Asciminib treatment optimization in = 3rd line CML-CP

Phase 1

• Conditions: Chronic Myelogenous Leukemia in chronic phase (CML-CP); MedDRA version: 21.0Level: LLTClassification code 10009012Term: Chronic myelogenous leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-006057-21-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-02
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 186

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
History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
Participation in a prior investigational study within 30 days prior to
randomization or
within 5-half-lives of the investigational product, whichever is longer.
Other protocol defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified