Last Update: Jun 25, 2026
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CABL001J1US01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Chronic Myelogenous Leukemia - Chronic Phase
Recruiting
1000
Dec 17, 2025
Apr 20, 2033
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Other

TKIs

There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.

Eligibility Criteria

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.

Avera Cancer

Recruiting

Sioux Falls,South Dakota,57105,United States

Tiffani Kirkpatrick

MultiCare Health System Institute

Recruiting

Tacoma,Washington,98405,United States

Nehal Masood
Ali Dadla

Fred Hutchinson Cancer Research Center

Recruiting

Seattle,Washington,98109-1024,United States

Vivian Oehler

Baylor Scott and White Research

Recruiting

Temple,Texas,76502,United States

Lucas Wong

University of Alabama at Birmingham

Recruiting

Birmingham,Alabama,35233-0271,United States

Omer Jamy

Oregon Oncology Specialists Salem

Recruiting

Salem,Oregon,97301,United States

John Strother

Tri-County Hematology and Oncology Associates

Recruiting

Canton,Ohio,44718,United States

Norman Rafique

SUNY Upstate Medical University

Recruiting

Syracuse,New York,13210,United States

Gillian Kupakuwana-Suk

NY Cancer and Blood Specialists

Recruiting

East Setauket,New York,11733,United States

Adam Hines

St Agnes Hospital

Recruiting

Baltimore,Maryland,21229,United States

Carole Miller

Sacred Heart Medical Oncology

Recruiting

Pensacola,Florida,32504,United States

Dany El-Sayah

Stamford Hospital

Recruiting

Stamford,Connecticut,06902,United States

Joshua Dower

Lundquist Inst BioMed at Harbor

Recruiting

Torrance,California,90509-2910,United States

Sarah Elizabeth Tomassetti

Stockton Hematology Oncology Medical Group Inc

Recruiting

Stockton,California,95204,United States

Ravleen Grewal

Worldwide Contacts

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