Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

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

Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.

This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).

→

primary · POSTED

The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.

The six patients who received induction and reported death. The analysis here examines whether their death is primarily attributable to treatment or not.

→

secondary · POSTED

Survival from enrollment to first event: relapse/progression, second malignancy, or death.

164 Group 1 All Patients received induction therapy.

→

secondary · POSTED

Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.

This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).

→

secondary · POSTED

To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.

RER with positive PET-1, Event-Free Survival for RER PET-1 positive patients is compared to that of RER with negative PET-1: n=57 PET-1 positive RER patients, compared to 2 events among n=20 PET-1 negative RER patients. Two PET-1 equivocal RER patients (1 with relapse and 1 censored) are not included in this analysis.

→

secondary · POSTED

A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy.

161 patients began consolidation therapy: 126 patients received risk-adapted radiotherapy after consolidation therapy ABVE-PC and 35 did not.

→

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-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id: NCT01026220
trial label: Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
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: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0000
source section id
NCT01026220-om-0000
source outcome index
0
endpoint
Second-event-free Survival
endpoint definition
Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.
time origin
At 4 years from enrollment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).
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-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0001
source section id
NCT01026220-om-0001
source outcome index
1
endpoint
Safety Analysis and Monitoring of Toxic Death
endpoint definition
The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.
time origin
Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The six patients who received induction and reported death. The analysis here examines whether their death is primarily attributable to treatment or not.
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-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0002
source section id
NCT01026220-om-0002
source outcome index
2
endpoint
Event Free Survival
endpoint definition
Survival from enrollment to first event: relapse/progression, second malignancy, or death.
time origin
At 3 years from enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
164 Group 1 All Patients received induction therapy.
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-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0003
source section id
NCT01026220-om-0003
source outcome index
3
endpoint
Second-event-free Survival
endpoint definition
Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.
time origin
At 4 years from enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).
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-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0004
source section id
NCT01026220-om-0004
source outcome index
4
endpoint
Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
endpoint definition
To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.
time origin
3 years from enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
RER with positive PET-1, Event-Free Survival for RER PET-1 positive patients is compared to that of RER with negative PET-1: n=57 PET-1 positive RER patients, compared to 2 events among n=20 PET-1 negative RER patients. Two PET-1 equivocal RER patients (1 with relapse and 1 censored) are not included in this 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-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0005
source section id
NCT01026220-om-0005
source outcome index
5
endpoint
Relapse-free Survival
endpoint definition
A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy.
time origin
3 years from enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
161 patients began consolidation therapy: 126 patients received risk-adapted radiotherapy after consolidation therapy ABVE-PC and 35 did not.
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-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0000
arm key
OG000
arm label
Group 1
regimen
All Patients
analyzed count
145
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0001
arm key
OG000
arm label
Group 1
regimen
All Patients
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0002
arm key
OG000
arm label
Group 1
regimen
All Patients
analyzed count
164
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0003
arm key
OG000
arm label
Group 2
regimen
Regimen 1
analyzed count
77
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0003
arm key
OG001
arm label
Group 3
regimen
Regimen II
analyzed count
68
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0004
arm key
OG000
arm label
Group 1
regimen
All Patients
analyzed count
77
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0004
arm key
OG001
arm label
Group 4
regimen
RER PET-1 positive
analyzed count
57
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0004
arm key
OG002
arm label
Group 5
regimen
RER PET-1 negative
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0004#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0005
arm key
OG000
arm label
Group 1
regimen
All Patients
analyzed count
161
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0005
arm key
OG001
arm label
Group 6
regimen
risk-adapted radiation therapy
analyzed count
126
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0005#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
outcome key
om-0005
arm key
OG002
arm label
Group 7
regimen
no risk-adapted radiation therapy
analyzed count
35
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01026220-om-0005#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
harm key
EG000
source section id
NCT01026220-ae
event group key
EG000
event group label
Group 1
serious affected
0
serious at risk
165
other affected
89
other at risk
165
frequency threshold
0
collection period
Source null
event definition
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
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-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
harm key
EG001
source section id
NCT01026220-ae
event group key
EG001
event group label
Group 2
serious affected
0
serious at risk
81
other affected
43
other at risk
81
frequency threshold
0
collection period
Source null
event definition
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
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-childhood-nodular-lymphocyte-predominant-b-cell-lymphoma
nct id
NCT01026220
harm key
EG002
source section id
NCT01026220-ae
event group key
EG002
event group label
Group 3
serious affected
0
serious at risk
80
other affected
46
other at risk
80
frequency threshold
0
collection period
Source null
event definition
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
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