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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time from 2L discontinuation to third-line treatment initiation
研究概览
简要总结
A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time from 2L discontinuation to third-line treatment initiation
时间窗: 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
时间窗: 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
时间窗: throughout the study (study used data from 2000 to 2021)
Number of patients who discontinued 3L treatment were reported
Number of patients: Year patient initiated on the line identified as T315I line of interest
时间窗: throughout the study (study used data from 2000 to 2021)
Following categories included: Before 2010 2010-2014 2015-2019
Number of patients: Type of therapy received in third-line treatment
时间窗: throughout the study (study used data from 2000 to 2021)
* TKI agent * Allo-SCT
Number of treatment sequence for patients with chronic myeloid leukemia with T315I mutation
时间窗: 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 patients: Reasons for 3L discontinuation
时间窗: 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 with T315I mutation
时间窗: 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 last line of therapy for patients with chronic myeloid leukemia with T315I mutation
时间窗: 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
Duration of third-line treatment
时间窗: throughout the study (study used data from 2000 to 2021)
Duration of third-line treatment was reported
Number of patients: Year patient initiated third-line treatment
时间窗: throughout the study (study used data from 2000 to 2021)
Following categories included: Before 2010 2010-2014 2015-2019 2020-2021
Number of most frequent treatment sequences for patients with chronic myeloid leukemia in third-line treatment
时间窗: 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
时间窗: 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 still on line of therapy identified as T315I line of interest as of data collection date
时间窗: 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
时间窗: 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 line identified as T315I line of interest
时间窗: throughout the study (study used data from 2000 to 2021)
Number of line identified as T315I line of interest were reported
Number of lines of therapy for patients with chronic myeloid leukemia in third-line treatment
时间窗: 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
Duration of the line identified as T315I line of interest
时间窗: 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
时间窗: throughout the study (study used data from 2000 to 2021)
* TKI agent * Allo-SCT
次要结局
- Laboratory and clinical results: LDL cholesterol (mg/dl)(throughout the study (study used data from 2000 to 2021))
- Cytogenetic response (CyR) for 3L patients(12 and 24 months)
- Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 24 months(24 months post treatment)
- Laboratory and clinical results: Total cholesterol (mg/dl)(throughout the study (study used data from 2000 to 2021))
- Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 12 months(12 months post treatment)
- Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 12 months(12 months post treatment)
- Proportion of patients with Adverse Events (AEs) in third-line treatment(throughout the study (study used 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(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(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(Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy))
- Laboratory and clinical results: Fasting blood glucose (mg/dl)(throughout the study (study used data from 2000 to 2021))
- Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 24 months(24 months post treatment)
- Age of patients with chronic myeloid leukemia in third-line treatment(Index date defined as the date of initiation of 3L therapy (data from 2000 to 2021))
- Sex of patients with chronic myeloid leukemia in third-line treatment(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(Index date defined as the date of initiation of 3L therapy (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(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(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(throughout the study (data source from 2000 to 2021))
- Number of patients with any ischemic condition prior to the index date in patients with chronic myeloid leukemia in third-line treatment(Baseline (6 months prior to index date, defined as the date of initiation of 3L therapy))
- Time to sustained deep molecular response (MR4.5) among patients with chronic myeloid leukemia in third-line treatment(12, 24, 36, 48, 60, 72 and 84 months post treatment)
- Laboratory and clinical results: Blood pressure(throughout the study (study used data from 2000 to 2021))
- Laboratory and clinical results: Spleen size below costal margin(throughout the study (study used data from 2000 to 2021))
- Laboratory and clinical results: Blood cell count(throughout the study (study used data from 2000 to 2021))
- Proportion of patients achieving response among patients with chronic myeloid leukemia with T315I mutation(throughout the study (study used data from 2000 to 2021))
- Time to deep molecular response (MR4.5) among patients with chronic myeloid leukemia in third-line treatment(12, 24, 36, 48, 60, 72 and 84 months post treatment)
- Time to Overall Survival (OS) for 3L patients(12, 24, 36, 48, 60, 72 and 84 months post treatment)
- Time to treatment discontinuation (TTD) for 3L patients(12, 24, 36, 48, 60, 72 and 84 months post treatment)
- Time to major molecular response (MMR) among patients with chronic myeloid leukemia in third-line treatment(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(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(12, 24, 36, 48, 60, 72 and 84 months post treatment)
- Time to Progression-free survival (PFS) for 3L patients(12, 24, 36, 48, 60, 72 and 84 months post treatment)
- Length of follow-up (month) characteristics of patients with chronic myeloid leukemia in third-line treatment(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(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(throughout the study (study used data 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(throughout the study (study used data from 2000 to 2021))
- Laboratory and clinical results: Bone marrow differential cell count(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(throughout the study (study used data from 2000 to 2021))
- Number of patients with comorbid conditions prior to the index date in patients with chronic myeloid leukemia in third-line treatment(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)(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(throughout the study (study used data from 2000 to 2021))