Trial · NCT04996160
Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia
NCT04996160, Phase 1, Completed, Tanja Andrea Gruber
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia. Trials, record NCT04996160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04996160
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia
- NCT number
- NCT04996160
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 2 participants, actual
- Lead sponsor
- Tanja Andrea Gruber
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric, Relapsed Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
- Interventions
- Palbociclib, Dexamethasone, Bortezomib, Doxorubicin
- First posted
- 2021-08-09
- Last updated
- 2026-04-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting Toxicity (DLT) | within 30 days from last treatment with palbociclib. | The primary outcome for this study, for the purposes of Clinical Trials.gov registration and results reporting, is dose-limiting toxicities (DLTs) experience by subjects without the Ph+ / Ph-like mutation (Cohort 1), and those with the Ph+ / Ph-like mutation (Cohort 2). The outcome will be reported for Cohorts 1 and 2 as the number of DLTs that occur within 30 days of last treatment with palbociclib. Results for Cohort 2 may be stratified by dose level administered. |
| Secondary | Overall response rate (ORR) | 24 months | The efficacy of the combination of palbociclib and chemotherapy with kinase inhibition will be assessed as the overall clinical response rate of subjects treated at the MTD, consisting of those with complete remission (CR); complete remission morphologic (CRM); and partial response (PR), defined as the flow cytometric results below. * CR: minimal residual disease (MRD) in bone marrow \< 0.01% ("MRD-negative"). * CRM: minimal residual disease (MRD) in bone marrow 0.01% to 5%. * PR: Decrease of at least 50% in the percentage of blasts and 5% to 25% blasts. The outcome will be reported as the number of participants Cohorts 1 and 2 with a clinical response, a number without dispersion. Results for Cohort 2 may be stratified by dose level administered. |
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/NCT04996160
GET https://conductscience.org/api/trials/v1/NCT04996160/registered