Chronic Myeloid LeukemiaNCT05619978
French Study to Highlight the Unmet Treatment Needs of 3L+ CP-CML and With T315I-mutated CML Patients
An observational study of Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 1 site in France.
Trial summary
A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- 3L Therapy and T315I
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2021to 29 Oct 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included CML-CP patients (i.e., 3L patients and patients with T315I mutation) who met the eligibility criteria
Who may be able to join
- Diagnosed with CML-CP
- Age ≥18 years at the time of CML-CP diagnosis
- For 3L patients: initiated one of the following 3L therapies in CML-CP after failing on ≥2 TKIs (i.e., bosutinib, dasatinib, imatinib, nilotinib, or ponatinib) or allo-SCT
- For T315I mutation patients: evidence of T315I mutation and treatment with TKI or allo-SCT
Who cannot join
- History of other active malignancies within the 3 years prior to the time of CML-CP diagnosis
- Documentation of anti-cancer therapies for any other malignancies prior to the time of 3L therapy initiation or at the time of treatment initiation after identification of T315I mutation
- Enrollment in a clinical trial at the time of 3L therapy initiation or at the time of treatment initiation after identification of T315I mutation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center Retrospective Chart Review Study Examining the Patient Characteristics, Treatment Patterns, Clinical Outcomes, and Burden of Illness Among Patients With Chronic Myeloid Leukemia in Third-line Treatment or With T315I Mutation in France (CML 3L+ & T315I)
A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France.
Read the detailed description
The index date for patients in the 3L cohort was defined as the date of initiation of 3L therapy. The index date for the T315I cohort was defined as the date of treatment initiation with TKI or allogeneic stem cell transplantation (allo-SCT) after identification of T315I mutation status. The baseline (i.e., pre-index) period was defined as the 6 months prior to the index date, and the post-index period was defined as the time from the index date to the date of last patient contact or patient death. Patients who were alive at the end of the follow-up period were censored at the date of last contact.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- 3L Therapy, T315I
- Keywords
- BCR::ABL,, Chronic myeloid leukemia,, Tyrosine kinase inhibitor,, 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.
3L TherapyOther
Also called third-line treatment
Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT
T315IOther
Patients with chronic myeloid leukemia with T315I mutation
| Study group | Role | What they receive |
|---|---|---|
| 3L+ Cohort | Patients who initiated third-line treatment (3L) therapy. Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT Receives: Other: 3L Therapy | |
| T315I cohort | Patients with chronic myeloid leukemia with T315I mutation Receives: Other: T315I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients: Year patient initiated third-line treatment
Following categories included:
Before 2010 2010-2014 2015-2019 2020-2021
Measured: throughout the study (study used data from 2000 to 2021)
Duration of third-line treatment
Duration of third-line treatment was reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients: Type of therapy received in third-line treatment
- TKI agent
- Allo-SCT
Measured: throughout the study (study used data from 2000 to 2021)
Time from 2L discontinuation to third-line treatment initiation
Time from 2L discontinuation to third-line treatment initiation was reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients still on 3L therapy as of data collection date
Number of patients still on 3L therapy as of data collection date was reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients discontinued 3L
Number of patients who discontinued 3L treatment were reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients: Reasons for 3L discontinuation
- Treatment switch due to AEs or intolerance
- Treatment switch due to resistance
- Treatment switch due to signs of ineffectiveness
- Treatment switch due to other reasons
Measured: throughout the study (study used data from 2000 to 2021)
Number of lines of therapy for patients with chronic myeloid leukemia in third-line treatment
Number of lines of therapy for patients with chronic myeloid leukemia in third-line treatment were reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of most frequent treatment sequences for patients with chronic myeloid leukemia in third-line treatment
Number of most frequent treatment sequences for patients with chronic myeloid leukemia in third-line treatment were reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of last line of therapy for patients with chronic myeloid leukemia in third-line treatment
Number of last line of therapy for patients with chronic myeloid leukemia in third-line treatment were reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients: Year patient initiated on the line identified as T315I line of interest
Following categories included:
Before 2010 2010-2014 2015-2019
Measured: throughout the study (study used data from 2000 to 2021)
Duration of the line identified as T315I line of interest
Duration of the line identified as T315I line of interest was reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients: Type of therapy received in the line identified as T315I line of interest
- TKI agent
- Allo-SCT
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients still on line of therapy identified as T315I line of interest as of data collection date
Number of patients still on line of therapy identified as T315I line of interest as of data collection date were reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients: Reasons for discontinuation on the line identified as T315I line of interest
- Adverse events or intolerance
- Resistance
- Signs of ineffectiveness Suboptimal response Progression to accelerated phase or blast phase
- Other reasons Acquired mutations
Measured: throughout the study (study used data from 2000 to 2021)
Number of lines of therapy for patients with chronic myeloid leukemia with T315I mutation
Number of lines of therapy for patients with chronic myeloid leukemia with T315I mutation were reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of line identified as T315I line of interest
Number of line identified as T315I line of interest were reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of treatment sequence for patients with chronic myeloid leukemia with T315I mutation
Number of treatment sequence for patients with chronic myeloid leukemia with T315I mutation were reported
Measured: throughout the study (study used data from 2000 to 2021)
Number of last line of therapy for patients with chronic myeloid leukemia with T315I mutation
Number of last line of therapy for patients with chronic myeloid leukemia with T315I mutation were reported
Measured: throughout the study (study used data from 2000 to 2021)
Secondary outcomes (40)
Cytogenetic response (CyR) for 3L patients
CCyR, defined as an absence of Philadelphia chromosome-positive (Ph+) metaphases in bone marrow cytogenetics
Measured: 12 and 24 months
Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 12 months
Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 12 months were reported
Measured: 12 months post treatment
Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 24 months
Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 24 months were reported.
Measured: 24 months post treatment
Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 12 months
Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 12 months were reported.
Measured: 12 months post treatment
Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 24 months
Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 24 months were reported.
Measured: 24 months post treatment
Time to major molecular response (MMR) among patients with chronic myeloid leukemia in third-line treatment
Time to MMR was defined as the time from third-line (3L) treatment initiation to the time patients achieved MMR (i.e., 0.01% IS < BCR::ABL1 transcript level ≤ 0.1% IS). Patients were censored at the earliest of treatment discontinuation or switch, loss to follow-up, end of data availability, or death.
Measured: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to deep molecular response (MR4.0) among patients with chronic myeloid leukemia in third-line treatment
Time to MR4.0 was defined as the time from third-line (3L) treatment initiation to the time patients achieved MR4.0 (i.e., 0.0032% IS < BCR::ABL1 transcript level ≤ 0.01% IS). Patients were censored at the earliest of treatment discontinuation or switch, loss to follow-up, end of data availability, or death.
Measured: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to sustained deep molecular response (MR4.0) among patients with chronic myeloid leukemia in third-line treatment
Time to sustained MR4.0 was defined as the time from third-line (3L) treatment initiation to the time patients achieved sustained MR4.0 or better (i.e., BCR::ABL1 ≤ 0.01%) in all consecutive assessments performed for at least 12 months (i.e., 365.25 days). Patients were censored at the earliest of treatment discontinuation or switch, loss to follow-up, end of data availability, or death.
Measured: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to deep molecular response (MR4.5) among patients with chronic myeloid leukemia in third-line treatment
Time to MR4.5 was defined as the time from third-line (3L) treatment initiation to the time patients achieved MR4.5 (i.e., 0.001% IS ≤ BCR::ABL1 transcript level ≤ 0.0032% IS). Patients were censored at the earliest of treatment discontinuation or switch, loss to follow-up, end of data availability, or death.
Measured: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to sustained deep molecular response (MR4.5) among patients with chronic myeloid leukemia in third-line treatment
Time to sustained MR4.5 was defined as the time from third-line (3L) treatment initiation to the time patients achieved sustained MR4.5 or better (i.e., BCR::ABL1 ≤ 0.0032%) in all consecutive assessments performed for at least 2 years (i.e., 730.5 days). Patients were censored at the earliest of treatment discontinuation or switch, loss to follow-up, end of data availability, or death.
Measured: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to Progression-free survival (PFS) for 3L patients
Time to PFS was defined as the time from third-line treatment initiation to earliest occurrence of documented disease progression to accelerated phase or blast crisis, or the date of death from any cause. Patients were censored at the earliest of treatment discontinuation or switch, loss to follow-up, or end of data availability.
Measured: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to Overall Survival (OS) for 3L patients
Time to OS was defined as the time from third-line treatment initiation to death from any cause. Patients were censored at the earliest of treatment discontinuation or switch, date of last follow-up, or end of data availability.
Measured: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to treatment discontinuation (TTD) for 3L patients
TTD was defined as the time from third-line treatment initiation to treatment discontinuation or switch. Patients were censored at the earliest of loss to follow-up, or end of data availability, or death
Measured: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Proportion of patients with Adverse Events (AEs) in third-line treatment
Proportion of patients with Adverse Events (AEs) were reported to evaluate the safety profile of third-line treatments for chronic myeloid leukemia
Measured: throughout the study (study used data from 2000 to 2021)
Age of patients with chronic myeloid leukemia in third-line treatment
Age information was reported.
Measured: Index date defined as the date of initiation of 3L therapy (data from 2000 to 2021)
Number of patients: Year of chronic myeloid leukemia in chronic phase (CML-CP) diagnosis of patients with chronic myeloid leukemia in third-line treatment
Year of CML-CP diagnosis of patients with chronic myeloid leukemia in third-line treatment was reported.
Measured: throughout the study (study used data from 2000 to 2021)
Sex of patients with chronic myeloid leukemia in third-line treatment
Sex information was reported.
Measured: Index date defined as the date of initiation of 3L therapy (data from 2000 to 2021)
Number of patients: Medical center of patients with chronic myeloid leukemia in third-line treatment
The following centers were included:
Centre Léon Bérard, Lyon Hématologie Institut Bergonié, Bordeaux Institut Universitaire du Cancer Toulouse, Toulouse
Measured: Index date defined as the date of initiation of 3L therapy (data from 2000 to 2021)
Length of follow-up (month) characteristics of patients with chronic myeloid leukemia in third-line treatment
Length of follow-up was defined as time from index date to the date of last known contact with patient or patient death.
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients: Smoking status at index date of patients with chronic myeloid leukemia in third-line treatment
Smoking status at index date of patients with chronic myeloid leukemia in third-line treatment was reported.
Measured: Index date defined as the date of initiation of 3L therapy (data from 2000 to 2021)
Time from CML-CP diagnosis to index date (month) of patients with chronic myeloid leukemia in third-line treatment
Time from CML-CP diagnosis to index date (month) of patients with chronic myeloid leukemia in third-line treatment was reported.
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients with Hasford score at CML-CP diagnosis (month) of patients with chronic myeloid leukemia in third-line treatment
Low risk (≤780) Intermediate risk (>780 to ≤1480) High risk (>1480) Not assessed Unknown / not sure
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients with Sokal score at CML-CP diagnosis (month) of patients with chronic myeloid leukemia in third-line treatment
Low risk (<0.8) Intermediate risk (≥0.8 to ≤1.2) High risk (>1.2) Not assessed Unknown / not sure
Measured: throughout the study (data source from 2000 to 2021)
Number of patients with ELTS risk score at CML-CP diagnosis (month) of patients with chronic myeloid leukemia in third-line treatment
ELTS: EUTOS long-term survival Low risk (≤1.5680) Intermediate risk (>1.5680 to ≤2.2185) High risk (>2.2185) Not assessed Unknown / not sure
Measured: throughout the study (data source from 2000 to 2021)
Number of patients with BCR::ABL1 rearrangement at CML-CP diagnosis of patients with chronic myeloid leukemia in third-line treatment
Major Minor Other
Measured: throughout the study (data source from 2000 to 2021)
Number of patients with Additional chromosomal abnormalities at CML-CP diagnosis of patients with chronic myeloid leukemia in third-line treatment
Yes No
Measured: throughout the study (study used data from 2000 to 2021)
Number of comorbid conditions prior to the index date in patients with chronic myeloid leukemia in third-line treatment
Number of comorbid conditions prior to the index date in patients with chronic myeloid leukemia in third-line treatment were reported.
Measured: Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy)
Number of patients with comorbid conditions prior to the index date in patients with chronic myeloid leukemia in third-line treatment
Cardiovascular disease Pulmonary disease/pulmonary arterial hypertension Gastrointestinal issues Renal disease Diabetes Liver disease Other No comorbidities Unknown / not sure
Measured: Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy)
Number of patients with any ischemic condition prior to the index date in patients with chronic myeloid leukemia in third-line treatment
Cardiovascular disease Cerebrovascular disease Peripheral arterial
Measured: Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy)
Number of patients with Cardiovascular risk factors prior to the index date in patients with chronic myeloid leukemia in third-line treatment
Hypertension Hyperlipidemia/dyslipidemia Diabetes Obesity
Measured: Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy)
Laboratory and clinical results: Random blood glucose (mg/dl)
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Fasting blood glucose (mg/dl)
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: LDL cholesterol (mg/dl)
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Total cholesterol (mg/dl)
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Blood pressure
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Spleen size below costal margin
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Blood cell count
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Bone marrow differential cell count
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Number of patients with BCR::ABL1 mutation status by line of therapy for patients with chronic myeloid leukemia in third-line treatment
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Proportion of patients achieving response among patients with chronic myeloid leukemia with T315I mutation
Laboratory and clinical results were reported.
Measured: throughout the study (study used data from 2000 to 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start3 May 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 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
- 200 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
- NCT05619978
- Sponsor's protocol ID
- CABL001A0FR01
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Retrospective Chart Review Study Examining the Patient Characteristics, Treatment Patterns, Clinical Outcomes, and Burden of Illness Among Patients With Chronic Myeloid Leukemia in Third-line Treatment or With T315I Mutation in France (CML 3L+ & T315I)
- ClinicalTrials.gov ID
- NCT05619978
- Acronym / sponsor ID
- CABL001A0FR01
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- BCR::ABL,, Chronic myeloid leukemia,, Tyrosine kinase inhibitor,, T315I mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 17 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.
A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France.
Detailed description
The index date for patients in the 3L cohort was defined as the date of initiation of 3L therapy. The index date for the T315I cohort was defined as the date of treatment initiation with TKI or allogeneic stem cell transplantation (allo-SCT) after identification of T315I mutation status. The baseline (i.e., pre-index) period was defined as the 6 months prior to the index date, and the post-index period was defined as the time from the index date to the date of last patient contact or patient death. Patients who were alive at the end of the follow-up period were censored at the date of last contact.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3L+ Cohort | – | Other: 3L TherapyPatients who initiated third-line treatment (3L) therapy. Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT |
| T315I cohort | – | Other: T315IPatients with chronic myeloid leukemia with T315I mutation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included CML-CP patients (i.e., 3L patients and patients with T315I mutation) who met the eligibility criteria
Key inclusion criteria (4 listed)
- Diagnosed with CML-CP
- Age ≥18 years at the time of CML-CP diagnosis
- For 3L patients: initiated one of the following 3L therapies in CML-CP after failing on ≥2 TKIs (i.e., bosutinib, dasatinib, imatinib, nilotinib, or ponatinib) or allo-SCT
- For T315I mutation patients: evidence of T315I mutation and treatment with TKI or allo-SCT
Key exclusion criteria (3 listed)
- History of other active malignancies within the 3 years prior to the time of CML-CP diagnosis
- Documentation of anti-cancer therapies for any other malignancies prior to the time of 3L therapy initiation or at the time of treatment initiation after identification of T315I mutation
- Enrollment in a clinical trial at the time of 3L therapy initiation or at the time of treatment initiation after identification of T315I mutation
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 |
|---|---|---|
| 3L TherapyAlso: third-line treatmentTreatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT | Other | 3L+ Cohort |
| T315IPatients with chronic myeloid leukemia with T315I mutation | Other | T315I cohort |
Primary outcome
Number of patients: Year patient initiated third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Following categories included: Before 2010 2010-2014 2015-2019 2020-2021
Duration of third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Duration of third-line treatment was reported
Number of patients: Type of therapy received in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
* TKI agent * Allo-SCT
Time from 2L discontinuation to third-line treatment initiation
Time frame: throughout the study (study used data from 2000 to 2021)
Time from 2L discontinuation to third-line treatment initiation was reported
Number of patients still on 3L therapy as of data collection date
Time frame: throughout the study (study used data from 2000 to 2021)
Number of patients still on 3L therapy as of data collection date was reported
Number of patients discontinued 3L
Time frame: throughout the study (study used data from 2000 to 2021)
Number of patients who discontinued 3L treatment were reported
Number of patients: Reasons for 3L discontinuation
Time frame: throughout the study (study used data from 2000 to 2021)
* Treatment switch due to AEs or intolerance * Treatment switch due to resistance * Treatment switch due to signs of ineffectiveness * Treatment switch due to other reasons
Number of lines of therapy for patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Number of lines of therapy for patients with chronic myeloid leukemia in third-line treatment were reported
Number of most frequent treatment sequences for patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Number of most frequent treatment sequences for patients with chronic myeloid leukemia in third-line treatment were reported
Number of last line of therapy for patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Number of last line of therapy for patients with chronic myeloid leukemia in third-line treatment were reported
Number of patients: Year patient initiated on the line identified as T315I line of interest
Time frame: throughout the study (study used data from 2000 to 2021)
Following categories included: Before 2010 2010-2014 2015-2019
Duration of the line identified as T315I line of interest
Time frame: throughout the study (study used data from 2000 to 2021)
Duration of the line identified as T315I line of interest was reported
Number of patients: Type of therapy received in the line identified as T315I line of interest
Time frame: throughout the study (study used data from 2000 to 2021)
* TKI agent * Allo-SCT
Number of patients still on line of therapy identified as T315I line of interest as of data collection date
Time frame: throughout the study (study used data from 2000 to 2021)
Number of patients still on line of therapy identified as T315I line of interest as of data collection date were reported
Number of patients: Reasons for discontinuation on the line identified as T315I line of interest
Time frame: throughout the study (study used data from 2000 to 2021)
* Adverse events or intolerance * Resistance * Signs of ineffectiveness Suboptimal response Progression to accelerated phase or blast phase * Other reasons Acquired mutations
Number of lines of therapy for patients with chronic myeloid leukemia with T315I mutation
Time frame: throughout the study (study used data from 2000 to 2021)
Number of lines of therapy for patients with chronic myeloid leukemia with T315I mutation were reported
Number of line identified as T315I line of interest
Time frame: throughout the study (study used data from 2000 to 2021)
Number of line identified as T315I line of interest were reported
Number of treatment sequence for patients with chronic myeloid leukemia with T315I mutation
Time frame: throughout the study (study used data from 2000 to 2021)
Number of treatment sequence for patients with chronic myeloid leukemia with T315I mutation were reported
Number of last line of therapy for patients with chronic myeloid leukemia with T315I mutation
Time frame: throughout the study (study used data from 2000 to 2021)
Number of last line of therapy for patients with chronic myeloid leukemia with T315I mutation were reported
40 secondary outcomes
Cytogenetic response (CyR) for 3L patients
Time frame: 12 and 24 months
Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 12 months
Time frame: 12 months post treatment
Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 24 months
Time frame: 24 months post treatment
Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 12 months
Time frame: 12 months post treatment
Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 24 months
Time frame: 24 months post treatment
Time to major molecular response (MMR) among patients with chronic myeloid leukemia in third-line treatment
Time frame: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to deep molecular response (MR4.0) among patients with chronic myeloid leukemia in third-line treatment
Time frame: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to sustained deep molecular response (MR4.0) among patients with chronic myeloid leukemia in third-line treatment
Time frame: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to deep molecular response (MR4.5) among patients with chronic myeloid leukemia in third-line treatment
Time frame: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to sustained deep molecular response (MR4.5) among patients with chronic myeloid leukemia in third-line treatment
Time frame: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to Progression-free survival (PFS) for 3L patients
Time frame: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to Overall Survival (OS) for 3L patients
Time frame: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Time to treatment discontinuation (TTD) for 3L patients
Time frame: 12, 24, 36, 48, 60, 72 and 84 months post treatment
Proportion of patients with Adverse Events (AEs) in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Age of patients with chronic myeloid leukemia in third-line treatment
Time frame: Index date defined as the date of initiation of 3L therapy (data from 2000 to 2021)
Number of patients: Year of chronic myeloid leukemia in chronic phase (CML-CP) diagnosis of patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Sex of patients with chronic myeloid leukemia in third-line treatment
Time frame: Index date defined as the date of initiation of 3L therapy (data from 2000 to 2021)
Number of patients: Medical center of patients with chronic myeloid leukemia in third-line treatment
Time frame: Index date defined as the date of initiation of 3L therapy (data from 2000 to 2021)
Length of follow-up (month) characteristics of patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Number of patients: Smoking status at index date of patients with chronic myeloid leukemia in third-line treatment
Time frame: Index date defined as the date of initiation of 3L therapy (data from 2000 to 2021)
Time from CML-CP diagnosis to index date (month) of patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Number of patients with Hasford score at CML-CP diagnosis (month) of patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Number of patients with Sokal score at CML-CP diagnosis (month) of patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (data source from 2000 to 2021)
Number of patients with ELTS risk score at CML-CP diagnosis (month) of patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (data source from 2000 to 2021)
Number of patients with BCR::ABL1 rearrangement at CML-CP diagnosis of patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (data source from 2000 to 2021)
Number of patients with Additional chromosomal abnormalities at CML-CP diagnosis of patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Number of comorbid conditions prior to the index date in patients with chronic myeloid leukemia in third-line treatment
Time frame: Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy)
Number of patients with comorbid conditions prior to the index date in patients with chronic myeloid leukemia in third-line treatment
Time frame: Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy)
Number of patients with any ischemic condition prior to the index date in patients with chronic myeloid leukemia in third-line treatment
Time frame: Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy)
Number of patients with Cardiovascular risk factors prior to the index date in patients with chronic myeloid leukemia in third-line treatment
Time frame: Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy)
Laboratory and clinical results: Random blood glucose (mg/dl)
Time frame: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Fasting blood glucose (mg/dl)
Time frame: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: LDL cholesterol (mg/dl)
Time frame: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Total cholesterol (mg/dl)
Time frame: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Blood pressure
Time frame: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Spleen size below costal margin
Time frame: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Blood cell count
Time frame: throughout the study (study used data from 2000 to 2021)
Laboratory and clinical results: Bone marrow differential cell count
Time frame: throughout the study (study used data from 2000 to 2021)
Number of patients with BCR::ABL1 mutation status by line of therapy for patients with chronic myeloid leukemia in third-line treatment
Time frame: throughout the study (study used data from 2000 to 2021)
Proportion of patients achieving response among patients with chronic myeloid leukemia with T315I mutation
Time frame: throughout the study (study used data from 2000 to 2021)
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 17 Nov 2022.
- 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 France.
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 4 inclusion and 3 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 17 Nov 2022. 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 France. 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 patients: Year patient initiated third-line treatment (time frame: throughout the study (study used data from 2000 to 2021)). The study lists 19 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 17 Nov 2022.