Trial · NCT04075747
A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia
NCT04075747, Phase 1, Completed, Jazz Pharmaceuticals
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia. Trials, record NCT04075747. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04075747
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia
- NCT number
- NCT04075747
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 57 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Acute Myeloid Leukemia
- Interventions
- CPX-351, Venetoclax, Midostaurin, Enasidenib
- First posted
- 2019-09-03
- Last updated
- 2023-10-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the Recommended Phase 2 Dose (RP2D) | Up to 30 months | The RP2D will be determined by the specified dose de-escalation/dose escalation algorithm. |
| Primary | Safety and Tolerability of CPX-351 and Targeted Agents: incidence of adverse events (AEs) and dose limiting toxicities (DLTs) | Up to 30 months | The safety and tolerability of CPX-351 and targeted agents when given in combination, based on the incidence of adverse events (AEs) and dose limiting toxicities (DLTs) |
| Secondary | Proportion of subjects who have achieved CR, CRi, CRh, CR + CRi, CR + CRh, and morphologic leukemia-free state (MLFS) | Up to 30 months | After up to 2 inductions |
| Secondary | Proportion of subjects who have achieved CR / CRi with MRD negative status | Up to 30 months | After up to 2 inductions |
| Secondary | Proportion of subjects who have achieved CR / CRh with MRD negative status | Up to 30 months | After up to 2 inductions |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40932876 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04075747
GET https://conductscience.org/api/trials/v1/NCT04075747/registered