Trial · NCT00333840
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
NCT00333840, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-10-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia. Trials, record NCT00333840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00333840
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
- NCT number
- NCT00333840
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,106 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Myelogenous Leukemia
- Interventions
- imatinib mesilate, interferon-alpha (INF-a), cytarabine (ARA-C)
- First posted
- 2006-06-06
- Last updated
- 2013-10-14
- Results first posted
- 2013-10-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment. |
| Secondary | Kaplan Meier Estimates of Event Free Survival (All Randomized Participants) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment: * progression to Accelerated Phase (AP) or Blast Crisis (BC) * loss of Complete Hematological Response (CHR) * loss of Major Cytogenetic Response (MCyR) confirmed * loss of Major Cytogenetic Response (MCyR) unconfirmed * increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC) * death (due to any cause when reported as primary reason for discontinuation of treatment). Kaplan Meier estimates of the percentage of participants with Event Free Survival at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment. |
| Secondary | Percentage of Participants With Event Free Survival Events (All Randomized Participants) | 144 months | Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment: * progression to Accelerated Phase (AP) or Blast Crisis (BC) * loss of Complete Hematological Response (CHR) * loss of Major Cytogenic Response (MCyR) confirmed * loss of Major Cytogenic Response (MCyR) unconfirmed * increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC) * death (due to any cause when reported as primary reason for discontinuation of treatment). The percentage of participants with Event Free Survival events in each category was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment. |
| Secondary | Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Time to progression to AP/BC is defined as the time between randomization and either of the following events on treatment: death (due to CML when reported as primary reason for discontinuation of treatment) or progression to Accelerated Phase or Blast Crisis and is censored at last examination date for patients without event. No data after discontinuation of study treatment was included. The Kaplan Meier estimates of the percentage of participants with survival without progression to AP/BC at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment. |
| Secondary | Percentage of Participants With Best Cytogenetic Response (First-line Treatment) | 144 months | Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Philadelphia chromosome positive (Ph+) metaphases) and amount of blasts and promyelocytes in bone marrow to establish cytogenetic response. Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= \> 0 and ≤ 35 % of Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated. |
| Secondary | Percentage of Participants With Best Cytogenetic Response (Second-line Treatment) | 144 months | Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Ph chromosome (Ph+) containing metaphases) and the amount of blasts and promyelocytes in bone marrow to establish cytogenetic response. Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= \> 0 and ≤ 35 % Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated. |
| Secondary | Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment) | 144 months | A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant |
| Secondary | Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment) | 144 months | A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant |
| Secondary | Percentage of Participants With Major Molecular Response (First-line Treatment) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale. |
| Secondary | Percentage of Participants With Major Molecular Response (Second-line Treatment) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval | Percentage of participants | NUMBER |
| SECONDARY | Kaplan Meier Estimates of Event Free Survival (All Randomized Participants) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Event Free Survival Events (All Randomized Participants) | 144 months | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Cytogenetic Response (First-line Treatment) | 144 months | Intent-to-treat participants included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Cytogenetic Response (Second-line Treatment) | 144 months | Intent-to-treat participants included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment) | 144 months | Safety Population included all randomized participants who received study drug. | Participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment) | 144 months | Safety Population included all randomized participants who received study drug. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (First-line Treatment) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (Second-line Treatment) | 12,24,36,48,60,72,84,96,108,120,132 and 144 months | Intent-to-treat population included all randomized participants. No participants in the imatinib to IFN-a + Ara-C arm were available for testing. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | Imatinib (STI571) | 12 months (n = 553, 553) | 98.9 | 98 to 100 | Percentage of participants |
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | IFN-a + Ara-C | 12 months (n = 553, 553) | 97.7 | 96 to 99 | Percentage of participants |
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | Imatinib (STI571) | 24 months (n = 542, 512) | 96.0 | Percentage of participants | |
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | IFN-a + Ara-C | 24 months (n = 542, 512) | 93.6 | Percentage of participants | |
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | Imatinib (STI571) | 36 months (n = 518, 471) | 92.4 | Percentage of participants | |
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | IFN-a + Ara-C | 36 months (n = 518, 471) | 89.8 | Percentage of participants | |
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | Imatinib (STI571) | 48 months (n = 492, 441) | 90.4 | Percentage of participants | |
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | IFN-a + Ara-C | 48 months (n = 492, 441) | 87.7 | Percentage of participants | |
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | Imatinib (STI571) | 60 months (n = 475, 411) | 89.4 | Percentage of participants | |
| Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) | IFN-a + Ara-C | 60 months (n = 475, 411) | 85.4 | Percentage of participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First-line Treatment Period | STARTED | Imatinib (STI571) | 553 | |
| First-line Treatment Period | STARTED | IFN-a + Ara-C | 553 | |
| First-line Treatment Period | STARTED | Imatinib to IFN-a + Ara-C | 0 | |
| First-line Treatment Period | STARTED | IFN-a + Ara-C to Imatinib | 0 | |
| First-line Treatment Period | Safety Population; Received Study Drug | Imatinib (STI571) | 551 | |
| First-line Treatment Period | Safety Population; Received Study Drug | IFN-a + Ara-C | 533 | |
| First-line Treatment Period | Safety Population; Received Study Drug | Imatinib to IFN-a + Ara-C | 0 | |
| First-line Treatment Period | Safety Population; Received Study Drug | IFN-a + Ara-C to Imatinib | 0 | |
| First-line Treatment Period | COMPLETED | Imatinib (STI571) | 267 | |
| First-line Treatment Period | COMPLETED | IFN-a + Ara-C | 7 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events3,204
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 (STI571) | 64 | 551 | |
| other | Anaemia | Blood and lymphatic system disorders | IFN-a + Ara-C | 58 | 533 | |
| other | Anaemia | Blood and lymphatic system disorders | Imatinib to IFN-a + Ara-C | 0 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | IFN-a + Ara-C to Imatinib | 37 | 363 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib (STI571) | 26 | 551 | |
| other | Leukopenia | Blood and lymphatic system disorders | IFN-a + Ara-C | 28 | 533 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib to IFN-a + Ara-C | 2 | 14 | |
| other | Leukopenia | Blood and lymphatic system disorders | IFN-a + Ara-C to Imatinib | 14 | 363 | |
| other | Monocytopenia | Blood and lymphatic system disorders | Imatinib (STI571) | 0 | 551 | |
| other | Monocytopenia | Blood and lymphatic system disorders | IFN-a + Ara-C | 0 | 533 |
1 to 10 of 3,204Source ClinicalTrials.gov
See all 3,204 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib (STI571) | ||
| Total, all-cause mortality | IFN-a + Ara-C | ||
| Total, all-cause mortality | Imatinib to IFN-a + Ara-C | ||
| Total, all-cause mortality | IFN-a + Ara-C to Imatinib | ||
| Total, other adverse events | Imatinib (STI571) | 541 | 551 |
| Total, other adverse events | IFN-a + Ara-C | 531 | 533 |
| Total, other adverse events | Imatinib to IFN-a + Ara-C | 13 | 14 |
| Total, other adverse events | IFN-a + Ara-C to Imatinib | 347 | 363 |
| Total, serious adverse events | Imatinib (STI571) | 226 | 551 |
| Total, serious adverse events | IFN-a + Ara-C | 163 | 533 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Imatinib to IFN-a + Ara-C vs IFN-a + Ara-C to Imatinib: Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment) | Trial comparisons |
| Imatinib (STI571) vs IFN-a + Ara-C: Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment) | 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/NCT00333840
GET https://conductscience.org/api/trials/v1/NCT00333840/results?page=2