ASC4FIRST = Oral Asciminib Versus Other TKIs in Newly Diagnosed Ph+ CML-CP [Asia-Pacific, Australia, Europe, Israel, North America, Russian Federation]

Type of study

First line trial

Phase

3

Current status

Recruiting

Study title

ASC4FIRST = A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Scientific title

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Other trial ID

(ClinicalTrials.gov NCT04971226, EudraCT no. 2021-000678-27)

What is the purpose of the study

This is a study to compare the efficacy of asciminib 80 mg once daily with a tyrosine kinase inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The TKI will be selected by the investigator and will be either imatinib 400 mg once daily or nilotinib 300 mg twice daily or dasatinib 100 mg once daily or bosutinib 400 mg once daily.

What will happen during the study

Patients will be randomly assigned to one of two treatment arms.
Participants in Arm 1 will receive asciminib 80 mg once daily under fasting conditions.
Participants in Arm 2 will receive investigator selected TKI that will include one of the below treatments:

  • imatinib 400 mg once daily administered with food, or
  • niilotinib 300 mg twice daily administered under fasting conditions, or
  • dasatinib 100 mg once daila administered with or without meal, or
  • bosutinib 400 mg once daily administered with food.

Key inclusion criteria

This study includes male or female patients who:

  • are aged 18 years or older
  • have been diagnosed with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) within 3 months of study entry.

Key exclusion criteria

This study does not include patients who:

  • have been treated for CML with any other anti-cancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Treatment with either imatinib, or nilotinib, or dasatinib or bosutinib for ≤2 weeks is allowed, but no other treatment with other tyrosine kinase inhibitors prior to randomization is permitted.

Further criteria may apply. Please discuss these with your doctor or study staff.

 

Estimated primary completion date

September 2024

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study descripiton in the EU Clinical Trials Registry which is hosted by the European Medicines Agency (EMA)

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

Novartis Pharmaceuticals

Study centers / principal investigators

Australia

Novartis Investigative Site
SouthPort, 4215

Novartis Investigative Site
Kingswood, New South Wales, 2747

Novartis Investigative Site
Port Macquarie, New South Wales, 2444


Austria

Novartis Investigative Site
Linz, 4010

Novartis Investigative Site
Vienna, 1090


Belgium

Novartis Investigative Site
Bruxelles, 1000

Novartis Investigative Site
Leuven, 3000


Bulgaria

Novartis Investigative Site
Sofia, 1797

Novartis Investigative Site
Varna, 9010


Canada

Alberta

Novartis Investigative Site
Calgary, Alberta, T2N 4N2

Ontario

Novartis Investigative Site
Hamilton, Ontario, L8V 1C3

Novartis Investigative Site
Ottawa, Ontario, K1H 8L6

Novartis Investigative Site
Toronto, Ontario, M5G 2M9


China

Novartis Investigative Site
Beijing, 100044

Novartis Investigative Site
Beijing, 100730

Novartis Investigative Site
Lanzhou

Novartis Investigative Site
Shanghai, 200025

China, Anhui

Novartis Investigative Site
Hefei, Anhui, 230001

China, Guangdong

Novartis Investigative Site
Guangzhou, Guangdong, 510515

Novartis Investigative Site
Shenzhen, Guangdong, 518037

China, Henan

Novartis Investigative Site
Zhengzhou, Henan, 450008

China, Hubei

Novartis Investigative Site
Wuhan, Hubei, 430022

China, Jiangsu

Novartis Investigative Site
Nanjing, Jiangsu

Novartis Investigative Site
Nantong, Jiangsu, 226000

Novartis Investigative Site
Suzhou, Jiangsu, 215006

China, Shanxi

Novartis Investigative Site
Xian, Shanxi, 710068

China, Sichuan

Novartis Investigative Site
Chengdu, Sichuan, 610041

China, Tianjin

Novartis Investigative Site
Tianjin, Tianjin, 300020

China, Zhejiang

Novartis Investigative Site
Hangzhou, Zhejiang, 310003

Novartis Investigative Site
Wenzhou, Zhejiang, 325000


Czechia, Czech Republic

Novartis Investigative Site
Brno Bohunice, 625 00

Novartis Investigative Site
Hradec Kralove, 500 05

Novartis Investigative Site
Ostrava, Poruba, 708 52


Denmark

Novartis Investigative Site
Aarhus, 8000

Novartis Investigative Site
Copenhagen, 2100

Novartis Investigative Site
Roskilde, 4000


Finland

Novartis Investigative Site
Helsinki, 00290

Novartis Investigative Site
Turku, 20520


France

Novartis Investigative Site
Bordeaux, 33076

Novartis Investigative Site
Lyon Cedex, 69373

Novartis Investigative Site
Nantes Cedex 1, 44093

Novartis Investigative Site
Paris Cedex, 75475


Germany

Novartis Investigative Site
Aachen, 52074

Novartis Investigative Site
Berlin, 13353

Novartis Investigative Site
Frankfurt, 60590

Novartis Investigative Site
Jena, 07740

Novartis Investigative Site
Lübeck, 23538

Novartis Investigative Site
Mannheim, 68305


Hungary

Novartis Investigative Site
Debrecen, 4032

Novartis Investigative Site
Kaposvar, 7400

Novartis Investigative Site
Kecskemet, 6001


India

Novartis Investigative Site
Delhi, 110 085


Israel

Novartis Investigative Site
Petah Tikva

Novartis Investigative Site
Ramat Gan, 52621

Novartis Investigative Site
Tel Aviv, 6423906


Italy

Novartis Investigative Site
Bologna, BO, 40138

Novartis Investigative Site
Milano, MI, 20122

Novartis Investigative Site
Reggio Emilia, RE, 42123

Novartis Investigative Site
Roma, RM, 00161

Novartis Investigative Site
Verona, VR, 37126


Japan

Novartis Investigative Site
Akita, 010 8543

Japan, Akita

Novartis Investigative Site
Akita, 010 8543

Japan, Aichi

Novartis Investigative Site
Nagoya, Aichi, 453-8511

Novartis Investigative Site
Toyoake city, Aichi, 470 1192

Japan, Chiba

Novartis Investigative Site
Kashiwa, Chiba, 277 8577

Japan, Fukuoka

Novartis Investigative Site
Fukuoka city, Fukuoka, 812-8582

Japan, Fukushima

Novartis Investigative Site
Fukushima city, Fukushima, 960 1295

Japan, Hokkaido

Novartis Investigative Site
Sapporo city, Hokkaido, 060 8648

Japan, Hyogo

Novartis Investigative Site
Kobe-city, Hyogo, 650-0047

Japan, Okayama

Novartis Investigative Site
Kurashiki-city, Okayama, 710-8602

Japan, Osaka

Novartis Investigative Site
Osaka, 545-8586

Novartis Investigative Site
Osaka Sayama, Osaka, 589 8511

Novartis Investigative Site
Suita city, Osaka, 565 0871

Japan, Shizuoka

Novartis Investigative Site
Sunto Gun, Shizuoka, 411 8777

Japan, Tochigi

Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498

Japan, Yamagata

Novartis Investigative Site
Yamagata, 990 9585

Japan, Yamanashi

Novartis Investigative Site
Chuo-city, Yamanashi, 409-3898


Korea, Republic of

Novartis Investigative Site
Seoul, 03080

Novartis Investigative Site
Seoul, 03722

Novartis Investigative Site
Seoul, 06351

Novartis Investigative Site
Seoul, Seocho Gu, 06591

Novartis Investigative Site
Uijeongbu si, Gyeonggi Do, 11759


Malaysia

Novartis Investigative Site
Kuantan, 25100

Novartis Investigative Site
Pulau Pinang, 10990

Novartis Investigative Site
Selangor, 68000

Novartis Investigative Site
Subang Jaya, 47500


Norway

Novartis Investigative Site
Bergen, 5021

Novartis Investigative Site
Oslo, 0372

Novartis Investigative Site
Trondheim, 7006


Portugal

Novartis Investigative Site
Porto, 4200 072

Novartis Investigative Site
Vila Nova de Gaia, 4434 502


Russian Federation

Novartis Investigative Site
Moscow, 127644

Novartis Investigative Site
Saint Petersburg, 191024


Singapore

Novartis Investigative Site
Singapore, 119228

Novartis Investigative Site
Singapore, 169608


Slovakia

Novartis Investigative Site
Bratislava, 83310

Novartis Investigative Site
Kosice, 040 66


Spain

Novartis Investigative Site
Barcelona, 08035

Novartis Investigative Site
El Palmar, 30120

Novartis Investigative Site
Granada, 18014

Novartis Investigative Site
Madrid, 28041

Novartis Investigative Site
Pamplona, 31008


Sweden

Novartis Investigative Site
Goteborg, 413 45

Novartis Investigative Site
Lund 221 85

Novartis Investigative Site
Stockholm; 141 86


Switzerland

Novartis Investigative Site
Bellinzona, 6850

Novartis Investigative Site
Zurich, 8091


Taiwan

Novartis Investigative Site
Kaohsiung City, 83301

Novartis Investigative Site
Taichung, 40447


United Kingdom

Novartis Investigative Site
London, W12 0HS

Novartis Investigative Site
Nottingham, NG5

Novartis Investigative Site
Oxford, OX3 7LJ


United States

California

City of Hope National Medical Center
Duarte, California, 91010
Principal Investigator: Paul Koller

Colorado

Rocky Mountain Cancer Center
Denver, Colorado, 80501
Principal Investigator: David J Andorsky

Florida

Florida Cancer Specialists Dept. of Oncology
Fort Myers. Florida, 33901
Principal Investigator: Vijay Patel

Florida Cancer Specialists
Fort Myers. Florida, 33901
Principal Investigator: Anjan J Patel

Florida Cancer Specialists Panhandle
Tallahassee, Florida, 32308
Principal Investigator: Pareshkumar Patel

Florida Cancer Specialists
West Palm Beach, Florida, 33401
Principal Investigator: Shachar Peles

Illinois

Illinois Cancer Care P.C. IL Cancer Specialists
Chicago, Illinois, 61615-7828
Principal Investigator: Leonard Klein

Kentucky

University of Kentucky
Lexington, Kentucky, 40536
Principal Investigator: Reinhold Munker

Massachusetts

University of Massachusetts Medical Center Dept of Oncology
Worcester, Massachusetts, 01655
Principal Investigator: Jonathan Gerber

Michigan

University of Michigan Clinical Trials Office
Ann Arbor, Michigan, 48109
Principal Investigator: Moshe Talpaz

North Carolina

Wake Forest University Baptist Medical Center Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157

Ohio

Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
Principal Investigator: Edward R Broun

Oregon

Williamette Cancer Center
Eugene, Oregon, 97401
Principal Investigator: Luke Fletcher

South Dakota

Avera Cancer Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Principal Investigator: Roberto Ferro Valdes

Tennessee

Chattanooga Oncology and Hematologiy Associates PC
Tennessee Oncology Chattanooga
Principal Investigator: Bertrand Marquess Anz

Texas

Texas Oncology Texas Onc – Amarillo
Dallas, Texas, 75246
Principal Investigator: Praveen Kumar Tumula

Texas Oncology-Baylor USO
Dallas, Texas, 75246
Principal Investigator: Moshe Levy

Texas Oncology P A Austin
Dallas, Texas, 75251
Principal Investigator: Jason M Melear

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Ghayas C Issa

Texas Oncology Northeast Texas
Tyler, Texas, 75702
Principal Investigator: Habte Yimer

Virginia

Virginia Cancer Specialists
Gainesville, Virginia, 20155
Principal Investigator: Mitul Gandhi

Virginia Oncology Associates
Norfolk, Virginia, 23502
Principal Investigator: Celeste Bremer