Chronic Myelogenous Leukemia - Chroni...

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

About this trial

Last updated 10 months ago

Study ID

CABL001J1US01

Status

Not yet recruiting

Type

Observational

Placebo

Accepting

18 to 100 Years

All Sexes

Trial Timing

Started 7 months ago

What is this trial 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.

What are the participation requirements?

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.