Trial · NCT03792256

Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

NCT03792256, Phase 1, Completed, Children's Oncology Group; results first posted 2024-08-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL). Trials, record NCT03792256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03792256

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
NCT number: NCT03792256
Status: Completed
Phases: Phase 1
Enrollment: 12 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Leukemia, Lymphocytic, Lymphoblastic Lymphoma, T-cell Lymphoma, T-cell Leukemia, Recurrent Disease, Acute Leukemia
Interventions: Palbociclib, Cytarabine, Methotrexate, Hydrocortisone, Doxorubicin, Prednisolone, Vincristine, Pegaspargase, Hydrocortisone, Prednisone
First posted: 2019-01-03
Last updated: 2025-03-21
Results first posted: 2024-08-16

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Frequency of Dose Limiting Toxicities of Palbociclib	Up to 32 days	The frequency (%) of patients experiencing a cycle 1 dose limiting toxicity at least possibly attributable to Palbociclib by study part and dose level.
Primary	Frequency of Adverse Events of Palbociclib	Up to 26 months	The frequency (%) of patients experiencing adverse events at least possibly attributable to Palbociclib by study part and dose level.
Primary	Area Under the Drug Concentration Curve of Palbociclib	Up to 11 days	The median (min, max) of the area under the drug concentration curve for Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level.
Primary	Half-life of Palbociclib	Up to 11 days	The median (min, max) of the half-life of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level.
Primary	Maximum Serum Concentration of Palbociclib	Up to 11 days	Median (min, max) of the maximum serum concentration of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level
Primary	Time to Reach Maximum Serum Concentration of Palbociclib	Up to 11 days	Median (min, max) of the maximum time to reach serum concentration of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level
Primary	Clearance of Palbociclib	Up to 11 days	Median (min, max) of the clearance of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level
Secondary	Number of Participants With at Least Partial Response to Palbociclib	up to 26 months	Frequency (%) of patients with at least partial response to Palbociclib per leukemia/lymphoma specific response criteria: Complete Response (CR), M1 marrow (\<5% blasts) and absolute neutrophil count (ANC) at least 500/uL and platelet count at least 50000/uL without transfusion for 7 days; Complete response with incomplete recovery (CRi), M1 marrow (\<5% blasts), ANC\<500uL, platelet count \<50,000uL; Partial Response (PR), Complete disappearance of circulating blasts and achievement of M2 marrow status if M3 originally, without new sites of extramedullary disease, and with ANC ≥ 500/µL. Complete response in the marrow without resolution of extramedullary sites. Overall Response (OR) = CR+CRi+PR
Secondary	Absolute Peripheral Blast Count of Palbociclib	Up to 3 days	Median (min, max) of absolute peripheral blast count of palbociclib by study part and dose level
Secondary	Radiographic Response of Palbociclib in Patients With LL Patients	Day 32	Number of LL patients with radiographic response by study part and dose level. Complete Response (CR): Disappearance of all disease; Partial Response (PR): 50% decrease in SPD (the sum of the products of the largest diameter and the perpendicular diameter for a tumor mass). Total responders = CR+PR

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Frequency of Dose Limiting Toxicities of Palbociclib	Up to 32 days	All enrolled patients	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Frequency of Adverse Events of Palbociclib	Up to 26 months	All enrolled patients	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Area Under the Drug Concentration Curve of Palbociclib	Up to 11 days	All enrolled patients	hr*ng/mL	MEDIAN
PRIMARY	Half-life of Palbociclib	Up to 11 days	All enrolled patients	Hours	MEDIAN
PRIMARY	Maximum Serum Concentration of Palbociclib	Up to 11 days	All enrolled patients	ng/mL	MEDIAN
PRIMARY	Time to Reach Maximum Serum Concentration of Palbociclib	Up to 11 days	All enrolled patients	Hours	MEDIAN
PRIMARY	Clearance of Palbociclib	Up to 11 days	All enrolled patients	L/h/m^2	MEDIAN
SECONDARY	Number of Participants With at Least Partial Response to Palbociclib	up to 26 months	All enrolled patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Absolute Peripheral Blast Count of Palbociclib	Up to 3 days	All eligible patients	peripheral blasts per microliter	MEDIAN
SECONDARY	Radiographic Response of Palbociclib in Patients With LL Patients	Day 32	LL patients only	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group31

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Frequency of Dose Limiting Toxicities of Palbociclib	Stratum 1 With 50 mg/m^2	1		Participants
Frequency of Dose Limiting Toxicities of Palbociclib	Stratum PK With 50 mg/m^2	0		Participants
Frequency of Adverse Events of Palbociclib	Stratum 1 With 50 mg/m^2	5		Participants
Frequency of Adverse Events of Palbociclib	Stratum PK With 50 mg/m^2	5		Participants
Area Under the Drug Concentration Curve of Palbociclib	Stratum 1 With 50 mg/m^2	1278.5	Full Range 530 to 2404	hr*ng/mL
Area Under the Drug Concentration Curve of Palbociclib	Stratum PK With 50 mg/m^2	1131.5	Full Range 486 to 1837	hr*ng/mL
Half-life of Palbociclib	Stratum 1 With 50 mg/m^2	23.04	Full Range 4 to 86.81	Hours
Half-life of Palbociclib	Stratum PK With 50 mg/m^2	16.78	Full Range 4 to 39.93	Hours
Maximum Serum Concentration of Palbociclib	Stratum 1 With 50 mg/m^2	70.8	Full Range 31.8 to 158	ng/mL
Maximum Serum Concentration of Palbociclib	Stratum PK With 50 mg/m^2	82.15	Full Range 39.6 to 120	ng/mL

1 to 10 of 31Source ClinicalTrials.gov

See all 31 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Stratum 1 With 50 mg/m^2	6
Overall Study	STARTED	Stratum PK With 50 mg/m^2	6
Overall Study	COMPLETED	Stratum 1 With 50 mg/m^2	6
Overall Study	COMPLETED	Stratum PK With 50 mg/m^2	3
Overall Study	NOT COMPLETED	Stratum 1 With 50 mg/m^2	0
Overall Study	NOT COMPLETED	Stratum PK With 50 mg/m^2	3

Source ClinicalTrials.gov

Adverse events356

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
other	Abdominal pain	Gastrointestinal disorders	Stratum 1 With 50 mg/m^2	0	6
other	Abdominal pain	Gastrointestinal disorders	Stratum PK With 50 mg/m^2	2	6
other	Activated partial thromboplastin time prolonged	Investigations	Stratum 1 With 50 mg/m^2	1	6
other	Activated partial thromboplastin time prolonged	Investigations	Stratum PK With 50 mg/m^2	3	6
other	Agitation	Psychiatric disorders	Stratum 1 With 50 mg/m^2	1	6
other	Agitation	Psychiatric disorders	Stratum PK With 50 mg/m^2	1	6
other	Alanine aminotransferase increased	Investigations	Stratum 1 With 50 mg/m^2	5	6
other	Alanine aminotransferase increased	Investigations	Stratum PK With 50 mg/m^2	3	6
other	Alkaline phosphatase increased	Investigations	Stratum 1 With 50 mg/m^2	0	6
other	Alkaline phosphatase increased	Investigations	Stratum PK With 50 mg/m^2	2	6

1 to 10 of 356Source ClinicalTrials.gov

See all 356 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stratum 1 With 50 mg/m^2	2	6
Total, all-cause mortality	Stratum PK With 50 mg/m^2	1	6
Total, other adverse events	Stratum 1 With 50 mg/m^2	6	6
Total, other adverse events	Stratum PK With 50 mg/m^2	6	6
Total, serious adverse events	Stratum 1 With 50 mg/m^2	6	6
Total, serious adverse events	Stratum PK With 50 mg/m^2	6	6

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37553297	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 comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Stratum 1 With 50 mg/m^2 vs Stratum PK With 50 mg/m^2: Number of Participants With at Least Partial Response to Palbociclib	Trial comparisons
Stratum 1 With 50 mg/m^2 vs Stratum PK With 50 mg/m^2: Frequency of Dose Limiting Toxicities of Palbociclib	Trial comparisons
Stratum 1 With 50 mg/m^2 vs Stratum PK With 50 mg/m^2: Frequency of Adverse Events of Palbociclib	Trial comparisons
Stratum 1 With 50 mg/m^2 vs Stratum PK With 50 mg/m^2: deaths from any cause	Trial comparisons
Stratum 1 With 50 mg/m^2 vs Stratum PK With 50 mg/m^2: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03792256

GET https://conductscience.org/api/trials/v1/NCT03792256/results?page=2

API reference For AI assistants