A Phase 2 interventional study of brentuximab vedotin and etoposide in Stage II Childhood Hodgkin Lymphoma, Stage III Childhood Hodgkin Lymphoma and Stage IV Childhood Hodgkin Lymphoma, sponsored by St. Jude Children's Research Hospital. Active, not recruiting at 6 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Treatment
This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
OUTLINE:
AEPA REGIMEN: Patients receive brentuximab vedotin on days 1, 8, and 15, etoposide on days 1 to 5, prednisone three times daily (TID) on days 1 to 15, and doxorubicin hydrochloride on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CAPDac REGIMEN: Patients receive cyclophosphamide on days 1 and 8, brentuximab vedotin days 1 and 8, prednisone TID on days 1 to 15, and dacarbazine on days 1 to 3. Treatment repeats every 21-28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Beginning 2-3 weeks after CAPDac chemotherapy, patients with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy undergo radiation therapy daily, 5 days a week for 3-4 weeks.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 77 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive AEPA regimen (brentuximab vedotin, etoposide, prednisone, doxorubicin), and CAPDac regimen (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine(R)). Filgrastim may be given as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. Some participants may volunteer to complete the quality of life assessment.
Drug: brentuximab vedotin · Drug: etoposide · Drug: prednisone · Drug: doxorubicin · Drug: cyclophosphamide · Drug: Dacarbazine(R) · Drug: filgrastim · Other: quality of life assessment · Radiation: radiation therapy
Given intravenously (IV).
Also known as: SGN-35, Adcetris(R)
Given IV.
Also known as: VP-16, Vepesid(R)
Given orally (PO).
Also known as: prednisolone
Given IV.
Also known as: Adriamycin(R)
Given IV.
Also known as: Cytoxan(R)
Given IV.
Also known as: Dimethyl Triazeno Imidazole Carboximide (DTIC)
Given subcutaneously (SQ) as clinically indicated.
Also known as: Neupogen(R)
Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant.
At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission.
Also known as: irradiation, radiotherapy, radiation
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.
Time frame: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.
Time frame: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Complete Response Rate Estimate for All Evaluable Participants
To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL).
Time frame: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2).
Time frame: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac.
The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
Time frame: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
Descriptive of Hematological Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Time frame: From enrollment to end of therapy (approximately 8 months)
Descriptive of Infectious Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Time frame: From enrollment to end of therapy (approximately 8 months)
Descriptive of Neuropathic Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Time frame: From enrollment to end of therapy (approximately 8 months)
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0)
Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 3. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0)
Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 4. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
Response Rate
Response compared to the Euro-Net C1 after 2 cycles of AEPA.
Time frame: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Patient Quality of Life (QoL)
Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).
Parent Proxy Quality of Life (QoL)
Parent's assessment of child's physical, emotional, social and school functioning over multiple time points. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points
The correlation of agreement between patient and parent Quality of Life is calculated by using the Pearson's Correlation Coefficient, which considers only the record with both parent and patient data. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
Participants were enrolled at 5 institutions between August 2013 to July 2018.
| Milestone | AEPA/CAPDac |
|---|---|
| Started | 77 |
| Completed | 75 |
| Not completed | 2 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal of consent | 1 |
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.
| percentage of participants | AEPA Chemotherapy |
|---|---|
| Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control | 31.25 (18.04 to 47.21) |
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.
| percentage of participants | AEPA Chemotherapy |
|---|---|
| Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control | 31.25 (16.12 to 50.01) |
To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL).
| percentage of participants | AEPA/CAPDac |
|---|---|
| Complete Response Rate Estimate for All Evaluable Participants | 35 (24 to 46) |
Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2).
| probability | AEPA/CAPDac |
|---|---|
| Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2). | 0.974 (0.951 to 0.997) |
The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
| Probability | AEPA/CAPDac |
|---|---|
| Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac. | 0.013 (0.0003 to 0.0702) |
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
| Participants | Cycle 1 - Grade 2 | Cycle 1 - Grade 3-4 | Cycle 2 - Grade 2 | Cycle 2 - Grade 3-4 | Cycle 3 - Grade 2 | Cycle 3 - Grade 3-4 | Cycle 4 - Grade 2 | Cycle 4 - Grade 3-4 | Cycle 5 - Grade 2 | Cycle 5 - Grade 3-4 | Cycle 6 - Grade 2 | Cycle 6 - Grade 3-4 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Leukopenia | 15 | 49 | 28 | 23 | 8 | 4 | 5 | 5 | 7 | 2 | 14 | 5 |
| Neutropenia | 5 | 62 | 13 | 51 | 7 | 10 | 5 | 3 | 4 | 3 | 8 | 6 |
| Lymphopenia | 15 | 36 | 18 | 15 | 9 | 7 | 16 | 15 | 13 | 22 | 20 | 31 |
| Anemia | 23 | 12 | 28 | 5 | 6 | 1 | 6 | 0 | 4 | 1 | 2 | 1 |
| Thrombocytopenia | 3 | 3 | 2 | 1 | 0 | 2 | 0 | 1 | 0 | 1 | 1 | 2 |
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
| Participants | Cycle 1 - Grade 2 | Cycle 1 - Grade 3-4 | Cycle 2 - Grade 2 | Cycle 2 - Grade 3-4 | Cycle 3 - Grade 2 | Cycle 3 - Grade 3-4 | Cycle 4 - Grade 2 | Cycle 4 - Grade 3-4 | Cycle 5 - Grade 2 | Cycle 5 - Grade 3-4 | Cycle 6 - Grade 2 | Cycle 6 - Grade 3-4 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Febrile neutropenia | 0 | 6 | 0 | 3 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 |
| Mucositis | 10 | 2 | 6 | 4 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
| Upper respiratory infection | 5 | 2 | 3 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Genitourinary infection | 1 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 2 | 0 | 0 | 0 |
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
| Participants | Cycle 1 - Grade 2 | Cycle 1 - Grade 3-4 | Cycle 2 - Grade 2 | Cycle 2 - Grade 3-4 | Cycle 3 - Grade 2 | Cycle 3 - Grade 3-4 | Cycle 4 - Grade 2 | Cycle 4 - Grade 3-4 | Cycle 5 - Grade 2 | Cycle 5 - Grade 3-4 | Cycle 6 - Grade 2 | Cycle 6 - Grade 3-4 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Peripheral sensory neuropathy | 0 | 0 | 1 | 0 | 2 | 0 | 3 | 0 | 1 | 0 | 1 | 0 |
| Pain in extremity | 3 | 1 | 4 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 0 |
| Neuralgia | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Pain NOS | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 3. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
| score on a scale | AEPA/CAPDac | HOD99 Unfavorable Risk 2 Arm (UR2) |
|---|---|---|
| PedsQL v.3.0 Total Score-T1 | 73.38 ± 15.97 | — |
| PedsQL v.3.0 Total Score-T2 | 80.41 ± 14.68 | 71.92 ± 14.58 |
| PedsQL v.3.0 Total Score-T3 | 83.33 ± 13.87 | 73.78 ± 17.72 |
| PedsQL v.3.0 Total Score-T4 | 85.33 ± 13.62 | 79.92 ± 16.25 |
| PedsQL v.3.0 Pain and Hurt-T1 | 73.41 ± 27.45 | — |
| PedsQL v.3.0 Pain and Hurt-T2 | 71.77 ± 29.94 | 66.09 ± 27.49 |
| PedsQL v.3.0 Pain and Hurt-T3 | 72.63 ± 30.03 | 69.81 ± 29.34 |
| PedsQL v.3.0 Pain and Hurt-T4 | 77.5 ± 30.3 | 82.2 ± 25.39 |
| PedsQL v.3.0 Nausea-T1 | 73.97 ± 21.2 | — |
| PedsQL v.3.0 Nausea-T2 | 75.52 ± 23.92 | 60.5 ± 23.83 |
| PedsQL v.3.0 Nausea-T3 | 79.66 ± 20.73 | 60.26 ± 26.92 |
| PedsQL v.3.0 Nausea-T4 | 88.1 ± 17.67 | 78.13 ± 22.69 |
| PedsQL v.3.0 Procedural Anxiety-T1 | 58.6 ± 37 | — |
| PedsQL v.3.0 Procedural Anxiety-T2 | 77.55 ± 26.64 | 71.17 ± 27.72 |
| PedsQL v.3.0 Procedural Anxiety-T3 | 81.61 ± 24.47 | 73.46 ± 27.98 |
| PedsQL v.3.0 Procedural Anxiety-T4 | 76.83 ± 30.36 | 77.65 ± 24.2 |
| PedsQL v.3.0 Treatment Anxiety-T1 | 84.52 ± 21.47 | — |
| PedsQL v.3.0 Treatment Anxiety-T2 | 91.39 ± 14.67 | 85.92 ± 17.06 |
| PedsQL v.3.0 Treatment Anxiety-T3 | 93.97 ± 12.37 | 85.06 ± 23.11 |
| PedsQL v.3.0 Treatment Anxiety-T4 | 93.17 ± 13.95 | 83.71 ± 22.9 |
| PedsQL v.3.0 Worry-T1 | 69.22 ± 24.08 | — |
| PedsQL v.3.0 Worry-T2 | 77.55 ± 22.51 | 64.63 ± 25.01 |
| PedsQL v.3.0 Worry-T3 | 84.2 ± 17.01 | 66.45 ± 25.33 |
| PedsQL v.3.0 Worry-T4 | 82.17 ± 20.89 | 69.57 ± 29.58 |
| PedsQL v.3.0 Cognitive Problems-T1 | 72.34 ± 23.09 | — |
| PedsQL v.3.0 Cognitive Problems-T2 | 81.25 ± 21.06 | 75.72 ± 19.48 |
| PedsQL v.3.0 Cognitive Problems-T3 | 84.38 ± 19.41 | 78.38 ± 22.03 |
| PedsQL v.3.0 Cognitive Problems-T4 | 87.04 ± 18.95 | 81.69 ± 17.84 |
| PedsQL v.3.0 Perceived Physical Appearance-T1 | 79.64 ± 25.21 | — |
| PedsQL v.3.0 Perceived Physical Appearance-T2 | 83.53 ± 22.99 | 78.07 ± 24.91 |
| PedsQL v.3.0 Perceived Physical Appearance-T3 | 82.69 ± 22.29 | 79.87 ± 22.47 |
| PedsQL v.3.0 Perceived Physical Appearance-T4 | 85.17 ± 22.48 | 79.95 ± 23.79 |
| PedsQL v.3.0 Communication-T1 | 74.6 ± 27.3 | — |
| PedsQL v.3.0 Communication-T2 | 85.38 ± 20.73 | 79.02 ± 18.58 |
| PedsQL v.3.0 Communication-T3 | 85.34 ± 20.9 | 81.93 ± 21.22 |
| PedsQL v.3.0 Communication-T4 | 87.33 ± 17.6 | 84.24 ± 21.16 |
Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 4. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
| score on a scale | AEPA/CAPDac | HOD99 Unfavorable Risk 2 Arm (UR2) |
|---|---|---|
| PedsQL v.4.0 Total Score-T1 | 72.94 ± 17.63 | 72.48 ± 17.37 |
| PedsQL v.4.0 Total Score-T2 | 79.38 ± 17.43 | 73.54 ± 16.71 |
| PedsQL v.4.0 Total Score-T3 | 80.39 ± 14.96 | 77.68 ± 17.25 |
| PedsQL v.4.0 Total Score-T4 | 86.06 ± 14.53 | 84.58 ± 15.02 |
| PedsQL v.4.0 Physical Functioning-T1 | 69.54 ± 21.78 | 70.41 ± 26.09 |
| PedsQL v.4.0 Physical Functioning-T2 | 73.86 ± 24.14 | 70.06 ± 22.73 |
| PedsQL v.4.0 Physical Functioning-T3 | 74.02 ± 22.13 | 72.94 ± 25.25 |
| PedsQL v.4.0 Physical Functioning-T4 | 82.45 ± 23.24 | 83.57 ± 18.86 |
| PedsQL v.4.0 Emotional Functioning-T1 | 71.75 ± 24.38 | 67.18 ± 18.25 |
| PedsQL v.4.0 Emotional Functioning-T2 | 83.06 ± 16.63 | 71.31 ± 20.96 |
| PedsQL v.4.0 Emotional Functioning-T3 | 82.07 ± 18.43 | 75.06 ± 22.38 |
| PedsQL v.4.0 Emotional Functioning-T4 | 84.81 ± 19.75 | 80.87 ± 20.63 |
| PedsQL v.4.0 Social Functioning-T1 | 86.21 ± 17.05 | 86.22 ± 17.69 |
| PedsQL v.4.0 Social Functioning-T2 | 88.47 ± 15.85 | 86.82 ± 15.42 |
| PedsQL v.4.0 Social Functioning-T3 | 90.22 ± 12.41 | 88.86 ± 13.84 |
| PedsQL v.4.0 Social Functioning-T4 | 92.31 ± 11.57 | 91.44 ± 14.35 |
| PedsQL v.4.0 School Functioning-T1 | 65.49 ± 22.72 | 67.82 ± 19.65 |
| PedsQL v.4.0 School Functioning-T2 | 75.66 ± 24.66 | 66.91 ± 21.79 |
| PedsQL v.4.0 School Functioning-T3 | 79.2 ± 21.49 | 69.1 ± 24.27 |
| PedsQL v.4.0 School Functioning-T4 | 86.9 ± 18.62 | 79.32 ± 17.77 |
Response compared to the Euro-Net C1 after 2 cycles of AEPA.
Results for this outcome have not been posted.
Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
| score on a scale | Timepoint 1 (T1) | Timepoint 4 (T4) | Timepoint 6 (T6) | Timepoint 8 (T8) | Timepoint 10 (T10) | Timepoint 11 (T11) | Timepoint 12 (T12) | Timepoint 13 (T13) |
|---|---|---|---|---|---|---|---|---|
| Physical Functioning | 69.5 ± 21.8 | 75.8 ± 21.8 | 73.9 ± 24.1 | 74 ± 22.1 | 82.5 ± 23.2 | 87.7 ± 20.3 | 87.1 ± 20.7 | 88.8 ± 19.4 |
| Emotional Functioning | 71.7 ± 24.4 | 80.3 ± 20.2 | 83.1 ± 16.6 | 82.1 ± 18.4 | 84.8 ± 19.8 | 88.4 ± 18.8 | 88.2 ± 16.4 | 80.9 ± 22.8 |
| Social Functioning | 86.2 ± 17 | 87.2 ± 18.3 | 88.5 ± 15.9 | 90.2 ± 12.4 | 92.3 ± 11.6 | 93.8 ± 11.9 | 94 ± 12.8 | 95.3 ± 12.2 |
| School Functioning | 65.5 ± 22.7 | 75.7 ± 24.3 | 75.7 ± 24.7 | 79.2 ± 21.5 | 86.9 ± 18.6 | 85.4 ± 16.2 | 87.2 ± 13.1 | 81.5 ± 23.1 |
Parent's assessment of child's physical, emotional, social and school functioning over multiple time points. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
| score on a scale | Timepoint 1 (T1) | Timepoint 4 (T4) | Timepoint 6 (T6) | Timepoint 8 (T8) | Timepoint 10 (T10) | Timepoint 11 (T11) | Timepoint 12 (T12) | Timepoint 13 (T13) |
|---|---|---|---|---|---|---|---|---|
| Physical Functioning | 61.8 ± 26.9 | 65.3 ± 20.8 | 66.8 ± 22.3 | 65.6 ± 24.1 | 74.5 ± 25.6 | 76.6 ± 29.0 | 75 ± 26.4 | 84.7 ± 29.1 |
| Emotional Functioning | 61.9 ± 23.1 | 69.3 ± 25.2 | 72 ± 22.5 | 73.7 ± 21.4 | 78.6 ± 21 | 84.2 ± 20.3 | 79 ± 23.3 | 85.5 ± 19.2 |
| Social Functioning | 80.3 ± 18.8 | 79.2 ± 21.6 | 79.6 ± 18.4 | 79.2 ± 19.8 | 84.5 ± 20.1 | 87.8 ± 17.9 | 82.5 ± 22.8 | 92.6 ± 13.5 |
| School Functioning | 63.2 ± 25.4 | 68.5 ± 25.6 | 67.1 ± 25.3 | 70.5 ± 25.2 | 80.3 ± 21.7 | 82.2 ± 22.9 | 78.2 ± 22.5 | 81 ± 19.4 |
The correlation of agreement between patient and parent Quality of Life is calculated by using the Pearson's Correlation Coefficient, which considers only the record with both parent and patient data. 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. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
| correlation coefficient | Timepoint 1 (T1) | Timepoint 4 (T4) | Timepoint 6 (T6) | Timepoint 8 (T8) | Timepoint 10 (T10) | Timepoint 11 (T11) | Timepoint 12 (T12) | Timepoint 13 (T13) |
|---|---|---|---|---|---|---|---|---|
| Physical Functioning | 0.701 (0.547 to 0.809) | 0.503 (0.286 to 0.671) | 0.536 (0.318 to 0.7) | 0.575 (0.363 to 0.73) | 0.406 (0.128 to 0.625) | 0.528 (0.263 to 0.719) | 0.468 (0.129 to 0.709) | 0.294 (-0.411 to 0.78) |
| Social Functioning | 0.309 (0.064 to 0.518) | 0.566 (0.362 to 0.718) | 0.534 (0.313 to 0.7) | 0.242 (-0.028 to 0.479) | 0.086 (-0.213 to 0.371) | 0.327 (0.021 to 0.577) | 0.135 (-0.236 to 0.473) | -0.027 (-0.645 to 0.613) |
| Emotional Functioning | 0.593 (0.402 to 0.734) | 0.664 (0.491 to 0.786) | 0.648 (0.464 to 0.778) | 0.588 (0.38 to 0.739) | 0.344 (0.056 to 0.579) | 0.671 (0.457 to 0.811) | 0.291 (-0.077 to 0.59) | 0.756 (0.24 to 0.939) |
| School Functioning | 0.444 (0.211 to 0.628) | 0.577 (0.364 to 0.733) | 0.501 (0.261 to 0.682) | 0.441 (0.188 to 0.639) | 0.694 (0.488 to 0.827) | 0.315 (0.004 to 0.57) | 0.209 (-0.17 to 0.535) | 0.574 (-0.088 to 0.884) |
Collected over Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 1 year. The timeframe for All-Cause Mortality was from start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AEPA/CAPDac | 1/77 (1.3%) | 2/77 (2.6%) | 75/77 (97.4%) |
| Event | AEPA/CAPDac |
|---|---|
| Ventricular tachycardiaCardiac disorders | 1/77 |
| Neutrophil count decreasedInvestigations | 1/77 |
| Event | AEPA/CAPDac |
|---|---|
| Neutrophil count decreasedInvestigations | 75/77 |
| Lymphocyte count decreasedInvestigations | 74/77 |
| White blood cell decreasedInvestigations | 73/77 |
| AnemiaBlood and lymphatic system disorders | 71/77 |
| Alanine aminotransferase increasedInvestigations | 56/77 |
| Weight gainInvestigations | 55/77 |
| Platelet count decreasedInvestigations | 51/77 |
| NauseaGastrointestinal disorders | 50/77 |
| HyperglycemiaMetabolism and nutrition disorders | 39/77 |
| HypoalbuminemiaMetabolism and nutrition disorders | 36/77 |
For staging: B symptoms (unexplained fevers, drenching night sweats or \> 10% weight loss). A= absence of B symptoms
| Age, Continuous(years) | AEPA/CAPDac |
|---|---|
| Median | 16 (6 to 19) |
| Sex: Female, Male(Participants) | AEPA/CAPDac |
|---|---|
| Female | 39 |
| Male | 38 |
| Race/Ethnicity, Customized(Participants) | AEPA/CAPDac |
|---|---|
| Asian | 4 |
| Black or African American | 17 |
| White | 50 |
| More than one race | 4 |
| Others | 2 |
| Region of Enrollment(Participants) | AEPA/CAPDac |
|---|---|
| United States — St. Jude Children's Research Hospital | 59 |
| United States — Stanford University Medical Center | 9 |
| United States — Dana Farber Cancer Institute | 4 |
| United States — Maine Medical Center | 1 |
| United States — Massachusetts General Hospital | 2 |
| United States — St. Jude Midwest Affiliate | 2 |
| Histology(Participants) | AEPA/CAPDac |
|---|---|
| Nodular sclerosing | 59 |
| Classical, NOS | 11 |
| Lymphocyte rich | 4 |
| Mixed cellularity | 3 |
| Stage(Participants) | AEPA/CAPDac |
|---|---|
| IIB | 13 |
| IIIB | 19 |
| IVA | 12 |
| IVB | 33 |
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St. Jude Children's Research Hospital