Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating MutationsPhase 3NCT03250338
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
A Phase 3 study testing Crenolanib, Cytarabine and Mitoxantrone in people with Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations, run by Arog Pharmaceuticals, Inc. at 62 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
- What is being tested?
- Crenolanib, Cytarabine and Mitoxantrone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 62 sitesin 6 countries
- Study dates
- 16 Aug 2018to 3 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
62 sites in 6 countries.
62 sites in 6 countries
Italy19 sites
AOU Policlinico Sant'Orsola-Malpighi
Bologna, 40138
ASST Spedali Civili di Brescia
Brescia, 25123
AOU Careggi
Florence, 50134
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
IRCCS San Raffaele Hospital
Milan, 20132
IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico
Milan, 20122
Istituto Europeo di Oncologia
Milan, 20141
Aorn Antonio Cardarelli
Naples, 80131
AOU Federico II
Naples, 80131
AOU Maggiore della Carità
Novara, 28100
AO Ospedali Riuniti Villa Sofia-Cervello
Palermo
AO Ospedali Riuniti Marche Nord
Pesaro, 61122
Ospedale Santa Maria delle Croci di Ravenna
Ravenna, 48121
Policlinico Tor Vergata
Roma, RM, 00133
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126
AO Ordine Mauriziano di Torino
Torino, 10128
Policlinico GB Rossi, University Hospital Verona
Verona, 37134
AULSS n 8 Berica Ospedale San Bortolo
Vicenza, 36100
Spain15 sites
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006
San Pedro de Alcantara Hospital
Cáceres, 10003
Reina Sofia University Hospital
Córdoba, 14004
Hospital Universitario de Donostia
Donostia / San Sebastian, 20014
Hospital Ramon y Cajal
Madrid, 28034
Fundacion Jimenez Diaz
Madrid, 28040
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia
Madrid
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, 33011
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Hospital U. Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706
Hospital U. Virgen del Rocio
Seville, Andalusia, 41013
Hospital Universitario y Politecnico La Fe
Valencia, 46026
France12 sites
Hospital Avicenne
Bobigny, 93000
CHU Grenoble Alpes
Grenoble, 38043
Hospital Center of Versailles (Le Chesnay)
Le Chesnay, 78157
Hospital Claude Huriez - Chru Lille
Lille, 59037
Institut Paoli-Calmettes
Marseille, 13009
CHU de Nantes - Hôtel Dieu
Nantes, 44093
University Hospital Nice L'Archet
Nice, 06200
Hôpital St Louis
Paris, 75010
CHU de Bordeaux
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69494
CHU de Poitiers
Poitiers, 86021
Institut Universitaire du Cancer Toulouse
Toulouse, 31059
United States9 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Chicago
Chicago, Illinois, 60637
Karmanos Cancer Center
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
University of Florida
Gainesville, Florida, 32610
Kansas University
Kansas City, Kansas, 666160
City of Hope National Medical Center
Sacramento, California, 95817
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27104
Germany6 sites
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Technische Universität Dresden
Dresden
Universitätsklinikum Essen (AöR)
Essen, 45147
Universitätsklinikum Frankfurt
Frankfurt
Universitätsklinikum Halle (Saale)
Halle
Universitätsklinikum Münster
Münster, 48149
About this study
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
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.
- Being tested
- Crenolanib, Cytarabine, Mitoxantrone, Placebo Oral Tablet, Fludarabine
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrenolanibDrug
Also called Crenolanib besylate
Crenolanib will be administered orally
CytarabineDrug
HAM regimen
FLAG-Ida
MitoxantroneDrug
HAM regimen
Placebo Oral TabletDrug
Placebo will be administered orally
FludarabineDrug
FLAG-Ida regimen
IdarubicinDrug
FLAG-Ida regimen
G-CSFDrug
FLAG-Ida regimen
| Study group | Role | What they receive |
|---|---|---|
| Crenolanib | Experimental | Crenolanib following salvage chemotherapy Receives: Drug: Crenolanib; Drug: Cytarabine; Drug: Mitoxantrone; Drug: Fludarabine; Drug: Idarubicin; Drug: G-CSF |
| Placebo | Placebo comparator | Placebo following salvage chemotherapy Receives: Drug: Cytarabine; Drug: Mitoxantrone; Drug: Placebo Oral Tablet; Drug: Fludarabine; Drug: Idarubicin; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
Measured: 3 years
Secondary outcomes (4)
Overall Survival
Measured: 3 years
Relapse-free Survival (RFS)
Measured: 3 years
Complete remission rate (CR)
Measured: 3 years
MRD negative complete remission rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start16 Aug 2018
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating MutationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arog Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eunice Wang, MD, Principal investigator, Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250338
- Sponsor's protocol ID
- ARO-013
- Other IDs
- 2017-001600-29, 2017
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2017
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03250338
- Acronym / sponsor ID
- ARO-013
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Arog Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crenolanib | Experimental | Drug: Crenolanib, Drug: Cytarabine, Drug: Mitoxantrone, Drug: Fludarabine, Drug: Idarubicin, Drug: G-CSFCrenolanib following salvage chemotherapy |
| Placebo | Placebo comparator | Drug: Cytarabine, Drug: Mitoxantrone, Drug: Placebo Oral Tablet, Drug: Fludarabine, Drug: Idarubicin, Drug: G-CSFPlacebo following salvage chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrenolanibAlso: Crenolanib besylateCrenolanib will be administered orally | Drug | Crenolanib |
| CytarabineHAM regimen FLAG-Ida | Drug | Crenolanib, Placebo |
| MitoxantroneHAM regimen | Drug | Crenolanib, Placebo |
| Placebo Oral TabletPlacebo will be administered orally | Drug | Placebo |
| FludarabineFLAG-Ida regimen | Drug | Crenolanib, Placebo |
| IdarubicinFLAG-Ida regimen | Drug | Crenolanib, Placebo |
| G-CSFFLAG-Ida regimen | Drug | Crenolanib, Placebo |
Primary outcome
Event-free survival (EFS)
Time frame: 3 years
4 secondary outcomes
Overall Survival
Time frame: 3 years
Relapse-free Survival (RFS)
Time frame: 3 years
Complete remission rate (CR)
Time frame: 3 years
MRD negative complete remission rate
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunice Wang, MD principal investigator
Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
62 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crenolanib, Cytarabine and Mitoxantrone in people with Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations, run by Arog Pharmaceuticals, Inc. at 62 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Italy, Spain, France, United States, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.