C92.10
Conditions
Interventions
Group 1: Observation group:
Patients with BCR::ABL1-positive chronic myelogenous leukemia in the chronic phase (CML-CP), who receive routine treatment with Daruph
Sponsors
Zentiva, k.s.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Adult patients of 18 years or older at index date • A clinical diagnosis of CML-CP with confirmed BCR::ABL1 positivity • Started treatment with Daruph, or switched to Daruph from another dasatinib formulation, according to label and local market reimbursement no more than 6 months before enrolment • Able and willing to read and comprehend written instructions • Have provided written informed consent
Exclusion criteria
Exclusion criteria: • Diagnosed with CML in the blast phase (CML-BP) • Previously received another dasatinib formulation for > 6 months prior to Daruph treatment • Has dasatinib-resistant mutations • Participating in an ongoing interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study will be as follows: • To assess the proportion of CML-CP patients still receiving Daruph treatment at 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives will be as follows: 1. To assess the rate of major molecular response (MMR) at 6, 12 and 24 months as defined by a BCR::ABL1 international score (IS) of = 0.1%at 6, 12 and 24 months. 2. To describe the frequency of adverse events and serious adverse events (SAEs) at 6, 12 and 24 months. 3. To describe the distribution of concomitant treatment with PPIs, H2 antagonists and antacids at 6, 12 and 24 months. 4. To assess the frequency of Daruph dose modifications at 6, 12 and 24 months. 5. To assess change in quality of life via QLQ-C30 and QLQ-CML24 PRO questionnaires and treatment satisfaction at 12 and 24 months. | — |
Countries
Germany
Contacts
Public ContactLaura Langer
IQVIA Commercial GmbH & Co. OHG
Outcome results
None listed