Trial · NCT00123474
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
NCT00123474, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2015-08-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML. Trials, record NCT00123474. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00123474
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
- NCT number
- NCT00123474
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 724 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Myeloid Leukemia, Chronic, Chronic-Phase
- Interventions
- dasatinib, dasatinib, dasatinib, dasatinib
- First posted
- 2005-07-25
- Last updated
- 2016-08-25
- Results first posted
- 2015-08-26
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up | 6 months | Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified. |
| Secondary | Percent of Participants With MCyR At or Prior to 24 Months Follow-Up | 24 months | CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified. |
| Secondary | Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up | 6 months, 24 months | A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets \< 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); \< 5% myelocytes plus metamyelocytes in PB; Basophils in PB \< 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date. |
| Secondary | Time to MCyR in Participants With MCyR at 6 Months Follow-Up | 6 months | Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). |
| Secondary | Time to CHR in Participants With CHR at 6 Months Follow-Up | 6 months | Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders). |
| Secondary | Time to MCyR in Participants With MCyR at 24 Months Follow-Up | 24 months | Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up. |
| Secondary | Time to CHR in Participants With CHR At 24 Months Follow-Up | 24 months | Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up. |
| Secondary | Number of Participants With MCyR Whose Disease Progressed by 24 Months | 24 months | Progression in a participant=participant achieved a CHR and no longer met the criteria consistently over consecutive 2-weeks after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to \>20,000/mm\^3 or an increase by \> 50,000/mm\^3 on two assessments performed at least 2 weeks apart; participant met criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of MCyR, medium duration of MCyR could not be estimated because the majority of participants with MCyR continued to respond, or could not be reliably estimated because of the large number of censored participants. Cytogenetic assessments were not done after the 24 month follow-up. |
| Secondary | Number of Participants With CHR Whose Disease Progressed by 24 Months | 24 months | Progression in a participant=achieved a CHR and subsequently no longer met the criteria consistently over a consecutive 2-week period after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to \>20,000/mm\^3 or an increase by \> 50,000/mm\^3 on two assessments performed at least 2 weeks apart; met the criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of CHR, medium duration of CHR could not be estimated because the majority of participants with CHR continued to respond, or could not be reliably estimated because of the large number of censored participants. |
| Secondary | Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants | Baseline up to 24 months | BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up | 6 months | All randomized imatinib-resistant participants with available data were summarized. | percentage of Participants | NUMBER |
| SECONDARY | Percent of Participants With MCyR At or Prior to 24 Months Follow-Up | 24 months | All randomized imatinib-resistant participants with available data were summarized. | percentage of Participants | NUMBER |
| SECONDARY | Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up | 6 months, 24 months | All randomized imatinib-resistant participants with available data were summarized. | percentage of participants | NUMBER |
| SECONDARY | Time to MCyR in Participants With MCyR at 6 Months Follow-Up | 6 months | Randomized imatinib-resistant participants with MCyR and available data were summarized. | Months | MEDIAN |
| SECONDARY | Time to CHR in Participants With CHR at 6 Months Follow-Up | 6 months | Randomized imatinib-resistant participants with CHR and available data were summarized. | Months | MEDIAN |
| SECONDARY | Time to MCyR in Participants With MCyR at 24 Months Follow-Up | 24 months | Randomized imatinib-resistant participants with MCyR were summarized. | Months | MEDIAN |
| SECONDARY | Time to CHR in Participants With CHR At 24 Months Follow-Up | 24 months | Randomized imatinib-resistant participants with CHR were summarized. | Months | MEDIAN |
| SECONDARY | Number of Participants With MCyR Whose Disease Progressed by 24 Months | 24 months | All imatinib-resistant participants who had achieved MCyR and experienced disease progression were summarized. | participants | NUMBER |
| SECONDARY | Number of Participants With CHR Whose Disease Progressed by 24 Months | 24 months | All imatinib-resistant participants who achieved CHR and then experienced disease progression were summarized. | participants | NUMBER |
| SECONDARY | Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants | Baseline up to 24 months | All randomized, treated participants with available mutation data were summarized. | participants | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group262
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up | QD Dasatinib | 51.8 | 95% Confidence Interval 45.4 to 58.2 | percentage of Participants | |
| Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up | BID Dasatinib | 49.0 | 95% Confidence Interval 42.7 to 55.4 | percentage of Participants | |
| Percent of Participants With MCyR At or Prior to 24 Months Follow-Up | Dasatinib QD | 58.3 | 95% Confidence Interval 51.9 to 64.5 | percentage of Participants | |
| Percent of Participants With MCyR At or Prior to 24 Months Follow-Up | Dasatinib BID | 56.4 | 95% Confidence Interval 50.0 to 62.6 | percentage of Participants | |
| Percent of Participants With MCyR At or Prior to 24 Months Follow-Up | Dasatinib 100 mg Total Daily Dose | 57.3 | 95% Confidence Interval 50.8 to 63.5 | percentage of Participants | |
| Percent of Participants With MCyR At or Prior to 24 Months Follow-Up | Dasatinib 140 mg Total Daily Dose | 57.4 | 95% Confidence Interval 51.0 to 63.7 | percentage of Participants | |
| Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up | Dasatinib 100 mg QD | 6 Months (n=124,123,124,127) | 86.3 | 95% Confidence Interval 79.0 to 91.8 | percentage of participants |
| Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up | Dasatinib 140 mg QD | 6 Months (n=124,123,124,127) | 85.4 | 95% Confidence Interval 77.9 to 91.1 | percentage of participants |
| Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up | Dasatinib 50 mg BID | 6 Months (n=124,123,124,127) | 91.1 | 95% Confidence Interval 84.7 to 95.5 | percentage of participants |
| Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up | Dasatinib 70 mg BID | 6 Months (n=124,123,124,127) | 87.4 | 95% Confidence Interval 80.3 to 92.6 | percentage of participants |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized to Treatment | STARTED | Dasatinib 100 mg QD | 167 | |
| Randomized to Treatment | STARTED | Dasatinib 140 mg QD | 167 | |
| Randomized to Treatment | STARTED | Dasatinib 50 mg BID | 168 | |
| Randomized to Treatment | STARTED | Dasatinib 70 mg BID | 168 | |
| Randomized to Treatment | COMPLETED | Dasatinib 100 mg QD | 166 | |
| Randomized to Treatment | COMPLETED | Dasatinib 140 mg QD | 163 | |
| Randomized to Treatment | COMPLETED | Dasatinib 50 mg BID | 166 | |
| Randomized to Treatment | COMPLETED | Dasatinib 70 mg BID | 167 | |
| Randomized to Treatment | NOT COMPLETED | Dasatinib 100 mg QD | 1 | |
| Randomized to Treatment | NOT COMPLETED | Dasatinib 140 mg QD | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,432
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 | Acne | Skin and subcutaneous tissue disorders | 100mg QD | 5 | 165 | |
| other | Acne | Skin and subcutaneous tissue disorders | 140mg QD | 7 | 163 | |
| other | Acne | Skin and subcutaneous tissue disorders | 50mg BID | 7 | 167 | |
| other | Acne | Skin and subcutaneous tissue disorders | 70mg BID | 9 | 167 | |
| other | Hypertension | Vascular disorders | 100mg QD | 15 | 165 | |
| other | Hypertension | Vascular disorders | 140mg QD | 12 | 163 | |
| other | Hypertension | Vascular disorders | 50mg BID | 13 | 167 | |
| other | Hypertension | Vascular disorders | 70mg BID | 20 | 167 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | 100mg QD | 33 | 165 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | 140mg QD | 29 | 163 |
1 to 10 of 1,432Source ClinicalTrials.gov
See all 1,432 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 100mg QD | ||
| Total, all-cause mortality | 140mg QD | ||
| Total, all-cause mortality | 50mg BID | ||
| Total, all-cause mortality | 70mg BID | ||
| Total, other adverse events | 100mg QD | 160 | 165 |
| Total, other adverse events | 140mg QD | 155 | 163 |
| Total, other adverse events | 50mg BID | 160 | 167 |
| Total, other adverse events | 70mg BID | 165 | 167 |
| Total, serious adverse events | 100mg QD | 75 | 165 |
| Total, serious adverse events | 140mg QD | 78 | 163 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
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 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/NCT00123474
GET https://conductscience.org/api/trials/v1/NCT00123474/registered?page=2