Trial · NCT01593254
Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib
NCT01593254, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2019-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib. Trials, record NCT01593254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01593254
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib
- NCT number
- NCT01593254
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 262 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Phase Chronic Myeloid Leukemia
- Interventions
- Imatinib, Dasatinib
- First posted
- 2012-05-08
- Last updated
- 2023-06-22
- Other registries' IDs
- eudract:2011-006181-41
- Results first posted
- 2019-04-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment | At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib. | Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals. P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (\<=4 weeks vs \>4 weeks). |
| Secondary | Median Time to Major Molecular Response (MMR) | From randomization to study completion. Approximately 115 months | Median Time to Major Molecular Response (MMR) is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored. Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR. |
| Secondary | Time to Molecular Response (MR)^4.5 | From randomization to study completion. Approximately 115 months | Time to Molecular Response (MR)\^4.5 is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored. MR4.5 is defined as a 4.5-log reduction in BCR-ABL transcript from the standardized baseline (0.0032% IS, either detectable disease \<= 0.0032% BCR-ABL (IS) or undetectable disease in cDNA (in same volume used for BCR-ABL) with \>= 32,000 ABL transcripts. |
| Secondary | Progression Free Survival (PFS) | From randomization to study completion. Approximately 115 months | PFS is the time from randomization date to progression date or death date, whichever occurs first. Participants who neither progress nor die will be censored. Progression is defined as the following, meeting the criteria for accelerated or blast crisis CML are met at any time or death from any cause during treatment. Accelerated phase of CML: * The presence of ≥15%, but \< 30% blasts in the blood or bone marrow * At least 30% blasts plus promyelocytes in the blood or bone marrow * At least 20% peripheral basophils * Thrombocytopenia (fewer than 100,000 platelets/mm3) unrelated to treatment. Blast phase of CML * At least 30% blasts in the blood or bone marrow * Extramedullary involvement (e.g., chloromas), but not hepatosplenomegaly |
| Secondary | Overall Survival (OS) | From randomization to study completion. Approximately 115 months | OS is the time from randomization date to death date. Participants who have not died will be censored on the last date they are known to be alive. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment | At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib. | All Randomized Participants | Percentage of Patients | NUMBER |
| SECONDARY | Median Time to Major Molecular Response (MMR) | From randomization to study completion. Approximately 115 months | All Randomized Participants | Months | MEDIAN |
| SECONDARY | Time to Molecular Response (MR)^4.5 | From randomization to study completion. Approximately 115 months | All Randomized participants | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From randomization to study completion. Approximately 115 months | All randomized participants with a progression event | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to study completion. Approximately 115 months | All randomized participants who died | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment | Arm 1: Imatinib (≥400 mg) | 12.8 | 95% Confidence Interval 6.6 to 21.7 | Percentage of Patients | |
| Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment | Arm 2: Dasatinib (100 mg) | 28.7 | 95% Confidence Interval 22.1 to 36.1 | Percentage of Patients | |
| Median Time to Major Molecular Response (MMR) | Arm 1: Imatinib (≥400 mg) | 19.7 | 95% Confidence Interval 14.2 to 26.4 | Months | |
| Median Time to Major Molecular Response (MMR) | Arm 2: Dasatinib (100 mg) | 13.9 | 95% Confidence Interval 11.6 to 17.6 | Months | |
| Time to Molecular Response (MR)^4.5 | Arm 1: Imatinib (≥400 mg) | 67.7 | 95% Confidence Interval 55.9 to NA | Months | |
| Time to Molecular Response (MR)^4.5 | Arm 2: Dasatinib (100 mg) | 74.5 | 95% Confidence Interval 67.1 to 91.8 | Months | |
| Progression Free Survival (PFS) | Arm 1: Imatinib (≥400 mg) | NA | 95% Confidence Interval 89.3 to NA | Months | |
| Progression Free Survival (PFS) | Arm 2: Dasatinib (100 mg) | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | Arm 1: Imatinib (≥400 mg) | NA | 95% Confidence Interval 89.3 to NA | Months | |
| Overall Survival (OS) | Arm 2: Dasatinib (100 mg) | NA | 95% Confidence Interval NA to NA | Months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Imatinib (≥400 mg) | 86 | |
| Overall Study | STARTED | Arm 2: Dasatinib (100 mg) | 174 | |
| Overall Study | Crossed Over to Dasatinib | Arm 1: Imatinib (≥400 mg) | 46 | |
| Overall Study | Crossed Over to Dasatinib | Arm 2: Dasatinib (100 mg) | 0 | |
| Overall Study | COMPLETED | Arm 1: Imatinib (≥400 mg) | 0 | |
| Overall Study | COMPLETED | Arm 2: Dasatinib (100 mg) | 0 | |
| Overall Study | NOT COMPLETED | Arm 1: Imatinib (≥400 mg) | 86 | |
| Overall Study | NOT COMPLETED | Arm 2: Dasatinib (100 mg) | 174 |
Source ClinicalTrials.gov
Adverse events363
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 | Anaemia | Blood and lymphatic system disorders | Arm 1: Imatinib | 20 | 86 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 2: Dasatinib | 53 | 171 | |
| other | Anaemia | Blood and lymphatic system disorders | Dasatinib After Crossover From Imatinib | 15 | 46 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm 1: Imatinib | 8 | 86 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm 2: Dasatinib | 17 | 171 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dasatinib After Crossover From Imatinib | 8 | 46 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm 1: Imatinib | 20 | 86 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm 2: Dasatinib | 42 | 171 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dasatinib After Crossover From Imatinib | 20 | 46 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm 1: Imatinib | 12 | 86 |
1 to 10 of 363Source ClinicalTrials.gov
See all 363 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Imatinib | 1 | 86 |
| Total, all-cause mortality | Arm 2: Dasatinib | 11 | 174 |
| Total, all-cause mortality | Dasatinib After Crossover From Imatinib | 4 | 46 |
| Total, other adverse events | Arm 1: Imatinib | 68 | 86 |
| Total, other adverse events | Arm 2: Dasatinib | 159 | 171 |
| Total, other adverse events | Dasatinib After Crossover From Imatinib | 42 | 46 |
| Total, serious adverse events | Arm 1: Imatinib | 11 | 86 |
| Total, serious adverse events | Arm 2: Dasatinib | 48 | 171 |
| Total, serious adverse events | Dasatinib After Crossover From Imatinib | 8 | 46 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32265500 | DERIVED |
Source PubMed
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/NCT01593254
GET https://conductscience.org/api/trials/v1/NCT01593254/events?page=2