A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy (ASC4REAL-2)

Novartis

Status: Not yet enrolling

Conditions: Chronic Myelogenous Leukemia - Chronic Phase

Treatments: Other: TKIs

Study type: Observational

Funder types: Industry

Identifiers

NCT07091019

CABL001J1US01

Details and patient eligibility

About

This CML disease registry (ASC4REAL-2) aims to gather evidence on the tolerability, safety, effectiveness, and patient-reported outcomes (PRO) in real-world healthcare from patients with Ph+-CML-CP treated with TKIs approved for 1L and 2L, including prospective follow-up for 5 years identifying and describing long-term treatment outcomes.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older at the time of Ph+-CML-CP diagnosis.
• Receiving TKI treatment (asciminib, bosutinib, dasatinib, imatinib, or nilotinib) in routine medical care either as initial therapy or after 1 prior TKI therapy.
• Receiving treatment at US and US territories (i.e., Puerto Rico) medical practice (e.g. community-based, office-based, hospital-based, academic).
• Signed informed consent form (ICF) prior to participation in the study including agreement to be tokenized so that the patient's anonymized RWD (EMRs and/or claims data) can be accessed.

Exclusion criteria

• Active participation in an interventional trial that may influence the management of their Ph+-CML-CP disease.
• Currently being treated with a CML TKI in 3L or beyond.
• Known presence of T315I mutation.
• Currently in TFR phase and are not on active CML TKI therapy.
• Previously received treatment with a prior stem cell transplant
• Pregnant or nursing (lactating) female.

Trial design

1,000 participants in 5 patient groups

Asciminib

Description:

Patients who started their 1L or 2L asciminib following FDA approval on or after Oct-2024 OR Patients who have exited an asciminib interventional study in US for 1L/2L CML and are continuing treatment with asciminib in routine medical care

Treatment:

Other: TKIs

Bosutinib

Description:

Patients who started 1L or 2L bosutinib on or after Oct-2021

Treatment:

Other: TKIs

Dasatinib

Description:

Patients who started 1L or 2L dasatinib on or after Oct-2021

Treatment:

Other: TKIs

Imatinib

Description:

Patients who started 1L or 2L imatinib on or after Oct-2021

Treatment:

Other: TKIs

Nilotinib

Description:

Patients who started 1L or 2L nilotinib on or after Oct-2021

Treatment:

Other: TKIs