Trial · NCT00101647
Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
NCT00101647, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2010-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia. Trials, record NCT00101647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00101647
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
- NCT number
- NCT00101647
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 197 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Myelogenous Leukemia
- Interventions
- Dasatinib
- First posted
- 2005-01-13
- Last updated
- 2011-04-15
- Results first posted
- 2010-03-02
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major and Overall Hematologic Response (MaHR and OHR) | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment | MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea. Maintaining a response=no 2 consecutive records of nonresponse at assessment. Criteria for CHR and NEL specified in Outcome Measure 2 and criteria for MiHR in Outcome Measure 4. |
| Secondary | Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response) | 12 months | MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; \<5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; \<5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 \& \<1000/mm3; platelets ≥20,000/mm3 \& \<100,000/mm3. |
| Secondary | Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response) | 24 months | Percentage of participants in the Imatinib-Resistant Group who achieved MaHR and did not progress at Month 24, based on the Kaplan-Meier estimate of the duration of response. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR and NEL are specified in Outcome Measure 2. |
| Secondary | Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months | 12 months, 24 months | Percentage of participants who achieved OHR and did not progress at specified timepoints, based on the Kaplan-Meier estimate of the duration of response. OHR=best confirmed response of MaHR or MiHR. MaHR criteria in Outcome Measure 2. MiHR= \<15% blasts in bone marrow and \<15% blasts in peripheral blood (PB); \<30% blasts+promyelocytes in bone marrow and \<30% blasts+promyelocytes in PB; \<20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response= confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea. |
| Secondary | Median Time in Days From First Dosing Date to Date of MaHR | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment | MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; \<5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; \<5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 \& \<1000/mm3; platelets ≥20,000/mm3 \& \<100,000/mm3. |
| Secondary | Time to OHR | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment | Median time (in months) from first dosing date to date of OHR. OHR=best confirmed response of MaHR or MiHR. Criteria for MaHR specified in Outcome Measure 2. MiHR= \<15% blasts in bone marrow and \<15% blasts in peripheral blood (PB); \<30% blasts+promyelocytes in bone marrow and \<30% blasts+promyelocytes in PB; \<20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response = response confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea. |
| Secondary | Best Cytogenetic Response | Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment | Number of participants with complete, partial, minor, minimal, or no cytogenetic response. Determination of cytogenetic response based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies). |
| Secondary | Best Confirmed Hematologic Response | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment | Number of participants with confirmed complete hematologic response (CHR) or No Evidence of Leukemia (NEL), minor hematologic response (MiHR), or no hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for CHR and NEL are specified in Outcome Measure 2; criteria for MiHR are specified in Outcome Measure 4. |
| Secondary | Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period | Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria). | Number of participants who achieved an MMR at any time during the treatment period. MMR was calculated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML). |
| Secondary | MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations | Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria). | Major hematologic and cytogenetic responses (MaHR and MCyR) to dasatinib in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). BCR-ABL=the fused gene found in subjects with this type of CML. Criteria for MaHR are specified in Outcome Measure 2. MCyR=combined complete cytogenetic and partial cytogenetic response rate. Complete Cytogenetic Response= 0% Ph+ Cells in Metaphase in Bone Marrow, Partial Cytogenetic Response \> 0% to 35% Ph+ Cells in Metaphase in Bone Marrow. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Major and Overall Hematologic Response (MaHR and OHR) | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment | All treated subjects | participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response) | 12 months | Population comprised of responders only. | percentage of responders | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response) | 24 months | Population comprised of responders only. NOTE: Projected duration of MaHR at 24 months in the Imatinib-Intolerant group was beyond the maximum observed time for this cohort, and therefore only the Imatinib-Resistant group is presented. | percentage of responders | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months | 12 months, 24 months | Population is comprised of responders only | Percentage of responders | NUMBER |
| SECONDARY | Median Time in Days From First Dosing Date to Date of MaHR | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment | Population is comprised of responders only | Days | MEDIAN |
| SECONDARY | Time to OHR | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment | Population comprised of responders only | days | MEDIAN |
| SECONDARY | Best Cytogenetic Response | Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment | All treated subjects | Participants | NUMBER |
| SECONDARY | Best Confirmed Hematologic Response | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment | All treated subjects | Participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period | Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria). | Number of Participants Analyzed=all treated subjects who were assessed for major molecular response; n=participants with or without CCyR in cohort. | participants | NUMBER |
| SECONDARY | MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations | Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria). | All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 162 of the 174 subjects (12/13 imatinib-intolerant and 150/161 imatinib-resistant). At baseline, 89 (59%) imatinib-resistant subjects and 1 imatinib-intolerant subject expressed imatinib resistant mutations. | Percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group162
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major and Overall Hematologic Response (MaHR and OHR) | Imatinib-intolerant | MaHR | 9 | participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Imatinib-resistant | MaHR | 103 | participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Total | MaHR | 112 | participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Imatinib-intolerant | OHR | 12 | participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Imatinib-resistant | OHR | 127 | participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Total | OHR | 139 | participants | |
| Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response) | Imatinib-intolerant | 85.7 | percentage of responders | ||
| Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response) | Imatinib-resistant | 78.3 | percentage of responders | ||
| Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response) | Total | 79.0 | percentage of responders | ||
| Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response) | Imatinib-resistant | 60.9 | percentage of responders |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 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 | 13 | |
| Overall Study | STARTED | Imatinib-resistant | 161 | |
| Overall Study | COMPLETED | Imatinib-intolerant | 13 | |
| Overall Study | COMPLETED | Imatinib-resistant | 161 | |
| Overall Study | NOT COMPLETED | Imatinib-intolerant | 0 | |
| Overall Study | NOT COMPLETED | Imatinib-resistant | 0 |
Source ClinicalTrials.gov
Adverse events748
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 | EYE SWELLING | Eye disorders | Intolerant | 1 | 13 | |
| other | EYE SWELLING | Eye disorders | Resistant | 2 | 161 | |
| other | VISION BLURRED | Eye disorders | Intolerant | 1 | 13 | |
| other | VISION BLURRED | Eye disorders | Resistant | 8 | 161 | |
| other | VITREOUS FLOATERS | Eye disorders | Intolerant | 1 | 13 | |
| other | VITREOUS FLOATERS | Eye disorders | Resistant | 1 | 161 | |
| other | SCLERAL HAEMORRHAGE | Eye disorders | Intolerant | 1 | 13 | |
| other | SCLERAL HAEMORRHAGE | Eye disorders | Resistant | 1 | 161 | |
| other | EYELID FUNCTION DISORDER | Eye disorders | Intolerant | 1 | 13 | |
| other | EYELID FUNCTION DISORDER | Eye disorders | Resistant | 0 | 161 |
1 to 10 of 748Source ClinicalTrials.gov
See all 748 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 | 13 | 13 |
| Total, other adverse events | Resistant | 158 | 161 |
| Total, serious adverse events | Intolerant | 12 | 13 |
| Total, serious adverse events | Resistant | 113 | 161 |
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/NCT00101647
GET https://conductscience.org/api/trials/v1/NCT00101647/results?page=2