Trial · NCT02166463
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
NCT02166463, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-05-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma. Trials, record NCT02166463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02166463
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
- NCT number
- NCT02166463
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 600 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma, Ann Arbor Stage IVA Hodgkin Lymphoma, Ann Arbor Stage IVB Hodgkin Lymphoma, Childhood Hodgkin Lymphoma, Classic Hodgkin Lymphoma
- Interventions
Bleomycin Sulfate, Brentuximab Vedotin, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Methylprednisolone, Pharmacological Study, Prednisone, Quality-of-Life Assessment, Questionnaire Administration, Vincristine Sulfate
- First posted
- 2014-06-18
- Last updated
- 2026-11-03
- Results first posted
- 2023-05-31
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death | Up to 48 months after the last enrollment | Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) \>1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) \>1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. |
| Secondary | Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review | After 42 days of chemotherapy | The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. |
| Secondary | Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale | From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. | The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The "Modified Balis scale of Pediatric Neuropathy" allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score \>/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05. |
| Other | Childhood International Prognostic Score (CHIPS) Score | Baseline | CHIPS will be computed for all patients and summarized by descriptive statistics. Will examine the association between CHIPS and early response by cross-tabulations and Chi-square tests within each arm separately, as well as logistic regression model where early response is the outcome variable and CHIPS the predictor variable combining the 2 arms with adjustment for randomized chemotherapy. |
| Other | Dose of Radiation Received by Normal Tissues Following Chemotherapy on Either Study Arm | Up to 48 months | Descriptive statistics will be used to summarize RT doses received by normal tissues on this study. Two-sample t-test will be used to compare the doses received on this study to those on prior studies. |
| Other | Efficacy of Involved Site Radiotherapy (ISRT) by Analyzing the Event-free Survival of Patients Treated With Response-adapted ISRT and by Evaluating Patterns of Relapse Following ISRT | Up to 3 years | EFS for patients on each arm as well as those receiving ISRT or those with slow early response (SER) on each arm will be estimated. One-sample log rank test will be used to compare the observed EFS to the assumed baseline of 82% at 3 years to see if the observed EFS is significantly lower than the projection in these subsets. |
| Other | Risk of Relapse Among RRL Subjects That Have at Least One Lesion That is Deauville 3 at PET 2 | Up to 48 months after the last enrollment | The risk of relapse for cases that are RRL, but have Deauville 3 lesions, will be compared to those that are classified as complete metabolic response at PET2 with solely Deauville 1 or 2 lesions with K-sample test. |
| Other | Pharmacokinetic (PK) Analyses | Pre-dose and end of infusion on day 1, days 2, 3, 8, and 15 of cycle 4 and pre-dose on day 1 and day 22 of cycle 5 (each cycle = 21 days) | PK concentration time profile will be evaluated. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death | Up to 48 months after the last enrollment | All the eligible patients who had undergone randomization | percentage of participants | NUMBER |
| SECONDARY | Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review | After 42 days of chemotherapy | All the eligible patients who had undergone randomization and had PET result by central review after completed cycle 2 | Percentage of patients | NUMBER |
| SECONDARY | Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale | From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. | All the eligible patients who had undergone randomization | Percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Childhood International Prognostic Score (CHIPS) Score | Baseline | |||
| OTHER_PRE_SPECIFIED | Dose of Radiation Received by Normal Tissues Following Chemotherapy on Either Study Arm | Up to 48 months | |||
| OTHER_PRE_SPECIFIED | Efficacy of Involved Site Radiotherapy (ISRT) by Analyzing the Event-free Survival of Patients Treated With Response-adapted ISRT and by Evaluating Patterns of Relapse Following ISRT | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Risk of Relapse Among RRL Subjects That Have at Least One Lesion That is Deauville 3 at PET 2 | Up to 48 months after the last enrollment | |||
| OTHER_PRE_SPECIFIED | Pharmacokinetic (PK) Analyses | Pre-dose and end of infusion on day 1, days 2, 3, 8, and 15 of cycle 4 and pre-dose on day 1 and day 22 of cycle 5 (each cycle = 21 days) |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death | Arm I (ABVE-PC) | 82.5 | 95% Confidence Interval 77.4 to 86.5 | percentage of participants | |
| Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death | ARM II (Bv-AVEPC) | 92.1 | 95% Confidence Interval 88.4 to 94.7 | percentage of participants | |
Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review | Arm I (ABVE-PC) | 80.7 | 95% Confidence Interval 76.1 to 85.3 | Percentage of patients | |
Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review | ARM II (Bv-AVEPC) | 81.2 | 95% Confidence Interval 76.7 to 85.7 | Percentage of patients | |
| Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale | Arm I (ABVE-PC) | 5.5 | 95% Confidence Interval 2.90 to 8.17 | Percentage of patients | |
| Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale | ARM II (Bv-AVEPC) | 6.7 | 95% Confidence Interval 3.87 to 9.55 | Percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (ABVE-PC) | 300 | |
| Overall Study | STARTED | ARM II (Bv-AVEPC) | 300 | |
| Overall Study | COMPLETED | Arm I (ABVE-PC) | 262 | |
| Overall Study | COMPLETED | ARM II (Bv-AVEPC) | 273 | |
| Overall Study | NOT COMPLETED | Arm I (ABVE-PC) | 38 | |
| Overall Study | NOT COMPLETED | ARM II (Bv-AVEPC) | 27 |
Source ClinicalTrials.gov
Adverse events450
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I (ABVE-PC) | 89 | 287 | 89 |
| other | Anemia | Blood and lymphatic system disorders | ARM II (Bv-AVEPC) | 107 | 295 | 107 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm I (ABVE-PC) | 1 | 287 | 1 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | ARM II (Bv-AVEPC) | 1 | 295 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (ABVE-PC) | 90 | 287 | 90 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ARM II (Bv-AVEPC) | 83 | 295 | 83 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (ABVE-PC) | 1 | 287 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | ARM II (Bv-AVEPC) | 0 | 295 | 0 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Arm I (ABVE-PC) | 1 | 287 | 1 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | ARM II (Bv-AVEPC) | 0 | 295 | 0 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (ABVE-PC) | 4 | 289 |
| Total, all-cause mortality | ARM II (Bv-AVEPC) | 2 | 298 |
| Total, other adverse events | Arm I (ABVE-PC) | 206 | 287 |
| Total, other adverse events | ARM II (Bv-AVEPC) | 209 | 295 |
| Total, serious adverse events | Arm I (ABVE-PC) | 11 | 287 |
| Total, serious adverse events | ARM II (Bv-AVEPC) | 66 | 295 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (ABVE-PC) vs ARM II (Bv-AVEPC): deaths from any cause | Trial comparisons |
| Arm I (ABVE-PC) vs ARM II (Bv-AVEPC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02166463
GET https://conductscience.org/api/trials/v1/NCT02166463/events?page=2