EUCTR2020-006057-21-IT
Active, not recruiting
Phase 1
A phase 3b, multi-center, open-label, treatment optimization study of oral asciminib in patients with Chronic Myelogenous Leukemia in chronic phase(CML-CP) previously treated with 2 or more tyrosine kinase inhibitors - CABL001A2302
DrugsNA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- OVARTIS PHARMA AG
- Enrollment
- 186
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Adequate end organ function (as per central laboratory tests) Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 124
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 62
Exclusion Criteria
- •Known presence of the BCR\-ABL1 T315I mutation at any time prior to
- •study entry
- •Known history of 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
Outcomes
Primary Outcomes
Not specified
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