Trial · NCT01660906
Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib
NCT01660906, Phase 4, Completed, Bristol-Myers Squibb; results first posted 2016-11-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib. Trials, record NCT01660906. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01660906
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib
- NCT number
- NCT01660906
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 39 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Phase Chronic Myeloid Leukemia
- Interventions
- Dasatinib
- First posted
- 2012-08-09
- Last updated
- 2016-11-22
- Other registries' IDs
- eudract:2011-006180-21
- Results first posted
- 2016-11-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | All treated participants. | adverse event(s) | NUMBER |
| 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 | Baseline to 3, 6, 12 months | All treated participants. | units on a scale | MEAN |
| 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 | Baseline to 6, 12 months | All treated participants | units on a scale | MEAN |
| 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 | Date of first dose to 30 post last dose of study drug, an average of 3 years | All treated participants. | Participants | COUNT_OF_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 | 3 months | All treated participants. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib | 6 and 12 months | All treated participants. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment | Dasatinib (100 mg) | Resolved | 91 | adverse event(s) | |
| The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment | Dasatinib (100 mg) | Improved | 2 | adverse event(s) | |
| The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment | Dasatinib (100 mg) | Unchanged | 27 | adverse event(s) | |
| The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment | Dasatinib (100 mg) | Worsened | 1 | adverse event(s) | |
| 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 | Dasatinib (100 mg) | Core Symptom Severity Score, Month 3; n=37 | -1.35 | Standard Deviation 1.78 | units on a scale |
| 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 | Dasatinib (100 mg) | Core Symptom Severity Score, Month 6; n=36 | -1.44 | Standard Deviation 1.84 | units on a scale |
| 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 | Dasatinib (100 mg) | Core Symptom Severity Score, Month 12; n=37 | -1.06 | Standard Deviation 1.87 | units on a scale |
| 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 | Dasatinib (100 mg) | Interference Score, Month 3; n=37 | -1.24 | Standard Deviation 2.36 | units on a scale |
| 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 | Dasatinib (100 mg) | Interference Score, Month 6; n=35 | -1.28 | Standard Deviation 2.45 | units on a scale |
| 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 | Dasatinib (100 mg) | Interference Score, Month 12; n=36 | -1.30 | Standard Deviation 2.56 | units on a scale |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib (100 mg) | 39 | |
| Overall Study | COMPLETED | Dasatinib (100 mg) | 36 | |
| Overall Study | NOT COMPLETED | Dasatinib (100 mg) | 3 |
Source ClinicalTrials.gov
Adverse events47
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dysphonia | Respiratory, thoracic and mediastinal disorders | Dasatinib | 2 | 39 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Dasatinib | 2 | 39 | |
| other | Left ventricular hypertrophy | Cardiac disorders | Dasatinib | 2 | 39 | |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Dasatinib | 10 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | Dasatinib | 5 | 39 | |
| other | Asthenia | General disorders | Dasatinib | 2 | 39 | |
| other | General physical health deterioration | General disorders | Dasatinib | 2 | 39 | |
| other | Headache | Nervous system disorders | Dasatinib | 15 | 39 | |
| other | Blood urea increased | Investigations | Dasatinib | 2 | 39 | |
| other | Dizziness | Nervous system disorders | Dasatinib | 4 | 39 |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | ||
| Total, other adverse events | Dasatinib | 36 | 39 |
| Total, serious adverse events | Dasatinib | 11 | 39 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01660906
GET https://conductscience.org/api/trials/v1/NCT01660906/results?page=2