Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals
About this trial
This is a multicenter, non-interventional real-world study designed to assess the efficacy and safety of asciminib in patients with newly diagnosed CML.The study uses a prospective data collection design to gather baseline, pre- and post-treatment, and long-term follow-up data, enabling a comprehensive assessment of asciminib's clinical benefits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older at the time of ICF signing;
Newly diagnosed with Ph+ CML-CP within 3 months before enrollment;
Prior treatment with a maximum of 2 weeks of TKIs;
Prior treatment with non-TKI regimens, including interferon and hydroxyurea, is allowed;
Disqualifiers
Previous diagnosis of CML-accelerated phase or blast crisis;
Currently participating in an interventional clinical study for CML;
Having rare, atypical transcript types that cannot be standardised internationally;
Women who are pregnant, lactating or planning to become pregnant during the study;
Trial population
patients newly diagnosed with CML-CP and confirmed with Ph+ CML in medical records
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Study Group
Trial outcomes
Primary outcomes
1
Cumulative rate of MMR
Cumulative rate of major molecular response (MMR) (BCR-ABL1 transcript level ≤ 0.1%) in patients receiving asciminib for 12 months
Time frame
Month 12Secondary outcomes
1
Cumulative rate of MMR
The cumulative MMR is defined as at least one BCR::ABL1 transcript level ≤ 0.1% during the follow-up period
Time frame
Month 3, Month 6, Month 9, Month 18 and Month 242
Cumulative rate of deep molecular response (DMR): MR4 and MR4.5
Cumulative rate of MR4 is defined as at least one BCR::ABL1 transcript level ≤ 0.01% during the follow-up period; Cumulative MR4.5 is defined as at least one BCR::ABL1 transcript level ≤0.0032% during the follow-up period
Time frame
Month 3, Month 6, Month 9, Month 12, Month 18, and Month 243
Cumulative rate of complete cytogenetic response (CCyR)
Cumulative CCyR is defined as at least one cytogenetic examination showing 0 Ph+ cells during the follow-up period
Time frame
Month 3, Month 6, and Month 124
Time to first MMR
Time to first MMR is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.1% during the follow-up period
Time frame
24 month follow up periodSponsors and contacts
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Source ClinicalTrials.gov