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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

RECRUITINGSponsored by Novartis Pharmaceuticals
Actively Recruiting
SponsorNovartis Pharmaceuticals
Started2025-12-17
Est. completion2033-04-20
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
Locations15 sites

Summary

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

Age: 18 Years – 100 YearsHealthy volunteers accepted
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.

Conditions2

CancerChronic Myelogenous Leukemia - Chronic Phase

Locations15 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35233-0271
+1 205 502 9967
Stockton Hematology Oncology Medical Group Inc
Stockton, California, 95204
+1 209 466 2626
Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910
Sarah Elizabeth Tomassetti
Stamford Hospital
Stamford, Connecticut, 06902
Joshua Dower
Sacred Heart Medical Oncology
Pensacola, Florida, 32504
+1 850 416 2730

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