NCT01077544 · STUDY IN CONTEXT

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.

Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.

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primary · POSTED

The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.

→

primary · POSTED

The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.

→

primary · POSTED

The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.

→

primary · POSTED

The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses

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secondary · POSTED

A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count \< 10 × 109/L; platelet \< 450 × 109/L; basophils \< 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes \< 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date.

Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id: NCT01077544
trial label: A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0000
source section id
NCT01077544-om-0000
source outcome index
0
endpoint
Summary of Nilotinib Non-compartmental PK Parameters: Cmax
endpoint definition
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.
time origin
Cycle 1 Day 1
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0002
source section id
NCT01077544-om-0002
source outcome index
2
endpoint
Summary of Nilotinib Non-compartmental PK Parameters: Tmax
endpoint definition
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.
time origin
Cycle 1 Day 1
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0003
source section id
NCT01077544-om-0003
source outcome index
3
endpoint
Summary of Nilotinib Non-compartmental PK Parameters: AUClast (Last = 24h)
endpoint definition
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.
time origin
Cycle 1 Day 1
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0004
source section id
NCT01077544-om-0004
source outcome index
4
endpoint
Summary of Nilotinib Non-compartmental PK Parameters: AUC0-12h
endpoint definition
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.
time origin
Cycle 1 Day 1
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0005
source section id
NCT01077544-om-0005
source outcome index
5
endpoint
Summary of Nilotinib Steady-state PK Parameters: AUCss
endpoint definition
The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses
time origin
Cycle 1 Day 8 - Cycle 1 Day 28
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0001
source section id
NCT01077544-om-0001
source outcome index
1
endpoint
Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)
endpoint definition
A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count \< 10 × 109/L; platelet \< 450 × 109/L; basophils \< 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes \< 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date.
time origin
minimum of 12 cycles (28 days per cycle)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0000
arm key
OG000
arm label
Group 1
regimen
1 year to \< 10 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0000
arm key
OG001
arm label
Group 2
regimen
\>= 10 years to \<18 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0001
arm key
OG000
arm label
Group 1
regimen
1 year to \< 10 years pediatric patients
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0001
arm key
OG001
arm label
Group 2
regimen
\>= 10 years to \<18 years pediatric patients
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0002
arm key
OG000
arm label
Group 1
regimen
1 year to \< 10 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0002
arm key
OG001
arm label
Group 2
regimen
\>= 10 years to \<18 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0003
arm key
OG000
arm label
Group 1
regimen
1 year to \< 10 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0003
arm key
OG001
arm label
Group 2
regimen
\>= 10 years to \<18 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0004
arm key
OG000
arm label
Group 1
regimen
1 year to \< 10 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0004
arm key
OG001
arm label
Group 2
regimen
\>= 10 years to \<18 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0005
arm key
OG000
arm label
Group 1
regimen
1 year to \< 10 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
outcome key
om-0005
arm key
OG001
arm label
Group 2
regimen
\>= 10 years to \<18 years pediatric patients
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01077544-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
harm key
EG000
source section id
NCT01077544-ae
event group key
EG000
event group label
Group 1
serious affected
2
serious at risk
8
other affected
8
other at risk
8
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-recurrent-91f65fbb
nct id
NCT01077544
harm key
EG001
source section id
NCT01077544-ae
event group key
EG001
event group label
Group 2
serious affected
3
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice