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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • TKIs

Treatment groups

1,000 Participants
are divided into 5 treatment groups

Sponsors and collaborators