Trial · NCT01030718
Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
NCT01030718, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2010-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rollover Study of BMS-354825 in Patients With CML and Ph+ALL. Trials, record NCT01030718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01030718
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
- NCT number
- NCT01030718
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Myelogenous Leukemia, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- Interventions
- dasatinib
- First posted
- 2009-12-11
- Last updated
- 2010-12-14
- Results first posted
- 2010-12-14
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. |
| Secondary | Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Philadelphia positive \[Ph+\] Cells in Metaphase in BM). |
| Secondary | Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). |
| Secondary | Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). |
| Secondary | Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454), | Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR. |
| Secondary | Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR. |
| Secondary | Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of progressed disease (PD) or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment. |
| Secondary | Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of PD or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment. |
| Secondary | Participants With CML-CP: Time to Major Cytogenetic Response (MCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first). |
| Secondary | Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation | All treated participants. Number of deaths represents all reported deaths, including after the study end. For AEs leading to discontinuation: 4 in CML-CP=1 insufficient effect (IE) +3 AEs in Participant Flow (PF); 7 in CML-AP/BP= 1 death + 5 AEs + 1 IE in PF; 4 in Ph+ALL=3 IE + 1AE in PF. | participants | NUMBER |
| SECONDARY | Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Treated CML-CP participants | Percentage of Participants | NUMBER |
| SECONDARY | Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Treated CML-AP/BP participants | Percentage of Participants | NUMBER |
| SECONDARY | Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Treated Ph+ ALL participants | Percentage of Participants | NUMBER |
| SECONDARY | Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454), | Participants achieving CCyR | Days | MEDIAN |
| SECONDARY | Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Participants achieving CCyR | Days | MEDIAN |
| SECONDARY | Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-CP group. | Days | MEDIAN |
| SECONDARY | Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-AP/BP group. | Days | MEDIAN |
| SECONDARY | Participants With CML-CP: Time to Major Cytogenetic Response (MCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Time to MCyR was computed only for participants whose best response was CCyR or PCyR. | Days | MEDIAN |
| SECONDARY | Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Time to MCyR was computed only for participants whose best response was CCyR or PCyR. | Days | MEDIAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | CML - Chronic Phase (CML-CP) | AEs (symptoms/signs and laboratory abnormalities) | 30 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | CML - Accelerated Phase and Blast Phase (CML-AP/BP) | AEs (symptoms/signs and laboratory abnormalities) | 11 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) | AEs (symptoms/signs and laboratory abnormalities) | 13 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | CML - Chronic Phase (CML-CP) | SAEs (symptoms/signs and laboratory abnormalities) | 13 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | CML - Accelerated Phase and Blast Phase (CML-AP/BP) | SAEs (symptoms/signs and laboratory abnormalities) | 9 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) | SAEs (symptoms/signs and laboratory abnormalities) | 11 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | CML - Chronic Phase (CML-CP) | Deaths | 1 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | CML - Accelerated Phase and Blast Phase (CML-AP/BP) | Deaths | 2 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) | Deaths | 3 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | CML - Chronic Phase (CML-CP) | AEs that led to discontinuation | 4 | participants |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Studies CA180-031 and -036 Combined | STARTED | CML - Chronic Phase (CML-CP) | 30 | |
| Studies CA180-031 and -036 Combined | STARTED | CML - Accelerated Phase and Blast Phase (CML-AP/BP) | 11 | |
| Studies CA180-031 and -036 Combined | STARTED | Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) | 13 | |
| Studies CA180-031 and -036 Combined | COMPLETED | CML - Chronic Phase (CML-CP) | 26 | |
| Studies CA180-031 and -036 Combined | COMPLETED | CML - Accelerated Phase and Blast Phase (CML-AP/BP) | 2 | |
| Studies CA180-031 and -036 Combined | COMPLETED | Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) | 1 | |
| Studies CA180-031 and -036 Combined | NOT COMPLETED | CML - Chronic Phase (CML-CP) | 4 | |
| Studies CA180-031 and -036 Combined | NOT COMPLETED | CML - Accelerated Phase and Blast Phase (CML-AP/BP) | 9 | |
| Studies CA180-031 and -036 Combined | NOT COMPLETED | Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) | 12 | |
| Study CA180-036 Only | STARTED | CML - Chronic Phase (CML-CP) | 29 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events205
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 | Anaemia | Blood and lymphatic system disorders | All Treated Participants | 23 | 54 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | All Treated Participants | 6 | 54 | |
| other | Neutropenia | Blood and lymphatic system disorders | All Treated Participants | 4 | 54 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | All Treated Participants | 3 | 54 | |
| other | Cardiomegaly | Cardiac disorders | All Treated Participants | 5 | 54 | |
| other | Palpitations | Cardiac disorders | All Treated Participants | 5 | 54 | |
| other | Pericardial effusion | Cardiac disorders | All Treated Participants | 4 | 54 | |
| other | Sinus bradycardia | Cardiac disorders | All Treated Participants | 3 | 54 | |
| other | Hypothyroidism | Endocrine disorders | All Treated Participants | 3 | 54 | |
| other | Eyelid oedema | Eye disorders | All Treated Participants | 10 | 54 |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Treated Participants | ||
| Total, other adverse events | All Treated Participants | 54 | 54 |
| Total, serious adverse events | All Treated Participants | 33 | 54 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01030718
GET https://conductscience.org/api/trials/v1/NCT01030718/registered?page=2