Chronic Myeloid Leukemia With T315I MutationNCT06211153
Real-world Effectiveness of Asciminib and Treatment Patterns in Patients With Chronic Myeloid Leukemia With T315I Mutation - a Chart Review Study of Patients Treated in the Asciminib Managed Access Program (MAP)
An observational study of Chronic Myeloid Leukemia With T315I Mutation, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia With T315I Mutation
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Dec 2021to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
None listed.
Who cannot join
- Age less than 18 years old at the time of initiating asciminib treatment.
Trial locations and contacts
1 site in 1 country.
About this study
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asciminib | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major molecular response (MMR) at 6 months
Measured: At 6 months
Major molecular response (MMR) by 6 months
Measured: By 6 months
Secondary outcomes (24)
MMR at and by 3, 9, and 12 months
Measured: At and by 3, 9, and 12 months
Complete cytogenic response (CCyR) at and by 3, 6, 9, and 12 months
Measured: At and by 3, 6, 9, and 12 months
Complete hematologic response (CHR) at and by 3, 6, 9, and 12 months
Measured: At and by 3, 6, 9, and 12 months
Time to first CCyR at and by 3, 6, 9, and 12 months
Measured: At and by 3, 6, 9, and 12 months
Gender
Measured: Baseline
Race
Measured: Baseline
Time from CML diagnosis to study index (i.e., asciminib) start date
Measured: Baseline
Country of residence
Measured: Baseline
Status of CML at baseline
Measured: Baseline
Number of patients per response type at asciminib start date
Response types were MMR, CCyR, and CHR.
Measured: Baseline
Stem-cell transplant performed status
Measured: Baseline
Medical history by system-organ-class, preferred term from CML diagnosis to asciminib start date
Measured: Baseline
Overall tyrosine kinase inhibitors (TKIs) prior to index date
Measured: Baseline
Prior TKIs between CML diagnosis and T315I mutation diagnosis
Measured: Baseline
Prior TKIs between T315I mutation diagnosis and index date
Measured: Baseline
Sequence of prior TKI treatment patterns
Measured: Baseline
Number of patients with response to prior TKIs from CML diagnosis to asciminib (index date)
Response types were MMR, CCyR, and CHR.
Measured: Baseline
Number of patients with response to prior TKIs between CML diagnosis to T315I mutation diagnosis
Response types were MMR, CCyR, and CHR.
Measured: Baseline
Number of patients with response to prior TKIs between T315I mutation diagnosis to asciminib start (index date)
Response types were MMR, CCyR, and CHR.
Measured: Baseline
Number of patients with intolerance to prior TKIs, per category
Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Measured: Baseline
Number of patients with intolerance to last TKI prior to asciminib, per category
Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Measured: Baseline
Asciminib dose
Measured: Up to 13 months
Asciminib discontinuation
Measured: Up to 13 months
Duration of exposure to asciminib
Measured: Up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start31 Dec 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia With T315I MutationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
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
- NCT06211153
- Sponsor's protocol ID
- CABL001A2004
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness of Asciminib and Treatment Patterns in Patients With Chronic Myeloid Leukemia With T315I Mutation - a Chart Review Study of Patients Treated in the Asciminib Managed Access Program (MAP)
- ClinicalTrials.gov ID
- NCT06211153
- Acronym / sponsor ID
- CABL001A2004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 18 Jan 2024 (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 non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asciminib | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Age less than 18 years old at the time of initiating asciminib treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major molecular response (MMR) at 6 months
Time frame: At 6 months
Major molecular response (MMR) by 6 months
Time frame: By 6 months
24 secondary outcomes
MMR at and by 3, 9, and 12 months
Time frame: At and by 3, 9, and 12 months
Complete cytogenic response (CCyR) at and by 3, 6, 9, and 12 months
Time frame: At and by 3, 6, 9, and 12 months
Complete hematologic response (CHR) at and by 3, 6, 9, and 12 months
Time frame: At and by 3, 6, 9, and 12 months
Time to first CCyR at and by 3, 6, 9, and 12 months
Time frame: At and by 3, 6, 9, and 12 months
Gender
Time frame: Baseline
Race
Time frame: Baseline
Time from CML diagnosis to study index (i.e., asciminib) start date
Time frame: Baseline
Country of residence
Time frame: Baseline
Status of CML at baseline
Time frame: Baseline
Number of patients per response type at asciminib start date
Time frame: Baseline
Stem-cell transplant performed status
Time frame: Baseline
Medical history by system-organ-class, preferred term from CML diagnosis to asciminib start date
Time frame: Baseline
Overall tyrosine kinase inhibitors (TKIs) prior to index date
Time frame: Baseline
Prior TKIs between CML diagnosis and T315I mutation diagnosis
Time frame: Baseline
Prior TKIs between T315I mutation diagnosis and index date
Time frame: Baseline
Sequence of prior TKI treatment patterns
Time frame: Baseline
Number of patients with response to prior TKIs from CML diagnosis to asciminib (index date)
Time frame: Baseline
Number of patients with response to prior TKIs between CML diagnosis to T315I mutation diagnosis
Time frame: Baseline
Number of patients with response to prior TKIs between T315I mutation diagnosis to asciminib start (index date)
Time frame: Baseline
Number of patients with intolerance to prior TKIs, per category
Time frame: Baseline
Number of patients with intolerance to last TKI prior to asciminib, per category
Time frame: Baseline
Asciminib dose
Time frame: Up to 13 months
Asciminib discontinuation
Time frame: Up to 13 months
Duration of exposure to asciminib
Time frame: Up to 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site 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 With T315I Mutation, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major molecular response (MMR) at 6 months (time frame: At 6 months). The study lists 2 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 18 Jan 2024.