Trial · NCT03504410
Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
NCT03504410, Phase 3, Terminated, Cornerstone Pharmaceuticals; results first posted 2022-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML. Trials, record NCT03504410. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03504410
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
- NCT number
- NCT03504410
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 200 participants, actual
- Lead sponsor
- Cornerstone Pharmaceuticals
- Conditions
- Relapsed/Refractory Acute Myeloid Leukemia
- Interventions
- CPI-613 + High Dose Cytarabine and Mitoxantrone, High Dose Cytarabine and Mitoxantrone, Mitoxantrone, Etoposide and Cytarabine, Fludarabine, Cytarabine, Filgrastim
- First posted
- 2018-04-20
- Last updated
- 2023-02-08
- Results first posted
- 2022-12-13
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Remission (CR) | 12 months | Complete disappearance of all clinical evidence of disease |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Remission (CR) | 12 months | Number of Participants with Complete Remission (CR) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Remission (CR) | CPI-613 + HD Cytarabine and Mitoxantrone | 20 | Participants | ||
| Complete Remission (CR) | Control (HAM) and Control Sub-groups (MEC and FLAG) | 22 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CPI-613 + HD Cytarabine and Mitoxantrone | 98 | |
| Overall Study | STARTED | Control (HAM) and Control Sub-groups (MEC and FLAG) | 102 | |
| Overall Study | COMPLETED | CPI-613 + HD Cytarabine and Mitoxantrone | 11 | |
| Overall Study | COMPLETED | Control (HAM) and Control Sub-groups (MEC and FLAG) | 11 | |
| Overall Study | NOT COMPLETED | CPI-613 + HD Cytarabine and Mitoxantrone | 87 | |
| Overall Study | NOT COMPLETED | Control (HAM) and Control Sub-groups (MEC and FLAG) | 91 |
Source ClinicalTrials.gov
Adverse events934
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 | Abdominal abscess | Infections and infestations | CPI-613 + HD Cytarabine and Mitoxantrone | 1 | 96 | |
| other | Abdominal abscess | Infections and infestations | Control (HAM) and Control Sub-groups (MEC and FLAG) | 0 | 97 | |
| other | Abdominal distension | Gastrointestinal disorders | CPI-613 + HD Cytarabine and Mitoxantrone | 3 | 96 | |
| other | Abdominal distension | Gastrointestinal disorders | Control (HAM) and Control Sub-groups (MEC and FLAG) | 3 | 97 | |
| other | Abdominal pain | Gastrointestinal disorders | CPI-613 + HD Cytarabine and Mitoxantrone | 5 | 96 | |
| other | Abdominal pain | Gastrointestinal disorders | Control (HAM) and Control Sub-groups (MEC and FLAG) | 7 | 97 | |
| other | Abdominal pain upper | Gastrointestinal disorders | CPI-613 + HD Cytarabine and Mitoxantrone | 3 | 96 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Control (HAM) and Control Sub-groups (MEC and FLAG) | 1 | 97 | |
| other | Abnormal loss of weight | Metabolism and nutrition disorders | CPI-613 + HD Cytarabine and Mitoxantrone | 1 | 96 | |
| other | Abnormal loss of weight | Metabolism and nutrition disorders | Control (HAM) and Control Sub-groups (MEC and FLAG) | 0 | 97 |
1 to 10 of 934Source ClinicalTrials.gov
See all 934 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CPI-613 + HD Cytarabine and Mitoxantrone | 52 | 96 |
| Total, all-cause mortality | Control (HAM) and Control Sub-groups (MEC and FLAG) | 55 | 97 |
| Total, other adverse events | CPI-613 + HD Cytarabine and Mitoxantrone | 93 | 96 |
| Total, other adverse events | Control (HAM) and Control Sub-groups (MEC and FLAG) | 94 | 97 |
| Total, serious adverse events | CPI-613 + HD Cytarabine and Mitoxantrone | 36 | 96 |
| Total, serious adverse events | Control (HAM) and Control Sub-groups (MEC and FLAG) | 34 | 97 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40454396 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CPI-613 + HD Cytarabine and Mitoxantrone vs Control (HAM) and Control Sub-groups (MEC and FLAG): Complete Remission (CR) | Trial comparisons |
| CPI-613 + HD Cytarabine and Mitoxantrone vs Control (HAM) and Control Sub-groups (MEC and FLAG): deaths from any cause | Trial comparisons |
| CPI-613 + HD Cytarabine and Mitoxantrone vs Control (HAM) and Control Sub-groups (MEC and FLAG): 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/NCT03504410
GET https://conductscience.org/api/trials/v1/NCT03504410/events?page=2