Trial · NCT00101816
Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
NCT00101816, 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. Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate. Trials, record NCT00101816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00101816
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
- NCT number
- NCT00101816
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Myeloid Leukemia, Blast Crisis
- Interventions
- Dasatinib
- First posted
- 2005-01-14
- Last updated
- 2010-08-10
- Results first posted
- 2010-03-02
Source ClinicalTrials.gov
Registered outcomes19
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 Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. OHR=best confirmed response of MaHR or minor HR (MiHR). 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 first documented event with no concomitant use of anagrelide or hydroxyurea. |
| Secondary | Median Duration of Major Hematologic Response (MaHR) | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | MaHR=best confirmed 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 the following: ANC ≥500/mm3 \& \<1000/mm3; platelets ≥20,000/mm3 \& \<100,000/mm3. |
| Secondary | Median Duration of Overall Hematologic Response (OHR) | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | OHR=best confirmed response of MaHR or MiHR. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1. Maintaining a response was defined as no 2 consecutive records of non-response (ie, a single record of non-response between 2 assessments of response was not considered a loss of response). |
| Secondary | Time to MaHR and OHR | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | Median time from first dosing to date of OHR and/or MaHR in subjects who achieved OHR and MaHR. 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). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1. |
| Secondary | Number of Participants With Complete, Partial, Minor, Minimal, or No Cytogenetic Response | Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment | Best confirmed cytogenetic response. Determination of cytogenetic response is based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies). |
| Secondary | Number of Participants With CHR or NEL, MiHR, or no Hematologic Response | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycles 1 and 2; After every 2nd cycle for Cycles 3+; at end of treatment | Best confirmed 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 complete hematologic response (CHR) or No Evidence of Leukemia (NEL) are specified in Outcome Measure 2. Criteria for minor hematologic response (MiHR) are specified in Outcome Measure 1. |
| Secondary | Number of Participants Achieving Major Molecular Response (MMR) | Baseline, every 12 weeks, and at time of Complete Cytogenetic Response (CCyR) for quantitative Polyermase Chain Reaction (qPCR) analysis | Number of participants who achieved an MMR at any time during the treatment period. MMR was calulated 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 Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations | baseline, at time of disease progression | MaHR and MCyR in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). Criteria for MaHR are specified in Outcome Measure 2. MCyR=rate of complete cytogenetic responses + the rate of partial cytogenetic responses, as defined in Outcome Measure 5. BCR-ABL=the fused gene found in subjects with this type of CML. This table contains those mutations observed in at least 3 participants. The categories "1 IRM w/2-4-fold increase in resistance" and "≥1 IRM w/≥5-fold increase in resistance" refer to increase in resistance to imatinib. |
| Secondary | Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) | Baseline, Every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up | Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, \& functional well-being (PWB, SWB, EWB, FWB). Score range: 0-108; 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, \& SWB score change of 2 or more=minimal clinical important change. |
| Secondary | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs | Continuously throughout study, from pre-treatment visit through end of study (due to death, unacceptable toxicity, treatment failure, etc) and follow-up period | AE=any new untoward medical occurrence or worsening of a pre-existing 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 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | All treated subjects | Participants | NUMBER |
| SECONDARY | Median Duration of Major Hematologic Response (MaHR) | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | Participants who achieved MaHR | months | MEDIAN |
| SECONDARY | Median Duration of Overall Hematologic Response (OHR) | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | Participants who achieved OHR | months | MEDIAN |
| SECONDARY | Time to MaHR and OHR | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | Participants who achieved OHR and MaHR | days | MEDIAN |
| SECONDARY | Number of Participants With Complete, Partial, Minor, Minimal, or No 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 | Number of Participants With CHR or NEL, MiHR, or no Hematologic Response | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycles 1 and 2; After every 2nd cycle for Cycles 3+; at end of treatment | All treated subjects | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving Major Molecular Response (MMR) | Baseline, every 12 weeks, and at time of Complete Cytogenetic Response (CCyR) for quantitative Polyermase Chain Reaction (qPCR) analysis | treated participants with or without CCyR who were assessed for major molecular response | participants | NUMBER |
| SECONDARY | MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations | baseline, at time of disease progression | All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 103 of the 109 subjects (10/10 imatinib-intolerant and 93/99 imatinib-resistant). At baseline, 39 (42%) imatinib-resistant subjects and 3 imatinib-intolerant subject had imatinib-resistant mutations | Percentage of Participants | NUMBER |
| SECONDARY | Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) | Baseline, Every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up | Number of participants with FACT-G assessments at baseline and at least one assessment during treatment | Participants | NUMBER |
| SECONDARY | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs | Continuously throughout study, from pre-treatment visit through end of study (due to death, unacceptable toxicity, treatment failure, etc) and follow-up period | All treated subjects | Participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group125
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 | 2 | Participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Imatinib-resistant | MaHR | 34 | Participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Total | MaHR | 36 | Participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Imatinib-intolerant | OHR | 4 | Participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Imatinib-resistant | OHR | 50 | Participants | |
| Major and Overall Hematologic Response (MaHR and OHR) | Total | OHR | 54 | Participants | |
| Median Duration of Major Hematologic Response (MaHR) | Participants Acheiving MaHR | 22.4 | Full Range 1.6 to 27.3 | months | |
| Median Duration of Overall Hematologic Response (OHR) | Participants Acheiving OHR | 14.7 | 95% Confidence Interval 10.0 to 22.6 | months | |
| Time to MaHR and OHR | Participants Acheiving MaHR | 63.5 | 95% Confidence Interval 40.0 to 85.0 | days | |
| Time to MaHR and OHR | Participants Acheiving OHR | 30.0 | 95% Confidence Interval 29.0 to 37.0 | days |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 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 | 10 | |
| Overall Study | STARTED | Imatinib-resistant | 99 | |
| Overall Study | COMPLETED | Imatinib-intolerant | 10 | |
| Overall Study | COMPLETED | Imatinib-resistant | 99 | |
| Overall Study | NOT COMPLETED | Imatinib-intolerant | 0 | |
| Overall Study | NOT COMPLETED | Imatinib-resistant | 0 |
Source ClinicalTrials.gov
Adverse events582
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 | DRY EYE | Eye disorders | Imatinib-intolerant | 1 | 10 | |
| other | DRY EYE | Eye disorders | Imatinib-resistant | 0 | 99 | |
| other | EYE OEDEMA | Eye disorders | Imatinib-intolerant | 1 | 10 | |
| other | EYE OEDEMA | Eye disorders | Imatinib-resistant | 1 | 99 | |
| other | EYELID OEDEMA | Eye disorders | Imatinib-intolerant | 1 | 10 | |
| other | EYELID OEDEMA | Eye disorders | Imatinib-resistant | 4 | 99 | |
| other | EYE HAEMORRHAGE | Eye disorders | Imatinib-intolerant | 0 | 10 | |
| other | EYE HAEMORRHAGE | Eye disorders | Imatinib-resistant | 6 | 99 | |
| other | RETINAL HAEMORRHAGE | Eye disorders | Imatinib-intolerant | 1 | 10 | |
| other | RETINAL HAEMORRHAGE | Eye disorders | Imatinib-resistant | 1 | 99 |
1 to 10 of 582Source ClinicalTrials.gov
See all 582 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib-intolerant | ||
| Total, all-cause mortality | Imatinib-resistant | ||
| Total, other adverse events | Imatinib-intolerant | 10 | 10 |
| Total, other adverse events | Imatinib-resistant | 97 | 99 |
| Total, serious adverse events | Imatinib-intolerant | 7 | 10 |
| Total, serious adverse events | Imatinib-resistant | 80 | 99 |
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 |
|---|
| Imatinib-intolerant vs Imatinib-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/NCT00101816
GET https://conductscience.org/api/trials/v1/NCT00101816/results?page=2