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Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

Primary Purpose

Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Crenolanib
Cytarabine
Mitoxantrone
Placebo Oral Tablet
Fludarabine
Idarubicin
G-CSF
Sponsored by
Arog Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
  2. Presence of FLT3-ITD and/or D835 mutation(s)
  3. 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
  4. Age ≥ 18 years and ≤ 75 years
  5. Adequate hepatic function
  6. Adequate renal functions
  7. ECOG performance status ≤ 3

Exclusion Criteria:

  1. Known clinically active central nervous system(CNS) leukemia
  2. Severe liver disease
  3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  4. 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.
  5. Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.

Sites / Locations

  • City of Hope National Medical CenterRecruiting
  • UC Davis Comprehensive Cancer CenterRecruiting
  • University of FloridaRecruiting
  • University of ChicagoRecruiting
  • Kansas UniversityRecruiting
  • Karmanos Cancer CenterRecruiting
  • Henry Ford Health SystemRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • Wake Forest Baptist Medical CenterRecruiting
  • University of AlbertaRecruiting
  • Hospital AvicenneRecruiting
  • CHU Grenoble AlpesRecruiting
  • Hospital Center of Versailles (Le Chesnay)Recruiting
  • Hospital Claude Huriez - Chru LilleRecruiting
  • Institut Paoli-CalmettesRecruiting
  • CHU de Nantes - Hôtel DieuRecruiting
  • University Hospital Nice L'ArchetRecruiting
  • Hôpital St LouisRecruiting
  • CHU de BordeauxRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • CHU de PoitiersRecruiting
  • Institut Universitaire du Cancer ToulouseRecruiting
  • Klinikum Chemnitz gGmbHRecruiting
  • Technische Universität DresdenRecruiting
  • Universitätsklinikum Essen (AöR)Recruiting
  • Universitätsklinikum FrankfurtRecruiting
  • Universitätsklinikum Halle (Saale)Recruiting
  • Universitätsklinikum MünsterRecruiting
  • Policlinico Tor VergataRecruiting
  • AOU Policlinico Sant'Orsola-MalpighiRecruiting
  • ASST Spedali Civili di BresciaRecruiting
  • AOU CareggiRecruiting
  • IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting
  • IRCCS Foundation Ca 'Granda Ospedale Maggiore PoliclinicoRecruiting
  • Istituto Europeo di OncologiaRecruiting
  • IRCCS San Raffaele HospitalRecruiting
  • Aorn Antonio CardarelliRecruiting
  • AOU Federico IIRecruiting
  • AOU Maggiore della CaritàRecruiting
  • AO Ospedali Riuniti Villa Sofia-CervelloRecruiting
  • AO Ospedali Riuniti Marche NordRecruiting
  • Ospedale Santa Maria delle Croci di RavennaRecruiting
  • Fondazione Policlinico Universitario Agostino GemelliRecruiting
  • A.O.U. Città della Salute e della Scienza di TorinoRecruiting
  • AO Ordine Mauriziano di TorinoRecruiting
  • Policlinico GB Rossi, University Hospital VeronaRecruiting
  • AULSS n 8 Berica Ospedale San BortoloRecruiting
  • Hospital U. Virgen del RocioRecruiting
  • Hospital Universitario Central de Asturias (HUCA)Recruiting
  • Complejo Hospitalario Universitario A CorunaRecruiting
  • San Pedro de Alcantara HospitalRecruiting
  • Reina Sofia University HospitalRecruiting
  • Hospital Universitario de DonostiaRecruiting
  • Hospital Ramon y CajalRecruiting
  • Fundacion Jimenez DiazRecruiting
  • Hospital 12 de OctubreRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Gregorio Maranon Servicio de Hematologia y HemoterapiaRecruiting
  • Hospital Clinico Universitario de SalamancaRecruiting
  • Hospital U. Marques de ValdecillaRecruiting
  • Hospital Clinico Universitario de SantiagoRecruiting
  • Hospital Universitario y Politecnico La FeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Crenolanib

Placebo

Arm Description

Crenolanib following salvage chemotherapy

Placebo following salvage chemotherapy

Outcomes

Primary Outcome Measures

Event-free survival (EFS)

Secondary Outcome Measures

Overall Survival
Relapse-free Survival (RFS)
Complete remission rate (CR)
MRD negative complete remission rate

Full Information

First Posted
August 11, 2017
Last Updated
April 28, 2021
Sponsor
Arog Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03250338
Brief Title
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arog Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
322 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crenolanib
Arm Type
Experimental
Arm Description
Crenolanib following salvage chemotherapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo following salvage chemotherapy
Intervention Type
Drug
Intervention Name(s)
Crenolanib
Other Intervention Name(s)
Crenolanib besylate
Intervention Description
Crenolanib will be administered orally
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
HAM regimen FLAG-Ida
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Description
HAM regimen
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo will be administered orally
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
FLAG-Ida regimen
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Description
FLAG-Ida regimen
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Description
FLAG-Ida regimen
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Title
Relapse-free Survival (RFS)
Time Frame
3 years
Title
Complete remission rate (CR)
Time Frame
3 years
Title
MRD negative complete remission rate
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
General Contact
Phone
214-593-0500
Email
info@arogpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunice Wang, MD
Organizational Affiliation
Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope National Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chatchada Karanes, MD
Phone
626-218-2405
Email
CKaranes@coh.org
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Jonas, MD
Phone
916-734-5959
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Hsu, MD
Phone
352-273-7832
Email
jack.hsu@medicine.ufl.edu
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongtao Liu, MD
Email
hliu@medicine.bsd.uchicago.edu
Facility Name
Kansas University
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
666160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Abhyankar, MD
First Name & Middle Initial & Last Name & Degree
Sunil Abhyankar, MD
Facility Name
Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Yang, MD
Email
yangj@karmanos.org
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Guo, MD
First Name & Middle Initial & Last Name & Degree
Yue Guo, MD
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunice Wang, MD
First Name & Middle Initial & Last Name & Degree
Eunice Wang, MD
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupali Bhave, MD
Phone
336-716-5487
Email
rbhave@wakehealth.edu
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Brandwein, M.D.
Phone
780-407-7482
Email
jbrandwe@ualberta.ca
Facility Name
Hospital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten Braun, MD
Phone
+33(0)-1-48-95-75-05
Email
Thorsten.braun@aphp.fr
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Yves Cahn, MD
Email
JYCahn@chu-grenoble.fr
Facility Name
Hospital Center of Versailles (Le Chesnay)
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Rousselot, MD
Phone
+33 (0)1.39.63.86.22
Email
phrousselot@ch-versailles.fr
Facility Name
Hospital Claude Huriez - Chru Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Quesnel, MD
Phone
+33 (0)3 20 44 66 40
Email
bruno.quesnel@chru-lille.fr
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Vey, MD
Phone
+33491223754
Email
veyn@ipc.unicancer.fr
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Peterlin, MD
Phone
+33(0)2.44.76.84.45
Email
Pierre.peterlin@chu-nantes.fr
Facility Name
University Hospital Nice L'Archet
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Cluzeau
Phone
+33(0) 492 035 839
Email
cluzeau.thomas@gmail.com
Facility Name
Hôpital St Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Raffoux, MD
Phone
01 42 49 96 49
Email
emmanuel.raffoux@aphp.fr
Facility Name
CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Pigneux, MD
Phone
+ 33 5 57 65 65 11
Email
arnaud.pigneux@chu-bordeaux.fr
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69494
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Thomas, MD
Phone
+33 47886 2240
Email
xavier.thomas@chu-lyon.fr
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria-Pilar Gallego-Hernanz, MD
Phone
+33 (0)5.49.44.30.29
Email
Maria-Pilar.Gallego-Hernanz@chu-poitiers.fr
Facility Name
Institut Universitaire du Cancer Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Recher, MD
Phone
+33 0531156355
Email
Recher.christian@iuct-oncopole.fr
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathias Hänel, MD
Phone
+49 371 333 44500
Email
m.haenel@skc.de
Facility Name
Technische Universität Dresden
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Rollig, MD
Email
Christoph.Roellig@uniklinikum-dresden.de
Facility Name
Universitätsklinikum Essen (AöR)
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Noppeney, MD
Phone
+49 201 723-84706
Email
Richard.noppeney@uk-essen.de
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjorn Steffen, MD
Phone
+49 69 6301 83654
Email
steffen@em.uni-frankfurt.de
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haifa Kathrin Al-Ali, MD
Phone
+49 345 557 4909
Email
haifa.al-ali@uk-halle.de
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan-Henrik Mikesch, MD
Phone
+49 251 835 2818
Email
Jan-Henrik.Mikesch@ukmuenster.de
Facility Name
Policlinico Tor Vergata
City
Roma
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriano Venditti, MD
Phone
+39 0620903226
Email
adriano.venditti@uniroma2.it
Facility Name
AOU Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Curti, MD
Phone
+39 051 2144074
Email
antonio.curti2@unibo.it
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiara Cattaneo, MD
Phone
+39 030 3996269/6416
Email
chiara.cattaneo@asst-spedalicivili.it
Facility Name
AOU Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Bosi, MD
Phone
+39 0557947476
Email
alberto.bosi@unifi.it
Facility Name
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Mertinelli, MD
Phone
+39 0543739480
Email
giovanni.martinelli@irst.emr.it
Facility Name
IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Fracchiolla, MD
Email
nicola.fracchiolla@policlinico.mi.it
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabetta Todisco, MD
Phone
+39 0294372920
Email
elisabetta.todisco@ieo.it
Facility Name
IRCCS San Raffaele Hospital
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Ciceri, MD
Phone
+39 0226434289
Email
ciceri.fabio@hsr.it
Facility Name
Aorn Antonio Cardarelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felicetto Ferrara, MD
Phone
0039-0817472241
Email
felicetto.ferrara@aocardarelli.it
Facility Name
AOU Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Pane, MD
Phone
+39 0817462037
Email
fabrizio.pane@unina.it
Facility Name
AOU Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monia Lunghi, MD
Phone
+39 0321 3732194
Email
monia.lunghi@med.uniupo.it
Facility Name
AO Ospedali Riuniti Villa Sofia-Cervello
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Mulè
Phone
+39 339 352 9159
Email
a.mule@villasofia.it
Facility Name
AO Ospedali Riuniti Marche Nord
City
Pesaro
ZIP/Postal Code
61122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Visani, MD
Phone
+39 0721364039
Email
giuseppe.visani@ospedalimarchenord.it
Facility Name
Ospedale Santa Maria delle Croci di Ravenna
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Lanza, MD
Phone
+39 0544285752
Email
francesco.lanza@auslromagna.it
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Chiusolo, MD
Phone
+39(0)630154968
Email
patrizia.chiusolo@unicatt.it
Facility Name
A.O.U. Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano D'Ardia, MD
Phone
+39 0116335611
Email
sdardia@cittadellasalute.to.it
Facility Name
AO Ordine Mauriziano di Torino
City
Torino
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Saglio, MD
Phone
+39 0115082175
Email
giuseppe.saglio@unito.it
Facility Name
Policlinico GB Rossi, University Hospital Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianpaolo Nadali, MD
Phone
+39-(0)45-8124420
Email
gianpaolo.nadali@univr.it
Facility Name
AULSS n 8 Berica Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eros Di Bona, MD
Phone
+39-0444-753518
Email
eros.dibona@aulss8.veneto.it
Facility Name
Hospital U. Virgen del Rocio
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Antonio Perez Simon, MD
Phone
34 95 501 3273
Email
josea.perez.simon.sspa@juntadeandalucia.es
Facility Name
Hospital Universitario Central de Asturias (HUCA)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Bernal del Castillo, MD
Phone
00 34 618 75 39 04
Email
bernaldelcastillo@gmail.com
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Noriega Concepcion, MD
Phone
34 981178055
Email
victor.noriega.concepcion@sergas.es
Facility Name
San Pedro de Alcantara Hospital
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Bergua Bergues, MD
Phone
+34 927 62 15 40
Email
jmberguaburg@gmail.com
Facility Name
Reina Sofia University Hospital
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josefina Serrano Lopez, MD
Phone
+ 34 607680781
Email
josefina.serrano@iname.com
Facility Name
Hospital Universitario de Donostia
City
Donostia San Sebastian
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther P Santaolalla, MD
Phone
+34 943 00 75 72
Email
esther.perezsantaolalla@osakidetza.es
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Herrera Puente, MD
Phone
34 91 336 8967
Email
pherrera.hrc@gmail.com
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Luis Lopez, MD
Phone
+34 622284472
Email
JLLopez@quironsalud.es
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Calbacho Robles, MD
Phone
34 91 390 8652
Email
mcalbachorobles@gmail.com
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene S Vadillo, MD
Phone
+34 912071247
Email
Irene.sanchezv@gmail.com
Facility Name
Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Monsalvo, MD
Phone
+34 915868396
Email
silvia.monsalvo@salud.madrid.org
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belen Vidriales, MD
Phone
+34923291100
Ext
55375
Email
mbvidriales@saludcastillayleon.es
Facility Name
Hospital U. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercedes Colorado Araujo, MD
Phone
34 94 220 2520
Email
mcolorado@humv.es; mercedes.colorado@scsalud.es
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia A Vence, MD
Phone
+34 981950172
Email
natalia.alonso.vence@sergas.es
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pau Montesinos, MD
Phone
+34 961244000
Email
montesinos_pau@gva.es

12. IPD Sharing Statement

Learn more about this trial

Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

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