Real‑world CML patient registry looks at experiences and outcomes with first- or second-line TKI therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects real-world data on patients with Ph+ CML in chronic phase who are receiving TKIs as initial or later lines of therapy. It tracks tolerability, safety, effectiveness, and patient-reported outcomes, with up to five years of prospective follow-up. Data come from routine clinical practice in US sites, and English-language consent allows access to anonymized electronic records and claims data. The study aims to describe long-term treatment outcomes and experiences in a diverse patient population treated in real-world settings. Enrollment is restricted to adults receiving TKI therapy in the United States or its territories who provide informed consent.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Stockton Hematology Oncology Medical Group Inc
  Stockton, California, United States Recruiting
• Lundquist Inst BioMed at Harbor
  Torrance, California, United States Recruiting
• Stamford Hospital
  Stamford, Connecticut, United States Recruiting
• Sacred Heart Medical Oncology
  Pensacola, Florida, United States Recruiting
• Cancer Care Specialists of Central Illinois
  Decatur, Illinois, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.