Trial · NCT00788892
Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
NCT00788892, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2018-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of CPX-351 in Newly Diagnosed Elderly AML Patients. Trials, record NCT00788892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00788892
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
- NCT number
- NCT00788892
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Acute Myeloid Leukemia
- Interventions
- CPX-351, Cytarabine, Daunorubicin
- First posted
- 2008-11-11
- Last updated
- 2018-01-12
- Results first posted
- 2018-01-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Remission | Within 6 weeks of the last induction treatment | Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of \>1000/µL and peripheral blood platelets of \>100,000/µL in the absence of bone marrow blasts. |
| Secondary | Remission Duration/Time to Remission | Following achievement of CR over the study period | Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died. Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met. |
| Secondary | Event Free Survival | Up to 1 year from randomization | Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first. |
| Secondary | Overall Survival Rate at 1 Year | 1 year | Survival defined as the time from randomization to death. |
| Secondary | Rate of Stem Cell Transplant | Up to 1 year | The rate of patients who underwent stem cell transplant. |
| Secondary | Aplasia Rate | Day 14 (1st Induction) | Bone marrow aplasia was defined as \<20% cellularity and 5% blasts in the bone marrow aspiration evaluation. |
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 | Number of Participants With Complete Remission | Within 6 weeks of the last induction treatment | Efficacy Evaluable Analysis Set: All randomized subjects who received at least 1 dose of study drug. One subject who developed Philadelphia chromosome positive disease prior to any efficacy assessment was excluded from the Efficacy Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Remission Duration/Time to Remission | Following achievement of CR over the study period | Efficacy Evaluable Analysis Set | days | MEDIAN |
| SECONDARY | Event Free Survival | Up to 1 year from randomization | Efficacy Evaluable Analysis Set | days | MEDIAN |
| SECONDARY | Overall Survival Rate at 1 Year | 1 year | Efficacy Evaluable Analysis Set | participants | NUMBER |
| SECONDARY | Rate of Stem Cell Transplant | Up to 1 year | Efficacy Evaluable Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Aplasia Rate | Day 14 (1st Induction) | Efficacy Evaluable Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Complete Remission | Arm A: CPX-351 | 41 | Participants | ||
| Number of Participants With Complete Remission | Arm B: Cytarabine + Daunorubicin | 20 | Participants | ||
| Remission Duration/Time to Remission | Arm A: CPX-351 | Remission Duration | 275 | Full Range 40 to 730 | days |
| Remission Duration/Time to Remission | Arm B: Cytarabine + Daunorubicin | Remission Duration | 235 | Full Range 36 to 703 | days |
| Remission Duration/Time to Remission | Arm A: CPX-351 | Time to Remission | 49 | Full Range 32 to 163 | days |
| Remission Duration/Time to Remission | Arm B: Cytarabine + Daunorubicin | Time to Remission | 40 | Full Range 21 to 89 | days |
| Event Free Survival | Arm A: CPX-351 | 161 | 95% Confidence Interval 116 to 226 | days | |
| Event Free Survival | Arm B: Cytarabine + Daunorubicin | 55 | 95% Confidence Interval 34 to 205 | days | |
| Overall Survival Rate at 1 Year | Arm A: CPX-351 | 39 | participants | ||
| Overall Survival Rate at 1 Year | Arm B: Cytarabine + Daunorubicin | 18 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 | 85 | |
| Overall Study | STARTED | Arm B: Cytarabine + Daunorubicin | 41 | |
| Overall Study | COMPLETED | Arm A: CPX-351 | 36 | |
| Overall Study | COMPLETED | Arm B: Cytarabine + Daunorubicin | 18 | |
| Overall Study | NOT COMPLETED | Arm A: CPX-351 | 49 | |
| Overall Study | NOT COMPLETED | Arm B: Cytarabine + Daunorubicin | 23 |
Source ClinicalTrials.gov
Adverse events382
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 | Arm A: CPX-351 | 3 | 85 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Cytarabine + Daunorubicin | 3 | 41 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Arm A: CPX-351 | 50 | 85 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Arm B: Cytarabine + Daunorubicin | 19 | 41 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: CPX-351 | 7 | 85 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: Cytarabine + Daunorubicin | 6 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: CPX-351 | 7 | 85 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B: Cytarabine + Daunorubicin | 5 | 41 | |
| other | Angina Pectoris | Cardiac disorders | Arm A: CPX-351 | 2 | 85 | |
| other | Angina Pectoris | Cardiac disorders | Arm B: Cytarabine + Daunorubicin | 5 | 41 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 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 | ||
| Total, all-cause mortality | Arm B: Cytarabine + Daunorubicin | ||
| Total, other adverse events | Arm A: CPX-351 | 85 | 85 |
| Total, other adverse events | Arm B: Cytarabine + Daunorubicin | 41 | 41 |
| Total, serious adverse events | Arm A: CPX-351 | 47 | 85 |
| Total, serious adverse events | Arm B: Cytarabine + Daunorubicin | 16 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24687088 | 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 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: Cytarabine + Daunorubicin: Number of Participants With Complete Remission | Trial comparisons |
| Arm A: CPX-351 vs Arm B: Cytarabine + Daunorubicin: Overall Survival Rate at 1 Year | Trial comparisons |
| Arm A: CPX-351 vs Arm B: Cytarabine + Daunorubicin: Aplasia Rate | Trial comparisons |
| Arm A: CPX-351 vs Arm B: Cytarabine + Daunorubicin: Rate of Stem Cell Transplant | Trial comparisons |
| Arm A: CPX-351 vs Arm B: Cytarabine + Daunorubicin: 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/NCT00788892
GET https://conductscience.org/api/trials/v1/NCT00788892/events?page=2