Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
April 28, 2021 updated by: Arog Pharmaceuticals, Inc.
Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia
This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
322
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: General Contact
- Phone Number: 214-593-0500
- Email: info@arogpharma.com
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2R3
- Recruiting
- University of Alberta
-
Contact:
- Joseph Brandwein, M.D.
- Phone Number: 780-407-7482
- Email: jbrandwe@ualberta.ca
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Bobigny, France, 93000
- Recruiting
- Hospital Avicenne
-
Contact:
- Thorsten Braun, MD
- Phone Number: +33(0)-1-48-95-75-05
- Email: Thorsten.braun@aphp.fr
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Grenoble, France, 38043
- Recruiting
- CHU Grenoble Alpes
-
Contact:
- Jean-Yves Cahn, MD
- Email: JYCahn@chu-grenoble.fr
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Le Chesnay, France, 78157
- Recruiting
- Hospital Center of Versailles (Le Chesnay)
-
Contact:
- Philippe Rousselot, MD
- Phone Number: +33 (0)1.39.63.86.22
- Email: phrousselot@ch-versailles.fr
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Lille, France, 59037
- Recruiting
- Hospital Claude Huriez - Chru Lille
-
Contact:
- Bruno Quesnel, MD
- Phone Number: +33 (0)3 20 44 66 40
- Email: bruno.quesnel@chru-lille.fr
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Marseille, France, 13009
- Recruiting
- Institut Paoli-Calmettes
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Contact:
- Norbert Vey, MD
- Phone Number: +33491223754
- Email: veyn@ipc.unicancer.fr
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Nantes, France, 44093
- Recruiting
- CHU de Nantes - Hotel Dieu
-
Contact:
- Pierre Peterlin, MD
- Phone Number: +33(0)2.44.76.84.45
- Email: Pierre.peterlin@chu-nantes.fr
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Nice, France, 06200
- Recruiting
- University Hospital Nice L'Archet
-
Contact:
- Thomas Cluzeau
- Phone Number: +33(0) 492 035 839
- Email: cluzeau.thomas@gmail.com
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Paris, France, 75010
- Recruiting
- Hopital St Louis
-
Contact:
- Emmanuel Raffoux, MD
- Phone Number: 01 42 49 96 49
- Email: emmanuel.raffoux@aphp.fr
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Pessac, France, 33604
- Recruiting
- CHU de Bordeaux
-
Contact:
- Arnaud Pigneux, MD
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Contact:
- Phone Number: + 33 5 57 65 65 11
- Email: arnaud.pigneux@chu-bordeaux.fr
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Pierre-Bénite, France, 69494
- Recruiting
- Centre Hospitalier Lyon Sud
-
Contact:
- Xavier Thomas, MD
- Phone Number: +33 47886 2240
- Email: xavier.thomas@chu-lyon.fr
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Poitiers, France, 86021
- Recruiting
- CHU de Poitiers
-
Contact:
- Maria-Pilar Gallego-Hernanz, MD
- Phone Number: +33 (0)5.49.44.30.29
- Email: Maria-Pilar.Gallego-Hernanz@chu-poitiers.fr
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Toulouse, France, 31059
- Recruiting
- Institut Universitaire du Cancer Toulouse
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Contact:
- Christian Recher, MD
- Phone Number: +33 0531156355
- Email: Recher.christian@iuct-oncopole.fr
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Chemnitz, Germany, 09116
- Recruiting
- Klinikum Chemnitz gGmbH
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Contact:
- Mathias Hänel, MD
- Phone Number: +49 371 333 44500
- Email: m.haenel@skc.de
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Dresden, Germany
- Recruiting
- Technische Universitat Dresden
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Contact:
- Christoph Rollig, MD
- Email: Christoph.Roellig@uniklinikum-dresden.de
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Essen, Germany, 45147
- Recruiting
- Universitatsklinikum Essen (Aor)
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Contact:
- Richard Noppeney, MD
- Phone Number: +49 201 723-84706
- Email: Richard.noppeney@uk-essen.de
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Frankfurt, Germany
- Recruiting
- Universitatsklinikum Frankfurt
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Contact:
- Bjorn Steffen, MD
- Phone Number: +49 69 6301 83654
- Email: steffen@em.uni-frankfurt.de
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Halle, Germany
- Recruiting
- Universitatsklinikum Halle (Saale)
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Contact:
- Haifa Kathrin Al-Ali, MD
- Phone Number: +49 345 557 4909
- Email: haifa.al-ali@uk-halle.de
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Münster, Germany, 48149
- Recruiting
- Universitatsklinikum Munster
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Contact:
- Jan-Henrik Mikesch, MD
- Phone Number: +49 251 835 2818
- Email: Jan-Henrik.Mikesch@ukmuenster.de
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Bologna, Italy, 40138
- Recruiting
- AOU Policlinico Sant'Orsola-Malpighi
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Contact:
- Antonio Curti, MD
- Phone Number: +39 051 2144074
- Email: antonio.curti2@unibo.it
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Brescia, Italy, 25123
- Recruiting
- ASST Spedali Civili di Brescia
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Contact:
- Chiara Cattaneo, MD
- Phone Number: +39 030 3996269/6416
- Email: chiara.cattaneo@asst-spedalicivili.it
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Firenze, Italy, 50134
- Recruiting
- AOU Careggi
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Contact:
- Alberto Bosi, MD
- Phone Number: +39 0557947476
- Email: alberto.bosi@unifi.it
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Meldola, Italy, 47014
- Recruiting
- IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Contact:
- Giovanni Mertinelli, MD
- Phone Number: +39 0543739480
- Email: giovanni.martinelli@irst.emr.it
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Milan, Italy, 20132
- Recruiting
- IRCCS San Raffaele Hospital
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Contact:
- Fabio Ciceri, MD
- Phone Number: +39 0226434289
- Email: ciceri.fabio@hsr.it
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Milano, Italy, 20141
- Recruiting
- Istituto Europeo di Oncologia
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Contact:
- Elisabetta Todisco, MD
- Phone Number: +39 0294372920
- Email: elisabetta.todisco@ieo.it
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Milano, Italy, 20122
- Recruiting
- IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico
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Contact:
- Nicola Fracchiolla, MD
- Email: nicola.fracchiolla@policlinico.mi.it
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Napoli, Italy, 80131
- Recruiting
- AOU Federico II
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Contact:
- Fabrizio Pane, MD
- Phone Number: +39 0817462037
- Email: fabrizio.pane@unina.it
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Napoli, Italy, 80131
- Recruiting
- AORN Antonio Cardarelli
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Contact:
- Felicetto Ferrara, MD
- Phone Number: 0039-0817472241
- Email: felicetto.ferrara@aocardarelli.it
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Novara, Italy, 28100
- Recruiting
- Aou Maggiore Della Carita
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Contact:
- Monia Lunghi, MD
- Phone Number: +39 0321 3732194
- Email: monia.lunghi@med.uniupo.it
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Palermo, Italy
- Recruiting
- AO Ospedali Riuniti Villa Sofia-Cervello
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Contact:
- Antonio Mulè
- Phone Number: +39 339 352 9159
- Email: a.mule@villasofia.it
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Pesaro, Italy, 61122
- Recruiting
- AO Ospedali Riuniti Marche Nord
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Contact:
- Giuseppe Visani, MD
- Phone Number: +39 0721364039
- Email: giuseppe.visani@ospedalimarchenord.it
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Ravenna, Italy, 48121
- Recruiting
- Ospedale Santa Maria delle Croci di Ravenna
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Contact:
- Francesco Lanza, MD
- Phone Number: +39 0544285752
- Email: francesco.lanza@auslromagna.it
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Roma, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli
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Contact:
- Patrizia Chiusolo, MD
- Phone Number: +39(0)630154968
- Email: patrizia.chiusolo@unicatt.it
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Torino, Italy, 10126
- Recruiting
- A.O.U. Città della Salute e della Scienza di Torino
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Contact:
- Stefano D'Ardia, MD
- Phone Number: +39 0116335611
- Email: sdardia@cittadellasalute.to.it
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Torino, Italy, 10128
- Recruiting
- AO Ordine Mauriziano di Torino
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Contact:
- Giuseppe Saglio, MD
- Phone Number: +39 0115082175
- Email: giuseppe.saglio@unito.it
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Verona, Italy, 37134
- Recruiting
- Policlinico GB Rossi, University Hospital Verona
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Contact:
- Gianpaolo Nadali, MD
- Phone Number: +39-(0)45-8124420
- Email: gianpaolo.nadali@univr.it
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Vicenza, Italy, 36100
- Recruiting
- AULSS n 8 Berica Ospedale San Bortolo
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Contact:
- Eros Di Bona, MD
- Phone Number: +39-0444-753518
- Email: eros.dibona@aulss8.veneto.it
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RM
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Roma, RM, Italy, 00133
- Recruiting
- Policlinico Tor Vergata
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Contact:
- Adriano Venditti, MD
- Phone Number: +39 0620903226
- Email: adriano.venditti@uniroma2.it
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A Coruña, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario A Coruña
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Contact:
- Victor Noriega Concepcion, MD
- Phone Number: 34 981178055
- Email: victor.noriega.concepcion@sergas.es
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Cáceres, Spain, 10003
- Recruiting
- San Pedro de Alcántara Hospital
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Contact:
- Juan Bergua Bergues, MD
- Phone Number: +34 927 62 15 40
- Email: jmberguaburg@gmail.com
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Córdoba, Spain, 14004
- Recruiting
- Reina Sofia University Hospital
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Contact:
- Josefina Serrano Lopez, MD
- Phone Number: + 34 607680781
- Email: josefina.serrano@iname.com
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Donostia San Sebastian, Spain, 20014
- Recruiting
- Hospital Universitario de Donostia
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Contact:
- Esther P Santaolalla, MD
- Phone Number: +34 943 00 75 72
- Email: esther.perezsantaolalla@osakidetza.es
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Madrid, Spain, 28041
- Recruiting
- Hospital 12 de Octubre
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Contact:
- Maria Calbacho Robles, MD
- Phone Number: 34 91 390 8652
- Email: mcalbachorobles@gmail.com
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Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
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Contact:
- Irene S Vadillo, MD
- Phone Number: +34 912071247
- Email: Irene.sanchezv@gmail.com
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Madrid, Spain, 28034
- Recruiting
- Hospital Ramon y Cajal
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Contact:
- Pilar Herrera Puente, MD
- Phone Number: 34 91 336 8967
- Email: pherrera.hrc@gmail.com
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Madrid, Spain, 28040
- Recruiting
- Fundacion Jimenez Diaz
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Contact:
- Jose Luis Lopez, MD
- Phone Number: +34 622284472
- Email: JLLopez@quironsalud.es
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Madrid, Spain
- Recruiting
- Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia
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Contact:
- Silvia Monsalvo, MD
- Phone Number: +34 915868396
- Email: silvia.monsalvo@salud.madrid.org
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Salamanca, Spain, 37007
- Recruiting
- Hospital Clínico Universitario de Salamanca
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Contact:
- Belen Vidriales, MD
- Phone Number: 55375 +34923291100
- Email: mbvidriales@saludcastillayleon.es
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Santander, Spain, 39008
- Recruiting
- Hospital U. Marques de Valdecilla
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Contact:
- Mercedes Colorado Araujo, MD
- Phone Number: 34 94 220 2520
- Email: mcolorado@humv.es; mercedes.colorado@scsalud.es
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Santiago De Compostela, Spain, 15706
- Recruiting
- Hospital Clinico Universitario de Santiago
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Contact:
- Natalia A Vence, MD
- Phone Number: +34 981950172
- Email: natalia.alonso.vence@sergas.es
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Valencia, Spain, 46026
- Recruiting
- Hospital Universitario y Politécnico La Fe
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Contact:
- Pau Montesinos, MD
- Phone Number: +34 961244000
- Email: montesinos_pau@gva.es
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Andalucia
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Sevilla, Andalucia, Spain, 41013
- Recruiting
- Hospital U. Virgen del Rocio
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Contact:
- Jose Antonio Perez Simon, MD
- Phone Number: 34 95 501 3273
- Email: josea.perez.simon.sspa@juntadeandalucia.es
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Asturias
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Oviedo, Asturias, Spain, 33011
- Recruiting
- Hospital Universitario Central de Asturias (HUCA)
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Contact:
- Teresa Bernal del Castillo, MD
- Phone Number: 00 34 618 75 39 04
- Email: bernaldelcastillo@gmail.com
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California
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Sacramento, California, United States, 95817
- Recruiting
- UC Davis Comprehensive Cancer Center
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Contact:
- Brian Jonas, MD
- Phone Number: 916-734-5959
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Sacramento, California, United States, 95817
- Recruiting
- City of Hope National Medical Center
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Contact:
- Chatchada Karanes, MD
- Phone Number: 626-218-2405
- Email: CKaranes@coh.org
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Florida
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Gainesville, Florida, United States, 32610
- Recruiting
- University of Florida
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Contact:
- Jack Hsu, MD
- Phone Number: 352-273-7832
- Email: jack.hsu@medicine.ufl.edu
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
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Contact:
- Hongtao Liu, MD
- Email: hliu@medicine.bsd.uchicago.edu
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Kansas
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Kansas City, Kansas, United States, 666160
- Recruiting
- Kansas University
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Contact:
- Sunil Abhyankar, MD
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Principal Investigator:
- Sunil Abhyankar, MD
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Michigan
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Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Health System
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Contact:
- Yue Guo, MD
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Principal Investigator:
- Yue Guo, MD
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Detroit, Michigan, United States, 48201
- Recruiting
- Karmanos Cancer Center
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Contact:
- Jay Yang, MD
- Email: yangj@karmanos.org
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New York
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Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
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Principal Investigator:
- Eunice Wang, MD
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Contact:
- Eunice Wang, MD
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North Carolina
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Winston-Salem, North Carolina, United States, 27104
- Recruiting
- Wake Forest Baptist Medical Center
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Contact:
- Rupali Bhave, MD
- Phone Number: 336-716-5487
- Email: rbhave@wakehealth.edu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
- Presence of FLT3-ITD and/or D835 mutation(s)
- Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML
- Age ≥ 18 years and ≤ 75 years
- Adequate hepatic function
- Adequate renal functions
- ECOG performance status ≤ 3
Exclusion Criteria:
- Known clinically active central nervous system(CNS) leukemia
- Severe liver disease
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed.
- Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Crenolanib
Crenolanib following salvage chemotherapy
|
Crenolanib will be administered orally
Other Names:
HAM regimen FLAG-Ida
HAM regimen
FLAG-Ida regimen
FLAG-Ida regimen
FLAG-Ida regimen
|
|
Placebo Comparator: Placebo
Placebo following salvage chemotherapy
|
HAM regimen FLAG-Ida
HAM regimen
FLAG-Ida regimen
FLAG-Ida regimen
FLAG-Ida regimen
Placebo will be administered orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Event-free survival (EFS)
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival
Time Frame: 3 years
|
3 years
|
|
Relapse-free Survival (RFS)
Time Frame: 3 years
|
3 years
|
|
Complete remission rate (CR)
Time Frame: 3 years
|
3 years
|
|
MRD negative complete remission rate
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eunice Wang, MD, Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2018
Primary Completion (Anticipated)
October 1, 2024
Study Completion (Anticipated)
October 1, 2024
Study Registration Dates
First Submitted
August 11, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (Actual)
August 15, 2017
Study Record Updates
Last Update Posted (Actual)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 28, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Fludarabine
- Cytarabine
- Idarubicin
- Mitoxantrone
- Crenolanib
Other Study ID Numbers
- ARO-013
- 2017-001600-29 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
-
Arog Pharmaceuticals, Inc.CompletedPhase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating MutationsRelapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating MutationsUnited States
-
Arog Pharmaceuticals, Inc.CompletedAcute Myeloid Leukemia With FLT3 Activating Mutations That Has Relapsed or Been Refractory After One or More Prior TherapiesUnited States
-
Arog Pharmaceuticals, Inc.CompletedNewly Diagnosed AML With FLT3 Activating MutationsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)TerminatedSecondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Acute Myeloid Leukemia With FLT3/ITD Mutation | Acute Myeloid Leukemia With Gene Mutations | FLT3 Tyrosine Kinase Domain Point MutationUnited States
-
French Innovative Leukemia OrganisationAcute Leukemia French AssociationRecruitingAML, Adult | Relapsed Adult AML | Refractory AML | FLT3-TKD Mutation | FLT3-ITDFrance
-
French Innovative Leukemia OrganisationAcute Leukemia French AssociationCompletedRelapsed Adult AML | Refractory AML | FLT3-TKD Mutation | FLT3-ITDFrance
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.RecruitingFLT3-positive Relapsed/Refractory Acute Myeloid LeukemiaChina
-
Arog Pharmaceuticals, Inc.WithdrawnRelapsed/Refractory FLT3-mutated AML
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Acute Myeloid Leukemia | Acute Myeloid Leukemia With FLT3/ITD Mutation | Refractory Acute LeukemiaUnited States
-
Uma BorateRecruitingRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia With FLT3/ITD Mutation | Acute Myeloid Leukemia With KMT2A Rearrangement | Acute Myeloid Leukemia With NPM1 MutationUnited States
Clinical Trials on Crenolanib
-
Arog Pharmaceuticals, Inc.Terminated
-
Arog Pharmaceuticals, Inc.CompletedAcute Myeloid Leukemia With FLT3 Activating Mutations That Has Relapsed or Been Refractory After One or More Prior TherapiesUnited States
-
Arog Pharmaceuticals, Inc.CompletedRecurrent/Refractory GlioblastomaUnited States
-
Arog Pharmaceuticals, Inc.AvailableFLT3-ITD Mutation | FLT3/TKD Mutation | PDGFR-Alpha D842V | PDGFRA Gene AmplificationItaly
-
Arog Pharmaceuticals, Inc.Centre Leon Berard; Fox Chase Cancer CenterUnknownGIST With D842V Mutated PDGFRA GeneUnited States, France, Spain, Italy, Germany, Norway, Poland
-
Arog Pharmaceuticals, Inc.CompletedD842-related Mutant GISTUnited States
-
Arog Pharmaceuticals, Inc.CompletedAcute Myeloid LeukemiaUnited States
-
Arog Pharmaceuticals, Inc.CompletedPhase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating MutationsRelapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating MutationsUnited States
-
St. Jude Children's Research HospitalArog Pharmaceuticals, Inc.; The V Foundation for Cancer ResearchCompletedDiffuse Intrinsic Pontine Glioma | Progressive or Refractory High-Grade GliomaUnited States
-
Arog Pharmaceuticals, Inc.WithdrawnRelapsed/Refractory FLT3-mutated AML