Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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
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

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Chronic Myelogenous Leukemia - Chronic Phase

Interventions: TKIs

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
Locations (17)
  • Birmingham, Alabama, United States
  • Stockton, California, United States
  • Torrance, California, United States
  • Stamford, Connecticut, United States
  • Pensacola, Florida, United States
  • Decatur, Illinois, United States
  • Baltimore, Maryland, United States
  • Kansas City, Missouri, United States
  • East Setauket, New York, United States
  • Syracuse, New York, United States
  • Canton, Ohio, United States
  • Salem, Oregon, United States
  • Sioux Falls, South Dakota, United States
  • Temple, Texas, United States
  • Seattle, Washington, United States
  • Tacoma, Washington, United States
  • Tacoma, Washington, United States