNAurora, Colorado, 80045, United States
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Unicamp
RECRUITINGSão Paulo, 13083-878, Brazil
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Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)
RECRUITINGSão Paulo, 05403-000, Brazil
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Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO
RECRUITINGFlorence, Italy
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Universitaetsklinikum Jena - Klinik fuer Innere Medizin II
WITHDRAWNJena, 07747, Germany
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Universitaetsspital Basel
RECRUITINGBasel, Switzerland
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University College Hospital,
RECRUITINGLondon, NW1 2BU, United Kingdom
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University Hospital of Wales, Cardiff
RECRUITINGCardiff, CF14 4XW, United Kingdom
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University of Alabama Hospital (UAB Hospital)
ACTIVE_NOT_RECRUITINGBirmingham, Alabama, 35233-1932, United States
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University of California Los Angeles (UCLA) - David Geffen School of Medicine
RECRUITINGLos Angeles, California, 90095, United States
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University of Cincinnati Medical Center (University Hospital)
RECRUITINGCincinnati, Ohio, 45267, United States
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University of Iowa Hospitals and Clinics
RECRUITINGIowa City, Iowa, 52242, United States
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University of Kansas Cancer Center
RECRUITINGWestwood, Kansas, 66103, United States
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University of Leipzig Medical Center
ACTIVE_NOT_RECRUITINGLeipzig, 04103, Germany
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University of Maryland Medical Center (UMMC)
RECRUITINGBaltimore, Maryland, 21201-1544, United States
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University of Pennsylvania - Abramson Cancer Center
SUSPENDEDPhiladelphia, Pennsylvania, 19104-4206, United States
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University of Rochester Medical Center (URMC)
RECRUITINGRochester, New York, 14642, United States
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Universitätsklinikum Freiburg
RECRUITINGFreiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Universitätsklinikum Halle
RECRUITINGHalle, Germany
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Uniwersyteckie Centrum Kliniczne (UCK)
RECRUITINGGdansk, 80-952, Poland
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