Trial · NCT02130557
A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
NCT02130557, Phase 3, Completed, Pfizer; results first posted 2018-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia. Trials, record NCT02130557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02130557
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
- NCT number
- NCT02130557
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 536 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
- Interventions
- Bosutinib, Imatinib
- First posted
- 2014-05-05
- Last updated
- 2021-05-18
- Other registries' IDs
- eudract:2013-005101-31
- Results first posted
- 2018-11-14
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Major Molecular Response (MMR) at Month 12 | Month 12 | MMR was defined as a ratio of breakpoint cluster region to abelson (BCR-ABL/ABL) less than or equal to (\<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to \[\>=\] 3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts \[\>=3000 ABL required\]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR). The percentage of participants with MMR at Month 12 are reported. |
| Secondary | Percentage of Participants With Major Molecular Response (MMR) Up to Month 18 | Up to Month 18 | MMR was defined as a ratio of BCR-ABL/ABL \<=0.1% on the international scale (\>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts \[\>=3000 ABL required\]) by quantitative RT-qPCR. The percentage of participants with MMR for up to Month 18 are reported. |
| Secondary | Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48 | Month 48 | The Kaplan-Meier curve was generated based on the first date of MMR until the date of the confirmed loss of MMR or censoring, objectively documented, for responders only. Confirmed loss of MMR was BCR-ABL/ABL IS ratio \>0.1% in association with a \>=5-fold increase in BCR-ABL/ABL IS ratio from the lowest value achieved up to that time-point confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of MMR. PD was defined as disease progression to accelerated phase (AP) or blast phase (BP) CML. |
| Secondary | Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12 | Up to Month 12 | Complete Cytogenetic Response (CCyR) was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. The percentage of participants with CCyR for up to Month 12 are reported. |
| Secondary | Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48 | Month 48 | The Kaplan-Meier curve was generated based on the first date of CCyR until the date of the confirmed loss of CCyR or censoring, objectively documented, for responders only. Confirmed loss of CCyR was the presence of at least one Ph+ metaphase confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, PD or death due to PD within 28 days of last dose were considered confirmed loss of CCyR. PD was defined as disease progression to AP or BP CML. |
| Secondary | Cumulative Incidence of Event Free Survival (EFS) Events | Up to Month 60 | EFS was defined as time from randomization to death due to any cause, transformation to AP or BP at any time, confirmed loss of complete hematologic response (CHR), confirmed loss of CCyR or censoring. Loss of CHR was defined as a hematologic assessment of non-CHR (chronic phase, AP, or BP) confirmed by 2 assessments at least 4 weeks apart. Loss of CHR was defined as appearance of any of the following: WBC count that rises to \>20.0\*10\^9/L, platelet count rises to \>=600\*10\^9/L, appearance of palpable spleen or other extramedullary involvement proven by biopsy, appearance of 5% myelocytes in peripheral blood, appearance of blasts or promyelocytes in peripheral blood. Loss of CCyR was defined as at least 1 Ph+ metaphase from analysis of \<100 metaphases confirmed by follow up cytogenetic analysis after 1 month. Cumulative incidence of EFS was defined as percentage of participants with EFS event at Month 60 and was adjusted for competing risk of treatment discontinuation without event. |
| Secondary | Overall Survival (OS) Rate | Up to Month 60 | OS was defined as the time (in months) from randomization to the occurrence of death due to any cause or censoring. Kaplan-meier analysis was used for determination of OS. Percentage of participants who were alive were estimated in this outcome measure. |
| Other | Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) of Bosutinib | Pre-dose on Days 28, 56 and 84 | CCyR was based on the prevalence of Ph+ metaphases among cells in metaphase on a BM aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. Trough plasma concentration of participants who had CCyR are presented in this outcome measure. |
| Other | Summary of Trough Plasma Concentration by Major Molecular Response (MMR) of Bosutinib | Pre-dose on Days 28, 56 and 84 | MMR was defined as a ratio of BCR-ABL/ABL \<=0.1% on the international scale (\>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts) by quantitative RT-qPCR. Trough plasma concentration of participants who had MMR are presented in this outcome measure. |
| Other | Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib | Pre-dose on Days 28, 56 and 84 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 1 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Major Molecular Response (MMR) at Month 12 | Month 12 | Modified intent-to-treat (mITT) population included all randomized participants with Philadelphia chromosome positive (Ph+) CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies greater than (\>) 0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) Up to Month 18 | Up to Month 18 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48 | Month 48 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization and who achieved MMR (responders). Here, Overall number of Participants Analyzed (N) signifies number of participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12 | Up to Month 12 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48 | Month 48 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization and who achieved CCyR (responders). Here, N signifies number of participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Event Free Survival (EFS) Events | Up to Month 60 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) Rate | Up to Month 60 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) of Bosutinib | Pre-dose on Days 28, 56 and 84 | Pharmacokinetic (PK) population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, N signifies number of participants evaluable for this outcome measure and number analyzed (n) signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | nanogram per milliliter (ng/mL) | MEAN |
| OTHER_PRE_SPECIFIED | Summary of Trough Plasma Concentration by Major Molecular Response (MMR) of Bosutinib | Pre-dose on Days 28, 56 and 84 | PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib | Pre-dose on Days 28, 56 and 84 | PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | ng/mL | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Major Molecular Response (MMR) at Month 12 | Bosutinib | 47.2 | 95% Confidence Interval 40.9 to 53.4 | percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) at Month 12 | Imatinib | 36.9 | 95% Confidence Interval 30.8 to 43.0 | percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) Up to Month 18 | Bosutinib | 61.0 | 95% Confidence Interval 54.9 to 67.1 | percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) Up to Month 18 | Imatinib | 52.7 | 95% Confidence Interval 46.4 to 59.0 | percentage of participants | |
| Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48 | Bosutinib | 92.2 | 95% Confidence Interval 86.8 to 95.4 | percentage of participants | |
| Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48 | Imatinib | 92.0 | 95% Confidence Interval 85.9 to 95.5 | percentage of participants | |
| Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12 | Bosutinib | 77.2 | 95% Confidence Interval 72.0 to 82.5 | percentage of participants | |
| Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12 | Imatinib | 66.4 | 95% Confidence Interval 60.4 to 72.4 | percentage of participants | |
| Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48 | Bosutinib | 97.4 | 95% Confidence Interval 93.9 to 98.9 | percentage of participants | |
| Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48 | Imatinib | 93.7 | 95% Confidence Interval 88.9 to 96.5 | percentage of participants |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bosutinib | 268 | |
| Overall Study | STARTED | Imatinib | 268 | |
| Overall Study | Treated | Bosutinib | 268 | |
| Overall Study | Treated | Imatinib | 265 | |
| Overall Study | mITT Population | Bosutinib | 246 | |
| Overall Study | mITT Population | Imatinib | 241 | |
| Overall Study | COMPLETED | Bosutinib | 232 | |
| Overall Study | COMPLETED | Imatinib | 231 | |
| Overall Study | NOT COMPLETED | Bosutinib | 36 | |
| Overall Study | NOT COMPLETED | Imatinib | 37 |
Source ClinicalTrials.gov
Adverse events488
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 | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib | 96 | 268 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imatinib | 53 | 265 | |
| other | Anaemia | Blood and lymphatic system disorders | Bosutinib | 59 | 268 | |
| other | Anaemia | Blood and lymphatic system disorders | Imatinib | 59 | 265 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bosutinib | 33 | 268 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib | 61 | 265 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bosutinib | 18 | 268 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib | 34 | 265 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Bosutinib | 15 | 268 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Imatinib | 8 | 265 |
1 to 10 of 488Source ClinicalTrials.gov
See all 488 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosutinib | 14 | 268 |
| Total, all-cause mortality | Imatinib | 14 | 268 |
| Total, other adverse events | Bosutinib | 264 | 268 |
| Total, other adverse events | Imatinib | 260 | 265 |
| Total, serious adverse events | Bosutinib | 98 | 268 |
| Total, serious adverse events | Imatinib | 68 | 265 |
Source ClinicalTrials.gov
Papers5
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bosutinib vs Imatinib: Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Trial comparisons |
| Bosutinib vs Imatinib: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Trial comparisons |
| Bosutinib vs Imatinib: deaths from any cause | Trial comparisons |
| Bosutinib vs Imatinib: Number of Participants With Vital Signs Abnormalities | Trial comparisons |
| Bosutinib vs Imatinib: serious adverse events | 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/NCT02130557
GET https://conductscience.org/api/trials/v1/NCT02130557/results?page=2