Chronic Myeloid LeukemiaNCT05943522
Asciminib RMP Study
An observational study of Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 17 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Asciminib
- How many people
- 600 participants
- Where
- 17 sitesSouth Korea
- Study dates
- 19 Jul 2023to 7 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
17 sites in 1 country
South Korea17 sites, 17 recruiting
- Recruiting
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 14068
- Recruiting
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 14584
- Recruiting
Novartis Investigative Site
Gyeonggi-do, Korea, 10408
- Recruiting
Novartis Investigative Site
Incheon, Korea, 405 760
- Recruiting
Novartis Investigative Site
Jeollanam, 519763
- Recruiting
Novartis Investigative Site
Pusan, 614 735
- Recruiting
Novartis Investigative Site
Seoul, Korea, 02841
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 03080
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 06351
- Recruiting
Novartis Investigative Site
Seoul, Yangcheon gu, 07985
- Recruiting
Novartis Investigative Site
Seoul, 03722
- Recruiting
Novartis Investigative Site
Seoul, 05505
- Recruiting
Novartis Investigative Site
Seoul, 06591
- Recruiting
Novartis Investigative Site
Suwon, Yeongtong Gu, 16499
- Recruiting
Novartis Investigative Site
Taegu, 41944
- Recruiting
Novartis Investigative Site
Uijeongbu-si, Gyeonggi-do, 11759
- Recruiting
Novartis Investigative Site
Wŏnju, Gangwon-do, 26426
About this study
Official title: A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea
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.
Read the detailed description
The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Asciminib.
This study will enroll all patients by total enumeration for those prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice for 2 years after the market launch.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Asciminib
- Keywords
- Scemblix, Asciminib, CML, Chronic Myeloid Leukemia
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsciminibOther
Also called Scemblix
There is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
| Study group | Role | What they receive |
|---|---|---|
| Asciminib | Patients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice Receives: Other: Asciminib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with an AE / ADR
Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)
Measured: 24 weeks
Percentage of participants with a SAE / SADR
Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)
Measured: 24 weeks
Percentage of participants with an UAE/ UADR
Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)
Measured: 24 weeks
Percentage of participants with a SUAE/ SUADR
Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)
Measured: 24 weeks
Secondary outcomes (4)
Major molecular response rate
Major molecular response (MMR) rate at week 12 and week 24
Measured: week 12, week 24
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).
Measured: week 12, week 24
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).
Measured: week 12 ,week 24
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.
Measured: week 12,week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start19 Jul 2023
- Primary completion7 Jun 2030 (estimated)
- Study completion7 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943522
- Sponsor's protocol ID
- CABL001A2006
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea
- ClinicalTrials.gov ID
- NCT05943522
- Acronym / sponsor ID
- CABL001A2006
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Scemblix, Asciminib, CML, Chronic Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 7 Jun 2030 (estimated)
- Study completion
- 7 Jun 2030 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Asciminib.
This study will enroll all patients by total enumeration for those prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice for 2 years after the market launch.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asciminib | – | Other: AsciminibPatients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsciminibAlso: ScemblixThere is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis | Other | Asciminib |
Primary outcome
Percentage of participants with an AE / ADR
Time frame: 24 weeks
Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)
Percentage of participants with a SAE / SADR
Time frame: 24 weeks
Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)
Percentage of participants with an UAE/ UADR
Time frame: 24 weeks
Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)
Percentage of participants with a SUAE/ SUADR
Time frame: 24 weeks
Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)
4 secondary outcomes
Major molecular response rate
Time frame: week 12, week 24
Molecular response 4 rate
Time frame: week 12, week 24
Molecular response 4.5 rate
Time frame: week 12 ,week 24
Number of participants with CCyR and/or BCR-ABL1 IS<1%
Time frame: week 12,week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 17 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with an AE / ADR (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.