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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01123 | Registry Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| Seagen Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | Given intravenously (IV). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matt Ehrhardt, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37505794 | Derived | Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28. | |
| 33826362 | Derived |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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All the 77 patients are eligible for the study. Two out of 77 enrolled patients did not complete the study. One patient died during therapy, and 1 patient withdrew from the study. But both patients are evaluable for the primary objective.
Participants were enrolled at 5 institutions between August 2013 to July 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | AEPA/CAPDac | Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive: 2 cycles of AEPA chemotherapy: (A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m^2 IV days 1-5, (P) Prednisone 60 mg/m^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m^2 IV days 1 and 15), Followed by 4 cycles of CAPDac: (C) Cyclophosphamide 500 mg/m^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m^2 IV days 1-3.). Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2023 |
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| etoposide | Drug | Given IV. |
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| prednisone | Drug | Given orally (PO). |
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| doxorubicin | Drug | Given IV. |
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| cyclophosphamide | Drug | Given IV. |
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| Dacarbazine(R) | Drug | Given IV. |
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| filgrastim | Drug | Given subcutaneously (SQ) as clinically indicated. |
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| quality of life assessment | Other | 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. |
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| radiation therapy | Radiation | 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. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment) |
| St. Jude Midwest Affiliate |
| Peoria |
| Illinois |
| 61637 |
| United States |
| Maine Children's Cancer Program (MCCP) | Scarborough | Maine | 04704 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Harvard Cancer Center | Boston | Massachusetts | 02115 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Metzger ML, Link MP, Billett AL, Flerlage J, Lucas JT Jr, Mandrell BN, Ehrhardt MJ, Bhakta N, Yock TI, Friedmann AM, de Alarcon P, Luna-Fineman S, Larsen E, Kaste SC, Shulkin B, Lu Z, Li C, Hiniker SM, Donaldson SS, Hudson MM, Krasin MJ. Excellent Outcome for Pediatric Patients With High-Risk Hodgkin Lymphoma Treated With Brentuximab Vedotin and Risk-Adapted Residual Node Radiation. J Clin Oncol. 2021 Jul 10;39(20):2276-2283. doi: 10.1200/JCO.20.03286. Epub 2021 Apr 7. |
| Clinical Trials Open at St. Jude | View source |
| COMPLETED |
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| NOT COMPLETED |
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For staging: B symptoms (unexplained fevers, drenching night sweats or > 10% weight loss). A= absence of B symptoms
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| ID | Title | Description |
|---|---|---|
| BG000 | AEPA/CAPDac | Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive: 2 cycles of AEPA chemotherapy: (A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m^2 IV days 1-5, (P) Prednisone 60 mg/m^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m^2 IV days 1 and 15), Followed by 4 cycles of CAPDac: (C) Cyclophosphamide 500 mg/m^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m^2 IV days 1-3.). Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Histology | Abbreviation: NOS, not otherwise specified. | Count of Participants | Participants |
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| Stage | II: Involvement of 2 or more lymph node regions on the same side of the diaphragm (II) or localized contiguous involvement of a single extra-lymphatic organ or site and its regional lymph node(s) III: Involvement of lymph node regions on both sides of the diaphragm (III), which may also be accompanied by localized contiguous involvement of an extra-lymphatic organ or site (IIIE) IV: Disseminated (multifocal) involvement of 1 or more extra-lymphatic organs or tissues, with/without associated lymph node involvement, or isolated extra-lymphatic organ involvement with distant nodal involvement | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | The first 32 evaluable participants enrolled was evaluated. | Posted | Number | 90% Confidence Interval | percentage of participants | After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment) |
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| Primary | 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. | The first 32 evaluable participants enrolled was evaluated. | Posted | Number | 95% Confidence Interval | percentage of participants | After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment) |
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| Primary | 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). | All the evaluable participants that completed the first 2 cycles of chemotherapy. | Posted | Number | 95% Confidence Interval | percentage of participants | After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant) |
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| Primary | 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). | For HLHR13, all the evaluable participants that treated with AEPA/CAPDac; for HOD99 Unfavorable Risk 2 Arm (UR2), all the evaluable participants that treated with Stanford V + RT. | Posted | Number | 95% Confidence Interval | probability | From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment) |
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| Secondary | 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). | All the evaluable participants treated with AEPA/CAPDac. | Posted | Number | 95% Confidence Interval | Probability | From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment) |
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| Secondary | 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. | Toxicities reported below for the current study (HLHR13) include all reported hematological toxicities from a participant's on-study date through end of therapy. | Posted | Count of Participants | Participants | From enrollment to end of therapy (approximately 8 months) |
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| Secondary | 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. | Toxicities reported below for the current study (HLHR13) include all reported infectious toxicities from a participant's on-study date through end of therapy. | Posted | Count of Participants | Participants | From enrollment to end of therapy (approximately 8 months) |
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| Secondary | 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. | Toxicities reported below for the current study (HLHR13) include all reported neuropathic toxicities from a participant's on-study date through end of therapy. | Posted | Count of Participants | Participants | From enrollment to end of therapy (approximately 8 months) |
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| Secondary | 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. | Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient. The Peds QL 3.0 data was not collected on the HOD 99 patients at the T1 time point. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Secondary | 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. | Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Secondary | Response Rate | Response compared to the Euro-Net C1 after 2 cycles of AEPA. | Not Posted | after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient. | Posted | Mean | Standard Deviation | score on a scale | At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by parent. | Posted | Mean | Standard Deviation | score on a scale | At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by participant. | Posted | Number | 95% Confidence Interval | correlation coefficient | At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment) |
|
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).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AEPA/CAPDac | Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive: 2 cycles of AEPA chemotherapy: (A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m^2 IV days 1-5, (P) Prednisone 60 mg/m^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m^2 IV days 1 and 15), Followed by 4 cycles of CAPDac: (C) Cyclophosphamide 500 mg/m^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m^2 IV days 1-3.). Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given. | 1 | 77 | 2 | 77 | 75 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Avascular necrosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt Ehrhardt, MD | St. Jude Children's Research Hospital | (901) 595-5913 | matt.ehrhardt@stjude.org |
| Oct 26, 2023 |
| Prot_SAP_002.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D005047 | Etoposide |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D003606 | Dacarbazine |
| D000069585 | Filgrastim |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011246 | Pregnadienetriols |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D001685 | Biological Factors |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
Not provided
Not provided
| White |
|
| More than one race |
|
| Others |
|
| Dana Farber Cancer Institute |
|
| Maine Medical Center |
|
| Massachusetts General Hospital |
|
| St. Jude Midwest Affiliate |
|
| Lymphocyte rich |
|
| Mixed cellularity |
|
| Title | Measurements |
|---|
|
| IVA |
|
| IVB |
|
| Superiority |
|
|
|
|
|
|
|
| Cycle 2 - Grade 2 |
Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. |
| OG003 | Cycle 2 - Grade 3-4 | Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. |
| OG004 | Cycle 3 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG005 | Cycle 3 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG006 | Cycle 4 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG007 | Cycle 4 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG008 | Cycle 5 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG009 | Cycle 5 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG010 | Cycle 6 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG011 | Cycle 6 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
|
|
| Cycle 2 - Grade 2 |
Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. |
| OG003 | Cycle 2 - Grade 3-4 | Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. |
| OG004 | Cycle 3 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG005 | Cycle 3 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG006 | Cycle 4 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG007 | Cycle 4 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG008 | Cycle 5 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG009 | Cycle 5 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG010 | Cycle 6 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG011 | Cycle 6 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
|
|
| Cycle 2 - Grade 2 |
Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. |
| OG003 | Cycle 2 - Grade 3-4 | Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. |
| OG004 | Cycle 3 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG005 | Cycle 3 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG006 | Cycle 4 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG007 | Cycle 4 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG008 | Cycle 5 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG009 | Cycle 5 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG010 | Cycle 6 - Grade 2 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
| OG011 | Cycle 6 - Grade 3-4 | Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV |
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Ann Arbor stage IIB, IIIB, IVA, or IVB risk participants received 2 cycles of AEPA/CAPDac chemotherapy and reported symptoms distress scale (SDS). |
| OG001 | HOD99 Unfavorable Risk 2 Arm (UR2) | Ann Arbor stage IIB, IIIB, or any IV risk participants received 12 weeks Stanford V Chemotherapy |
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| OG001 | HOD99 Unfavorable Risk 2 Arm (UR2) | Ann Arbor stage IIB, IIIB, or any IV risk participants received 12 weeks Stanford V Chemotherapy |
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| OG002 | Timepoint 6 (T6) | Course 3 Day 1 |
| OG003 | Timepoint 8 (T8) | Course 6 Day 1 |
| OG004 | Timepoint 10 (T10) | 4-6 weeks after chemotherapy or 4-6 weeks after radiation |
| OG005 | Timepoint 11 (T11) | 1 year off therapy |
| OG006 | Timepoint 12 (T12) | 2 years off therapy (approximately 2 years and 8 months |
| OG007 | Timepoint 13 (T13) | 5 years off therapy (approximately 5 years and 8 months) |
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| OG002 |
| Timepoint 6 (T6) |
Course 3 Day 1 |
| OG003 | Timepoint 8 (T8) | Course 6 Day 1 |
| OG004 | Timepoint 10 (T10) | 4-6 weeks after chemotherapy or 4-6 weeks after radiation |
| OG005 | Timepoint 11 (T11) | 1 year off therapy |
| OG006 | Timepoint 12 (T12) | 2 years off therapy (approximately 2 years and 8 months |
| OG007 | Timepoint 13 (T13) | 5 years off therapy (approximately 5 years and 8 months) |
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Course 2 Day 1 |
| OG002 | Timepoint 6 (T6) | Course 3 Day 1 |
| OG003 | Timepoint 8 (T8) | Course 6 Day 1 |
| OG004 | Timepoint 10 (T10) | 4-6 weeks after chemotherapy or 4-6 weeks after radiation |
| OG005 | Timepoint 11 (T11) | 1 year off therapy |
| OG006 | Timepoint 12 (T12) | 2 years off therapy (approximately 2 years and 8 months |
| OG007 | Timepoint 13 (T13) | 5 years off therapy (approximately 5 years and 8 months) |
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