NCT00025259 · STUDY IN CONTEXT

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease

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

Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.

Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

→

secondary · POSTED

Number of participants with complete response and very good partial response at the end of protocol therapy.

Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

→

secondary · POSTED

Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.

Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

→

secondary · POSTED

Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.

Arm V (RER with PD), has been excluded as there were no deaths observed by the Time Frame of 5 years. Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

→

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-hodgkin-lymphoma-pediatric
nct id: NCT00025259
trial label: Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
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: 4
harms Count: 7
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0000
source section id
NCT00025259-om-0000
source outcome index
0
endpoint
Event-free Survival
endpoint definition
Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.
time origin
5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0001
source section id
NCT00025259-om-0001
source outcome index
1
endpoint
Disease Response Assessed by Modified RECIST Criteria
endpoint definition
Number of participants with complete response and very good partial response at the end of protocol therapy.
time origin
Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0002
source section id
NCT00025259-om-0002
source outcome index
2
endpoint
Grade 3 or 4 Non-hematologic Toxicity
endpoint definition
Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.
time origin
Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0003
source section id
NCT00025259-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.
time origin
5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Arm V (RER with PD), has been excluded as there were no deaths observed by the Time Frame of 5 years. Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0000
arm key
OG000
arm label
Arm I (Patients Off-therapy Before Callback-Induction Only)
regimen
All patients-off therapy before callback-Induction only
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0000
arm key
OG001
arm label
Arm II (RER With CR [ABVE-PC, IFRT])
regimen
RER with Complete Response - IFRT (Standard Arm)
analyzed count
380
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0000
arm key
OG002
arm label
Arm III (RER With CR [ABVE-PC])
regimen
RER with Complete Response - no IFRT (Reduced Therapy Arm)
analyzed count
382
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0000
arm key
OG003
arm label
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
regimen
RER with less than Complete Response - IFRT
analyzed count
571
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0000
arm key
OG004
arm label
Arm V (RER With PD)
regimen
RER with Progressive Disease - Off Therapy
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0000
arm key
OG005
arm label
Arm VI (SER [DECA, ABVE-PC, IFRT])
regimen
SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
analyzed count
153
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0000
arm key
OG006
arm label
Arm VII (SER [ABVE-PC, IFRT])
regimen
SER - randomized to ABVE-PCX2 + IFRT
analyzed count
152
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0001
arm key
OG000
arm label
Arm I (Patients Off-therapy Before Callback-Induction Only)
regimen
All patients-off therapy before callback-Induction only
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0001
arm key
OG001
arm label
Arm II (RER With CR [ABVE-PC, IFRT])
regimen
RER with Complete Response - IFRT (Standard Arm)
analyzed count
380
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0001
arm key
OG002
arm label
Arm III (RER With CR [ABVE-PC])
regimen
RER with Complete Response - no IFRT ( Reduced Therapy Arm)
analyzed count
382
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0001
arm key
OG003
arm label
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
regimen
RER with less than Complete Response - IFRT
analyzed count
571
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
outcome key
om-0001
arm key
OG004
arm label
Arm V (RER With PD)
regimen
RER with Progressive Disease - Off Therapy
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00025259-om-0001#groups/OG004

harms

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT00025259
harm key
EG000
source section id
NCT00025259-ae
event group key
EG000
event group label
Arm I (Patients Off-therapy Before Callback-Induction Only)
serious affected
1
serious at risk
38
other affected
23
other at risk
38
frequency threshold
0
collection period
Source null
event definition
Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
harm key
EG001
source section id
NCT00025259-ae
event group key
EG001
event group label
Arm II (RER With CR [ABVE-PC, IFRT])
serious affected
2
serious at risk
380
other affected
341
other at risk
380
frequency threshold
0
collection period
Source null
event definition
Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
harm key
EG002
source section id
NCT00025259-ae
event group key
EG002
event group label
Arm III (RER With CR [ABVE-PC])
serious affected
1
serious at risk
382
other affected
334
other at risk
382
frequency threshold
0
collection period
Source null
event definition
Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
harm key
EG003
source section id
NCT00025259-ae
event group key
EG003
event group label
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
serious affected
5
serious at risk
571
other affected
497
other at risk
571
frequency threshold
0
collection period
Source null
event definition
Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
harm key
EG004
source section id
NCT00025259-ae
event group key
EG004
event group label
Arm V (RER With PD)
serious affected
1
serious at risk
36
other affected
26
other at risk
36
frequency threshold
0
collection period
Source null
event definition
Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
harm key
EG005
source section id
NCT00025259-ae
event group key
EG005
event group label
Arm VI (SER [DECA, ABVE-PC, IFRT])
serious affected
2
serious at risk
153
other affected
135
other at risk
153
frequency threshold
0
collection period
Source null
event definition
Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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-hodgkin-lymphoma-pediatric
nct id
NCT00025259
harm key
EG006
source section id
NCT00025259-ae
event group key
EG006
event group label
Arm VII (SER [ABVE-PC, IFRT])
serious affected
1
serious at risk
152
other affected
133
other at risk
152
frequency threshold
0
collection period
Source null
event definition
Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
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