Trial · NCT01275196
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Molecular Response (MMR) at 12 Months - With Imputation. | 12 months | Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as 'responders' and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as 'non-responders'. This endpoint was calculated based on the 12 month analysis. |
| Secondary | MMR Rate at Each Time Point | Months 3,6,9,12,15, 18, 21, 24, 36 | Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as 'responders' and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as 'non-responders'. These time points including the 12 month data were calculated based on the final analysis after the end of the study. |
| Secondary | Best MMR by Each Timepoint | Months 3,6,9,12,15, 18, 21, 24, 36 | Best MMR rates by scheduled time point are cumulative response rates up to that time point. In this analysis, patients who had achieved MMR at or before the time point were counted as responders, no matter if they lost the response/discontinued or not. Therefore, this response rate represented the best observed response rate up to that specific time point. |
| Secondary | Kaplan-Meier Estimates of Time to First MMR | End of study (up to 40 months) | Time to first MMR (months) = (date of first MMR or censoring - date of randomization + 1) / 30.4375. |
| Secondary | Durable MMR Rate at 24 Months | 24 months | The rate of durable MMR at 24 months, defined as the proportion of patients who have achieved MMR at 12 months, and also maintain continuous MMR until the 24 month time point (1 month = 28 days) without intervening loss of MMR in between 12 and 24 months |
| Secondary | Kaplan-Meier Estimates of Duration of First MMR Among Patients Who Achieved MMR | End of Study (Up to 40 months) | Duration of first MMR (months) = (date of loss of MMR or censoring-date of first MMR + 1)/30.4375. |
| Secondary | Best Complete Cytogenic Response (CCyR) Rate by Each Time Point | Months 6, 12, 18, 30, 24, 36 | CCyR is defined as 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics. |
| Secondary | Kaplan-Meier Estimates of Time to First CCYR | End of study (up to 40 months) | Time to first CCyR (months) = (date of first CCyR - date of randomization + 1) / 30.4375. |
| Secondary | Kaplan-Meier Estimates of Duration of First CCyR Among Patients Who Achieved CCyR | End of Study (up to 40 months) | Duration of CCyR (months) = (date of CCyR loss or censoring-date of first CCyR + 1)/30.4375 |
| Secondary | Kaplan-Meier Estimates of Time to Progression to Accelerated Phase/Blast Crisis (AP/BC) on Treatment | End of study (up to 40 months) | Time to progression to AP/BC was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of CML-related death, whichever is earlier. This variable was analyzed in 2 ways: * On-treatment: included progressions to AP/BC or CML-related deaths occurring on treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease, or cytogenetic evaluation) in the study for patients without event. * On-study: included progressions to AP/BC or CML-related deaths occurring in the study or during the follow-up period after discontinuation of treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment |
| Secondary | Kaplan-Meier Estimates of Event-free Survival (EFS) on Treatment | End of Study (up to 40 months) | Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following:-Death due to any cause, - Progression to AP or BC, Loss of partial cytogenetic response (PCyR), - Loss of CCyR, - Loss of CHR |
| Secondary | Kaplan-Meier Estimates of Progression-free Survival (PFS) on Treatment | End of study (up to 40 months) | Progression-free survival was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of death from any cause, whichever is earlier. This variable was analyzed in 2 ways: * On-treatment: included progressions to AP/BC or deaths occurring only on-treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease or cytogenetic evaluation) in the study before the cut-off date of the analysis for patients without event. * On-study: included progressions to AP/BC or deaths occurring in the study or during the follow-up period after discontinuation of study treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment. |
| Secondary | Kaplan-Meier Estimates of Overall Survival (OS) on Treatment | End of Study (up to 40 months) | Patients who discontinued study treatment early or completed the study protocol and did not enter into the extension protocol were to be followed for survival every 3 months for up to 2 calendar years from the date the last patient randomized received the first dose of study drug and every 6 months until Last Patient Last Visit. Overall survival (all deaths) was defined as the time between date of randomization and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment, i.e. overall survival on-study. The time was censored at the date of last assessment in the study for patients who are still being treated and at the date of last contact for patients who discontinued treatment. |
| Secondary | Best Complete Hematologic Response (CHR) | Months 1, 3, 4, 5, 6, 9,12, 15,18, 21, 24, 30, 36 | CHR was defined as having all of the following criteria present at any assessment, which was confirmed by another assessment at least after 4 weeks: • WBC count \< 10 x 10E9 /L • Platelet count \< 450 x 10E9 /L • Basophils \< 5% • No blasts and promyelocytes in peripheral blood • Myelocytes + metamyelocytes \< 5 % in peripheral blood • No evidence of extramedullary involvement. The assessment was not considered CHR, if there were any values indicative of CML in AP or BC (i.e. by blasts in bone marrow). For confirmation of CHR, both the initial CHR as well as the confirming assessment (at least 4 weeks after the initial assessment) had to satisfy all criteria mentioned above, without any assessment in between which indicated 'No response'. |
| Secondary | Modified ELN2009 Criteria | End of Study (up to 40 months) | Patients satisfying criteria for several "modified ELN 2009" categories are presented once under the worst category (Optimal\> Suboptimal \> Treatment failure). Patients in the "Discontinued" category are those who discontinued before the time point considered without satisfying any of the ELN 2009 criteria. Patients in the "Missing" category are those ongoing in the trial at the time point considered but with only missing or non evaluable data for ELN 2009 criteria. |
| Secondary | Actual Dose Intensity | End of Study (up to 40 months) | Total dose/time on treatment (periods of zero dose were included). |
| Secondary | Summary Statistics of Trough Imatinib and Major Metabolite CGP74588 of Imatinib and Nilotinib PK Concentration by Time Point | 12 Months | Pharmacokinetic Analysis Set |
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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