Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.

All 67 patients on Arm C (Safety and Efficacy at Dose Level 2) were included in the analysis.

→

secondary · POSTED

Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.

All eligible Arm B and ARM C (Dose Level 2) patients were included in the analysis.

→

secondary · POSTED

Lestaurtinib-related dose-limiting toxicity proportions, as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, will by summarized by dose level for Safety phase patients.

Arm C patients of Safety Phase who were evaluable for DLT. The first 10 evaluable patients enrolled on each dose level were included for monitoring dose limiting toxicity.

→

secondary · POSTED

Pharmacokinetic AGP levels in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.

Data was and never will be collected

→

secondary · POSTED

Pharmacokinetic albumin in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.

Data was and never will be collected

→

secondary · POSTED

Summarized with mean and standard deviation for those with available data in Arm C

Arm C Dose Level 2 (DL2) patients who had data available for analysis.

→

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-acute-lymphoblastic-leukemia-pediatric
nct id: NCT00557193
trial label: Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 7
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0000
source section id
NCT00557193-om-0000
source outcome index
0
endpoint
Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
endpoint definition
EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.
time origin
From start of post-induction therapy for up to 10 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All 67 patients on Arm C (Safety and Efficacy at Dose Level 2) were included in the analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0001
source section id
NCT00557193-om-0001
source outcome index
1
endpoint
Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
endpoint definition
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.
time origin
From start of post-induction therapy for up to 10 years.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible Arm B and ARM C (Dose Level 2) patients were included in the analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0002
source section id
NCT00557193-om-0002
source outcome index
2
endpoint
Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
endpoint definition
Lestaurtinib-related dose-limiting toxicity proportions, as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, will by summarized by dose level for Safety phase patients.
time origin
Up to 12 weeks from start of induction
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Arm C patients of Safety Phase who were evaluable for DLT. The first 10 evaluable patients enrolled on each dose level were included for monitoring dose limiting toxicity.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0003
source section id
NCT00557193-om-0003
source outcome index
3
endpoint
Pharmacokinetic AGP Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
endpoint definition
Pharmacokinetic AGP levels in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.
time origin
Up to 12 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data was and never will be collected
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0004
source section id
NCT00557193-om-0004
source outcome index
4
endpoint
Pharmacokinetic Albumin in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
endpoint definition
Pharmacokinetic albumin in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.
time origin
Up to 12 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data was and never will be collected
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0005
source section id
NCT00557193-om-0005
source outcome index
5
endpoint
Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
endpoint definition
Summarized with mean and standard deviation for those with available data in Arm C
time origin
Sampled between weeks 6-12 from start of induction
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Arm C Dose Level 2 (DL2) patients who had data available for analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0000
arm key
OG000
arm label
Arm C (Safety/Efficacy Dose Level 2)
regimen
Arm C (Safety and Efficacy), IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
analyzed count
67
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00557193-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0001
arm key
OG000
arm label
Arm B (IR/HR MLL-R Chemotherapy)
regimen
Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00557193-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0001
arm key
OG001
arm label
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)
regimen
Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Lestaurtinib: Given PO Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV
analyzed count
67
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00557193-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0002
arm key
OG000
arm label
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 1)
regimen
Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL1 (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00557193-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0002
arm key
OG001
arm label
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 2)
regimen
Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00557193-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0003
arm key
OG000
arm label
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)
regimen
Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Lestaurtinib: Given PO Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00557193-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0004
arm key
OG000
arm label
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)
regimen
Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Lestaurtinib: Given PO Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00557193-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
outcome key
om-0005
arm key
OG000
arm label
Arm C (Safety/Efficacy Dose Level 2)
regimen
Arm C (Safety and Efficacy), IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00557193-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
harm key
EG000
source section id
NCT00557193-ae
event group key
EG000
event group label
Induction (All Patients)
serious affected
9
serious at risk
210
other affected
181
other at risk
210
frequency threshold
0
collection period
Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.
event definition
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
harm key
EG001
source section id
NCT00557193-ae
event group key
EG001
event group label
Post Induction (Follow-up Only)
serious affected
0
serious at risk
12
other affected
5
other at risk
12
frequency threshold
0
collection period
Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.
event definition
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
harm key
EG002
source section id
NCT00557193-ae
event group key
EG002
event group label
Arm A (Standard Risk MLL-G)
serious affected
2
serious at risk
60
other affected
59
other at risk
60
frequency threshold
0
collection period
Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.
event definition
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
harm key
EG003
source section id
NCT00557193-ae
event group key
EG003
event group label
Arm B (IR/HR MLL-R Chemotherapy)
serious affected
9
serious at risk
54
other affected
54
other at risk
54
frequency threshold
0
collection period
Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.
event definition
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
harm key
EG004
source section id
NCT00557193-ae
event group key
EG004
event group label
Arm C (Safety/ Dose Level 1)
serious affected
8
serious at risk
11
other affected
11
other at risk
11
frequency threshold
0
collection period
Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.
event definition
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
harm key
EG005
source section id
NCT00557193-ae
event group key
EG005
event group label
Arm C (Safety/ Dose Level 2)
serious affected
7
serious at risk
11
other affected
11
other at risk
11
frequency threshold
0
collection period
Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.
event definition
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00557193
harm key
EG006
source section id
NCT00557193-ae
event group key
EG006
event group label
Arm C (Efficacy/ Dose Level 2)
serious affected
41
serious at risk
56
other affected
55
other at risk
56
frequency threshold
0
collection period
Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.
event definition
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
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