Trial · NCT00145600
Therapy for Pediatric Hodgkin Lymphoma
NCT00145600, Phase 2, Completed, St. Jude Children's Research Hospital; results first posted 2013-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Therapy for Pediatric Hodgkin Lymphoma. Trials, record NCT00145600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00145600
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapy for Pediatric Hodgkin Lymphoma
- NCT number
- NCT00145600
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 296 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Hodgkin Lymphoma
- Interventions
- 12 Week Stanford V Chemotherapy, 4 cycles of VAMP chemotherapy, 2 alternating cycles of VAMP/COP chemotherapy, 3 alternating cycles of VAMP/COP chemotherapy
- First posted
- 2005-09-05
- Last updated
- 2022-10-20
- Results first posted
- 2013-05-07
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival Probability by Risk Group | Median 6.4 year follow-up | Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the Greenwood's formula. |
| Secondary | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Secondary | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Secondary | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Secondary | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Secondary | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Secondary | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Secondary | Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Secondary | Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Secondary | Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival Probability by Risk Group | Median 6.4 year follow-up | Nine patients were ineligible for analysis. | probability of 5 yr. event free survival | NUMBER |
| SECONDARY | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. | units on a scale | MEAN |
| SECONDARY | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. | units on a scale | MEAN |
| SECONDARY | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. | units on a scale | MEAN |
| SECONDARY | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. | units on a scale | MEAN |
| SECONDARY | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. | units on a scale | MEAN |
| SECONDARY | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. | units on a scale | MEAN |
| SECONDARY | Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | units on a scale | MEAN |
| SECONDARY | Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | units on a scale | MEAN |
| SECONDARY | Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | units on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival Probability by Risk Group | Favorable Risk | 0.886 | 95% Confidence Interval 0.820 to 0.953 | probability of 5 yr. event free survival | |
| Event-free Survival Probability by Risk Group | Intermediate Risk | 0.844 | 95% Confidence Interval 0.739 to 0.950 | probability of 5 yr. event free survival | |
| Event-free Survival Probability by Risk Group | Unfavorable Risk, Group 1 | 0.667 | 95% Confidence Interval 0.400 to 0.933 | probability of 5 yr. event free survival | |
| Event-free Survival Probability by Risk Group | Unfavorable Risk, Group 2 | 0.793 | 95% Confidence Interval 0.726 to 0.860 | probability of 5 yr. event free survival | |
| Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | Patient At Diagnosis (T1) | 77.2 | Standard Deviation 21.4 | units on a scale | |
| Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | Parent At Diagnosis (T1) | 73.9 | Standard Deviation 24.5 | units on a scale | |
| Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | Patient Completion of 2 Cycles of Chemotherapy (T2) | 72.3 | Standard Deviation 20.2 | units on a scale | |
| Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | Parent Completion of 2 Cycles of Chemotherapy (T2) | 65.4 | Standard Deviation 21.9 | units on a scale | |
| Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | Patient Completion of 4 Cycles of Chemotherapy (T3) | 74.7 | Standard Deviation 20.9 | units on a scale | |
| Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | Parent Completion of 4 Cycles of Chemotherapy (T3) | 66.5 | Standard Deviation 21 | units on a scale |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Favorable Risk | 91 | |
| Overall Study | STARTED | Intermediate Risk | 46 | |
| Overall Study | STARTED | Unfavorable Risk, Group 1 | 13 | |
| Overall Study | STARTED | Unfavorable Risk, Group 2 | 146 | |
| Overall Study | COMPLETED | Favorable Risk | 83 | |
| Overall Study | COMPLETED | Intermediate Risk | 36 | |
| Overall Study | COMPLETED | Unfavorable Risk, Group 1 | 8 | |
| Overall Study | COMPLETED | Unfavorable Risk, Group 2 | 130 | |
| Overall Study | NOT COMPLETED | Favorable Risk | 8 | |
| Overall Study | NOT COMPLETED | Intermediate Risk | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin | Blood and lymphatic system disorders | Favorable Risk | 0 | 88 | 0 |
| other | Hemoglobin | Blood and lymphatic system disorders | Intermediate Risk | 2 | 46 | 3 |
| other | Hemoglobin | Blood and lymphatic system disorders | Unfavorable Risk, Group 1 | 1 | 13 | 4 |
| other | Hemoglobin | Blood and lymphatic system disorders | Unfavorable Risk, Group 2 | 52 | 146 | 85 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Favorable Risk | 15 | 88 | 22 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Intermediate Risk | 24 | 46 | 51 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Unfavorable Risk, Group 1 | 10 | 13 | 42 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Unfavorable Risk, Group 2 | 89 | 146 | 236 |
| other | Lymphopenia | Blood and lymphatic system disorders | Favorable Risk | 0 | 88 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Intermediate Risk | 0 | 46 | 0 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Favorable Risk | ||
| Total, all-cause mortality | Intermediate Risk | ||
| Total, all-cause mortality | Unfavorable Risk, Group 1 | ||
| Total, all-cause mortality | Unfavorable Risk, Group 2 | ||
| Total, other adverse events | Favorable Risk | 54 | 88 |
| Total, other adverse events | Intermediate Risk | 39 | 46 |
| Total, other adverse events | Unfavorable Risk, Group 1 | 12 | 13 |
| Total, other adverse events | Unfavorable Risk, Group 2 | 116 | 146 |
| Total, serious adverse events | Favorable Risk | 0 | 91 |
| Total, serious adverse events | Intermediate Risk | 0 | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22735430 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00145600
GET https://conductscience.org/api/trials/v1/NCT00145600/results?page=2