Trial · NCT03128411
Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
NCT03128411, Phase 2, Completed, Pfizer; results first posted 2020-11-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia. Trials, record NCT03128411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03128411
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
- NCT number
- NCT03128411
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Leukemia, Chronic Myelogenous
- Interventions
- Bosutinib
- First posted
- 2017-04-25
- Last updated
- 2022-05-19
- Results first posted
- 2020-11-24
Source ClinicalTrials.gov
Registered outcomes37
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 | A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at the 12-month visit; any MMR gained and lost, or never achieved at or before the 12-month visit was considered as non-responder. |
| Secondary | Percentage of Participants With Major Molecular Response (MMR) by Month 12 | Up to Month 12 | A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at or before the 12-month visit. |
| Secondary | Percentage of Participants With Major Molecular Response (MMR) by Month 18 | Up to Month 18 | A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at or before the 18-month visit. |
| Secondary | Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12 | Up to Month 12 | CCyR is based on the prevalence of Philadelphia chromosome positive metaphases among cells in metaphase on a bone marrow sample. CCyR was defined as absence of detectable Philadelphia chromosome positive cells. CCyR was achieved when there were "0" Philadelphia chromosome positive metaphases among at least 20 metaphases from a bone marrow sample or when MMR was achieved if no bone marrow analysis was performed. The CCyR value was counted only if the response was demonstrated at or before the 12-month visit. |
| Secondary | Probability of Maintaining Major Molecular Response (MMR) at Month 36 | At Month 36 | Duration of MMR: time from first date of MMR until first date of confirmed loss of MMR, treatment discontinuation due to progressive disease (PD), or death due to PD within 28 days after last dose or censoring. PD: progression to Accelerated phase (AP) or to Blast Phase (BP). AP: 15-29% blasts in blood or marrow, or\>30% blasts plus promyelocytes in blood or marrow with blasts \<30%; ≥20% basophils in blood. BP: ≥30% Blasts in blood or bone marrow, extramedullary blast proliferation, other than in spleen. Kaplan-Meier analysis was used. |
| Secondary | Probability of Maintaining Complete Cytogenetic Response (CCyR) at Month 36 | At Month 36 | Duration of CCyR, from first date of CCyR to confirmed loss of CCyR, treatment discontinuation due to PD, death due to PD within 28 days after last dose or censoring. Confirmed loss: at least 1 Ph+ metaphase confirmed by a second determination \>=4 weeks later or unconfirmed loss followed by treatment discontinuation due to suboptimal response. PD: progression to AP or to BP. Kaplan-Meier analysis was used. |
| Secondary | Cumulative Incidence of Event Free Survival (EFS) at Month 36 | Up to Month 36 | EFS: time from 1st dose until 1st occurrence of 1 of the following events or censoring: 1)death from any cause 2)transformation to AP or BP 3)loss of complete hematologic response (CHR) 4)loss of CCyR 5)participants not achieving CHR: doubling of WBCs \>= 1 month apart with 2nd value \>20\*10\^9/L and maintained in subsequent assessments for \>=2 weeks. Loss of CHR: appearance of any of the following confirmed by 2nd determination\>=4 weeks later (unless associated with CML-related treatment discontinuation): WBC count: \>20.0\*10\^9/L, platelet count: \>=600\*10\^9/L, appearance of palpable spleen/other extra medullary involvement, appearance of 5% myelocytes or blasts or promyelocytes in peripheral blood. Loss of CCyR:\>= one Ph+ metaphase confirmed by 2nd determination \>=4 weeks later(unless associated with CML-related treatment discontinuation). Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without event. |
| Secondary | Probability of Overall Survival (OS) at Month 36 | Up to Month 36 | Overall survival was defined as the time from first dose of study drug to death due to any cause or censoring. Kaplan-Meier analysis was used for determination of probability of overall survival. |
| Secondary | Trough Plasma Concentrations of Bosutinib | Pre-dose on Day 1, Day 28, Day 56, Day 84 | |
| Secondary | Summary and Analysis of Trough Bosutinib Plasma Concentration by Major Molecular Response (MMR) Response | Pre-dose on Day 28, Day 56 and Day 84 | Trough bosutinib plasma concentration is reported classified on basis of participants with MMR response as "Yes" and "No" at specified time points. A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
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 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) by Month 12 | Up to Month 12 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) by Month 18 | Up to Month 18 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12 | Up to Month 12 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Probability of Maintaining Major Molecular Response (MMR) at Month 36 | At Month 36 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and who had MMR. | Percentage of participants | NUMBER |
| SECONDARY | Probability of Maintaining Complete Cytogenetic Response (CCyR) at Month 36 | At Month 36 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and who had CCyR. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Event Free Survival (EFS) at Month 36 | Up to Month 36 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Probability of Overall Survival (OS) at Month 36 | Up to Month 36 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Trough Plasma Concentrations of Bosutinib | Pre-dose on Day 1, Day 28, Day 56, Day 84 | The PK population will be defined as any patient in the safety population of patients who had at least 1 concentration of bosutinib on-treatment. | Nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Summary and Analysis of Trough Bosutinib Plasma Concentration by Major Molecular Response (MMR) Response | Pre-dose on Day 28, Day 56 and Day 84 | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against Yes and No categories respectively. | ng/mL | MEAN |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group161
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 | 55.0 | 90% Confidence Interval 44.4 to 65.6 | Percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) by Month 12 | Bosutinib | 61.7 | 90% Confidence Interval 51.3 to 72.0 | Percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) by Month 18 | Bosutinib | 66.7 | 90% Confidence Interval 56.7 to 76.7 | Percentage of participants | |
| Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12 | Bosutinib | 80.0 | 90% Confidence Interval 71.5 to 88.5 | Percentage of participants | |
| Probability of Maintaining Major Molecular Response (MMR) at Month 36 | Bosutinib | 100.0 | 90% Confidence Interval 100.0 to 100.0 | Percentage of participants | |
| Probability of Maintaining Complete Cytogenetic Response (CCyR) at Month 36 | Bosutinib | 100.0 | 90% Confidence Interval 100.0 to 100.0 | Percentage of participants | |
| Cumulative Incidence of Event Free Survival (EFS) at Month 36 | Bosutinib | 1.7 | 90% Confidence Interval 0.2 to 6.4 | Percentage of participants | |
| Probability of Overall Survival (OS) at Month 36 | Bosutinib | 96.7 | 90% Confidence Interval 89.7 to 98.9 | Percentage of participants | |
| Trough Plasma Concentrations of Bosutinib | Bosutinib | Day 1 | 0.000 | Standard Deviation 0.000 | Nanogram per milliliter (ng/mL) |
| Trough Plasma Concentrations of Bosutinib | Bosutinib | Day 28 | 83.564 | Standard Deviation 64.1056 | Nanogram per milliliter (ng/mL) |
1 to 10 of 161Source ClinicalTrials.gov
See all 161 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | Bosutinib | 60 | |
| Treatment Phase | Received Treatment | Bosutinib | 60 | |
| Treatment Phase | COMPLETED | Bosutinib | 36 | |
| Treatment Phase | NOT COMPLETED | Bosutinib | 24 | |
| Long Term Follow-up Phase | STARTED | Bosutinib | 24 | |
| Long Term Follow-up Phase | COMPLETED | Bosutinib | 22 | |
| Long Term Follow-up Phase | NOT COMPLETED | Bosutinib | 2 |
Source ClinicalTrials.gov
Adverse events68
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 | Bosutinib | 10 | 60 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Bosutinib | 4 | 60 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib | 5 | 60 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Bosutinib | 6 | 60 | |
| other | Constipation | Gastrointestinal disorders | Bosutinib | 8 | 60 | |
| other | Diarrhoea | Gastrointestinal disorders | Bosutinib | 52 | 60 | |
| other | Nausea | Gastrointestinal disorders | Bosutinib | 17 | 60 | |
| other | Vomiting | Gastrointestinal disorders | Bosutinib | 16 | 60 | |
| other | Pyrexia | General disorders | Bosutinib | 15 | 60 | |
| other | Liver disorder | Hepatobiliary disorders | Bosutinib | 7 | 60 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosutinib | 2 | 60 |
| Total, other adverse events | Bosutinib | 60 | 60 |
| Total, serious adverse events | Bosutinib | 14 | 60 |
Source ClinicalTrials.gov
Papers4
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/NCT03128411
GET https://conductscience.org/api/trials/v1/NCT03128411/registered?page=2