Trial · NCT07156435
Vyxeos® With Clofarabine for Pediatric AML
NCT07156435, Phase 1, Recruiting, Princess Maxima Center for Pediatric Oncology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vyxeos® With Clofarabine for Pediatric AML. Trials, record NCT07156435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07156435
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vyxeos® With Clofarabine for Pediatric AML
- NCT number
- NCT07156435
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 25 participants, estimated
- Lead sponsor
- Princess Maxima Center for Pediatric Oncology
- Conditions
- Relapsed Pediatric AML, Refractory Pediatric AML
- Interventions
- Vyxeos 44 MG / 100 MG Liposome Injection, Clofarabine
- First posted
- 2025-09-05
- Last updated
- 2025-09-05
- Other registries' IDs
- eudract:2020-000142-34
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose finding for combination Vyxeos® with clofarabine | 2 years | To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML |
| Secondary | To determine the safety and tolerability of Vyxeos®/CPX-351 in combination with clofarabine by observing dose-limiting toxicities (DLTs) | 4 years | |
| Secondary | To determine the (preliminary) efficacy in terms of the hematological remission rate in these patients as determined by morphology with flow cytometric confirmation | 4 years | |
| Secondary | To describe the durability of response, including the number of patients that undergo stem- cell transplant after re-induction with this regimen | 4 years | |
| Other | To describe the pharmacokinetics parameters: serum concentration of Vyxeos® components (cytarabine and daunorubicin) and metabolites | 4 years | |
| Other | To describe the relationship between response (ORR) and intracellular Ara-CTP accumulation | 4 years | |
| Other | To describe the correlation between duration of response and measurable residual disease assessed by Flow-cytometry | 4 years |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07156435
GET https://conductscience.org/api/trials/v1/NCT07156435/registered