Asciminib RMP Study
ConditionChronic Myeloid Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix® treatment according to locally approval label
Patients who are willing to provide written informed consent prior to study enrollment
Disqualifiers
Patients with contraindication according to locally approved label of Scemblix®
Patients who receive or are going to receive any investigational medicine during the observation period
Trial population
Patients who are going to receive Scemblix® for the first time or those who are currently taking Scemblix® per clinical judgment are eligible and will be prescribed with Scemblix® under routine medical practice.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Asciminib
Other interventionThere is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Asciminib1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants with an AE / ADR
Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)
Time frame
24 weeks2
Percentage of participants with a SAE / SADR
Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)
Time frame
24 weeks3
Percentage of participants with an UAE/ UADR
Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)
Time frame
24 weeks4
Percentage of participants with a SUAE/ SUADR
Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)
Time frame
24 weeksSecondary outcomes
1
Major molecular response rate
Major molecular response (MMR) rate at week 12 and week 24
Time frame
week 12, week 242
Molecular response 4 rate
Molecular response 4 (MR4) rate. Molecular response (MR) is a Breakpoint Cluster Region protein Tyrosine-protein kinase ABL1 (BCR-ABL1) transcript that is assessed by real-time quantitative PCR (RQ-PCR) in the blood at screening. Molecular response levels are indicated with a superscript indicating the log reduction from the standardized baseline, corresponding to 100% on the international scale (IS).
Time frame
week 12, week 243
Molecular response 4.5 rate
Molecular response 4.5 (MR4.5) rate. Molecular response (MR) is a Breakpoint Cluster Region protein Tyrosine-protein kinase ABL1 (BCR-ABL1) transcript that is assessed by real-time quantitative PCR (RQ-PCR) in the blood at screening. Molecular response levels are indicated with a superscript indicating the log reduction from the standardized baseline, corresponding to 100% on the international scale (IS).
Time frame
week 12 ,week 244
Number of participants with CCyR and/or BCR-ABL1 IS<1%
Complete cytogenetic response (CCyR) rate and/or BCR-ABL1 IS\<1%. A complete cytogenetic response (CCyR) is defined as absence of the Ph (0%) among at least 20 cells in metaphase in a bone marrow aspirate.
Time frame
week 12,week 24Sponsors and contacts
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Source ClinicalTrials.gov