Trial · NCT02676323
Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT02676323, Phase 1, Terminated, St. Jude Children's Research Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome. Trials, record NCT02676323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02676323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome
- NCT number
- NCT02676323
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 19 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Interventions
- Panobinostat, Fludarabine, Cytarabine, Intrathecal Triples, Leucovorin
- First posted
- 2016-02-08
- Last updated
- 2018-11-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) | Up to 56 days following first dose of panobinostat | Any participant who experiences non-hematologic dose-limiting toxicity (DLT) during the first 28 days after taking the initial dose of panobinostat and before receiving non-protocol therapy is considered evaluable for toxicity. Non-hematologic DLT includes any Grade 5 event and any Grade 3 or 4 event that is at least possibly related to panobinostat, unless the event is clearly due to extraneous causes or disease progression. Hematologic DLT includes failure to recover counts by Day 56 in the absence of persistent leukemia. Participants without DLTs who receive at least 5 of the 6 prescribed cycle I doses of panobinostat and can be followed for 28 days (56 days for evaluation of hematologic toxicity) after their initial dose of panobinostat are considered evaluable for toxicity. Participants who are not evaluable for toxicity will be replaced. The MTD is defined as the highest dose level at which six participants have been treated with at most one participant experiencing a DLT. |
| Secondary | Clearance (CL) | From baseline pre-dose day 1 through 48 hours after panobinostat administration | Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the clearance. |
| Secondary | Clearance (CL) | On day 8 from pre-dose through 48 hours after panobinostat administration | Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the clearance. |
| Secondary | Drug Absorption (ka) | From baseline pre-dose day 1 through 48 hours after panobinostat administration | Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the drug absorption. |
| Secondary | Drug Absorption (ka) | On day 8 from pre-dose through 48 hours after panobinostat administration | Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the drug absorption. |
| Secondary | Area under curve (AUC) | From baseline pre-dose day 1 through 48 hours after panobinostat administration | Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the PK parameters. The AUC will be estimated based on the individual estimated PK. |
| Secondary | Area under curve (AUC) | On day 8 from pre-dose through 24 hours after panobinostat administration | Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the PK parameters. The AUC will be estimated based on the individual estimated PK. |
| Secondary | Maximum concentration (Cmax) | From baseline pre-dose day 1 through 48 hours after panobinostat administration | Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the PK parameters. The Cmax will be estimated based on the individual estimated PK. |
| Secondary | Maximum concentration (Cmax) | On day 8 from pre-dose through 24 hours after panobinostat administration | Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the PK parameters. The Cmax will be estimated based on the individual estimated PK. |
| Secondary | Complete response (CR) rate | Up to Day 42 after completion of therapy | Response will be based on blast percentage by flow cytometry. Blast percentages determined by morphology will be used in cases that are not evaluable by flow cytometry. The efficacy of the combination of panobinostat and chemotherapy, as measured by the CR rate will be assessed for patients enrolled at the MTD. The rate of CR will be presented as a point estimate with a 95% exact binomial confidence interval. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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/NCT02676323
GET https://conductscience.org/api/trials/v1/NCT02676323/registered