Trial · NCT01696084
Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
NCT01696084, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2017-10-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia. Trials, record NCT01696084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01696084
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
- NCT number
- NCT01696084
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 309 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- High Risk Acute Myeloid Leukemia
- Interventions
- CPX-351, 7+3 (cytarabine and daunorubicin)
- First posted
- 2012-09-28
- Last updated
- 2020-08-10
- Results first posted
- 2017-10-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From the date of randomization to death from any cause | Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive. |
| Secondary | Proportion of Subjects With a Response | Post Induction | Complete Remission (CR) |
| Secondary | Event-free Survival | From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first | All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study. |
| Secondary | Remission Duration | From the date of achievement of a remission until the date of relapse or death from any cause | Only subjects achieving CR or CRi were assessed for remission duration. |
| Secondary | Rate of Achieving Morphologic Leukemia-free State | Day 14 | All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS. |
| Secondary | Proportion of Subjects Receiving a Stem Cell Transplant | Post Induction | The number and percentage of subjects transferred for HSCT after induction treatment was recorded. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From the date of randomization to death from any cause | Intent-to-Treat (ITT) Population: All participants randomized in the study. | months | MEDIAN |
| SECONDARY | Proportion of Subjects With a Response | Post Induction | Intent-to-Treat (ITT) Population: All participants randomized in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Event-free Survival | From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first | Intent-to-Treat (ITT) Population: All participants randomized in the study. | months | MEDIAN |
| SECONDARY | Remission Duration | From the date of achievement of a remission until the date of relapse or death from any cause | Intent-to-Treat (ITT) Population: All participants randomized in the study. | months | MEDIAN |
| SECONDARY | Rate of Achieving Morphologic Leukemia-free State | Day 14 | Intent-to-Treat (ITT) Population: All participants randomized in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects Receiving a Stem Cell Transplant | Post Induction | Intent-to-Treat (ITT) Population: All participants randomized in the study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm A (CPX-351) | 9.56 | 95% Confidence Interval 6.60 to 11.86 | months | |
| Overall Survival | Arm B (7+3) | 5.95 | 95% Confidence Interval 4.99 to 7.75 | months | |
| Proportion of Subjects With a Response | Arm A (CPX-351) | 57 | Participants | ||
| Proportion of Subjects With a Response | Arm B (7+3) | 40 | Participants | ||
| Event-free Survival | Arm A (CPX-351) | 2.53 | 95% Confidence Interval 2.07 to 4.99 | months | |
| Event-free Survival | Arm B (7+3) | 1.31 | 95% Confidence Interval 1.08 to 1.64 | months | |
| Remission Duration | Arm A (CPX-351) | 6.93 | 95% Confidence Interval 4.60 to 9.23 | months | |
| Remission Duration | Arm B (7+3) | 6.11 | 95% Confidence Interval 3.45 to 8.71 | months | |
| Rate of Achieving Morphologic Leukemia-free State | Arm A (CPX-351) | 87 | Participants | ||
| Rate of Achieving Morphologic Leukemia-free State | Arm B (7+3) | 66 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (CPX-351) | 153 | |
| Overall Study | STARTED | Arm B (7+3) | 156 | |
| Overall Study | COMPLETED | Arm A (CPX-351) | 22 | |
| Overall Study | COMPLETED | Arm B (7+3) | 10 | |
| Overall Study | NOT COMPLETED | Arm A (CPX-351) | 131 | |
| Overall Study | NOT COMPLETED | Arm B (7+3) | 146 |
Source ClinicalTrials.gov
Adverse events450
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 | Febrile Neutropenia | Blood and lymphatic system disorders | Arm A (CPX-351) | 104 | 153 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Arm B (7+3) | 105 | 151 | |
| other | Atrial Fibrillation | Cardiac disorders | Arm A (CPX-351) | 8 | 153 | |
| other | Atrial Fibrillation | Cardiac disorders | Arm B (7+3) | 15 | 151 | |
| other | Conjunctival Haemorrhage | Eye disorders | Arm A (CPX-351) | 8 | 153 | |
| other | Conjunctival Haemorrhage | Eye disorders | Arm B (7+3) | 6 | 151 | |
| other | Vision Blurred | Eye disorders | Arm A (CPX-351) | 10 | 153 | |
| other | Vision Blurred | Eye disorders | Arm B (7+3) | 2 | 151 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm A (CPX-351) | 70 | 153 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm B (7+3) | 103 | 151 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (CPX-351) | 1 | 153 |
| Total, all-cause mortality | Arm B (7+3) | 0 | 151 |
| Total, other adverse events | Arm A (CPX-351) | 152 | 153 |
| Total, other adverse events | Arm B (7+3) | 151 | 151 |
| Total, serious adverse events | Arm A (CPX-351) | 90 | 153 |
| Total, serious adverse events | Arm B (7+3) | 65 | 151 |
Source ClinicalTrials.gov
Papers9
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (CPX-351) vs Arm B (7+3): Proportion of Subjects With a Response | Trial comparisons |
| Arm A (CPX-351) vs Arm B (7+3): Proportion of Subjects Receiving a Stem Cell Transplant | Trial comparisons |
| Arm A (CPX-351) vs Arm B (7+3): Rate of Achieving Morphologic Leukemia-free State | Trial comparisons |
| Arm A (CPX-351) vs Arm B (7+3): deaths from any cause | Trial comparisons |
| Arm A (CPX-351) vs Arm B (7+3): serious adverse events | 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/NCT01696084
GET https://conductscience.org/api/trials/v1/NCT01696084/events?page=2