Study Conducted Among Patients With CML
Completed
Conditions studied: Chronic Myeloid Leukemia
In brief
Retrospective, non-interventional observational cohort study conducted among patients with CML.
Key facts
- Study ID
- NCT05476562
- Run by
- Novartis Pharmaceuticals
- People needed
- 3234
- Starts
- 2021-03-08
- Expected to finish
- 2021-10-15
- Last updated by the study team
- 2022-11-08
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients were selected for the analysis of later lines of therapy in commercial claims (i.e., were previously treated with TKIs, who are relapsed/refractory to/intolerant of TKIs) if they met the following criteria:
- Had at least one diagnosis for CML, with first CML diagnosis observed in claims on or after May 10, 2001, the date of FDA approval for imatinib
- Were at least 18 years of age as of the first CML diagnosis
- Started a first line therapy for CML with imatinib, dasatinib, nilotinib, or bosutinib (conditional on FDA-approval dates)
- Initiated first line therapy within a maximum of 1 month prior to the first diagnosis for CML or a maximum 3 months following the first diagnosis for CML
- Had continuous health plan enrollment (pharmacy and medical benefits) from the washout period to at least 12 months following the first CML diagnosis
You may not qualify if…
- Patients had a diagnosis for CML remission or relapse anytime prior to first line therapy
- Patients had a medical claim associated with a clinical trial during the washout period up to the end of the observation period
- Patients had an HSCT during the washout period up to the first line therapy initiation
- Patients had chemotherapy treatment (except hydroxyurea) during the washout period up to the first line therapy initiation
Where it is running
- Novartis Investigative Site — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
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