Trial · NCT00574873
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
NCT00574873, Phase 3, Completed, Pfizer; results first posted 2012-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML. Trials, record NCT00574873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00574873
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
- NCT number
- NCT00574873
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 502 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Bosutinib, imatinib
- First posted
- 2007-12-17
- Last updated
- 2019-01-08
- Other registries' IDs
- eudract:2007-003780-50
- Results first posted
- 2012-11-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1 | Year 1 (48 weeks) | Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or less than (\<) 1% breakpoint cluster region Abelson protooncogene (Bcr-Abl) fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed. |
| Secondary | Percentage of Participants With Major Molecular Response (MMR) at Year 1 | Year 1 (48 weeks) | Molecular response was assessed using Bcr-Abl transcript levels measured by reverse transcriptase polymerase chain reaction (RT-PCR) from peripheral blood. A MMR was defined as a ratio Bcr-Abl/Abl less than or equal to (≤) 0.1% on the international scale (greater than or equal to \[≥\] 3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed. |
| Secondary | Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks | 192 weeks | The Kaplan-Meier curve was generated based the time from the first date of CCyR until the first date of confirmed loss of CCyR, objectively documented, for responders only. Participants without confirmed loss of CCyR were censored at the last valid cytogenetic assessment. CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. 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 \<1% Bcr-Abl fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed. The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CCyR by Year 1. |
| Secondary | Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks | 192 weeks | The Kaplan-Meier curve was generated based on the first date of confirmed CHR until the first date of loss of CHR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid hematologic assessment. CHR must have been of at least 4 weeks in duration confirmed by 2 assessments at least 4 weeks apart and was defined as follows: white blood cells ≤ institutional upper limit of normal, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes \<5% in blood, absolute neutrophil count ≥1.0\*10\^9/L, platelets ≥100 but \<450\*10\^9/L unless related to therapy, \<20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly). The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CHR by Year 1. |
| Secondary | Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks | 144 weeks | The Kaplan-Meier curve was generated based on the first date of MMR until the first date loss of MMR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid molecular assessment. Molecular response was assessed using Bcr-Abl transcript levels measured by RT-PCR from peripheral blood. MMR is defined as a ratio Bcr-Abl/Abl ≤0.1% on the international scale (≥3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed. The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Three years rate was displayed since the majority of imatinib participants had first MMR by Year 2. |
| Secondary | Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks | 192 weeks | The cumulative incidence curve was generated based on the time from randomization to the first date of transformation to AP or BP while on study treatment adjusting for the competing risk of treatment discontinuation without transformation, for each participant. Criteria for transformation to AP: 15 to 29% blasts; ≥30% blasts + promyelocytes; ≥20% basophils in blood or bone marrow; platelets \<100\*10\^9/L (not related to therapy), in blood. Criteria for transformation to BP: ≥30% blasts in blood or bone marrow and extramedullary involvement other than liver or spleen (example: chloromas). Time to transformation was calculated as weeks = (\[date of first documented occurrence of the event - date of randomization\] + 1)/7. If transformation was not obtained, censoring was at the last hematologic assessment or death (whichever was earliest). Participants who were not treated contributed time = 1 day/7. 95% confidence interval for the cumulative incidence is from Gray's method. |
Source ClinicalTrials.gov
Outcomes6
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 Complete Cytogenetic Response (CCyR) at Year 1 | Year 1 (48 weeks) | Intent-to-treat (ITT) population - included all participants who were randomized to test article. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) at Year 1 | Year 1 (48 weeks) | ITT Population | Percentage of Participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks | 192 weeks | Subgroup of participants from ITT population who had CCyR. | Percentage of Participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks | 192 weeks | Subgroup of participants from ITT population who had CHR. | Percentage of Participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks | 144 weeks | Subgroup of participants from ITT population who had MMR. | Percentage of Participants | NUMBER |
| SECONDARY | Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks | 192 weeks | ITT population | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
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 Complete Cytogenetic Response (CCyR) at Year 1 | Bosutinib | 70.0 | 95% Confidence Interval 64.3 to 75.7 | Percentage of Participants | |
| Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1 | Imatinib | 68.3 | 95% Confidence Interval 62.5 to 74.0 | Percentage of Participants | |
| Percentage of Participants With Major Molecular Response (MMR) at Year 1 | Bosutinib | 38.0 | 95% Confidence Interval 32.0 to 44.0 | Percentage of Participants | |
| Percentage of Participants With Major Molecular Response (MMR) at Year 1 | Imatinib | 25.4 | 95% Confidence Interval 20.0 to 30.8 | Percentage of Participants | |
| Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks | Bosutinib | 92.9 | 95% Confidence Interval 87.8 to 95.9 | Percentage of Participants | |
| Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks | Imatinib | 88.9 | 95% Confidence Interval 83.2 to 92.7 | Percentage of Participants | |
| Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks | Bosutinib | 91.6 | 95% Confidence Interval 86.5 to 94.9 | Percentage of Participants | |
| Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks | Imatinib | 86.0 | 95% Confidence Interval 80.7 to 90.0 | Percentage of Participants | |
| Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks | Bosutinib | 94.7 | 95% Confidence Interval 89.6 to 97.3 | Percentage of Participants | |
| Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks | Imatinib | 98.0 | 95% Confidence Interval 93.8 to 99.3 | Percentage of Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bosutinib | 250 | |
| Overall Study | STARTED | Imatinib | 252 | |
| Overall Study | Treated | Bosutinib | 248 | |
| Overall Study | Treated | Imatinib | 251 | |
| Overall Study | COMPLETED | Bosutinib | 12 | |
| Overall Study | COMPLETED | Imatinib | 1 | |
| Overall Study | NOT COMPLETED | Bosutinib | 238 | |
| Overall Study | NOT COMPLETED | Imatinib | 251 |
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 | 70 | 248 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imatinib | 72 | 251 | |
| other | Anaemia | Blood and lymphatic system disorders | Bosutinib | 63 | 248 | |
| other | Anaemia | Blood and lymphatic system disorders | Imatinib | 58 | 251 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bosutinib | 35 | 248 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib | 78 | 251 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bosutinib | 24 | 248 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib | 57 | 251 | |
| other | Eyelid oedema | Eye disorders | Bosutinib | 3 | 248 | |
| other | Eyelid oedema | Eye disorders | Imatinib | 20 | 251 |
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 | ||
| Total, all-cause mortality | Imatinib | ||
| Total, other adverse events | Bosutinib | 235 | 248 |
| Total, other adverse events | Imatinib | 238 | 251 |
| Total, serious adverse events | Bosutinib | 90 | 248 |
| Total, serious adverse events | Imatinib | 57 | 251 |
Source ClinicalTrials.gov
Papers7
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 |
|---|
| Bosutinib vs Imatinib: 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/NCT00574873
GET https://conductscience.org/api/trials/v1/NCT00574873/events?page=2