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Asciminib Treatment Optimization in ≥ 3rd Line CML-CP
Asciminib Treatment Optimization in ≥ 3rd Line CML-CP

NCT04948333

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Chronic Myelogenous Leukemia

Interventions: ABL001 40mg BID, ABL001 80mg QD, ABL001 200mg QD

Countries: Argentina, Austria, Brazil, Canada, France, Germany, Greece, Italy

The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs).

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion criteria:

* Signed informed consent must be obtained prior to participation in the study
* Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
* Treatment with a minimum of 2 or more prior TKIs (i.e. imatinib, nilotinib, dasatinib, bosutinib, radotinib or ponatinib)
* Warning or failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Adequate end organ function (as per central laboratory tests)

Key Exclusion criteria:

* Known presence of the BCR::ABL1 T315I mutation at any time prior to study entry
* Known second chronic phase of CML after previous progression to AP/BC
* Previous treatment with a hematopoietic stem-cell transplantation
* Patient planning to undergo allogeneic hematopoietic stem cell transplantation
* Uncontrolled cardiac repolarization abnormality
* Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
* Testing for Hepatitis B surface antigen (HbsAg) and Hepatitis B core antibody (HBcAb / anti HBc) will be performed at screening. Patients with active Hepatitis B Virus (HBV) infection (hepatitis B surface antigen \[HbsAg\] positive) will be excluded

Other Inclusion/Exclusion criteria may apply.
Locations (48)
  • CABA, Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Graz, Austria
  • Linz, Austria
  • Vienna, Austria
  • Rio de Janeiro, Rio de Janeiro, Brazil
  • São Paulo, Brazil
  • Vancouver, British Columbia, Canada
  • Toronto, Ontario, Canada
  • Bordeaux, France
  • Lyon, France
  • Montpellier, France
  • Nantes, France
  • Paris, France
  • Mannheim, Baden-Wurttemberg, Germany
  • Frankfurt am Main, Hesse, Germany
  • Jena, Thuringia, Germany
  • Berlin, Germany
  • Kiel, Germany
  • München, Germany
  • Athens, Greece
  • Thessaloniki, Greece
  • Monza, MB, Italy
  • Roma, RM, Italy
  • Verona, VR, Italy
  • George Town, Pulau Pinang, Malaysia
  • Kota Kinabalu, Sabah, Malaysia
  • Johor Bahru, Malaysia
  • Kuala Selangor, Malaysia
  • Khoudh, Oman
  • + 18 more on CT.gov