What is AML?

Acute myeloid leukemia (AML) is an aggressive and highly proliferative form of cancer where the bone marrow makes abnormal myeloblasts (a type of white blood cell). AML is the most common form of leukemia in adults and progresses quickly if left untreated.

With the widespread use of genetic testing in AML, a number of targeted therapies have been approved in the past few years and transformed AML into an active development space. While these recent approvals demonstrate the enthusiasm for targeted therapies, significant opportunity remains for improving patient outcomes.

AROG Pharmaceuticals

FLT3 Summary

AML is a highly heterogenous disease driven by multiple mutations. The most common driver mutations in AML occur in the gene FLT3 (FMS-like tyrosine kinase 3) and are found in approximately 33% of all AML patients. Chemotherapy offers limited benefits in treating cancer cells harboring FLT3 mutations.

FLT3 mutations lead to constitutive activation of the tyrosine kinase function, making FLT3 inhibition an attractive drug target in AML patients. Adding a FLT3 inhibitor to standard chemotherapy has been shown to produce longer lasting benefits compared to chemotherapy alone.

A polyclonal disease, multiple FLT3 mutations have been identified in subjects, including internal tandem duplications (ITD), mutations in the tyrosine kinase domain (TKD), and variant mutations. FLT3 mutations are generally regarded as poor prognostic markers in AML and a number of FLT3 mutations confer resistance to targeted inhibitors.

ARO-021

A Study for Combined Chemotherapy and Crenolanib in Newly Diagnosed AML

Acute Myeloid Leukemia

This is our company-sponsored, Phase III clinical trial of crenolanib in combination with induction chemotherapy for patients with newly diagnosed acute myeloid leukemia (AML) with mutations in the FLT3 gene.

The study is open at multiple centers in the United States – click below to view all locations.

State Center City
California City of Hope National Medical Center Duarte
Ronald Reagan UCLA Medical Center Los Angeles
US Davis Health Sacramento
Connecticut Yale Cancer Center New Haven
Florida Moffitt Cancer Center Tampa
Illinois Rush Medical Center Chicago
Indiana Indiana University Indianapolis
Iowa University of Iowa Hospitals and Clinics Iowa City
Kanas University of Kansas Kansas City
Massachusetts Massachusetts General Hospital Boston
Beth Israel Deaconess Medical Center Oncology Boston
Dana-Farber Cancer Institute Boston
Michigan Karmanos Cancer Institute Detroit
Henry Ford Health System Detroit
Minnesota University of Minnesota Minneapolis
New Jersey John Theurer Cancer Center at Hackensack UMC Hackensack
Rutgers Cancer Institute of New Jersey New Brunswick
New York
Roswell Park Buffalo
Mount Sinai New York
Columbia University New York
Cornell University New York
Memorial Sloan-Kettering Cancer Center New York
University of Rochester Medical Center New York
North Carolina The UNC Lineberger Comprehensive Cancer Center Chapel Hill
Wake Forest Baptist Health Winston-Salem
Oregon Oregon Health and Science University Portland
Virginia University of Virginia Health System Charlottesville

For more information about the study, please contact a study site by visiting HERE

ARO-013

A Study for Combined Chemotherapy and Crenolanib in Relapsed/Refractory AML

Acute Myeloid Leukemia

This is our company-sponsored, Phase III clinical trial of crenolanib in combination with salvage chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) with mutations in the FLT3 gene.

This study aims to find out how safe and effective this treatment is, compared with placebo, in this type of cancer.

The study is open at multiple centers in the United States and Europe as indicated below, and is planned to open in multiple centers in China.

State Center City
California City of Hope National Medical Center Sacramento
UC Davis Comprehensive Cancer Center Sacramento
Florida University of Florida Gainesville
Illinois University of Chicago Chicago
Kansas Kansas University Kansas City
Michigan Karmanos Cancer Center Detroit
Henry Ford Health System Detroit
New York Roswell Park Cancer Institute Buffalo
North Carolina Wake Forest Baptist Medical Center Winston-Salem
Country Center City
France Hospital Avicenne Bobigny
CHU Grenoble Alpes Grenoble
Hospital Center of Versailles (Le Chesnay) Le Chesnay
Hospital Claude Huriez – Chru Lille Lille
Institut Paoli-Calmettes Marseille
CHU de Nantes – Hôtel Dieu Nantes
University Hospital Nice L’Archet Nice
Hôpital St Louis Paris
CHU de Bordeaux Pessac
Centre Hospitalier Lyon Sud Pierre-Bénite
CHU de Poitiers Poitiers
Institut Universitaire du Cancer Toulouse Toulouse
Germany Klinikum Chemnitz gGmbH Chemnitz
Technische Universität Dresden Dresden
Universitätsklinikum Essen (AöR) Essen
Universitätsklinikum Frankfurt Frankfurt
Universitätsklinikum Halle (Saale) Halle
Universitätsklinikum Münster Münster
Italy Policlinico Tor Vergata Roma
AOU Policlinico Sant’Orsola-Malpighi Bologna
ASST Spedali Civili di Brescia Brescia
AOU Careggi Firenze
IRST – Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola
IRCCS Foundation Ca ‘Granda Ospedale Maggiore Policlinico Milano
Istituto Europeo di Oncologia Milano
IRCCS San Raffaele Hospital Milan
Aorn Antonio Cardarelli Napoli
AOU Federico II Napoli
AOU Maggiore della Carità Novara
AO Ospedali Riuniti Marche Nord Pesaro
Ospedale Santa Maria delle Croci di Ravenna Ravenna
Fondazione Policlinico Universitario Agostino Gemelli Roma
A.O.U. Città della Salute e della Scienza di Torino Torino
AO Ordine Mauriziano di Torino Torino
Policlinico GB Rossi, University Hospital Verona Verona
Spain Hospital U. Virgen del Rocio Sevilla
Hospital Universitario Central de Asturias (HUCA) Oviedo
Complejo Hospitalario Universitario A Coruna A Coruña
San Pedro de Alcantara Hospital Cáceres
Reina Sofia University Hospital Córdoba
Hospital Universitario de Donostia Donostia San Sebastian
Hospital Ramon y Cajal Madrid
Fundacion Jimenez Diaz Madrid
Hospital 12 de Octubre Madrid
Hospital Universitario La Paz Madrid
Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia Madrid
Hospital Clinico Universitario de Salamanca Salamanca
Hospital Clinico Universitario de Santiago Santiago De Compostela
China The First Affiliated Hospital of Soochow University Soochow
Fujian Medical University Union Hospital Fuzhou
Xinqiao Hospital of Army Medical University Chongqing
Qilu Hospital of Shandong University Jinan
The First Affiliated Hospital of Zhengzhou University Zhengzhou
The Second Hospital of Hebei Medical University Shijiazhuang
The Affiliated Hospital of Xuzhou Medical University Xuzhou
West China Hospital of Sichuan University Chengdu
Shengjing Hospital of China Medical University Shenyang
Zhujiang Hospital of Southern Medical University Guangzhou
Zhongda Hospital Southeast University Nanjing
The First Affiliated Hospital of Xi’an Jiaotong University Xi’an
The Second Affiliated Hospital of Xi’an Jiaotong University Xi’an
Xijing Hospital Xi’an
Tongji Hospital of Tongji University Shanghai
Xiyuan Hospital of China Academy of Chinese Medical Science Beijing
Lanzhou Military Region General Hospital Lanzhou
The First Affiliated Hospital of Anhui Medical University Hefei
Xiangya Hospital Central China University Changsha

For more information about the study, please contact a study site by visiting HERE and HERE.