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NCT07091019Recruiting

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

Novartis Pharmaceuticals

Start Date

12/17/2025

Completion Date

4/20/2033

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 Criteria

Age Range: 18 years to 100 years

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.

Interventions

OTHER

TKIs

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Conditions

Chronic Myelogenous Leukemia - Chronic Phase

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233-0271

United States

Stockton Hematology Oncology Medical Group Inc

Stockton, California 95204

United States

Lundquist Inst BioMed at Harbor

Torrance, California 90509-2910

United States

Stamford Hospital

Stamford, Connecticut 06902

United States

Sacred Heart Medical Oncology

Pensacola, Florida 32504

United States

Cancer Care Specialists of Central Illinois

Decatur, Illinois 62526

United States

St Agnes Hospital

Baltimore, Maryland 21229

United States

Truman Medical Center

Kansas City, Missouri 64108

United States

NY Cancer and Blood Specialists

East Setauket, New York 11733

United States

SUNY Upstate Medical University

Syracuse, New York 13210

United States

Tri-County Hematology and Oncology Associates

Canton, Ohio 44718

United States

Oregon Oncology Specialists Salem

Salem, Oregon 97301

United States

Avera Cancer

Sioux Falls, South Dakota 57105

United States

Baylor Scott and White Research

Temple, Texas 76502

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109-1024

United States

MultiCare Health System Institute

Tacoma, Washington 98405

United States

Northwest Medical Specialties

Tacoma, Washington 98405

United States