Trial · NCT03128411
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| 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. |
| Secondary | Summary and Analysis of Trough Bosutinib Plasma Concentration by CCyR Response | Pre-dose on Day 28, Day 56 and Day 84 | Trough bosutinib plasma concentration is reported classified on basis of participants with CCyR Response as "Yes" and "No" at specified time points. 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. |
| Secondary | Summary of Trough Bosutinib Plasma Concentration by Total Bilirubin | Pre-dose on Day 28, Day 56 and Day 84 | Trough bosutinib plasma concentration is reported classified on basis of total bilirubin level range at baseline. Level range 1: \<=7.7 micromole per liter (micromol/L), level rage 2: \>7.7 and \<= 10.3 micromol/L, level range 3: \>10.3 and \<=12.85 micromol/L and level range 4: \>12.85 micromol/L. |
| Secondary | Summary of Trough Bosutinib Plasma Concentration by Creatinine Clearance | Pre-dose on Day 28, Day 56 and Day 84 | Trough bosutinib plasma concentration is reported classified on basis of different ranges of creatinine clearance at baseline. Level range 1: \<=71.479 milliliter per minute (mL/min), level rage 2: \>71.479 and \<=100.936 mL/min, level range 3: \>100.936 and \<=129.355 mL/min) and level range 4: \>129.355 mL/min. |
| Secondary | Summary of Trough Bosutinib Plasma Concentration by Aspartate Aminotransferase | Pre-dose on Day 28, Day 56 and Day 84 | Trough bosutinib plasma concentration is reported classified on basis of different ranges of aspartate aminotransferase at baseline. Level range 1: \<=22 units per liter (U/L), level rage 2: \>22 and \<=26 U/L, level range 3: \>26 and \<=33 U/L and level range 4: \>33 U/L. |
| Secondary | Summary of Trough Bosutinib Plasma Concentration by Alanine Aminotransferase | Pre-dose on Day 28, Day 56 and Day 84 | Trough bosutinib plasma concentration is reported classified on basis of different ranges of alanine aminotransferase at baseline. Level range 1: \<=17.5 U/L, level rage 2: \>17.5 and \<=25 U/L, level range 3: \>25 and \<=32 U/L and level range 4: \>32 U/L. |
| Secondary | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Diarrhea | Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest | Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 diarrhea as "Yes" and "No" at specified time points. As per national cancer institute common terminology criteria (NCI-CTCAE) version 4.03, Grade 1: increase of \<4 stools per day over baseline. |
| Secondary | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Nausea | Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest | Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 Nausea as "Yes" and "No" at specified time points. As per NCI-CTCAE version 4.03, Grade 1: loss of appetite without alteration in eating habits. |
| Secondary | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Vomiting | Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest | Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 vomiting as "Yes" and "No" at specified time points. As per NCI-CTCAE version 4.03, Grade 1: 1 - 2 episodes (separated by 5 minutes) in 24 hours. |
| Secondary | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Thrombocytopenia | Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest | Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 thrombocytopenia as "Yes" and "No" at specified time points. As per NCI-CTCAE version 4.03, Grade 1: platelet count decreased: 75.0 - 50.0\*10\^9/L. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs): National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or Higher | From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention indicated AE. Grade 5 was death related to AE. Number of participants with Grade 3 or higher AEs are reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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