Trial · NCT00123487
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
NCT00123487, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2014-10-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML. Trials, record NCT00123487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00123487
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
- NCT number
- NCT00123487
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 638 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Myeloid Leukemia, Chronic, Accelerated Phase, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
- Interventions
- dasatinib, dasatinib
- First posted
- 2005-07-25
- Last updated
- 2014-11-03
- Results first posted
- 2014-10-22
- Limitations and caveats
Amendment 3 (7 March 2007) allowed participants to switch from BID to QD dosing. Therefore, results for BID summarized by treatment group after Year 2 may not be a complete reflection of the BID experience and should be interpreted with this in mind.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population | Randomization up to 6 months | MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percentage: number of participants with MaHR/number of randomized participants. |
| Secondary | Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population | Randomization up to 2 years | A MaHR was defined as a participant having either CHR or NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percent: number of participants with MaHR /number of participants randomized. |
| Secondary | Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population | Randomization up to 2 years | MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants. |
| Secondary | Median Time to Major Hematologic Response (MaHR) - Randomized Population | Day 1 up to 6 months (time of primary endpoint), 2 years | A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months. |
| Secondary | Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study | Day 1 up to 5 years | MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. Median duration was measured in months. |
| Secondary | Percent of Participants With Overall Hematologic Response - Randomized Population | Randomization up to 6 Months, 2 Years | Overall Hematologic Response (OHR) was defined as CHR, NEL or minor hematologic response (MiHR). CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. MiHR defined as: \< 15% blasts in BM and in PB; \< 30% blasts + promyelocytes in BM and PB; \< 20% basophils in PB; No extra-medullary disease other than spleen and liver. Percentage: participants with OHR/ randomized participants. |
| Secondary | Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population | Randomization up to 6 months, 2 years | Type of hematologic response: CHR defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \<100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. Minor Hematologic Response (MiHR): \<15% blasts in BM and in PB; \< 30% blasts + promyelocytes in BM and PB; \< 20% basophils in PB; No extra-medullary disease other than spleen and liver. Major hematologic response (MaHR ) was CHR or NEL. Overall hematologic response was CHR or NEL or MiHR. |
| Secondary | Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population | Randomization up to 6 Months, 2 Years | Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM; Major cytogenetic response (MCyR) was defined as CCyR or PCyR. Percentage: number of participants with MCyR and denominator is number of randomized participants. |
| Secondary | Number of Participants With Best Cytogenic Response (CyR) - Randomized Population | Randomization up to 6 Months, 2 Years | Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM. |
| Secondary | Median Progression Free Survival (PFS) - Randomized Population | Randomization up to 5 Years | PFS was defined as: Time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. Median duration was measured in months. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population | Randomization up to 6 months | Participants were analyzed based on the treatment they were randomized to receive (not what they actually received). 95% exact confidence interval (CI) presented. | percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population | Randomization up to 2 years | Participants were analyzed based on the treatment they were randomized to receive. | percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population | Randomization up to 2 years | Participants were analyzed based on the treatment they were randomized to receive. n=number of participants in disease group. | percentage of participants | NUMBER |
| SECONDARY | Median Time to Major Hematologic Response (MaHR) - Randomized Population | Day 1 up to 6 months (time of primary endpoint), 2 years | Participants were analyzed based on the treatment they were randomized to receive. | Months | MEDIAN |
| SECONDARY | Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study | Day 1 up to 5 years | Participants who achieved a MaHR during the study. | Months | MEDIAN |
| SECONDARY | Percent of Participants With Overall Hematologic Response - Randomized Population | Randomization up to 6 Months, 2 Years | Participants were analyzed based on the treatment they were randomized to receive. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population | Randomization up to 6 months, 2 years | Participants were analyzed based on the treatment they were randomized to receive. | participants | NUMBER |
| SECONDARY | Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population | Randomization up to 6 Months, 2 Years | Participants were analyzed based on the treatment they were randomized to receive. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Best Cytogenic Response (CyR) - Randomized Population | Randomization up to 6 Months, 2 Years | Participants were analyzed based on the treatment they were randomized to receive. | participants | NUMBER |
| SECONDARY | Median Progression Free Survival (PFS) - Randomized Population | Randomization up to 5 Years | Participants were analyzed based on the treatment they were randomized to receive. | Months | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group168
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 Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population | Dasatinib 140 mg QD | 48.0 | 95% Confidence Interval 42.3 to 53.8 | percentage of participants | |
| Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population | Dasatinib 70 mg BID | 47.9 | 95% Confidence Interval 42.1 to 53.6 | percentage of participants | |
| Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population | Dasatinib 140 mg QD | 50.7 | 95% Confidence Interval 44.9 to 56.4 | percentage of participants | |
| Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population | Dasatinib 70 mg BID | 49.8 | 95% Confidence Interval 44.1 to 55.6 | percentage of participants | |
| Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population | Dasatinib 140 mg QD | Accelerated Phase (n=158, 159) | 66.5 | 95% Confidence Interval 58.5 to 73.8 | percentage of participants |
| Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population | Dasatinib 70 mg BID | Accelerated Phase (n=158, 159) | 67.9 | 95% Confidence Interval 60.1 to 75.1 | percentage of participants |
| Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population | Dasatinib 140 mg QD | Myeloid Blast Phase (n=75,74) | 28.0 | 95% Confidence Interval 18.2 to 39.6 | percentage of participants |
| Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population | Dasatinib 70 mg BID | Myeloid Blast Phase (n=75,74) | 28.4 | 95% Confidence Interval 18.5 to 40.1 | percentage of participants |
| Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population | Dasatinib 140 mg QD | Lymphoid Blast Phase (n=33,28) | 42.4 | 95% Confidence Interval 25.5 to 60.8 | percentage of participants |
| Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population | Dasatinib 70 mg BID | Lymphoid Blast Phase (n=33,28) | 32.1 | 95% Confidence Interval 15.9 to 52.4 | percentage of participants |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized | STARTED | Dasatinib 140 mg QD | 306 | |
| Randomized | STARTED | Dasatinib 70 mg BID | 305 | |
| Randomized | COMPLETED | Dasatinib 140 mg QD | 305 | |
| Randomized | COMPLETED | Dasatinib 70 mg BID | 304 | |
| Randomized | NOT COMPLETED | Dasatinib 140 mg QD | 1 | |
| Randomized | NOT COMPLETED | Dasatinib 70 mg BID | 1 | |
| Treated With Study Drug | STARTED | Dasatinib 140 mg QD | 304 | |
| Treated With Study Drug | STARTED | Dasatinib 70 mg BID | 305 | |
| Treated With Study Drug | COMPLETED | Dasatinib 140 mg QD | 0 | |
| Treated With Study Drug | COMPLETED | Dasatinib 70 mg BID | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events816
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 | Bone pain | Musculoskeletal and connective tissue disorders | Dasatinib 140 mg QD | 30 | 304 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Dasatinib 70 mg BID | 25 | 305 | |
| other | Chills | General disorders | Dasatinib 140 mg QD | 12 | 304 | |
| other | Chills | General disorders | Dasatinib 70 mg BID | 19 | 305 | |
| other | Constipation | Gastrointestinal disorders | Dasatinib 140 mg QD | 44 | 304 | |
| other | Constipation | Gastrointestinal disorders | Dasatinib 70 mg BID | 37 | 305 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dasatinib 140 mg QD | 7 | 304 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dasatinib 70 mg BID | 16 | 305 | |
| other | Oral herpes | Infections and infestations | Dasatinib 140 mg QD | 22 | 304 | |
| other | Oral herpes | Infections and infestations | Dasatinib 70 mg BID | 12 | 305 |
1 to 10 of 816Source ClinicalTrials.gov
See all 816 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib 140 mg QD | ||
| Total, all-cause mortality | Dasatinib 70 mg BID | ||
| Total, other adverse events | Dasatinib 140 mg QD | 289 | 304 |
| Total, other adverse events | Dasatinib 70 mg BID | 290 | 305 |
| Total, serious adverse events | Dasatinib 140 mg QD | 228 | 304 |
| Total, serious adverse events | Dasatinib 70 mg BID | 236 | 305 |
Source ClinicalTrials.gov
Papers3
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 |
|---|
| Dasatinib 140 mg QD vs Dasatinib 70 mg BID: 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/NCT00123487
GET https://conductscience.org/api/trials/v1/NCT00123487/results?page=2