ASC4START (CABL001J12302) = Asciminib versus nilotinib in patients with newly diagnosed CML [Asia-Pacific, Africa, Europe, Middle East, North America, South America]

Study title

A study to compare asciminib versus nilotinib in patients with newly diagnosed chronic myelogenous leukemia (CML)

Scientific title

A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Type of study

First line trial

Phase

3

Current status

Recruiting

Other trial ID

CABL001J12302; EudraCT no. 2022-000995-21; ClinicalTrials.gov NCT05456191

What is the purpose of the study

This is a study to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP).

What will happen during the study

In this study, participants will be randomized into two groups and receive either oral asciminib 80 mg once daily or nilotinib 300 mg twice daily.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years or older
  • have been diagnosed with Philadelphia chronic myeloid leukemia in chronic phase (CML-CP) within 3 months of study entry
  • have evidence of a typical BCR::ABL1 transcript [e14a2 and/or e13a2] that can be quantified on standardized real time polymerase chain reaction (RT-PCR) by the central laboratory
  • have an Eastern Co-Operative Group (ECOG) status of 0 or 1.

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

Key exclusion criteria

This study does not include patients who:

  • have been treated previously 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.
  • have known infiltration of the central nervous system (CNS) by malignant cells, as confirmed by cytopathology (a specialist diagnostic technique to examine cells)
  • have impaired cardiac function or cardiac repolarization abnormality.

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

Estimated primary completion date

February 2027

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
You can also find a study description in the EU Clinical Trials Registry. This is a database hosted by the European Medicines Agency (EMA).

 

 

 

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

Study centers / principal investigators

Argentina

Novartis Investigative Site
Buenos Aires, C1114AAN

Novartis Investigative Site
Buenos Aires, C1425AUM

Novartis Investigative Site
Buenos Aires, C1039AAC

Novartis Investigative Site
Caba, Buenos Aires, C1181ACH

Novartis Investigative Site
Caba, Buenos Aires, C1221ADH


Bulgaria

Novartis Investigative Site
Pleven, 5800

Novartis Investigative Site
Plovdiv, 4002

Novartis Investigative Site
Sofia, 1413

Novartis Investigative Site
Sofia, 1431

Novartis Investigative Site
Sofia, 1797

Novartis Investigative Site
Varna, 9010


Canada

Ontario

Novartis Investigative Site
London, Ontario, N6A 4G4

Novartis Investigative Site
Toronto, Ontario, M5G 2M9


Czechia

Novartis Investigative Site
Brno Bohunice, 625 00

Novartis Investigative Site
Praha 2, 128 20

Novartis Investigative Site
Plzen-Bory, 30599

Novartis Investigative Site
Praha 10, 100 34


France

Novartis Investigative Site
Bordeaux, 33076

Novartis Investigative Site
Caen Cedex, 14033

Novartis Investigative Site
Clermont Ferrand, 63003

Novartis Investigative Site
Lille, 59037

Novartis Investigative Site
Lyon, 69373

Novartis Investigative Site
Marseille, 13273

Novartis Investigative Site
Nantes Cedex 1, 44093

Novartis Investigative Site
Nice, 06202

Novartis Investigative Site
Paris 10, 75475

Novartis Investigative Site
Poitiers, 86000

Novartis Investigative Site
Strasbourg, 67200

Novartis Investigative Site
Toulouse, 31059

Novartis Investigative Site
Vandoeuvre les Nancy cedex, 54511


Germany

Uniklinik RWTH Aachen
Medizinische Klinik IV
Principal Investigator: Prof. Dr. Tim Brümmendorf
Aachen, 52074

Novartis Investigative Site
Augsburg, 86179

Novartis Investigative Site
Bad Saarow, 15526

Klinik für Onkologie und Hämatologie
Klinikum Bayreuth
Principal Investigator: Prof. Dr. Alexaner Kiani
Bayreuth, 95445

Novartis Investigative Site
Berlin, 13353

Universitätsklinikum Bonn
Medizinischen Klinik und Poliklinik III
Principal Investigator: Dr. med. Lino Teichmann
Bonn, 53105

Klinikum Bremen Mitte gGmbH
Principal Investigator: Dr. med. Matthias Bormann
Bremen, 28177

Klinikum Chemnitz GmbH
Principal Investigator: PD Dr. Mathias Hänel
Chemnitz, 09113

Novartis Investigative Site
Dresden, 01307

Novartis Investigative Site
Erlangen, 91054

Universitätsklinikum Essen
Principal Investigator: PD Dr. Joachim Göthert
Essen, 45122

Novartis Investigative Site
Frankfurt, 60590

Novartis Investigative Site
Freiburg, 79106

Universitätsklinikum Halle (Saale)
Principal Investigator: Dr. med. Nadja Jäkel
Halle, 06120

Novartis Investigative Site
Hamburg, 20246

Praxis für Hämatologie und Onkologie
Principal Investigator: Dr. med. Eyck von der Heyde
Hannover, 30161

Universitätsklinikum Heidelberg
Principal Investigator: Dr. med. Tim Sauer
Heidelberg, 69120

Universitätsklinikum Jena
Klinikum für Innere Medizin II
Principal Investigator: Prof. Dr. Andreas Hochhaus
Jena, 07743

Universitätsklinikum Leipzig
Principal Investigator: Dr. med. Georg-Nikolaus Franke
Leipzig, 04103

Novartis Investigative Site
Lübeck, 23538

Novartis Investigative Site
Magdeburg, 39104

Novartis Investigative Site
Mannheim, 68305

Novartis Investigative Site
Marburg, 35039

Novartis Investigative Site
München, 80377

Brüderkrankenhaus St. Josef Paderborn
Principal Investigator: Dr. med. Tobias Gaska
Paderborn, 33098

Krankenhaus Barmherzige Brüder Regensburg
Principal Investigator: Dr. med. Michael Schenk
Regensburg, 93049

Universitätsklinikum Tübingen
Principal Investigator: Prof. Dr. Martin Möhle
Tübingen, 72076

Universitätsklinikum Ulm
Principal Investigator: PD Dr. Frank Stegelmann
Ulm, 89081

Gemeinschaftspraxis für Innere Medizin Hämatologie
Principal Investigator: Dr. med Arnd Nusch
Velbert, 42551

Novartis Investigative Site
Würzburg, 97080


Greece

Novartis Investigative Site
Athens, 106 76

Novartis Investigative Site
Athens, 115 27

Novartis Investigative Site
Ioannina, 455 00

Novartis Investigative Site
Thessaloniki, 570 10

Novartis Investigative Site
Athens, 115 27

Novartis Investigative Site
Patras, 265 00


Hungary

Novartis Investigative Site
Budapest, 1085

Novartis Investigative Site
Budapest, 1097

Novartis Investigative Site
Eger, 3300


India

Novartis Investigative Site
New Delhi, 110029

India, Gujrat

Novartis Investigative Site
Ahmedabad, Gujrat, 380009

India, Tamilnadu

Novartis Investigative Site
Chennai, Tamilnadu, India, 600036

India, Uttar Pradesh

Novartis Investigative Site
Varanasi, Uttar Pradesh, 221010

Novartis Investigative Site
Rishikesh, Uttarakhand, 249203


Italy

Novartis Investigative Site
Bari, BA, 70124

Novartis Investigative Site
Meldola, FC, 47014

Novartis Investigative Site
Milano, MI, 20162

Novartis Investigative Site
Pisa, PI, 56126

Novartis Investigative Site
Roma, RM, 00144

Novartis Investigative Site
Torino, TO, 10126


Jordan

Novartis Investigative Site
Amman, 11941


Korea, Republic of

Novartis Investigative Site
Bundang Gu, Gyeonggi Do, 13620

Novartis Investigative Site
Uijeongbu si, Gyeonggi Do, 11759


Malaysia

Novartis Investigative Site
Kuala Lumpur, 59100

Novartis Investigative Site
Penang, 10050

Malaysia, Kedah

Novartis Investigative Site
Alor Setar, Kedah, Malaysia, 05460

Malaysia, Sarawak

Novartis Investigative Site
Kuching, Sarawak,93586

Malaysia, Selangor Darul Ehsan

Novartis Investigative Site
Petaling Jaya, Selangor Darul Ehsan, 46150


Netherlands

Novartis Investigative Site
Dordrecht, 3318AT


Oman

Novartis Investigative Site
Muscat, 123


Romania

Novartis Investigative Site
Bucharest, 030 171

Novartis Investigative Site
Bucharest, District 2, 022328

Novartis Investigative Site
Bucuresti, 021494

Novartis Investigative Site
Cluj-Napoca, 400124

Novartis Investigative Site
Craiova, 200136

Novartis Investigative Site
Sibiu, 550245

Novartis Investigative Site
Timisoara, 300079

Novartis Investigative Site
Tg Mures, Mures, 540136


Singapore

Novartis Investigative Site
Singapore, 119228

Novartis Investigative Site
Singapore, 169608

Novartis Investigative Site
Singapore, S308433


Slovakia

Novartis Investigative Site
Kosice, 040 66

Novartis Investigative Site
Bratislava, 85107


South Africa

Novartis Investigative Site
Pretoria, 0044

South Africa, Gauteng

Novartis Investigative Site
Soweto, Gauteng, 2013


Switzerland

Novartis Investigative Site
Genève, 1211


Turkey

Novartis Investigative Site
Ankara, 06100

Novartis Investigative Site
Izmir, 35040

Novartis Investigative Site
Istanbul, 34098


United Arab Emirates

Novartis Investigative Site
Abu Dhabi, United Arab Emirates


United Kingdom

Novartis Investigative Site
Glasgow, G12 0YN

Novartis Investigative Site
Gloucester, GL1 3NN

Novartis Investigative Site
Gwent, NP9 2UB

Novartis Investigative Site
London, SE5 9RS

Novartis Investigative Site
London, W12 0HS

Novartis Investigative Site
Truro, Cornwall, TR1 3LJ


United States

Arizona

Arizona Oncology Associates
Principal Investigator: Alan Langerak
Phoenix, Arizona,  85016

California

Kaiser Permanente California South Kaiser – Irvine
Principal Investigator: Ashraf Aziz
San Diego, California, 92120

Colorado

Rocky Mountain Cancer Centers USOR
Principal Investigator: David J Andorsky
Boulder, Colorado, 80304

Florida

Florida Cancer Specialists Dept. of Concology
Principal Investigator: Adewale Alade Fawole
Fort Myers, Florida, 33901

Florida Cancer Specialists Pan.
Principal Investigator: Jeffrey Bubis
Tallahassee, Florida, 32308

Illinois

Illinois Cancer Center
Principal Investigator: Srinivas Jujjararapu
Peoria, Illinois, 61615

Louisiana

Hematology and Oncology Clinic
Principal Investigator: Michael Castine III
Baton Rouge, Louisiana, 70809

Minnesota

Minnesota Oncology Hematology P A Minnesota Oncology Hematology
Principal Investigator: Danielle Tippit
Minneapolis, Minnesota, 55404

Regions Hospital Oncology Research Consortium
Principal Investigator: Yan Ji
Saint Paul, Minnesota, 55101

North Carolina

Messino Cancer Centers
Principal Investigator: Andrew Beardsley
Asheville, North Carolina, 28806

Ohio

Oncology Hematology Care Inc
Principal Investigator: Kruti Patel
Cincinnati, Ohio, 45242

Oregon

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

Tennessee

Sarah Cannon Research Institute HCA Healthcare Research Inst.
Principal Investigator: Stephen Strickland
Nashville, Tennessee, 37203

Texas

Texas Oncology P A .
Principal Investigator: Andrew Jackson
Bedford, Texas, 76022

Texas Oncology PA Bedford
Principal Investigator: Henrik Illum
Bedford, Texas, 76022

Texas Oncology Midtown
Principal Investigator: Jason M Melear
Dallas, Texas, 75251

Lumi Research
Saleha Sajid
Kingwood, Texas, 77339

Virginia

Virginia Oncology Associates VOA – Princess Anne
Principal Investigator: Celeste Bremer
Norfolk, Virginia,  23502