Chronic Myeloid LeukemiaNCT05611216
Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation
An observational study of Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The study was a retrospective, non-interventional patient chart review and used a panel of oncologists/hematologists from the US to collect real-world clinical outcomes of patients with CML-CP in 3L+ and those with the T315I mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 23 Dec 2021
- 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: Patients with Chronic Myeloid Leukemia and those with T315I Mutation in the United States
Who may be able to join
- Physician selection
- Physicians were eligible to participate in the study if they fulfilled all of the following criteria:
- Completed medical subspecialty training
- Reported hematology, medical oncology, or any other oncology subspecialties as the primary medical subspecialty
- Were responsible for treatment decisions and follow-up for ≥ 1 adult patient with Ph+ CML-CP who received a 3L or those with the T315I mutation since January 2013 (the date from which molecular monitoring response on the International Scale (IS) became a more standard procedure/commonly available
- Had access to molecular monitoring results reported on the IS, and with a sensitivity level of precision for molecular response of MR3 (BCR ABL1/ABL1 ≤ 0.1% or 3-log reduction) or better
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- Patient selection Participating physicians were directed to provide information on patients who were included into the following separate cohorts. Each participating physician contributed up to 5 patient medical charts from each cohort.
- For the 3L cohort:
- Adult patients diagnosed with Ph+ CML-CP who initiated a 1L therapy, switched to a 2L therapy, and initiated a 3L therapy for CML-CP
- All lines of therapy (TKIs or other CML treatments) received outside of an interventional clinical trial setting
- 3L therapy was initiated on or after January 1st, 2013 (when molecular monitoring became a common practice in CML monitoring) and no later than November 30th, 2018, to have a minimum of 2 years of follow-up after therapy initiation, except if the patient died before
- For the T315I cohort:
- Adult patients diagnosed with Ph+ CML-CP who initiated ≥ 1 line of therapy for Ph+ CML-CP and T315I mutation was identified
- All lines of therapy (TKIs or other CML treatments) received outside of an interventional clinical trial setting
- Line of therapy identified as the T315I line of interest was initiated on or after January 1st, 2013, and no later than November 30th, 2018, to have a minimum of 2 years of follow-up after therapy initiation, except if the patient died before
- For both cohorts:
- Patients with Ph+ CML-CP for whom the physician had complete information on the CML related care from CML diagnosis and for ≥ 2 years after the initiation of line of therapy of interest (i.e., 3L or line of therapy identified as the T315I line of interest), unless the patient died before. Complete information included: CML treatments, treatment duration, routine laboratory (e.g., complete blood count (CBC), BCR-ABL), CML status (e.g., SOKAL risk score, CP/accelerated phase (AP)/ blast crisis (BC)), medications, and clinical status (e.g., history, physical exam)
- The physician had access to molecular monitoring results reported on the IS from initiation of the line of therapy of interest and with a sensitivity level of precision for molecular response of MR3 (BCR-ABL1/ABL1≤0.1% or 3-log reduction) or better Of note, the cohorts were not mutually exclusive such that patients included in the 3L cohort with T315I mutation was included in the T315I cohort. Thereafter, there was an oversampling of patients with T315I mutation. Patients from the T315I cohort from the oversampling with a 3L were not included in the 3L cohort.
Who cannot join
- Physicians and patients who did not meet study inclusion criteria detailed above were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936
About this study
Official title: Assessing Real-world Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation in the United States (ARC Study)
The study was a retrospective, non-interventional patient chart review and used a panel of oncologists/hematologists from the US to collect real-world clinical outcomes of patients with CML-CP in 3L+ and those with the T315I mutation.
Read the detailed description
This study included two distinct cohorts of CML-CP patients; that is, patients with CML-CP who initiated 3L for CML-CP (i.e., 3L cohort) and patients with CML-CP with T315I mutation (i.e., T315I cohort).
Study design for the analyses of the 3L cohort:
- The index date: date of initiation of 3L therapy for CML-CP
- The study period: period of ≥ 24 months following the index date unless the patient died before
- Patient characteristics were measured at CML diagnosis and at the index date
- The clinical outcomes of interest were measured during the study period
Study design for the analyses of the T315I cohort:
- The index date: date of initiation of a line of therapy identified as the T315I line of interest (i.e., identification of T315I mutation before initiation or over the course of line of therapy)
- The study period: period of ≥ 24 months following the index date unless the patient died before
- Patient characteristics were measured at CML diagnosis and at the index date.
- The clinical outcomes of interest were measured during the study period
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- CML,, CP,, case report from,, lines of therapy,, T315I mutation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Third-line (3L) Cohort | patients with Chronic Myeloid Leukemia - Chronic Phase (CML-CP) who initiated 3L for CML-CP | |
| T315I Cohort | patients with CML-CP with T315I mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lines of therapy
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients with total number of lines
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients: Treatment received
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients: Calendar year of line of therapy initiation
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Duration of line of therapy
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients with most frequent treatment sequences from first- to third-line of therapy
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who died after initiation of third-line therapy
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who progressed to AP/BC after initiation of third-line therapy
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who underwent HSCT after initiation of third-line therapy
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients developed graft versus host disease after undergoing HSCT3
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who were still on the third-line therapy as of the data collection date
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Secondary outcomes (20)
Number of patients who achieved molecular response during third-line therapy
To evaluate the effectiveness of TKIs and other CML treatments used in 3L+ settings in patients with CML-CP
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved cytogenic response during third-line therapy
To evaluate the effectiveness of TKIs and other CML treatments used in 3L+ settings in patients with CML-CP
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved complete hematologic response during third-line therapy
To evaluate the effectiveness of TKIs and other CML treatments used in 3L+ settings in patients with CML-CP
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved molecular response during the line of therapy identified as the T315I line of interest
To evaluate the effectiveness of TKIs and other treatments used in a line of therapy identified as the T315I line of interest in patients with CML-CP
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved cytogenic response during the line of therapy identified as the T315I line of interest
To evaluate the effectiveness of TKIs and other treatments used in a line of therapy identified as the T315I line of interest in patients with CML-CP
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved complete hematologic response during the line of therapy identified as the T315I line of interest
To evaluate the effectiveness of TKIs and other treatments used in a line of therapy identified as the T315I line of interest in patients with CML-CP
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of lines of therapy in T315I cohort
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients: Total number of lines in T315I cohort
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number pf patients: Line identified as the T315I line of interest
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients: Treatment received in T315I Cohort
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients: Calendar year of line of therapy initiation in T315I Cohort
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Duration of line of therapy in T315I Cohort
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Most frequent treatment sequences in T315I Cohort
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who died after initiation of the line identified as the T315I line of interest
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who progressed to AP/BC after initiation of the line identified as the T315I line of interest
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who underwent HSCT after initiation of the line identified as the T315I line of interest
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients developed graft versus host disease after undergoing HSCT
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who were still on the line identified as the T315I line of interest as of the data collection date
To evaluate treatment patterns in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients with BCR-ABL testing in 3L cohort
To evaluate real-world BCR-ABL testing frequency per the latest National Comprehensive Cancer Network (NCCN) guidelines in 3L settings in patients with CML-CP
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients with BCR-ABL testing in T315I cohort
To evaluate real-world BCR-ABL testing frequency per the latest NCCN guidelines in patients with CML-CP with T315I mutation
Measured: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Dec 2020
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 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
- NCT05611216
- Sponsor's protocol ID
- CABL001AUS09
- Status last verified
- Apr 2023
- First submitted
- 4 Nov 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Real-world Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation in the United States (ARC Study)
- ClinicalTrials.gov ID
- NCT05611216
- Acronym / sponsor ID
- CABL001AUS09
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- CML,, CP,, case report from,, lines of therapy,, T315I mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 9 Nov 2022 (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.
The study was a retrospective, non-interventional patient chart review and used a panel of oncologists/hematologists from the US to collect real-world clinical outcomes of patients with CML-CP in 3L+ and those with the T315I mutation.
Detailed description
This study included two distinct cohorts of CML-CP patients; that is, patients with CML-CP who initiated 3L for CML-CP (i.e., 3L cohort) and patients with CML-CP with T315I mutation (i.e., T315I cohort).
Study design for the analyses of the 3L cohort:
- The index date: date of initiation of 3L therapy for CML-CP
- The study period: period of ≥ 24 months following the index date unless the patient died before
- Patient characteristics were measured at CML diagnosis and at the index date
- The clinical outcomes of interest were measured during the study period
Study design for the analyses of the T315I cohort:
- The index date: date of initiation of a line of therapy identified as the T315I line of interest (i.e., identification of T315I mutation before initiation or over the course of line of therapy)
- The study period: period of ≥ 24 months following the index date unless the patient died before
- Patient characteristics were measured at CML diagnosis and at the index date.
- The clinical outcomes of interest were measured during the study period
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Third-line (3L) Cohort | – | –patients with Chronic Myeloid Leukemia - Chronic Phase (CML-CP) who initiated 3L for CML-CP |
| T315I Cohort | – | –patients with CML-CP with T315I mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Myeloid Leukemia and those with T315I Mutation in the United States
Key inclusion criteria (18 listed)
- Physician selection
- Physicians were eligible to participate in the study if they fulfilled all of the following criteria:
- Completed medical subspecialty training
- Reported hematology, medical oncology, or any other oncology subspecialties as the primary medical subspecialty
- Were responsible for treatment decisions and follow-up for ≥ 1 adult patient with Ph+ CML-CP who received a 3L or those with the T315I mutation since January 2013 (the date from which molecular monitoring response on the International Scale (IS) became a more standard procedure/commonly available
Key exclusion criteria (1 listed)
- Physicians and patients who did not meet study inclusion criteria detailed above were excluded.
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
Number of lines of therapy
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Number of patients with total number of lines
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Number of patients: Treatment received
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Number of patients: Calendar year of line of therapy initiation
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Duration of line of therapy
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Number of patients with most frequent treatment sequences from first- to third-line of therapy
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Number of patients who died after initiation of third-line therapy
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Number of patients who progressed to AP/BC after initiation of third-line therapy
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Number of patients who underwent HSCT after initiation of third-line therapy
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Number of patients developed graft versus host disease after undergoing HSCT3
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
Number of patients who were still on the third-line therapy as of the data collection date
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy
20 secondary outcomes
Number of patients who achieved molecular response during third-line therapy
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved cytogenic response during third-line therapy
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved complete hematologic response during third-line therapy
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved molecular response during the line of therapy identified as the T315I line of interest
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved cytogenic response during the line of therapy identified as the T315I line of interest
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who achieved complete hematologic response during the line of therapy identified as the T315I line of interest
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of lines of therapy in T315I cohort
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients: Total number of lines in T315I cohort
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number pf patients: Line identified as the T315I line of interest
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients: Treatment received in T315I Cohort
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients: Calendar year of line of therapy initiation in T315I Cohort
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Duration of line of therapy in T315I Cohort
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Most frequent treatment sequences in T315I Cohort
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who died after initiation of the line identified as the T315I line of interest
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who progressed to AP/BC after initiation of the line identified as the T315I line of interest
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who underwent HSCT after initiation of the line identified as the T315I line of interest
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients developed graft versus host disease after undergoing HSCT
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients who were still on the line identified as the T315I line of interest as of the data collection date
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients with BCR-ABL testing in 3L cohort
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
Number of patients with BCR-ABL testing in T315I cohort
Time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)
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 6 Apr 2023.
- Results for CABL001AUS09 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- 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. 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, run by Novartis Pharmaceuticals at 1 site in United States.
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 18 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 6 Apr 2023. 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 United States. 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?
Number of lines of therapy (time frame: throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)). The study lists 11 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 6 Apr 2023.