Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Bosutinib

Nilotinib

Dasatinib

Ponatinib

Tyrosine Kinase Inhibitors

Imatinib Mesylate

Tyrosine

Patients who initiated third-line treatment (3L) therapy. Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT

Patients with chronic myeloid leukemia with T315I mutation

Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT

3L Therapy

T315I

Novartis Pharmaceuticals

A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France.

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.

French Study to Highlight the Unmet Treatment Needs of 3L+ CP-CML and With T315I-mutated CML Patients

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)

Following categories included:

Before 2010 2010-2014 2015-2019 2020-2021

Duration of third-line treatment was reported

Time from 2L discontinuation to third-line treatment initiation was reported

Number of patients still on 3L therapy as of data collection date was reported

Number of patients who discontinued 3L treatment were reported

* 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 were reported

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 were reported

Following categories included:

Before 2010 2010-2014 2015-2019

Duration of the line identified as T315I line of interest was reported

Number of patients still on line of therapy identified as T315I line of interest as of data collection date were reported

* 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 were reported

Number of line identified as T315I line of interest were reported

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 were reported

CCyR, defined as an absence of Philadelphia chromosome-positive (Ph+) metaphases in bone marrow cytogenetics

Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 12 months were reported

Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 24 months were reported.

Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 12 months were reported.

Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 24 months were reported.

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.

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.

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.

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.

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.

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.

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.

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

Proportion of patients with Adverse Events (AEs) were reported to evaluate the safety profile of third-line treatments for chronic myeloid leukemia

Year of CML-CP diagnosis of patients with chronic myeloid leukemia in third-line treatment was reported.

The following centers were included:

Centre Léon Bérard, Lyon Hématologie Institut Bergonié, Bordeaux Institut Universitaire du Cancer Toulouse, Toulouse

Length of follow-up was defined as time from index date to the date of last known contact with patient or patient death.

Smoking status at index date of patients with chronic myeloid leukemia in third-line treatment was reported.

Time from CML-CP diagnosis to index date (month) of patients with chronic myeloid leukemia in third-line treatment was reported.

Low risk (≤780) Intermediate risk (\>780 to ≤1480) High risk (\>1480) Not assessed Unknown / not sure

Low risk (\<0.8) Intermediate risk (≥0.8 to ≤1.2) High risk (\>1.2) Not assessed Unknown / not sure

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

Number of comorbid conditions prior to the index date in patients with chronic myeloid leukemia in third-line treatment were reported.

Cardiovascular disease Pulmonary disease/pulmonary arterial hypertension Gastrointestinal issues Renal disease Diabetes Liver disease Other No comorbidities Unknown / not sure

Cardiovascular disease Cerebrovascular disease Peripheral arterial

Hypertension Hyperlipidemia/dyslipidemia Diabetes Obesity

Laboratory and clinical results were reported.

Spots Global Cancer Trial Database for bcr::abl,

Every month we try and update this database with for bcr::abl, cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bcr::abl,

Every month we try and update this database with for bcr::abl, cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bcr::abl, cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.