RecruitingRecruiting
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
NCT07091019 · Novartis
In plain English
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About this study
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
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.
Study design
Enrollment target: 1000 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-12-17
Estimated completion: 2033-04-20
Last updated: 2026-07-20
Interventions
Other: TKIs
Primary outcomes
- • Rate of discontinuation of index TKI due to AEs (Up to 5 years)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (17)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Stockton Hematology Oncology Medical Group IncRecruiting
Stockton, California, United States
Lundquist Inst BioMed at HarborRecruiting
Torrance, California, United States
Stamford HospitalRecruiting
Stamford, Connecticut, United States
Sacred Heart Medical OncologyRecruiting
Pensacola, Florida, United States
Cancer Care Specialists of Central IllinoisRecruiting
Decatur, Illinois, United States
St Agnes HospitalRecruiting
Baltimore, Maryland, United States
Truman Medical CenterRecruiting
Kansas City, Missouri, United States
NY Cancer and Blood SpecialistsRecruiting
East Setauket, New York, United States
SUNY Upstate Medical UniversityRecruiting
Syracuse, New York, United States
Tri-County Hematology and Oncology AssociatesRecruiting
Canton, Ohio, United States
Oregon Oncology Specialists SalemRecruiting
Salem, Oregon, United States
Avera CancerRecruiting
Sioux Falls, South Dakota, United States
Baylor Scott and White ResearchRecruiting
Temple, Texas, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
MultiCare Health System InstituteRecruiting
Tacoma, Washington, United States
Northwest Medical SpecialtiesRecruiting
Tacoma, Washington, United States