Ireland
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Recruiting Observational

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 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2025-12-17
Last updated
2026-07-20

Condition(s) studied

Chronic Myelogenous Leukemia - Chronic Phase

Investigational drug(s) / intervention(s)

TKIs

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

Study 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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rate of discontinuation of index TKI due to AEs — Up to 5 years
    Rate of discontinuation of index Tyrosine kinase inhibitor (TKI) due to Adverse Events (AEs)

Trial sites (17)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Stockton Hematology Oncology Medical Group Inc Stockton California Recruiting
Lundquist Inst BioMed at Harbor Torrance California Recruiting
Stamford Hospital Stamford Connecticut Recruiting
Sacred Heart Medical Oncology Pensacola Florida Recruiting
Cancer Care Specialists of Central Illinois Decatur Illinois Recruiting
St Agnes Hospital Baltimore Maryland Recruiting
Truman Medical Center Kansas City Missouri Recruiting
NY Cancer and Blood Specialists East Setauket New York Recruiting
SUNY Upstate Medical University Syracuse New York Recruiting
Tri-County Hematology and Oncology Associates Canton Ohio Recruiting
Oregon Oncology Specialists Salem Salem Oregon Recruiting
Avera Cancer Sioux Falls South Dakota Recruiting
Baylor Scott and White Research Temple Texas Recruiting
Fred Hutchinson Cancer Research Center Seattle Washington Recruiting
MultiCare Health System Institute Tacoma Washington Recruiting
Northwest Medical Specialties Tacoma Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07091019 on ClinicalTrials.gov ↗ ← All trials in the USA