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)

January 8, 2024 updated by: Novartis Pharmaceuticals
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

Study Population: Key Inclusion/Exclusion Criteria Inclusion criteria

  • Diagnosis of CML (chronic phase, accelerated phase or blast crisis).
  • Confirmed presence of T315I mutation prior to asciminib initiation.
  • Patients enrolled in the asciminib MAP and received their first dose of asciminib between 01 November 2018 and 30 April 2022. Patients must have received at least one dose of asciminib.

  • Appropriate approval was obtained for the patient chart review including:

    • Patient signed the informed consent form (ICF) or,
    • Individual ICF waiver was granted by an institutional review board/ Independent Ethics Committee (IRB)/ IEC.

Exclusion criteria

• Age less than 18 years old at the time of initiating asciminib treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Asciminib

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Major molecular response (MMR) at 6 months
Time Frame: At 6 months
At 6 months
Major molecular response (MMR) by 6 months
Time Frame: By 6 months
By 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: Baseline
Baseline
Race
Time Frame: Baseline
Baseline
MMR at and by 3, 9, and 12 months
Time Frame: At and by 3, 9, and 12 months
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
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
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
At and by 3, 6, 9, and 12 months
Time from CML diagnosis to study index (i.e., asciminib) start date
Time Frame: Baseline
Baseline
Country of residence
Time Frame: Baseline
Baseline
Status of CML at baseline
Time Frame: Baseline
Baseline
Number of patients per response type at asciminib start date
Time Frame: Baseline
Response types were MMR, CCyR, and CHR.
Baseline
Stem-cell transplant performed status
Time Frame: Baseline
Baseline
Medical history by system-organ-class, preferred term from CML diagnosis to asciminib start date
Time Frame: Baseline
Baseline
Overall tyrosine kinase inhibitors (TKIs) prior to index date
Time Frame: Baseline
Baseline
Prior TKIs between CML diagnosis and T315I mutation diagnosis
Time Frame: Baseline
Baseline
Prior TKIs between T315I mutation diagnosis and index date
Time Frame: Baseline
Baseline
Sequence of prior TKI treatment patterns
Time Frame: Baseline
Baseline
Number of patients with response to prior TKIs from CML diagnosis to asciminib (index date)
Time Frame: Baseline
Response types were MMR, CCyR, and CHR.
Baseline
Number of patients with response to prior TKIs between CML diagnosis to T315I mutation diagnosis
Time Frame: Baseline
Response types were MMR, CCyR, and CHR.
Baseline
Number of patients with response to prior TKIs between T315I mutation diagnosis to asciminib start (index date)
Time Frame: Baseline
Response types were MMR, CCyR, and CHR.
Baseline
Number of patients with intolerance to prior TKIs, per category
Time Frame: Baseline
Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Baseline
Number of patients with intolerance to last TKI prior to asciminib, per category
Time Frame: Baseline
Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Baseline
Asciminib dose
Time Frame: Up to 13 months
Up to 13 months
Asciminib discontinuation
Time Frame: Up to 13 months
Up to 13 months
Duration of exposure to asciminib
Time Frame: Up to 13 months
Up to 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CABL001A2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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