Trial · NCT00124748
Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)
NCT00124748, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2012-02-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity). Trials, record NCT00124748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00124748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)
- NCT number
- NCT00124748
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 476 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Leukemia, Myeloid, Chronic Phase
- Interventions
- Imatinib mesylate
- First posted
- 2005-07-28
- Last updated
- 2012-02-03
- Results first posted
- 2012-02-03
Source ClinicalTrials.gov
Registered outcomes19
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) Rates at 12 Months | 12 months | MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region \[Bcr\] gene and Abelson proto-oncogene \[Abl\] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction \[RT-PCR\] (performed centrally). |
| Secondary | Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months | 24, 36 and 42 months | MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region \[Bcr\] gene and Abelson proto-oncogene \[Abl\] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction \[RT-PCR\] (performed centrally). |
| Secondary | Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months | 12, 24, 36, 42 months | Cytogenetic response (CyR)is the percentage of Philadelphia chromosome positive metaphases (among at least 20 metaphase cells in bone marrow (BM)) with Complete Cytogenetic Response (CCyR) being 0 percent. |
| Secondary | Percentage of Participants With Complete Hematological Response (CHR) Rates at 12, 24, 36, and 42 Months | 12, 24, 36, and 42 months | Complete Hematologic Response (CHR) is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count \<10 x 109/L, Platelet count \<450 x 109/L, Basophils \<5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) \< 5% in PB and No evidence of extramedullary involvement. |
| Secondary | Percentage of Patients With Undetectable Levels of Bcr-Abl (A Fusion Gene of the Breakpoint Cluster Region [Bcr] Gene and Abelson Proto-oncogene [Abl] Genes) Transcripts | 12 , 24, 36 and 42 months | "Undetectable levels" or Complete molecular response is defined as Bcr-Abl ratio (%) on international scale (IS) \<= 0.0032% (≥ 4.5 log reduction of BCR-Abl transcripts from a standardized baseline). |
| Secondary | Time to First Major Molecular Response | 42 months overall | MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region \[Bcr\] gene and Abelson proto-oncogene \[Abl\] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction \[RT-PCR\] (performed centrally). Time to MMR (months) = (date of first MMR or censoring - date of randomization + 1) / 30.4375. Time to first MMR was evaluated using the Kaplan-Meier method |
| Secondary | Time to First Complete Cytogenetic Response | 60 months overall | Cytogenetic response (CyR) is the percentage of Philadelphia positive metaphases (among at least 20 metaphase cells in Bone Marrow) with Complete Cytogenetic Response (CCyR) being 0 percent. Time to CCyR (months) = (date of first CCyR or censoring - date of randomization + 1) / 30.4375. Time to first CCyR was evaluated using the Kaplan-Meier method. |
| Secondary | Time to First Complete Hematological Response (CHR)] | 60 months overall | Complete Hematological Response (CHR) is defined is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count \<10 x 109/L, Platelet count \<450 x 109/L, Basophils \<5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) \< 5% in PB and No evidence of extramedullary involvement. Time to CHR (months) = (date of first CHR or censoring - date of randomization + 1) / 30.4375. Time to first CHR was evaluated using the Kaplan-Meier method. |
| Secondary | Estimated Rate of Event Free Survival (EFS) in Two Treatment Arms | 60 months over all | EFS on treatment was defined as time between randomization and either (1) death due to any cause during study treatment, (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment, (3) loss of complete hematological response (CHR), or (4) loss of major cytogenic response (MCyR) while on treatment. Estimated rate of EFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval). |
| Secondary | Estimated Rate of Progression Free Survival (PFS) in Two Treatment Arms | 60 months over all and follow up period | PFS on study which was defined as time between randomization and either (1) death due to any cause on treatment of during follow-up after discontinuation of treatment or (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment during follow-up after discontinuation of study treatment. Estimated rate of PFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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) Rates at 12 Months | 12 months | Intent-to-treat (ITT) population consisted of all patients who are randomized into the study. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months | 24, 36 and 42 months | Intent-to-treat (ITT) population consisted of all patients who are randomized into the study. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months | 12, 24, 36, 42 months | Intent-to-treat (ITT) population consisted of all patients who are randomized into the study. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Hematological Response (CHR) Rates at 12, 24, 36, and 42 Months | 12, 24, 36, and 42 months | Intent-to-treat (ITT) population consisted of all patients who are randomized into the study. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Undetectable Levels of Bcr-Abl (A Fusion Gene of the Breakpoint Cluster Region [Bcr] Gene and Abelson Proto-oncogene [Abl] Genes) Transcripts | 12 , 24, 36 and 42 months | Intent-to-treat (ITT) population consisted of all patients who were randomized into the study. | Percentage of Partcipants | NUMBER |
| SECONDARY | Time to First Major Molecular Response | 42 months overall | Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment. | Months | MEDIAN |
| SECONDARY | Time to First Complete Cytogenetic Response | 60 months overall | Intent-to-treat (ITT) population consisted of all patients who are randomized into the study. | Months | MEDIAN |
| SECONDARY | Time to First Complete Hematological Response (CHR)] | 60 months overall | Intent-to-treat (ITT) population consisted of all patients who are randomized into the study. | Months | MEDIAN |
| SECONDARY | Estimated Rate of Event Free Survival (EFS) in Two Treatment Arms | 60 months over all | Intent-to-treat (ITT) population consisted of all patients who are randomized into the study. | Percent probability | NUMBER |
| SECONDARY | Estimated Rate of Progression Free Survival (PFS) in Two Treatment Arms | 60 months over all and follow up period | Intent-to-treat (ITT) population consisted of all patients who are randomized into the study. | Percent probability | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group138
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) Rates at 12 Months | Imatinib 400 mg | 38.9 | Percentage of participants | ||
| Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months | Imatinib 800 mg | 45.1 | Percentage of participants | ||
| Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months | Imatinib 400 mg | 24 months | 53.5 | Percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months | Imatinib 800 mg | 24 months | 50.8 | Percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months | Imatinib 400 mg | 36 months | 52.2 | Percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months | Imatinib 800 mg | 36 months | 49.8 | Percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months | Imatinib 400 mg | 42 months | 51.6 | Percentage of participants | |
| Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months | Imatinib 800 mg | 42 months | 50.2 | Percentage of participants | |
| Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months | Imatinib 400 mg | 12 months | 66.9 | Percentage of Participants | |
| Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months | Imatinib 800 mg | 12 months | 70.2 | Percentage of Participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 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 400 mg | 157 | |
| Overall Study | STARTED | Imatinib 800 mg | 319 | |
| Overall Study | Safety Population | Imatinib 400 mg | 157 | |
| Overall Study | Safety Population | Imatinib 800 mg | 316 | |
| Overall Study | COMPLETED | Imatinib 400 mg | 14 | |
| Overall Study | COMPLETED | Imatinib 800 mg | 35 | |
| Overall Study | NOT COMPLETED | Imatinib 400 mg | 143 | |
| Overall Study | NOT COMPLETED | Imatinib 800 mg | 284 |
Source ClinicalTrials.gov
Adverse events602
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 400mg | 41 | 157 | |
| other | Anaemia | Blood and lymphatic system disorders | Imatinib 800mg | 120 | 316 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib 400mg | 20 | 157 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib 800mg | 51 | 316 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib 400mg | 38 | 157 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib 800mg | 107 | 316 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imatinib 400mg | 36 | 157 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imatinib 800mg | 111 | 316 | |
| other | Conjunctival haemorrhage | Eye disorders | Imatinib 400mg | 8 | 157 | |
| other | Conjunctival haemorrhage | Eye disorders | Imatinib 800mg | 19 | 316 |
1 to 10 of 602Source ClinicalTrials.gov
See all 602 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib 400mg | ||
| Total, all-cause mortality | Imatinib 800mg | ||
| Total, other adverse events | Imatinib 400mg | 157 | 157 |
| Total, other adverse events | Imatinib 800mg | 315 | 316 |
| Total, serious adverse events | Imatinib 400mg | 42 | 157 |
| Total, serious adverse events | Imatinib 800mg | 121 | 316 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Imatinib 400mg vs Imatinib 800mg: 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.
GET https://conductscience.org/api/trials/v1/NCT00124748
GET https://conductscience.org/api/trials/v1/NCT00124748/results?page=2