Trial Outcomes & Findings for Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease (NCT NCT00107198)
NCT ID: NCT00107198
Last Updated: 2025-09-18
Results Overview
The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (\> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
188 participants
Primary outcome timeframe
At 5 years
Results posted on
2025-09-18
Participant Flow
Participant milestones
| Measure |
Surgery or Combination Chemotherapy, With/Without Radiotherapy
Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT
|
|---|---|
|
Overall Study
STARTED
|
188
|
|
Overall Study
COMPLETED
|
136
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Surgery or Combination Chemotherapy, With/Without Radiotherapy
Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT
|
|---|---|
|
Overall Study
Lack of Efficacy
|
28
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Ineligible
|
5
|
Baseline Characteristics
Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease
Baseline characteristics by cohort
| Measure |
Surgery or Combination Chemotherapy, With/Without Radiotherapy
n=188 Participants
Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT
|
|---|---|
|
Age, Categorical
<=18 years
|
184 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
13 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
162 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 5 yearsPopulation: Of 188 patients enrolled, five ineligible patients and five patients who did not receive the upfront chemotherapy +/- RT per protocol were excluded from this analysis. 178 patients are included. The median follow-up for the 164 censored patients is 61.2 (range 3.5-107.4) months.
The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (\> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause.
Outcome measures
| Measure |
Surgery or Combination Chemotherapy, With/Without Radiotherapy
n=178 Participants
Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT
|
|---|---|
|
Failure-free Survival (FFS)
|
0.91 Probability participants
Interval 0.86 to 0.95
|
SECONDARY outcome
Timeframe: At 5 yearsPopulation: Of 188 patients enrolled, five ineligible patients were excluded from this analysis. 183 patients are included. The median follow-up time for the 155 censored patients is 61.2 months (range 0.03-107.4).
Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment.
Outcome measures
| Measure |
Surgery or Combination Chemotherapy, With/Without Radiotherapy
n=183 Participants
Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT
|
|---|---|
|
Event-free Survival
|
0.85 Probability participants
Interval 0.78 to 0.89
|
SECONDARY outcome
Timeframe: At 2 yearsPopulation: Of 188 patients enrolled, five ineligible patients were excluded. 52 patients with Stage IA, single node LPHL were enrolled with a confirmed total resection (TR). The median follow up among the 39 censored patients is 56.3 months (range 3.9-107.4).
To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.
Outcome measures
| Measure |
Surgery or Combination Chemotherapy, With/Without Radiotherapy
n=52 Participants
Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT
|
|---|---|
|
Cure by Surgery Alone in Stage I Resected Patients
|
0.82 Probability participants
Interval 0.68 to 0.9
|
SECONDARY outcome
Timeframe: At 5 yearsPopulation: Of 188 patients enrolled, five ineligible patients were excluded. 136 patients received upfront AV-PC with or without RT per protocol. Of these 135 achieved CR with AV-PC and avoided RT. The median follow up among the 121 censored patients is 62.2 months (range 3.4-104.5).
To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy.
Outcome measures
| Measure |
Surgery or Combination Chemotherapy, With/Without Radiotherapy
n=135 Participants
Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT
|
|---|---|
|
Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients
|
0.89 Probability participants
Interval 0.82 to 0.93
|
SECONDARY outcome
Timeframe: Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.Population: Eligible patients beginning AV-PC.
Outcome measures
| Measure |
Surgery or Combination Chemotherapy, With/Without Radiotherapy
n=136 Participants
Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT
|
|---|---|
|
Grade 3 or 4 Toxicity
|
26 Participants
|
Adverse Events
Surgery or Combination Chemotherapy, With/Without Radiotherapy
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Surgery or Combination Chemotherapy, With/Without Radiotherapy
n=183 participants at risk
Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
7/183 • Number of events 7
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Gastrointestinal disorders
Constipation
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
3/183 • Number of events 3
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
4/183 • Number of events 4
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Infections and infestations
Catheter related infection
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Infections and infestations
Device related infection
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.1%
2/183 • Number of events 2
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Infections and infestations
Upper respiratory infection
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Investigations
Lipase increased
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Investigations
Neutrophil count decreased
|
1.6%
3/183 • Number of events 3
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Investigations
White blood cell decreased
|
1.1%
2/183 • Number of events 2
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.1%
2/183 • Number of events 2
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Nervous system disorders
Headache
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
|
Psychiatric disorders
Personality change
|
0.55%
1/183 • Number of events 1
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER