Trial · NCT00101660
Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
NCT00101660, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2010-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib. Trials, record NCT00101660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00101660
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
- NCT number
- NCT00101660
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 387 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia
- Interventions
- Dasatinib
- First posted
- 2005-01-13
- Last updated
- 2012-03-02
- Results first posted
- 2010-02-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR) | 2 years | Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases. |
| Secondary | Number of Imatinib-intolerant Participants With MCyR | Baseline to 2 years | Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases. |
| Secondary | Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months | 12 and 24 Months | Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases. |
| Secondary | Median Time From First Dosing Date to Date of MCyR | Baseline (within 4 weeks of Day 1) and every 12 weeks | MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases. |
| Secondary | Number of Participants With Complete Hematologic Response (CHR) | Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study | CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \<450,000/mm\^3; no blasts or promyelocytes in peripheral blood; \<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date. |
| Secondary | Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months | 12 and 24 months | Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm\^3; no blasts or promyelocytes in peripheral blood; \<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date. |
| Secondary | Median Time From First Dosing Until CHR | Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study | CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \<450,000/mm\^3; no blasts or promyelocytes in peripheral blood; \<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date. |
| Secondary | Number of Participants With Major Molecular Response (MMR) | Baseline to 2 years | MMR is defined as ≤3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor. |
| Secondary | Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores | Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria. | Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, \& FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics. |
| Secondary | Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE | Continuously, from baseline through 2 years | AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR) | 2 years | All imatinib-resistant participants who received treatment. | Participants | NUMBER |
| SECONDARY | Number of Imatinib-intolerant Participants With MCyR | Baseline to 2 years | All imatinib-intolerant participants who received treatment. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months | 12 and 24 Months | Population is limited to responders (those who acheived MCyR) who were also assessed for duration of MCyR. | Percentage of participants | NUMBER |
| SECONDARY | Median Time From First Dosing Date to Date of MCyR | Baseline (within 4 weeks of Day 1) and every 12 weeks | Population is limited to responders (those who acheived MCyR) only | Months | MEDIAN |
| SECONDARY | Number of Participants With Complete Hematologic Response (CHR) | Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study | All participants who received treatment. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months | 12 and 24 months | Population limited to responders (those achieving CHR) only | Percentage of participants | NUMBER |
| SECONDARY | Median Time From First Dosing Until CHR | Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study | Population limited to responders (those achieving CHR) only | Months | MEDIAN |
| SECONDARY | Number of Participants With Major Molecular Response (MMR) | Baseline to 2 years | All participants who received treatment. | Participants | NUMBER |
| SECONDARY | Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores | Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria. | Number of participants with assessments at baseline and timepoint | Participants | NUMBER |
| SECONDARY | Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE | Continuously, from baseline through 2 years | All imitanib-intolerant participants who received treatment. | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR) | Dasatinib, 70 mg, Twice Daily (BID) | 159 | Participants | ||
| Number of Imatinib-intolerant Participants With MCyR | Dastinib, 70 mg, BID | 81 | Participants | ||
| Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months | Dasatanib, 70 mg BID | Imatinib-intolerant group: 12 months (n=81) | 98.5 | Percentage of participants | |
| Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months | Dasatanib, 70 mg BID | Imatinib-intolerant group: 24 months (n=81) | 96.7 | Percentage of participants | |
| Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months | Dasatanib, 70 mg BID | Imatinib-resistant group: 12 months (n=159) | 93.7 | Percentage of participants | |
| Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months | Dasatanib, 70 mg BID | Imatinib-resistant group: 24 months (n=159) | 83.6 | Percentage of participants | |
| Median Time From First Dosing Date to Date of MCyR | Dasatinib, 70 mg BID | Imatinib-intolerant | 2.79 | Full Range 0.79 to 16.39 | Months |
| Median Time From First Dosing Date to Date of MCyR | Dasatinib, 70 mg BID | Imatinib-resistant | 2.92 | Full Range 0.95 to 22.37 | Months |
| Number of Participants With Complete Hematologic Response (CHR) | Dasatinib, 70 mg BID | Imatinib-intolerant (n=99) | 93 | Participants | |
| Number of Participants With Complete Hematologic Response (CHR) | Dasatinib, 70 mg BID | Imatinib-resistant (n=288) | 259 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imatinib-intolerant | 99 | |
| Overall Study | STARTED | Imatinib-resistant | 288 | |
| Overall Study | COMPLETED | Imatinib-intolerant | 99 | |
| Overall Study | COMPLETED | Imatinib-resistant | 288 | |
| Overall Study | NOT COMPLETED | Imatinib-intolerant | 0 | |
| Overall Study | NOT COMPLETED | Imatinib-resistant | 0 |
Source ClinicalTrials.gov
Adverse events540
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 | EYELID OEDEMA | Eye disorders | Intolerant | 5 | 99 | |
| other | EYELID OEDEMA | Eye disorders | Resistant | 6 | 288 | |
| other | VISION BLURRED | Eye disorders | Intolerant | 8 | 99 | |
| other | VISION BLURRED | Eye disorders | Resistant | 12 | 288 | |
| other | WEIGHT DECREASED | Investigations | Intolerant | 12 | 99 | |
| other | WEIGHT DECREASED | Investigations | Resistant | 39 | 288 | |
| other | WEIGHT INCREASED | Investigations | Intolerant | 10 | 99 | |
| other | WEIGHT INCREASED | Investigations | Resistant | 30 | 288 | |
| other | PALPITATIONS | Cardiac disorders | Intolerant | 6 | 99 | |
| other | PALPITATIONS | Cardiac disorders | Resistant | 16 | 288 |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intolerant | ||
| Total, all-cause mortality | Resistant | ||
| Total, other adverse events | Intolerant | 96 | 99 |
| Total, other adverse events | Resistant | 287 | 288 |
| Total, serious adverse events | Intolerant | 48 | 99 |
| Total, serious adverse events | Resistant | 146 | 288 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Intolerant vs Resistant: serious adverse events |
Source Trial comparisons
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/NCT00101660
GET https://conductscience.org/api/trials/v1/NCT00101660/results?page=2