Clinical Study

Cabl001aus04 An Open Label, Multi-Center Phase IIIb Study Of Asciminib (Abl001) Monotherapy In Previously Treated Patients With Chronic Myeloid Leukemia In Chronic Phase (Cml-Cp) With And Without T315i Mutation

Posted Date: Jul 6, 2021

  • Investigator: Emily Curran
  • Specialties: Cancer, Oncology
  • Type of Study: Drug

The primary objective of this trial is to study the effect of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior TKI. Efficacy will be determined by the number of adverse and serious adverse events. Patients in Arm A will receive 40 mg asciminib orally twice daily (BID). Patients in Arm B will receive 80 mg asciminib orally once daily (QD). Patients in Arm C will receive 200 mg asciminib orally twice daily (BID).


Participants Must Have Ecog Score Of 0, 1, Or 2. Participants Must Have Adequate End Organ Function. Participants Must Have Mutation Analysis Testing Performed 6 Months Before Study Entry. Patients Must Meet All Of The Following Laboratory Values At The Screening Visit: < 15% Blasts In Peripheral Blood And/Or Bone Marrow < 30% Blasts Plus Promyelocytes In Peripheral Blood And/Or Bone Marrow < 20% Basophils In The Peripheral Blood = 50 X 109/L (= 50,000/ Mm3) Platelets. No Previous Treatment With A Hematopoietic Stem-Cell Transplantation, No Cardiac Or Cardiac Repolarization Abnormality, No History Of Acute Pancreatitis Within 1 Year Of Study Entry Or Past Medical History Of Chronic Pancreatitis, No History Of Other Active Malignancy Within 3 Years Prior To Study Entry With The Exception Of Previous Or Concomitant Basal Cell Skin Cancer And Previous Carcinoma In Situ Treated Curatively, No Impairment Of Gastrointestinal (Gi) Function Or Gi Disease That May Significantly Alter The Absorption Of Study Drug.



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