Trial · NCT01275196
Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients
NCT01275196, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients. Trials, record NCT01275196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01275196
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients
- NCT number
- NCT01275196
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 267 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Nilotinib, Imatinib
- First posted
- 2011-01-12
- Last updated
- 2016-04-08
- Results first posted
- 2015-12-09
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Major Molecular Response (MMR) at 12 Months - With Imputation. | 12 months | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization. | Percentage of Participants | NUMBER |
| SECONDARY | MMR Rate at Each Time Point | Months 3,6,9,12,15, 18, 21, 24, 36 | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization. | Percentage of Participants | NUMBER |
| SECONDARY | Best MMR by Each Timepoint | Months 3,6,9,12,15, 18, 21, 24, 36 | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization. | Percentage of Participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Time to First MMR | End of study (up to 40 months) | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization. | months | MEDIAN |
| SECONDARY | Durable MMR Rate at 24 Months | 24 months | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization. | Perentage of Participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Duration of First MMR Among Patients Who Achieved MMR | End of Study (Up to 40 months) | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization. | Months | MEDIAN |
| SECONDARY | Best Complete Cytogenic Response (CCyR) Rate by Each Time Point | Months 6, 12, 18, 30, 24, 36 | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization. | Percentage of Participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Time to First CCYR | End of study (up to 40 months) | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates of Duration of First CCyR Among Patients Who Achieved CCyR | End of Study (up to 40 months) | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization | Months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates of Time to Progression to Accelerated Phase/Blast Crisis (AP/BC) on Treatment | End of study (up to 40 months) | Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization | Months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Molecular Response (MMR) at 12 Months - With Imputation. | Imatinib | 27.8 | 95% Confidence Interval 20.4 to 36.3 | Percentage of Participants | |
| Major Molecular Response (MMR) at 12 Months - With Imputation. | Nilotinib | 52.2 | 95% Confidence Interval 43.4 to 60.9 | Percentage of Participants | |
| MMR Rate at Each Time Point | Imatinib | 3 Months | 3.0 | 95% Confidence Interval 0.8 to 7.5 | Percentage of Participants |
| MMR Rate at Each Time Point | Nilotinib | 3 Months | 13.4 | 95% Confidence Interval 8.2 to 20.4 | Percentage of Participants |
| MMR Rate at Each Time Point | Imatinib | 6 Months | 18.0 | 95% Confidence Interval 11.9 to 25.6 | Percentage of Participants |
| MMR Rate at Each Time Point | Nilotinib | 6 Months | 44.8 | 95% Confidence Interval 36.2 to 53.6 | Percentage of Participants |
| MMR Rate at Each Time Point | Imatinib | 9 Months | 21.1 | 95% Confidence Interval 14.5 to 29.0 | Percentage of Participants |
| MMR Rate at Each Time Point | Nilotinib | 9 Months | 47.8 | 95% Confidence Interval 39.1 to 56.6 | Percentage of Participants |
| MMR Rate at Each Time Point | Imatinib | 12 Months | 27.8 | 95% Confidence Interval 20.4 to 36.3 | Percentage of Participants |
| MMR Rate at Each Time Point | Nilotinib | 12 Months | 53.0 | 95% Confidence Interval 44.2 to 61.7 | Percentage of Participants |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imatinib | 133 | |
| Overall Study | STARTED | Nilotinib | 134 | |
| Overall Study | Intended to Continue Into Extension | Imatinib | 112 | |
| Overall Study | Intended to Continue Into Extension | Nilotinib | 113 | |
| Overall Study | COMPLETED | Imatinib | 113 | |
| Overall Study | COMPLETED | Nilotinib | 113 | |
| Overall Study | NOT COMPLETED | Imatinib | 20 | |
| Overall Study | NOT COMPLETED | Nilotinib | 21 |
Source ClinicalTrials.gov
Adverse events132
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 | Imatinib 400 mg qd | 18 | 132 | |
| other | Anaemia | Blood and lymphatic system disorders | Nilotinib 300 mg Bid | 12 | 133 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib 400 mg qd | 35 | 132 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nilotinib 300 mg Bid | 27 | 133 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib 400 mg qd | 18 | 132 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nilotinib 300 mg Bid | 7 | 133 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imatinib 400 mg qd | 37 | 132 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nilotinib 300 mg Bid | 41 | 133 | |
| other | Eyelid oedema | Eye disorders | Imatinib 400 mg qd | 25 | 132 | |
| other | Eyelid oedema | Eye disorders | Nilotinib 300 mg Bid | 4 | 133 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib 400 mg qd | ||
| Total, all-cause mortality | Nilotinib 300 mg Bid | ||
| Total, other adverse events | Imatinib 400 mg qd | 124 | 132 |
| Total, other adverse events | Nilotinib 300 mg Bid | 131 | 133 |
| Total, serious adverse events | Imatinib 400 mg qd | 13 | 132 |
| Total, serious adverse events | Nilotinib 300 mg Bid | 11 | 133 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25766724 | DERIVED |
Source PubMed
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 |
|---|
| Imatinib 400 mg qd vs Nilotinib 300 mg Bid: 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.
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