Chronic Phase Chronic Myeloid Leukemia
Conditions
Brief summary
This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.
Interventions
DRUGDasatinib
tablets, oral, 100 mg, Once daily, Up to12 months on study,
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with CML-CP patients achieving an optimal response to imatinib treatment with Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or recurring at least 3 times in the preceding 12 months, despite best supportive care * Men and women with Chronic Myeloid Leukemia- Chronic Phase (CML-CP) Ph+ ≥ age 18 * Daily Eastern Co-Operative Group (ECOG) performance status = 0 - 2 * Patient willing and able to give informed consent * Life expectancy \> 6 months * Adequate renal function * Adequate hepatic function
Exclusion criteria
* Patients who are pregnant or breast feeding * Men whose partner is unwilling to avoid pregnancy. * Previous treatment with any other tyrosine-kinase inhibitor (TKI), except for imatinib * Current grade 3 or 4 imatinib related adverse event * Prior documented T315I mutation * Prior diagnosis of accelerated phase or blast crisis CML * Previous loss of complete hematologic response (CHR) or major cytogenetic response (MCyR) on imatinib * Concurrent medical condition of uncontrolled infection, cardiovascular diseases of cardiac failure, congenital long QT syndrome, ventricular arrhythmias, prolonged QT interval, second or third degree heart block, uncontrolled angina, myocardial infarction (MI) in the last 6 months, uncontrolled hypertension, pulmonary arterial hypertension, pleural or pericardial effusions, or history of bleeding disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment | 3 months after switch to dasatinib | Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 adverse events was assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or worsen or no change in grade. Worsened, grade Increased. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Baseline to 3, 6, 12 months | The MD Anderson Symptom Inventory Chronic Myeloid Leukemia (MDASI-CML) is a validated questionnaire completed by study participants to assess symptom severity and symptom interference on daily function. These categories are divided into 5 domain summary scores: Core Symptom Severity Score, Interference Score, Symptom Severity Score, CML-Specific Symptom Severity Score, and 5 Most Severe Symptom Score. Scores were evaluated at baseline and after switching to Dasatinib on a range from 1 to 10; 1=not present/did not interfere, 10=as bad as you can imagine/interfered completely. |
| Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Baseline to 6, 12 months | The EORTC QLQ-C30 questionnaire is completed by study participants to assess quality of life through nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social functioning); three symptom scales (fatigue, pain and nausea/vomiting); and a global health status/QoL scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures were evaluated at baseline and after switching to Dasatinib as an average raw score that was standardized by transformation, so that final scores were on a range in score from 0 to 100. A high score for a functional scale represents a healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale and single-item measures represents a high level of problematic symptomatology. |
| Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome | Date of first dose to 30 post last dose of study drug, an average of 3 years | SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug, dasatinib. |
| The Percentage of Participants With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib | 3 months | Dasatinib treatment was administered and its impact on the Imatinib-related Grade 1/2 adverse events was assessed. The percentage of participants is based on the number that had pre-existing Imatinib-related AEs. Measure assesses the participants with reduction or improvement of at least 1 Imatinib-related Grade 1 or Grade 2 chronic AE, without a worsening of any Imatinib-related, chronic adverse events after Dasatinib treatment. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Improved, AE grade reduced from Grade 2 to Grade 1. Worsened, Grade Increased. Confidence interval from Clopper-Pearson method. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib | 6 and 12 months | Molecular responses were assessed at 6 and 12 months after switching to dasatinib to determine if these baseline responses could be maintained. MR4.5, the number of treated participants with BCR-ABL transcripts ≤ 0.0032% (IS) at 6 and 12 months from the date of dasatinib initiation; MMR, Major Molecular Response = 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. |
Countries
France, Germany, Italy, South Korea, United States
Participant flow
Pre-assignment details
39 participants enrolled and were treated.
Participants by arm
| Arm | Count |
|---|---|
| Dasatinib (100 mg) Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discontinued due to study drug toxicity | 3 |
Baseline characteristics
| Characteristic | Dasatinib (100 mg) |
|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 15.13 |
| Age, Customized < 65 years | 27 Participants |
| Age, Customized >= 65 years | 12 Participants |
| Best Baseline Response CCyR | 4 Participants |
| Best Baseline Response Cytogenetic Test Not Performed | 3 Participants |
| Best Baseline Response MMR | 20 Participants |
| Best Baseline Response MR4.5 | 10 Participants |
| Best Baseline Response PCyR | 2 Participants |
| Gender Female | 18 Participants |
| Gender Male | 21 Participants |
| Imatinib Dose at Baseline < 400 milligrams | 19 Participants |
| Imatinib Dose at Baseline 400 milligrams | 20 Participants |
| Median Duration of Imatinib Treatment | 51.2 months |
| Median Time Since CML-CP Diagnosis | 51.3 months |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 22 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized White | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 36 / 39 |
| serious Total, serious adverse events | 11 / 39 |
Outcome results
Primary
The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment
Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 adverse events was assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or worsen or no change in grade. Worsened, grade Increased.
Time frame: 3 months after switch to dasatinib
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib (100 mg) | The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment | Resolved | 91 adverse event(s) |
| Dasatinib (100 mg) | The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment | Improved | 2 adverse event(s) |
| Dasatinib (100 mg) | The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment | Unchanged | 27 adverse event(s) |
| Dasatinib (100 mg) | The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment | Worsened | 1 adverse event(s) |
Secondary
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib
The MD Anderson Symptom Inventory Chronic Myeloid Leukemia (MDASI-CML) is a validated questionnaire completed by study participants to assess symptom severity and symptom interference on daily function. These categories are divided into 5 domain summary scores: Core Symptom Severity Score, Interference Score, Symptom Severity Score, CML-Specific Symptom Severity Score, and 5 Most Severe Symptom Score. Scores were evaluated at baseline and after switching to Dasatinib on a range from 1 to 10; 1=not present/did not interfere, 10=as bad as you can imagine/interfered completely.
Time frame: Baseline to 3, 6, 12 months
Population: All treated participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Core Symptom Severity Score, Month 3; n=37 | -1.35 units on a scale | Standard Deviation 1.78 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Core Symptom Severity Score, Month 6; n=36 | -1.44 units on a scale | Standard Deviation 1.84 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Core Symptom Severity Score, Month 12; n=37 | -1.06 units on a scale | Standard Deviation 1.87 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Interference Score, Month 3; n=37 | -1.24 units on a scale | Standard Deviation 2.36 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Interference Score, Month 6; n=35 | -1.28 units on a scale | Standard Deviation 2.45 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Interference Score, Month 12; n=36 | -1.30 units on a scale | Standard Deviation 2.56 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Symptom Severity Score, Month 3; n=37 | -1.73 units on a scale | Standard Deviation 1.8 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Symptom Severity Score, Month 6; n=36 | -1.80 units on a scale | Standard Deviation 1.85 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | Symptom Severity Score, Month 12; n=37 | -1.46 units on a scale | Standard Deviation 1.75 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | CML-specific Symptom Severity Score, Month 3; n=37 | -2.52 units on a scale | Standard Deviation 2.35 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | CML-specific Symptom Severity Score, Month 6; n=36 | -2.60 units on a scale | Standard Deviation 2.15 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | CML-specific Symptom Severity Score,Month 12; n=36 | -2.24 units on a scale | Standard Deviation 1.87 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | 5 Most Severe Symptom Score, Month 3; n=37 | -1.61 units on a scale | Standard Deviation 1.76 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | 5 Most Severe Symptom Score, Month 6; n=36 | -1.69 units on a scale | Standard Deviation 1.84 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib | 5 Most Severe Symptom Score, Month 12; n=37 | -1.43 units on a scale | Standard Deviation 1.72 |
Secondary
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib
The EORTC QLQ-C30 questionnaire is completed by study participants to assess quality of life through nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social functioning); three symptom scales (fatigue, pain and nausea/vomiting); and a global health status/QoL scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures were evaluated at baseline and after switching to Dasatinib as an average raw score that was standardized by transformation, so that final scores were on a range in score from 0 to 100. A high score for a functional scale represents a healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale and single-item measures represents a high level of problematic symptomatology.
Time frame: Baseline to 6, 12 months
Population: All treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Global Health Status/QOL, Month 6; n=36 | 0.46 units on a scale | Standard Deviation 23.733 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Global Health Status/QOL, Month 12; n=35 | 2.86 units on a scale | Standard Deviation 27.782 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Cognitive Functioning, Month 6; n=35 | 1.90 units on a scale | Standard Deviation 20.119 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Cognitive Functioning, Month 12; n=35 | 1.43 units on a scale | Standard Deviation 18.245 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Emotional Functioning, Month 6; n=35 | 11.19 units on a scale | Standard Deviation 23.216 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Emotional Functioning, Month 12; n=35 | 12.62 units on a scale | Standard Deviation 25.595 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Physical Functioning, Month 6; n=36 | -1.67 units on a scale | Standard Deviation 20.923 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Physical Functioning, Month 12; n=36 | 0.74 units on a scale | Standard Deviation 19.241 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Role Functioning, Month 6; n=36 | -4.17 units on a scale | Standard Deviation 27.422 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Role Functioning, Month 12; n=36 | 2.78 units on a scale | Standard Deviation 23.401 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Social Functioning, Month 6; n=35 | 13.81 units on a scale | Standard Deviation 26.036 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Social Functioning, Month 12; n=35 | 14.76 units on a scale | Standard Deviation 24.512 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Fatigue, Month 6; n=36 | -6.79 units on a scale | Standard Deviation 20.102 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Fatigue, Month 12; n=36 | -8.33 units on a scale | Standard Deviation 21.639 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Nausea and Vomiting, Month 6; n=36 | -9.72 units on a scale | Standard Deviation 31.966 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Nausea and Vomiting, Month 12; n=36 | -4.63 units on a scale | Standard Deviation 30.76 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Pain, Month 6; n=36 | -2.78 units on a scale | Standard Deviation 38.318 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Pain, Month 12; n=36 | -8.80 units on a scale | Standard Deviation 25.35 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Appetite Loss, Month 6; n=35 | 1.90 units on a scale | Standard Deviation 29.085 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Appetite Loss, Month 12; n=36 | 1.85 units on a scale | Standard Deviation 29.755 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Constipation, Month 6; n=36 | -0.93 units on a scale | Standard Deviation 28.156 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Constipation, Month 12; n=35 | 8.57 units on a scale | Standard Deviation 23.351 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Diarrhoea, Month 6; n=36 | 0.00 units on a scale | Standard Deviation 36.515 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Diarrhoea, Month 12; n=35 | -2.86 units on a scale | Standard Deviation 40.722 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Dyspnoea, Month 6; n=36 | 5.56 units on a scale | Standard Deviation 36.947 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Dyspnoea, Month 12; n=36 | 9.26 units on a scale | Standard Deviation 39.53 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Financial Difficulties, Month 6; n=35 | -10.48 units on a scale | Standard Deviation 21.038 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Financial Difficulties, Month 12; n=35 | -13.33 units on a scale | Standard Deviation 18.436 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Insomnia, Month 6; n=36 | 0.93 units on a scale | Standard Deviation 42.528 |
| Dasatinib (100 mg) | Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib | Insomnia, Month 12; n=36 | -1.85 units on a scale | Standard Deviation 38.991 |
Secondary
Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug, dasatinib.
Time frame: Date of first dose to 30 post last dose of study drug, an average of 3 years
Population: All treated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dasatinib (100 mg) | Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome | At least 1 AE | 37 Participants |
| Dasatinib (100 mg) | Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome | Discontinuation due to AE | 3 Participants |
| Dasatinib (100 mg) | Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome | Treatment-related AEs | 34 Participants |
| Dasatinib (100 mg) | Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome | SAEs | 11 Participants |
| Dasatinib (100 mg) | Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome | Treatment-related SAEs | 3 Participants |
| Dasatinib (100 mg) | Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome | Death | 0 Participants |
Secondary
The Percentage of Participants With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib
Dasatinib treatment was administered and its impact on the Imatinib-related Grade 1/2 adverse events was assessed. The percentage of participants is based on the number that had pre-existing Imatinib-related AEs. Measure assesses the participants with reduction or improvement of at least 1 Imatinib-related Grade 1 or Grade 2 chronic AE, without a worsening of any Imatinib-related, chronic adverse events after Dasatinib treatment. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Improved, AE grade reduced from Grade 2 to Grade 1. Worsened, Grade Increased. Confidence interval from Clopper-Pearson method.
Time frame: 3 months
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib (100 mg) | The Percentage of Participants With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib | 87.1 percentage of participants |
Other Pre-specified
Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib
Molecular responses were assessed at 6 and 12 months after switching to dasatinib to determine if these baseline responses could be maintained. MR4.5, the number of treated participants with BCR-ABL transcripts ≤ 0.0032% (IS) at 6 and 12 months from the date of dasatinib initiation; MMR, Major Molecular Response = 3-log reduction in BCR-ABL gene transcripts from a standardized baseline.
Time frame: 6 and 12 months
Population: All treated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dasatinib (100 mg) | Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib | MMR, Month 6 | 13 Participants |
| Dasatinib (100 mg) | Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib | MMR, Month 12 | 13 Participants |
| Dasatinib (100 mg) | Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib | MR4.5, Month 6 | 18 Participants |
| Dasatinib (100 mg) | Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib | MR4.5, Month 12 | 22 Participants |