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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Asciminib Patients who started their 1L or 2L asciminib following FDA approval on or after Oct-2024 OR Patients who have exited an asciminib interventional study in US for 1L/2L CML and are continuing treatment with asciminib in routine medical care
  • Other: TKIs
    There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.
    Other names:
    • Scemblix, Bosulif, Sprycel, Gleevec, Tasigna
Bosutinib Patients who started 1L or 2L bosutinib on or after Oct-2021
  • Other: TKIs
    There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.
    Other names:
    • Scemblix, Bosulif, Sprycel, Gleevec, Tasigna
Dasatinib Patients who started 1L or 2L dasatinib on or after Oct-2021
  • Other: TKIs
    There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.
    Other names:
    • Scemblix, Bosulif, Sprycel, Gleevec, Tasigna
Imatinib Patients who started 1L or 2L imatinib on or after Oct-2021
  • Other: TKIs
    There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.
    Other names:
    • Scemblix, Bosulif, Sprycel, Gleevec, Tasigna
Nilotinib Patients who started 1L or 2L nilotinib on or after Oct-2021
  • Other: TKIs
    There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.
    Other names:
    • Scemblix, Bosulif, Sprycel, Gleevec, Tasigna

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233-0271
Contact:
+1 205 502 9967

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.