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

NCT ID: NCT03250338

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-05

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Crenolanib

Crenolanib following salvage chemotherapy

Group Type EXPERIMENTAL

Crenolanib

Intervention Type DRUG

Crenolanib will be administered orally

Cytarabine

Intervention Type DRUG

HAM regimen

FLAG-Ida

Mitoxantrone

Intervention Type DRUG

HAM regimen

Fludarabine

Intervention Type DRUG

FLAG-Ida regimen

Idarubicin

Intervention Type DRUG

FLAG-Ida regimen

G-CSF

Intervention Type DRUG

FLAG-Ida regimen

Placebo

Placebo following salvage chemotherapy

Group Type PLACEBO_COMPARATOR

Cytarabine

Intervention Type DRUG

HAM regimen

FLAG-Ida

Mitoxantrone

Intervention Type DRUG

HAM regimen

Placebo Oral Tablet

Intervention Type DRUG

Placebo will be administered orally

Fludarabine

Intervention Type DRUG

FLAG-Ida regimen

Idarubicin

Intervention Type DRUG

FLAG-Ida regimen

G-CSF

Intervention Type DRUG

FLAG-Ida regimen

Interventions

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Crenolanib

Crenolanib will be administered orally

Intervention Type DRUG

Cytarabine

HAM regimen

FLAG-Ida

Intervention Type DRUG

Mitoxantrone

HAM regimen

Intervention Type DRUG

Placebo Oral Tablet

Placebo will be administered orally

Intervention Type DRUG

Fludarabine

FLAG-Ida regimen

Intervention Type DRUG

Idarubicin

FLAG-Ida regimen

Intervention Type DRUG

G-CSF

FLAG-Ida regimen

Intervention Type DRUG

Other Intervention Names

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Crenolanib besylate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arog Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eunice Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute, Buffalo, New York, United States, 14263

Locations

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City of Hope National Medical Center

Sacramento, California, United States

Site Status RECRUITING

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Kansas University

Kansas City, Kansas, United States

Site Status RECRUITING

Karmanos Cancer Center

Detroit, Michigan, United States

Site Status RECRUITING

Henry Ford Health System

Detroit, Michigan, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

Hospital Avicenne

Bobigny, , France

Site Status RECRUITING

CHU Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

Hospital Center of Versailles (Le Chesnay)

Le Chesnay, , France

Site Status RECRUITING

Hospital Claude Huriez - Chru Lille

Lille, , France

Site Status RECRUITING

Institut Paoli-Calmettes

Marseille, , France

Site Status RECRUITING

CHU de Nantes - Hôtel Dieu

Nantes, , France

Site Status RECRUITING

University Hospital Nice L'Archet

Nice, , France

Site Status RECRUITING

Hôpital St Louis

Paris, , France

Site Status RECRUITING

CHU de Bordeaux

Pessac, , France

Site Status RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status RECRUITING

CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

Institut Universitaire du Cancer Toulouse

Toulouse, , France

Site Status RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status RECRUITING

Technische Universität Dresden

Dresden, , Germany

Site Status RECRUITING

Universitätsklinikum Essen (AöR)

Essen, , Germany

Site Status RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Site Status RECRUITING

Universitätsklinikum Halle (Saale)

Halle, , Germany

Site Status RECRUITING

Universitätsklinikum Münster

Münster, , Germany

Site Status RECRUITING

Policlinico Tor Vergata

Roma, RM, Italy

Site Status RECRUITING

AOU Policlinico Sant'Orsola-Malpighi

Bologna, , Italy

Site Status RECRUITING

ASST Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

AOU Careggi

Florence, , Italy

Site Status RECRUITING

IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

Site Status RECRUITING

IRCCS San Raffaele Hospital

Milan, , Italy

Site Status RECRUITING

IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Istituto Europeo di Oncologia

Milan, , Italy

Site Status RECRUITING

Aorn Antonio Cardarelli

Napoli, , Italy

Site Status RECRUITING

AOU Federico II

Napoli, , Italy

Site Status RECRUITING

AOU Maggiore della Carità

Novara, , Italy

Site Status RECRUITING

AO Ospedali Riuniti Villa Sofia-Cervello

Palermo, , Italy

Site Status RECRUITING

AO Ospedali Riuniti Marche Nord

Pesaro, , Italy

Site Status RECRUITING

Ospedale Santa Maria delle Croci di Ravenna

Ravenna, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli

Roma, , Italy

Site Status RECRUITING

A.O.U. Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status RECRUITING

AO Ordine Mauriziano di Torino

Torino, , Italy

Site Status RECRUITING

Policlinico GB Rossi, University Hospital Verona

Verona, , Italy

Site Status RECRUITING

AULSS n 8 Berica Ospedale San Bortolo

Vicenza, , Italy

Site Status RECRUITING

Hospital U. Virgen del Rocio

Seville, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Complejo Hospitalario Universitario A Coruna

A Coruña, , Spain

Site Status RECRUITING

San Pedro de Alcantara Hospital

Cáceres, , Spain

Site Status RECRUITING

Reina Sofia University Hospital

Córdoba, , Spain

Site Status RECRUITING

Hospital Universitario de Donostia

Donostia / San Sebastian, , Spain

Site Status RECRUITING

Hospital Ramon y Cajal

Madrid, , Spain

Site Status RECRUITING

Fundacion Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Hospital 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia

Madrid, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Site Status RECRUITING

Hospital U. Marques de Valdecilla

Santander, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Santiago

Santiago de Compostela, , Spain

Site Status RECRUITING

Hospital Universitario y Politecnico La Fe

Valencia, , Spain

Site Status RECRUITING

Countries

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United States Canada France Germany Italy Spain

Central Contacts

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General Contact

Role: CONTACT

[email protected]
214-593-0500

Facility Contacts

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Chatchada Karanes, MD

Role: primary

[email protected]
626-218-2405

Brian Jonas, MD

Role: primary

916-734-5959

Jack Hsu, MD

Role: primary

[email protected]
352-273-7832

Hongtao Liu, MD

Role: primary

[email protected]

Sunil Abhyankar, MD

Role: primary

Jay Yang, MD

Role: primary

[email protected]

Yue Guo, MD

Role: primary

Eunice Wang, MD

Role: primary

Rupali Bhave, MD

Role: primary

[email protected]
336-716-5487

Joseph Brandwein, M.D.

Role: primary

[email protected]
780-407-7482

Thorsten Braun, MD

Role: primary

[email protected]
+33(0)-1-48-95-75-05

Jean-Yves Cahn, MD

Role: primary

[email protected]

Philippe Rousselot, MD

Role: primary

[email protected]
+33 (0)1.39.63.86.22

Bruno Quesnel, MD

Role: primary

[email protected]
+33 (0)3 20 44 66 40

Norbert Vey, MD

Role: primary

[email protected]
+33491223754

Pierre Peterlin, MD

Role: primary

[email protected]
+33(0)2.44.76.84.45

Thomas Cluzeau

Role: primary

[email protected]
+33(0) 492 035 839

Emmanuel Raffoux, MD

Role: primary

[email protected]
01 42 49 96 49

Arnaud Pigneux, MD

Role: primary

Role: backup

[email protected]
+ 33 5 57 65 65 11

Xavier Thomas, MD

Role: primary

[email protected]
+33 47886 2240

Maria-Pilar Gallego-Hernanz, MD

Role: primary

[email protected]
+33 (0)5.49.44.30.29

Christian Recher, MD

Role: primary

[email protected]
+33 0531156355

Mathias Hänel, MD

Role: primary

[email protected]
+49 371 333 44500

Christoph Rollig, MD

Role: primary

[email protected]

Richard Noppeney, MD

Role: primary

[email protected]
+49 201 723-84706

Bjorn Steffen, MD

Role: primary

[email protected]
+49 69 6301 83654

Haifa Kathrin Al-Ali, MD

Role: primary

[email protected]
+49 345 557 4909

Jan-Henrik Mikesch, MD

Role: primary

[email protected]
+49 251 835 2818

Adriano Venditti, MD

Role: primary

[email protected]
+39 0620903226

Antonio Curti, MD

Role: primary

[email protected]
+39 051 2144074

Chiara Cattaneo, MD

Role: primary

[email protected]
+39 030 3996269/6416

Alberto Bosi, MD

Role: primary

[email protected]
+39 0557947476

Giovanni Mertinelli, MD

Role: primary

[email protected]
+39 0543739480

Fabio Ciceri, MD

Role: primary

[email protected]
+39 0226434289

Nicola Fracchiolla, MD

Role: primary

[email protected]

Elisabetta Todisco, MD

Role: primary

[email protected]
+39 0294372920

Felicetto Ferrara, MD

Role: primary

[email protected]
0039-0817472241

Fabrizio Pane, MD

Role: primary

[email protected]
+39 0817462037

Monia Lunghi, MD

Role: primary

[email protected]
+39 0321 3732194

Antonio Mulè

Role: primary

[email protected]
+39 339 352 9159

Giuseppe Visani, MD

Role: primary

[email protected]
+39 0721364039

Francesco Lanza, MD

Role: primary

[email protected]
+39 0544285752

Patrizia Chiusolo, MD

Role: primary

[email protected]
+39(0)630154968

Stefano D'Ardia, MD

Role: primary

[email protected]
+39 0116335611

Giuseppe Saglio, MD

Role: primary

[email protected]
+39 0115082175

Gianpaolo Nadali, MD

Role: primary

[email protected]
+39-(0)45-8124420

Eros Di Bona, MD

Role: primary

[email protected]
+39-0444-753518

Jose Antonio Perez Simon, MD

Role: primary

[email protected]
34 95 501 3273

Teresa Bernal del Castillo, MD

Role: primary

[email protected]
00 34 618 75 39 04

Victor Noriega Concepcion, MD

Role: primary

[email protected]
34 981178055

Juan Bergua Bergues, MD

Role: primary

[email protected]
+34 927 62 15 40

Josefina Serrano Lopez, MD

Role: primary

[email protected]
+ 34 607680781

Esther P Santaolalla, MD

Role: primary

[email protected]
+34 943 00 75 72

Pilar Herrera Puente, MD

Role: primary

[email protected]
34 91 336 8967

Jose Luis Lopez, MD

Role: primary

[email protected]
+34 622284472

Maria Calbacho Robles, MD

Role: primary

[email protected]
34 91 390 8652

Irene S Vadillo, MD

Role: primary

[email protected]
+34 912071247

Silvia Monsalvo, MD

Role: primary

[email protected]
+34 915868396

Belen Vidriales, MD

Role: primary

[email protected]
+34923291100 ext. 55375

Mercedes Colorado Araujo, MD

Role: primary

[email protected]; [email protected]
34 94 220 2520

Natalia A Vence, MD

Role: primary

[email protected]
+34 981950172

Pau Montesinos, MD

Role: primary

[email protected]
+34 961244000

Other Identifiers

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2017-001600-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARO-013

Identifier Type: -

Identifier Source: org_study_id

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