Leukemia, Myeloid, Chronic-PhaseNCT07374120
Treatment Patterns and Key Endpoints Among Patients With Chronic-Phase Chronic Myeloid Leukemia in a Community Oncology Setting
An observational study of Leukemia, Myeloid, Chronic-Phase, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective observational study to examine treatment patterns, molecular testing patterns, treatment response, and clinical outcomes among patients initiating first-line (1L) tyrosine kinase inhibitor (TKI) treatment for CML-CP in The United States (US) Oncology Network practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic-Phase
- How many people
- 1,480 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 21 Jan 2025
- 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
- Patients whose data were accessible for research purposes during the study observation period.
- Patients diagnosed with CML-CP at first recorded diagnosis of CML.
- Patients ≥ 18 years of age at first recorded diagnosis of CML.
- Patients who initiated qualifying 1L therapy for CML-CP during the study identification period. Qualifying 1L therapy treatments consisted of imatinib, dasatinib, bosutinib, or nilotinib as monotherapy.
- Patients with ≥1 visit within The US Oncology Network practices following initiation of 1L therapy and through the end of the study observation period.
Who cannot join
- Patients enrolled in interventional clinical trials during the study observation period.
- Patients who received any systemic treatment indicated for another primary cancer during the study observation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns and Key Endpoints Among Patients With Chronic-Phase Chronic Myeloid Leukemia (CML-CP) in a Community Oncology Setting
This was a retrospective observational study to examine treatment patterns, molecular testing patterns, treatment response, and clinical outcomes among patients initiating first-line (1L) tyrosine kinase inhibitor (TKI) treatment for CML-CP in The United States (US) Oncology Network practices.
Patients who initiated 1L therapy between 01 January 2016 and 31 December 2022 were eligible for inclusion in the study. Study-eligible patients were followed longitudinally post-index until death (if the patient had documentation of death during the study observation period) or last available patient record that occurred on or before the end of the study observation period. The study observation period was from 01 January 2016 to 30 November 2023. The index date was defined as the start date of 1L therapy for CML-CP.
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Keywords
- CML, Tyrosine kinase inhibitors, Treatment patterns, Real-world
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
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 |
|---|---|---|
| CML-CP Group | Patients with a diagnosis of CML-CP who initiated 1L TKI treatment in The US Oncology Network practices between 01 January 2016 and 31 December 2022. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Initial CML Diagnosis to Initiation of 1L TKI Treatment
Measured: Baseline
Number of Patients who Received a Stem Cell Transplant (SCT)
Measured: Up to approximately 7 years
Number of Patients by Type of 1L and Second-line (2L) TKI Treatment
Measured: Up to approximately 7 years
Number of Patients by Initial Dose of Each TKI in 1L and 2L Treatment
Measured: Up to approximately 7 years
Number of Patients by Treatment Sequence From 1L TKI to 2L TKI Treatment
Measured: Up to approximately 7 years
Number of Patients by Dose Modification of 1L and 2L TKI Treatment
Dose modifications included dose escalation, reduction, or hold.
Measured: Up to approximately 7 years
Number of Patients by Reason for Dose Modification of 1L and 2L TKI Treatment
Dose modifications included dose escalation, reduction, or hold.
Measured: Up to approximately 7 years
Number of Patients who Discontinued 1L and 2L TKI Treatment
Measured: Up to approximately 7 years
Number of Patients by Reason for Discontinuing 1L and 2L TKI Treatment
Measured: Up to approximately 7 years
Number of Patients by Clinical Events of Interest During 1L and 2L TKI Treatment
Clinical events of interest included:
- Alopecia
- Anemia
- Arthralgia/Myalgia
- Diarrhea
- Elevated liver enzyme
- Elevated serum creatinine
- Fatigue
- Febrile neutropenia
- Infection secondary to neutropenia
- Interstitial lung disease-like events
- Leukopenia
- Nausea
- Neutropenia
- Pain
- Prolongation of QT interval
- Thrombocytopenia
- Venous embolism (including pulmonary embolism and/or deep vein thrombosis)
- Vomiting
Measured: Up to approximately 7 years
Number of Patients by Best Overall Molecular Response (MR) Achieved During 1L and 2L TKI Treatment
MR was based on BCR::ABL (International Scale [IS]) qPCR testing results. Molecular response was categorized as:
- MR 2: if BCR::ABL (IS) >0.1% - ≤ 1%
- Major MR (MMR)/MR 3: if BCR::ABL(IS) >0.01% - ≤0.1%
- MR 4: if BCR::ABL1 (IS) >0.0032% -≤0.01%
- MR 4.5: if BCR::ABL (IS) ≤0.0032%
- Not documented
Measured: Up to approximately 7 years
Number of Patients by Best Overall MR Achieved Within 12 Months of Initiating 1L and 2L TKI Treatment
MR was based on BCR::ABL (IS) qPCR testing results. Molecular response was categorized as:
- MR 2: if BCR::ABL (IS) >0.1% - ≤ 1%
- Major MR (MMR)/MR 3: if BCR::ABL(IS) >0.01% - ≤0.1%
- MR 4: if BCR::ABL1 (IS) >0.0032% -≤0.01%
- MR 4.5: if BCR::ABL (IS) ≤0.0032%
- Not documented
Measured: From Baseline up to 12 months
Number of Patients by MR Achieved After Initiating 1L and 2L TKI Treatment
MR was based on BCR::ABL (IS) qPCR testing results. Molecular response was categorized as:
- MR 2: if BCR::ABL (IS) >0.1% - ≤ 1%
- Major MR (MMR)/MR 3: if BCR::ABL(IS) >0.01% - ≤0.1%
- MR 4: if BCR::ABL1 (IS) >0.0032% -≤0.01%
- MR 4.5: if BCR::ABL (IS) ≤0.0032%
- Not documented
Measured: 6, 12, 18, and 24 months
Number of Patients who Achieved a BCR::ABL (IS) Result ≤10% Within 6 Months of Initiating 1L and 2L TKI Treatment
Measured: From Baseline up to 6 months
Number of Patients who Achieved or Sustained a BCR::ABL (IS) Result <1% Between 6 and 12 Months After Initiating 1L and 2L TKI Treatment
Measured: From Month 6 to Month 12
Number of Patients who Achieved or Sustained a BCR::ABL (IS) Result ≤0.1% Between 13 and 24 Months After Initiating 1L and 2L TKI Treatment
Measured: From Month 13 to Month 24
Number of Patients who Achieved or Sustained a BCR::ABL (IS) Result ≤0.1% After 24 Months Following Initiating 1L and 2L TKI Treatment
Measured: From Month 24 to end of study, up to approximately 6 years
Number of Patients who Achieved Complete Hematologic Response (CHR) During 1L and 2L TKI Treatment
CHR was observed when white blood cells, hemoglobin, and platelet counts were all within each respective normal lab range.
Measured: Up to approximately 7 years
Number of Patients who Achieved CHR Within 12 Months of Initiating 1L and 2L TKI Treatment
CHR was observed when white blood cells, hemoglobin, and platelet counts were all within each respective normal lab range.
Measured: From Baseline up to 12 months
Number of Patients who Achieved Complete Cytogenetic Response (CCyR) During 1L and 2L TKI Treatment
Cytogenetic response was based on the Philadelphia chromosome results. CCyR was defined as having no Philadelphia chromosome-positive metaphases.
Measured: Up to approximately 7 years
Number of Patients who Achieved CCyR Within 12 Months of Initiating 1L and 2L TKI Treatment
Cytogenetic response was based on the Philadelphia chromosome results. CCyR was defined as having no Philadelphia chromosome-positive metaphases.
Measured: From Baseline up to 12 months
Duration of Therapy (DOT) for 1L TKI Treatment
DOT was defined as the interval between the start date of the 1L therapy (index date) and the end date of 1L therapy, including any treatment interruptions or other breaks.
Measured: Up to approximately 7 years
DOT for 2L TKI Treatment
DOT was defined as the interval between the start date of the 2L therapy and the end date of 2L therapy, including any treatment interruptions or other breaks.
Measured: Up to approximately 7 years
Progression-free Survival (PFS) for 1L TKI Treatment
PFS was defined as physician-documented progression, loss of MR2, BCR::ABL (IS) ≤1%, or an increase in BCR::ABL1 transcript to >1%, or a 1-log increase in BCR::ABL1 transcript levels with loss of MMR.
Measured: Up to approximately 7 years
PFS for 2L TKI Treatment
PFS was defined as physician-documented progression, loss of MR2, BCR::ABL (IS) ≤1%, or an increase in BCR::ABL1 transcript to >1%, or a 1-log increase in BCR::ABL1 transcript levels with loss of MMR.
Measured: Up to approximately 7 years
Overall Survival (OS) for 1L TKI Treatment
OS was defined as the interval between the start date of 1L therapy (index date) and the date of death (any cause).
Measured: Up to approximately 7 years
Overall Survival (OS) for 2L TKI Treatment
OS was defined as the interval between the start date of 2L therapy and the date of death (any cause).
Measured: Up to approximately 7 years
Treatment-free Interval (TFI)
TFI was defined as the interval between the discontinuation date of 1L therapy and the start date of 2L therapy or date of death.
Measured: Up to approximately 7 years
Secondary outcomes (17)
Number of Patients With BCR::ABL Testing (per National Comprehensive Cancer Network (NCCN) Guidelines) at Diagnosis
Measured: Baseline
Number of Patients With BCR::ABL Testing (per NCCN Guidelines) in 3-Month Intervals After Initiation of 1L and 2L TKI Treatment Until BCR::ABL1 ≤1% was Achieved
Measured: Up to approximately 7 years
After Initiation of 1L and 2L TKI Treatment, Number of Patients With BCR::ABL Testing (per NCCN Guidelines) in 3-Month Intervals Within 2 Years After BCR::ABL1 ≤1% was Achieved
Measured: 2 years
After Initiation of 1L and 2L TKI Treatment, Number of Patients With BCR::ABL Testing (per NCCN Guidelines) Between 1 and 3 Months Following 2 Years After BCR::ABL1 ≤1% was Achieved
Measured: Up to approximately 5 years
Number of BCR::ABL Tests (per NCCN Guidelines) After Initiation of 1L and 2L TKI Treatment Until BCR::ABL1 ≤1% was Achieved
Measured: Up to approximately 7 years
Following Initiation of 1L and 2L TKI Treatment, Number of BCR::ABL Tests (per NCCN Guidelines) Within 2 Years After Achieving BCR::ABL1 ≤1%
Measured: 2 years
Following Initiation of 1L and 2L TKI Treatment, Number of BCR::ABL Tests (per NCCN Guidelines) Performed After 2 Years of Achieving BCR::ABL1 ≤1%
Measured: Up to approximately 5 years
Number of Patients With BCR::ABL Testing (per European LeukemiaNet (ELN) Guidelines) at Diagnosis
Measured: Baseline
Number of Patients With BCR::ABL Testing (per ELN Guidelines) in 3-Month Intervals After Initiation of 1L and 2L TKI Treatment Until BCR::ABL1 ≤0.1% was Achieved
Measured: Up to approximately 7 years
Number of Patients With BCR::ABL Testing (per ELN Guidelines) Tested in 3-Month Intervals After Initiation of 1L Until BCR::ABL1 ≤0.1% was Achieved and Tested Between 2 to 6 Months Until CCyR was Achieved
Measured: 5 months
Number of Patients With BCR::ABL Testing (per ELN Guidelines) Tested in 3-Month Intervals After Initiation of 2L Until BCR::ABL1 ≤0.1% was Achieved and Tested Between 2 to 6 Months Until CCyR was Achieved
Measured: 5 months
Number of Patients With BCR::ABL Testing (per ELN Guidelines) Tested in 3-Month Intervals After Initiation of 1L Until BCR::ABL1 ≤0.1% was Achieved and Tested Every 12 Months Until CCyR was Achieved
Measured: Up to approximately 7 years
Number of Patients With BCR::ABL Testing (per ELN Guidelines) Tested in 3-Month Intervals After Initiation of 2L Until BCR::ABL1 ≤0.1% was Achieved and Tested Every 12 Months Until CCyR was Achieved
Measured: Up to approximately 7 years
Number of BCR::ABL Tests (per ELN Guidelines) After Initiation of 1L and 2L TKI Treatment Until BCR::ABL1 ≤0.1% was Achieved
Measured: Up to approximately 7 years
Number of BCR::ABL Tests (per ELN Guidelines) After Initiation of 1L and 2L TKI Treatment Until CCyR was Achieved
Measured: Up to approximately 7 years
Number of Molecular Testing by Year Following Initiation of 1L TKI Treatment During Which the T315I Mutation was Identified
Measured: Up to approximately 7 years
Number of Patients With T3151 Mutation Testing During 1L and 2L TKI Treatment
Measured: Up to approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Feb 2024
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, Chronic-PhaseStudies 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
- 1,480 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
- NCT07374120
- Sponsor's protocol ID
- CABL001A0US12
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Key Endpoints Among Patients With Chronic-Phase Chronic Myeloid Leukemia (CML-CP) in a Community Oncology Setting
- ClinicalTrials.gov ID
- NCT07374120
- Acronym / sponsor ID
- CABL001A0US12
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Keywords
- CML, Tyrosine kinase inhibitors, Treatment patterns, Real-world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,480 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 28 Jan 2026 (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 was a retrospective observational study to examine treatment patterns, molecular testing patterns, treatment response, and clinical outcomes among patients initiating first-line (1L) tyrosine kinase inhibitor (TKI) treatment for CML-CP in The United States (US) Oncology Network practices.
Patients who initiated 1L therapy between 01 January 2016 and 31 December 2022 were eligible for inclusion in the study. Study-eligible patients were followed longitudinally post-index until death (if the patient had documentation of death during the study observation period) or last available patient record that occurred on or before the end of the study observation period. The study observation period was from 01 January 2016 to 30 November 2023. The index date was defined as the start date of 1L therapy for CML-CP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CML-CP Group | – | –Patients with a diagnosis of CML-CP who initiated 1L TKI treatment in The US Oncology Network practices between 01 January 2016 and 31 December 2022. |
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 (5 listed)
- Patients whose data were accessible for research purposes during the study observation period.
- Patients diagnosed with CML-CP at first recorded diagnosis of CML.
- Patients ≥ 18 years of age at first recorded diagnosis of CML.
- Patients who initiated qualifying 1L therapy for CML-CP during the study identification period. Qualifying 1L therapy treatments consisted of imatinib, dasatinib, bosutinib, or nilotinib as monotherapy.
- Patients with ≥1 visit within The US Oncology Network practices following initiation of 1L therapy and through the end of the study observation period.
Key exclusion criteria (2 listed)
- Patients enrolled in interventional clinical trials during the study observation period.
- Patients who received any systemic treatment indicated for another primary cancer during the study 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.
Primary outcome
Time From Initial CML Diagnosis to Initiation of 1L TKI Treatment
Time frame: Baseline
Number of Patients who Received a Stem Cell Transplant (SCT)
Time frame: Up to approximately 7 years
Number of Patients by Type of 1L and Second-line (2L) TKI Treatment
Time frame: Up to approximately 7 years
Number of Patients by Initial Dose of Each TKI in 1L and 2L Treatment
Time frame: Up to approximately 7 years
Number of Patients by Treatment Sequence From 1L TKI to 2L TKI Treatment
Time frame: Up to approximately 7 years
Number of Patients by Dose Modification of 1L and 2L TKI Treatment
Time frame: Up to approximately 7 years
Dose modifications included dose escalation, reduction, or hold.
Number of Patients by Reason for Dose Modification of 1L and 2L TKI Treatment
Time frame: Up to approximately 7 years
Dose modifications included dose escalation, reduction, or hold.
Number of Patients who Discontinued 1L and 2L TKI Treatment
Time frame: Up to approximately 7 years
Number of Patients by Reason for Discontinuing 1L and 2L TKI Treatment
Time frame: Up to approximately 7 years
Number of Patients by Clinical Events of Interest During 1L and 2L TKI Treatment
Time frame: Up to approximately 7 years
Clinical events of interest included: * Alopecia * Anemia * Arthralgia/Myalgia * Diarrhea * Elevated liver enzyme * Elevated serum creatinine * Fatigue * Febrile neutropenia * Infection secondary to neutropenia * Interstitial lung disease-like events * Leukopenia * Nausea * Neutropenia * Pain * Prolongation of QT interval * Thrombocytopenia * Venous embolism (including pulmonary embolism and/or deep vein thrombosis) * Vomiting
Number of Patients by Best Overall Molecular Response (MR) Achieved During 1L and 2L TKI Treatment
Time frame: Up to approximately 7 years
MR was based on BCR::ABL (International Scale [IS]) qPCR testing results. Molecular response was categorized as: * MR 2: if BCR::ABL (IS) >0.1% - ≤ 1% * Major MR (MMR)/MR 3: if BCR::ABL(IS) >0.01% - ≤0.1% * MR 4: if BCR::ABL1 (IS) >0.0032% -≤0.01% * MR 4.5: if BCR::ABL (IS) ≤0.0032% * Not documented
Number of Patients by Best Overall MR Achieved Within 12 Months of Initiating 1L and 2L TKI Treatment
Time frame: From Baseline up to 12 months
MR was based on BCR::ABL (IS) qPCR testing results. Molecular response was categorized as: * MR 2: if BCR::ABL (IS) >0.1% - ≤ 1% * Major MR (MMR)/MR 3: if BCR::ABL(IS) >0.01% - ≤0.1% * MR 4: if BCR::ABL1 (IS) >0.0032% -≤0.01% * MR 4.5: if BCR::ABL (IS) ≤0.0032% * Not documented
Number of Patients by MR Achieved After Initiating 1L and 2L TKI Treatment
Time frame: 6, 12, 18, and 24 months
MR was based on BCR::ABL (IS) qPCR testing results. Molecular response was categorized as: * MR 2: if BCR::ABL (IS) >0.1% - ≤ 1% * Major MR (MMR)/MR 3: if BCR::ABL(IS) >0.01% - ≤0.1% * MR 4: if BCR::ABL1 (IS) >0.0032% -≤0.01% * MR 4.5: if BCR::ABL (IS) ≤0.0032% * Not documented
Number of Patients who Achieved a BCR::ABL (IS) Result ≤10% Within 6 Months of Initiating 1L and 2L TKI Treatment
Time frame: From Baseline up to 6 months
Number of Patients who Achieved or Sustained a BCR::ABL (IS) Result <1% Between 6 and 12 Months After Initiating 1L and 2L TKI Treatment
Time frame: From Month 6 to Month 12
Number of Patients who Achieved or Sustained a BCR::ABL (IS) Result ≤0.1% Between 13 and 24 Months After Initiating 1L and 2L TKI Treatment
Time frame: From Month 13 to Month 24
Number of Patients who Achieved or Sustained a BCR::ABL (IS) Result ≤0.1% After 24 Months Following Initiating 1L and 2L TKI Treatment
Time frame: From Month 24 to end of study, up to approximately 6 years
Number of Patients who Achieved Complete Hematologic Response (CHR) During 1L and 2L TKI Treatment
Time frame: Up to approximately 7 years
CHR was observed when white blood cells, hemoglobin, and platelet counts were all within each respective normal lab range.
Number of Patients who Achieved CHR Within 12 Months of Initiating 1L and 2L TKI Treatment
Time frame: From Baseline up to 12 months
CHR was observed when white blood cells, hemoglobin, and platelet counts were all within each respective normal lab range.
Number of Patients who Achieved Complete Cytogenetic Response (CCyR) During 1L and 2L TKI Treatment
Time frame: Up to approximately 7 years
Cytogenetic response was based on the Philadelphia chromosome results. CCyR was defined as having no Philadelphia chromosome-positive metaphases.
Number of Patients who Achieved CCyR Within 12 Months of Initiating 1L and 2L TKI Treatment
Time frame: From Baseline up to 12 months
Cytogenetic response was based on the Philadelphia chromosome results. CCyR was defined as having no Philadelphia chromosome-positive metaphases.
Duration of Therapy (DOT) for 1L TKI Treatment
Time frame: Up to approximately 7 years
DOT was defined as the interval between the start date of the 1L therapy (index date) and the end date of 1L therapy, including any treatment interruptions or other breaks.
DOT for 2L TKI Treatment
Time frame: Up to approximately 7 years
DOT was defined as the interval between the start date of the 2L therapy and the end date of 2L therapy, including any treatment interruptions or other breaks.
Progression-free Survival (PFS) for 1L TKI Treatment
Time frame: Up to approximately 7 years
PFS was defined as physician-documented progression, loss of MR2, BCR::ABL (IS) ≤1%, or an increase in BCR::ABL1 transcript to >1%, or a 1-log increase in BCR::ABL1 transcript levels with loss of MMR.
PFS for 2L TKI Treatment
Time frame: Up to approximately 7 years
PFS was defined as physician-documented progression, loss of MR2, BCR::ABL (IS) ≤1%, or an increase in BCR::ABL1 transcript to >1%, or a 1-log increase in BCR::ABL1 transcript levels with loss of MMR.
Overall Survival (OS) for 1L TKI Treatment
Time frame: Up to approximately 7 years
OS was defined as the interval between the start date of 1L therapy (index date) and the date of death (any cause).
Overall Survival (OS) for 2L TKI Treatment
Time frame: Up to approximately 7 years
OS was defined as the interval between the start date of 2L therapy and the date of death (any cause).
Treatment-free Interval (TFI)
Time frame: Up to approximately 7 years
TFI was defined as the interval between the discontinuation date of 1L therapy and the start date of 2L therapy or date of death.
17 secondary outcomes
Number of Patients With BCR::ABL Testing (per National Comprehensive Cancer Network (NCCN) Guidelines) at Diagnosis
Time frame: Baseline
Number of Patients With BCR::ABL Testing (per NCCN Guidelines) in 3-Month Intervals After Initiation of 1L and 2L TKI Treatment Until BCR::ABL1 ≤1% was Achieved
Time frame: Up to approximately 7 years
After Initiation of 1L and 2L TKI Treatment, Number of Patients With BCR::ABL Testing (per NCCN Guidelines) in 3-Month Intervals Within 2 Years After BCR::ABL1 ≤1% was Achieved
Time frame: 2 years
After Initiation of 1L and 2L TKI Treatment, Number of Patients With BCR::ABL Testing (per NCCN Guidelines) Between 1 and 3 Months Following 2 Years After BCR::ABL1 ≤1% was Achieved
Time frame: Up to approximately 5 years
Number of BCR::ABL Tests (per NCCN Guidelines) After Initiation of 1L and 2L TKI Treatment Until BCR::ABL1 ≤1% was Achieved
Time frame: Up to approximately 7 years
Following Initiation of 1L and 2L TKI Treatment, Number of BCR::ABL Tests (per NCCN Guidelines) Within 2 Years After Achieving BCR::ABL1 ≤1%
Time frame: 2 years
Following Initiation of 1L and 2L TKI Treatment, Number of BCR::ABL Tests (per NCCN Guidelines) Performed After 2 Years of Achieving BCR::ABL1 ≤1%
Time frame: Up to approximately 5 years
Number of Patients With BCR::ABL Testing (per European LeukemiaNet (ELN) Guidelines) at Diagnosis
Time frame: Baseline
Number of Patients With BCR::ABL Testing (per ELN Guidelines) in 3-Month Intervals After Initiation of 1L and 2L TKI Treatment Until BCR::ABL1 ≤0.1% was Achieved
Time frame: Up to approximately 7 years
Number of Patients With BCR::ABL Testing (per ELN Guidelines) Tested in 3-Month Intervals After Initiation of 1L Until BCR::ABL1 ≤0.1% was Achieved and Tested Between 2 to 6 Months Until CCyR was Achieved
Time frame: 5 months
Number of Patients With BCR::ABL Testing (per ELN Guidelines) Tested in 3-Month Intervals After Initiation of 2L Until BCR::ABL1 ≤0.1% was Achieved and Tested Between 2 to 6 Months Until CCyR was Achieved
Time frame: 5 months
Number of Patients With BCR::ABL Testing (per ELN Guidelines) Tested in 3-Month Intervals After Initiation of 1L Until BCR::ABL1 ≤0.1% was Achieved and Tested Every 12 Months Until CCyR was Achieved
Time frame: Up to approximately 7 years
Number of Patients With BCR::ABL Testing (per ELN Guidelines) Tested in 3-Month Intervals After Initiation of 2L Until BCR::ABL1 ≤0.1% was Achieved and Tested Every 12 Months Until CCyR was Achieved
Time frame: Up to approximately 7 years
Number of BCR::ABL Tests (per ELN Guidelines) After Initiation of 1L and 2L TKI Treatment Until BCR::ABL1 ≤0.1% was Achieved
Time frame: Up to approximately 7 years
Number of BCR::ABL Tests (per ELN Guidelines) After Initiation of 1L and 2L TKI Treatment Until CCyR was Achieved
Time frame: Up to approximately 7 years
Number of Molecular Testing by Year Following Initiation of 1L TKI Treatment During Which the T315I Mutation was Identified
Time frame: Up to approximately 7 years
Number of Patients With T3151 Mutation Testing During 1L and 2L TKI Treatment
Time frame: Up to approximately 7 years
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 2 Feb 2026.
- Link to study resultsLink provided by the sponsor.
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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 Leukemia, Myeloid, Chronic-Phase, 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 5 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: finished, as of the sponsor's last update on 2 Feb 2026. 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?
Time From Initial CML Diagnosis to Initiation of 1L TKI Treatment (time frame: Baseline). The study lists 28 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 2 Feb 2026.