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

Recruiting now

Conditions studied: Chronic Myelogenous Leukemia - Chronic Phase

In brief

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.

Key facts

Study ID

NCT07091019

Run by

Novartis Pharmaceuticals

People needed

1000

Starts

2025-12-17

Expected to finish

2033-04-20

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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