ASC4MORE (CABL001E2201) = A Phase II Study of ABL001 in Patients With CML-CP without Deep Molecular Response [Asia, Australia, Europe, USA]

Study title

ASC4MORE (CABL001E2201) = A Phase II Study of Asciminib in Combination With Imatinib for Patients with CML-CP without Deep Molecular Response

Scientific title

A phase 2, multi-center, open-label, randomized study of oral asciminib added to imatinib versus continued imatinib versus switch to nilotinib in patients with CML-CP who have been previously treated with imatinib and have not achieved deep molecular response (EudraCT 2018-001594-24, ClinicalTrials.gov NCT03578367)

Indication and most important inclusion criteria

Male or female patients 18 years and older with Philadelphia chromosome-positive CML in chronic phase who previously received first line treatment with imatinib. Patients can be considered for inclusion in the study if they have BCR-ABL results of more than 0.1% and up to 1% on the international scale (IS) at the screening examination and did not reach deep molecular response (MR4 or better) at any time during prior imatinib treatment. To be eligible for inclusion, patients must have acceptable laboratory values at screeing, electrolytes within normal limits, and adequate end-organ function.

Short description of intervention

This is a study of the efficacy and safety of asciminib in addition to imatinib compared to continued imatinib or compared to nilotinib in pre-treated CML-CP patients without a deep level of molecular response on imatinib.

Type of study

Therapy optimization trial

Current status

recruiting

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

Novartis Pharmaceuticals

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health 

Study centers / principal investigators

Australia, South Australia
Adelaide, 5000
Novartis Investigative Site


Czech Republic
Brno - Bohunice, 639 01
Novartis Investigative Site


France
Bordeaux, 33076
Novartis Investigative Site


Hong Kong
Hong Kong
Novartis Investigative Site

Spain
Sevilla, 42009
Novartis Investigative Site

United Kingdom
London, W12 0HS
Novartis Investigative Site


USA
Maryland
Saint Agnes Healthcare Cancer Institute
Baltimore, 21229


 
   
 

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