The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02166463
Recruitment Status : Active, not recruiting
First Posted : June 18, 2014
Results First Posted : May 31, 2023
Last Update Posted : December 21, 2023
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
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 Biological: Bleomycin Sulfate
Drug: Brentuximab Vedotin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Methylprednisolone
Other: Pharmacological Study
Drug: Prednisone
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Vincristine Sulfate
Enrollment 600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (ABVE-PC) ARM II (Bv-AVEPC)
Hide Arm/Group Description Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 300 300
Completed 262 273
Not Completed 38 27
Reason Not Completed
Lost to Follow-up             0             1
Physician Decision             10             10
Ineligible             11             2
Progressive Disease             9             6
Repeat eligibility studies are outside the parameters required for eligibility             2             2
Patient enrollment onto another COG study with tumor therapeutic intent             1             0
Refusal of further protocol therapy             5             6
Arm/Group Title Arm I (ABVE-PC) ARM II (Bv-AVEPC) Total
Hide Arm/Group Description Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 300 300 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 300 participants 600 participants
<=18 years
285
  95.0%
290
  96.7%
575
  95.8%
Between 18 and 65 years
15
   5.0%
10
   3.3%
25
   4.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 300 participants 300 participants 600 participants
15.3  (3) 14.8  (3.1) 15  (3.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 300 participants 600 participants
Female
142
  47.3%
139
  46.3%
281
  46.8%
Male
158
  52.7%
161
  53.7%
319
  53.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 300 participants 600 participants
Hispanic or Latino
57
  19.0%
63
  21.0%
120
  20.0%
Not Hispanic or Latino
228
  76.0%
220
  73.3%
448
  74.7%
Unknown or Not Reported
15
   5.0%
17
   5.7%
32
   5.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 300 participants 600 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.2%
Asian
9
   3.0%
7
   2.3%
16
   2.7%
Native Hawaiian or Other Pacific Islander
3
   1.0%
2
   0.7%
5
   0.8%
Black or African American
33
  11.0%
34
  11.3%
67
  11.2%
White
221
  73.7%
224
  74.7%
445
  74.2%
More than one race
0
   0.0%
5
   1.7%
5
   0.8%
Unknown or Not Reported
34
  11.3%
27
   9.0%
61
  10.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 300 participants 300 participants 600 participants
United States 281 277 558
Canada 19 23 42
1.Primary Outcome
Title Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
Hide Description 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.
Time Frame Up to 48 months after the last enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All the eligible patients who had undergone randomization
Arm/Group Title Arm I (ABVE-PC) ARM II (Bv-AVEPC)
Hide Arm/Group Description:
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 289 298
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.5
(77.4 to 86.5)
92.1
(88.4 to 94.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (ABVE-PC), ARM II (Bv-AVEPC)
Comments Assuming a 3-year EFS of 82% (5-year EFS of 78.4%, long term EFS of 76%) for standard arm, the study will have approximately 86% power for detecting an 8% improvement in 3-year EFS in the Bv-AVEPC arm (3-year EFS of 90%, 5-year EFS of 88.0%, long term EFS of 86.7%) in log rank test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Log Rank
Comments Used a one-sided log-rank test between 2 arms
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame After 42 days of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
All the eligible patients who had undergone randomization and had PET result by central review after completed cycle 2
Arm/Group Title Arm I (ABVE-PC) ARM II (Bv-AVEPC)
Hide Arm/Group Description:
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 285 292
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
80.7
(76.1 to 85.3)
81.2
(76.7 to 85.7)
3.Secondary Outcome
Title Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
Hide Description 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.
Time Frame From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All the eligible patients who had undergone randomization
Arm/Group Title Arm I (ABVE-PC) ARM II (Bv-AVEPC)
Hide Arm/Group Description:
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 289 298
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
5.5
(2.90 to 8.17)
6.7
(3.87 to 9.55)
4.Other Pre-specified Outcome
Title Childhood International Prognostic Score (CHIPS) Score
Hide Description 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.
Time Frame Baseline
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Dose of Radiation Received by Normal Tissues Following Chemotherapy on Either Study Arm
Hide Description 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.
Time Frame Up to 48 months
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title 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
Hide Description 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.
Time Frame Up to 3 years
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Risk of Relapse Among RRL Subjects That Have at Least One Lesion That is Deauville 3 at PET 2
Hide Description 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.
Time Frame Up to 48 months after the last enrollment
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Pharmacokinetic (PK) Analyses
Hide Description PK concentration time profile will be evaluated.
Time Frame 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)
Outcome Measure Data Not Reported
Time Frame From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Event Reporting Description Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
 
Arm/Group Title Arm I (ABVE-PC) ARM II (Bv-AVEPC)
Hide Arm/Group Description Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I (ABVE-PC) ARM II (Bv-AVEPC)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/289 (1.38%)      2/298 (0.67%)    
Hide Serious Adverse Events
Arm I (ABVE-PC) ARM II (Bv-AVEPC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/287 (3.83%)      66/295 (22.37%)    
Blood and lymphatic system disorders     
Anemia †  0/287 (0.00%)  0 3/295 (1.02%)  3
Febrile neutropenia †  4/287 (1.39%)  4 9/295 (3.05%)  9
Cardiac disorders     
Chest pain - cardiac †  0/287 (0.00%)  0 1/295 (0.34%)  1
Heart failure †  0/287 (0.00%)  0 2/295 (0.68%)  2
Pericardial effusion †  0/287 (0.00%)  0 1/295 (0.34%)  1
Sinus tachycardia †  1/287 (0.35%)  1 2/295 (0.68%)  2
Gastrointestinal disorders     
Abdominal pain †  0/287 (0.00%)  0 6/295 (2.03%)  6
Colitis †  0/287 (0.00%)  0 3/295 (1.02%)  3
Constipation †  0/287 (0.00%)  0 3/295 (1.02%)  3
Diarrhea †  0/287 (0.00%)  0 1/295 (0.34%)  1
Esophagitis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Gastrointestinal pain †  0/287 (0.00%)  0 1/295 (0.34%)  1
Ileus †  0/287 (0.00%)  0 2/295 (0.68%)  2
Mucositis oral †  0/287 (0.00%)  0 6/295 (2.03%)  6
Nausea †  0/287 (0.00%)  0 3/295 (1.02%)  3
Oral pain †  0/287 (0.00%)  0 2/295 (0.68%)  2
Pancreatitis †  0/287 (0.00%)  0 2/295 (0.68%)  2
Proctitis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Rectal mucositis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Rectal pain †  0/287 (0.00%)  0 1/295 (0.34%)  1
Typhlitis †  0/287 (0.00%)  0 4/295 (1.36%)  4
Vomiting †  0/287 (0.00%)  0 1/295 (0.34%)  1
General disorders     
Chills †  0/287 (0.00%)  0 2/295 (0.68%)  2
Fatigue †  0/287 (0.00%)  0 1/295 (0.34%)  1
Fever †  0/287 (0.00%)  0 2/295 (0.68%)  2
Multi-organ failure †  0/287 (0.00%)  0 1/295 (0.34%)  1
Pain †  0/287 (0.00%)  0 1/295 (0.34%)  1
Immune system disorders     
Allergic reaction †  1/287 (0.35%)  1 1/295 (0.34%)  1
Anaphylaxis †  1/287 (0.35%)  1 3/295 (1.02%)  3
Infections and infestations     
Bone infection †  0/287 (0.00%)  0 1/295 (0.34%)  1
Catheter related infection †  0/287 (0.00%)  0 1/295 (0.34%)  1
Enterocolitis infectious †  0/287 (0.00%)  0 2/295 (0.68%)  2
Infections and infestations - Other, specify †  0/287 (0.00%)  0 2/295 (0.68%)  2
Lung infection †  1/287 (0.35%)  1 1/295 (0.34%)  1
Sepsis †  5/287 (1.74%)  5 6/295 (2.03%)  6
Skin infection †  0/287 (0.00%)  0 2/295 (0.68%)  2
Upper respiratory infection †  0/287 (0.00%)  0 1/295 (0.34%)  1
Injury, poisoning and procedural complications     
Fracture †  0/287 (0.00%)  0 1/295 (0.34%)  1
Infusion related reaction †  1/287 (0.35%)  1 0/295 (0.00%)  0
Vascular access complication †  0/287 (0.00%)  0 2/295 (0.68%)  2
Investigations     
Alanine aminotransferase increased †  0/287 (0.00%)  0 2/295 (0.68%)  2
Blood bilirubin increased †  0/287 (0.00%)  0 2/295 (0.68%)  2
Creatinine increased †  0/287 (0.00%)  0 1/295 (0.34%)  1
Ejection fraction decreased †  0/287 (0.00%)  0 1/295 (0.34%)  1
Lipase increased †  0/287 (0.00%)  0 1/295 (0.34%)  1
Lymphocyte count decreased †  0/287 (0.00%)  0 1/295 (0.34%)  1
Neutrophil count decreased †  0/287 (0.00%)  0 4/295 (1.36%)  4
Platelet count decreased †  0/287 (0.00%)  0 2/295 (0.68%)  2
Serum amylase increased †  0/287 (0.00%)  0 1/295 (0.34%)  1
White blood cell decreased †  0/287 (0.00%)  0 6/295 (2.03%)  6
Metabolism and nutrition disorders     
Dehydration †  0/287 (0.00%)  0 5/295 (1.69%)  5
Hyperglycemia †  0/287 (0.00%)  0 1/295 (0.34%)  1
Hypernatremia †  0/287 (0.00%)  0 1/295 (0.34%)  1
Hypokalemia †  0/287 (0.00%)  0 4/295 (1.36%)  4
Hyponatremia †  0/287 (0.00%)  0 2/295 (0.68%)  2
Hypophosphatemia †  0/287 (0.00%)  0 1/295 (0.34%)  1
Musculoskeletal and connective tissue disorders     
Back pain †  0/287 (0.00%)  0 1/295 (0.34%)  1
Musculoskeletal and connective tissue disorder - Other, specify †  0/287 (0.00%)  0 1/295 (0.34%)  1
Myalgia †  0/287 (0.00%)  0 2/295 (0.68%)  2
Pain in extremity †  0/287 (0.00%)  0 2/295 (0.68%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify †  0/287 (0.00%)  0 1/295 (0.34%)  1
Nervous system disorders     
Ataxia †  0/287 (0.00%)  0 1/295 (0.34%)  1
Dizziness †  0/287 (0.00%)  0 4/295 (1.36%)  4
Headache †  0/287 (0.00%)  0 2/295 (0.68%)  2
Muscle weakness left-sided †  0/287 (0.00%)  0 1/295 (0.34%)  1
Peripheral motor neuropathy †  1/287 (0.35%)  1 4/295 (1.36%)  4
Peripheral sensory neuropathy †  0/287 (0.00%)  0 6/295 (2.03%)  6
Seizure †  0/287 (0.00%)  0 1/295 (0.34%)  1
Syncope †  0/287 (0.00%)  0 1/295 (0.34%)  1
Psychiatric disorders     
Anxiety †  0/287 (0.00%)  0 1/295 (0.34%)  1
Delirium †  0/287 (0.00%)  0 1/295 (0.34%)  1
Insomnia †  0/287 (0.00%)  0 1/295 (0.34%)  1
Psychosis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Renal and urinary disorders     
Acute kidney injury †  1/287 (0.35%)  1 2/295 (0.68%)  2
Reproductive system and breast disorders     
Testicular pain †  0/287 (0.00%)  0 1/295 (0.34%)  1
Vaginal pain †  0/287 (0.00%)  0 1/295 (0.34%)  1
Respiratory, thoracic and mediastinal disorders     
Cough †  0/287 (0.00%)  0 1/295 (0.34%)  1
Dyspnea †  0/287 (0.00%)  0 3/295 (1.02%)  3
Epistaxis †  0/287 (0.00%)  0 2/295 (0.68%)  2
Pleural effusion †  1/287 (0.35%)  1 0/295 (0.00%)  0
Pleuritic pain †  0/287 (0.00%)  0 1/295 (0.34%)  1
Pneumonitis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Respiratory failure †  1/287 (0.35%)  1 3/295 (1.02%)  3
Sore throat †  0/287 (0.00%)  0 1/295 (0.34%)  1
Skin and subcutaneous tissue disorders     
Pruritus †  0/287 (0.00%)  0 1/295 (0.34%)  1
Rash maculo-papular †  0/287 (0.00%)  0 1/295 (0.34%)  1
Skin and subcutaneous tissue disorders - Other, specify †  0/287 (0.00%)  0 1/295 (0.34%)  1
Skin ulceration †  0/287 (0.00%)  0 1/295 (0.34%)  1
Vascular disorders     
Hypertension †  0/287 (0.00%)  0 2/295 (0.68%)  2
Hypotension †  4/287 (1.39%)  4 10/295 (3.39%)  10
Thromboembolic event †  0/287 (0.00%)  0 9/295 (3.05%)  9
Vascular disorders - Other, specify †  0/287 (0.00%)  0 1/295 (0.34%)  1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (ABVE-PC) ARM II (Bv-AVEPC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   206/287 (71.78%)      209/295 (70.85%)    
Blood and lymphatic system disorders     
Anemia †  89/287 (31.01%)  89 107/295 (36.27%)  107
Blood and lymphatic system disorders - Other, specify †  1/287 (0.35%)  1 1/295 (0.34%)  1
Febrile neutropenia †  90/287 (31.36%)  90 83/295 (28.14%)  83
Leukocytosis †  1/287 (0.35%)  1 0/295 (0.00%)  0
Cardiac disorders     
Cardiac disorders - Other, specify †  1/287 (0.35%)  1 0/295 (0.00%)  0
Sinus tachycardia †  4/287 (1.39%)  4 0/295 (0.00%)  0
Supraventricular tachycardia †  1/287 (0.35%)  1 0/295 (0.00%)  0
Eye disorders     
Blurred vision †  0/287 (0.00%)  0 1/295 (0.34%)  1
Gastrointestinal disorders     
Abdominal pain †  8/287 (2.79%)  8 2/295 (0.68%)  2
Anal fistula †  1/287 (0.35%)  1 0/295 (0.00%)  0
Colitis †  1/287 (0.35%)  1 1/295 (0.34%)  1
Constipation †  2/287 (0.70%)  2 5/295 (1.69%)  5
Dental caries †  1/287 (0.35%)  1 0/295 (0.00%)  0
Diarrhea †  1/287 (0.35%)  1 6/295 (2.03%)  6
Dysphagia †  1/287 (0.35%)  1 1/295 (0.34%)  1
Enterocolitis †  1/287 (0.35%)  1 0/295 (0.00%)  0
Esophageal pain †  0/287 (0.00%)  0 1/295 (0.34%)  1
Esophagitis †  1/287 (0.35%)  1 2/295 (0.68%)  2
Gastritis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Ileus †  0/287 (0.00%)  0 2/295 (0.68%)  2
Mucositis oral †  22/287 (7.67%)  22 28/295 (9.49%)  28
Nausea †  6/287 (2.09%)  6 10/295 (3.39%)  10
Oral pain †  1/287 (0.35%)  1 0/295 (0.00%)  0
Pancreatitis †  0/287 (0.00%)  0 4/295 (1.36%)  4
Proctitis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Rectal mucositis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Rectal pain †  1/287 (0.35%)  1 2/295 (0.68%)  2
Typhlitis †  2/287 (0.70%)  2 0/295 (0.00%)  0
Vomiting †  4/287 (1.39%)  4 11/295 (3.73%)  11
General disorders     
Fever †  6/287 (2.09%)  6 3/295 (1.02%)  3
General disorders and administration site conditions - Other, specify †  0/287 (0.00%)  0 1/295 (0.34%)  1
Non-cardiac chest pain †  1/287 (0.35%)  1 0/295 (0.00%)  0
Pain †  3/287 (1.05%)  3 4/295 (1.36%)  4
Hepatobiliary disorders     
Cholecystitis †  1/287 (0.35%)  1 0/295 (0.00%)  0
Immune system disorders     
Allergic reaction †  15/287 (5.23%)  15 7/295 (2.37%)  7
Anaphylaxis †  10/287 (3.48%)  10 7/295 (2.37%)  7
Infections and infestations     
Anorectal infection †  0/287 (0.00%)  0 1/295 (0.34%)  1
Appendicitis †  2/287 (0.70%)  2 2/295 (0.68%)  2
Arteritis infective †  1/287 (0.35%)  1 0/295 (0.00%)  0
Catheter related infection †  4/287 (1.39%)  4 2/295 (0.68%)  2
Enterocolitis infectious †  1/287 (0.35%)  1 4/295 (1.36%)  4
Esophageal infection †  0/287 (0.00%)  0 1/295 (0.34%)  1
Gum infection †  0/287 (0.00%)  0 1/295 (0.34%)  1
Herpes simplex reactivation †  0/287 (0.00%)  0 1/295 (0.34%)  1
Infections and infestations - Other, specify †  4/287 (1.39%)  4 7/295 (2.37%)  7
Infective myositis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Lung infection †  0/287 (0.00%)  0 3/295 (1.02%)  3
Meningitis †  1/287 (0.35%)  1 0/295 (0.00%)  0
Mucosal infection †  0/287 (0.00%)  0 3/295 (1.02%)  3
Otitis media †  1/287 (0.35%)  1 0/295 (0.00%)  0
Sepsis †  7/287 (2.44%)  7 2/295 (0.68%)  2
Shingles †  0/287 (0.00%)  0 1/295 (0.34%)  1
Sinusitis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Skin infection †  4/287 (1.39%)  4 4/295 (1.36%)  4
Soft tissue infection †  1/287 (0.35%)  1 0/295 (0.00%)  0
Thrush †  0/287 (0.00%)  0 1/295 (0.34%)  1
Upper respiratory infection †  0/287 (0.00%)  0 3/295 (1.02%)  3
Urinary tract infection †  2/287 (0.70%)  2 2/295 (0.68%)  2
Vaginal infection †  2/287 (0.70%)  2 0/295 (0.00%)  0
Vulval infection †  1/287 (0.35%)  1 0/295 (0.00%)  0
Wound infection †  2/287 (0.70%)  2 0/295 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture †  0/287 (0.00%)  0 1/295 (0.34%)  1
Infusion related reaction †  8/287 (2.79%)  8 1/295 (0.34%)  1
Vascular access complication †  4/287 (1.39%)  4 1/295 (0.34%)  1
Investigations     
Alanine aminotransferase increased †  10/287 (3.48%)  10 11/295 (3.73%)  11
Aspartate aminotransferase increased †  2/287 (0.70%)  2 3/295 (1.02%)  3
Blood bilirubin increased †  2/287 (0.70%)  2 2/295 (0.68%)  2
Carbon monoxide diffusing capacity decreased †  1/287 (0.35%)  1 0/295 (0.00%)  0
Ejection fraction decreased †  0/287 (0.00%)  0 2/295 (0.68%)  2
GGT increased †  2/287 (0.70%)  2 1/295 (0.34%)  1
Lipase increased †  1/287 (0.35%)  1 3/295 (1.02%)  3
Lymphocyte count decreased †  75/287 (26.13%)  75 71/295 (24.07%)  71
Lymphocyte count increased †  1/287 (0.35%)  1 0/295 (0.00%)  0
Neutrophil count decreased †  116/287 (40.42%)  116 144/295 (48.81%)  144
Platelet count decreased †  81/287 (28.22%)  81 95/295 (32.20%)  95
Serum amylase increased †  1/287 (0.35%)  1 1/295 (0.34%)  1
Vital capacity abnormal †  2/287 (0.70%)  2 1/295 (0.34%)  1
Weight gain †  1/287 (0.35%)  1 1/295 (0.34%)  1
Weight loss †  1/287 (0.35%)  1 0/295 (0.00%)  0
White blood cell decreased †  103/287 (35.89%)  103 121/295 (41.02%)  121
Metabolism and nutrition disorders     
Acidosis †  1/287 (0.35%)  1 0/295 (0.00%)  0
Alkalosis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Anorexia †  5/287 (1.74%)  5 8/295 (2.71%)  8
Dehydration †  3/287 (1.05%)  3 4/295 (1.36%)  4
Hyperglycemia †  4/287 (1.39%)  4 4/295 (1.36%)  4
Hyperkalemia †  0/287 (0.00%)  0 2/295 (0.68%)  2
Hypoalbuminemia †  4/287 (1.39%)  4 3/295 (1.02%)  3
Hypocalcemia †  4/287 (1.39%)  4 5/295 (1.69%)  5
Hypoglycemia †  0/287 (0.00%)  0 2/295 (0.68%)  2
Hypokalemia †  19/287 (6.62%)  19 13/295 (4.41%)  13
Hyponatremia †  9/287 (3.14%)  9 8/295 (2.71%)  8
Hypophosphatemia †  4/287 (1.39%)  4 6/295 (2.03%)  6
Musculoskeletal and connective tissue disorders     
Arthralgia †  1/287 (0.35%)  1 1/295 (0.34%)  1
Back pain †  2/287 (0.70%)  2 2/295 (0.68%)  2
Bone pain †  4/287 (1.39%)  4 5/295 (1.69%)  5
Muscle cramp †  1/287 (0.35%)  1 0/295 (0.00%)  0
Muscle weakness lower limb †  0/287 (0.00%)  0 1/295 (0.34%)  1
Myalgia †  2/287 (0.70%)  2 2/295 (0.68%)  2
Pain in extremity †  3/287 (1.05%)  3 2/295 (0.68%)  2
Nervous system disorders     
Aphonia †  1/287 (0.35%)  1 0/295 (0.00%)  0
Dizziness †  0/287 (0.00%)  0 1/295 (0.34%)  1
Headache †  5/287 (1.74%)  5 3/295 (1.02%)  3
Paresthesia †  1/287 (0.35%)  1 0/295 (0.00%)  0
Peripheral motor neuropathy †  28/287 (9.76%)  28 13/295 (4.41%)  13
Peripheral sensory neuropathy †  43/287 (14.98%)  43 42/295 (14.24%)  42
Recurrent laryngeal nerve palsy †  2/287 (0.70%)  2 1/295 (0.34%)  1
Seizure †  3/287 (1.05%)  3 0/295 (0.00%)  0
Syncope †  8/287 (2.79%)  8 2/295 (0.68%)  2
Psychiatric disorders     
Insomnia †  2/287 (0.70%)  2 0/295 (0.00%)  0
Renal and urinary disorders     
Cystitis noninfective †  1/287 (0.35%)  1 0/295 (0.00%)  0
Hematuria †  1/287 (0.35%)  1 0/295 (0.00%)  0
Urinary incontinence †  1/287 (0.35%)  1 0/295 (0.00%)  0
Reproductive system and breast disorders     
Pelvic pain †  0/287 (0.00%)  0 1/295 (0.34%)  1
Penile pain †  1/287 (0.35%)  1 0/295 (0.00%)  0
Premature menopause †  1/287 (0.35%)  1 0/295 (0.00%)  0
Vaginal inflammation †  1/287 (0.35%)  1 0/295 (0.00%)  0
Vaginal pain †  1/287 (0.35%)  1 0/295 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchospasm †  2/287 (0.70%)  2 0/295 (0.00%)  0
Cough †  1/287 (0.35%)  1 1/295 (0.34%)  1
Dyspnea †  0/287 (0.00%)  0 1/295 (0.34%)  1
Epistaxis †  0/287 (0.00%)  0 1/295 (0.34%)  1
Hoarseness †  1/287 (0.35%)  1 0/295 (0.00%)  0
Hypoxia †  2/287 (0.70%)  2 1/295 (0.34%)  1
Nasal congestion †  1/287 (0.35%)  1 0/295 (0.00%)  0
Pharyngeal mucositis †  1/287 (0.35%)  1 0/295 (0.00%)  0
Pharyngolaryngeal pain †  1/287 (0.35%)  1 0/295 (0.00%)  0
Pneumonitis †  1/287 (0.35%)  1 0/295 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus †  1/287 (0.35%)  1 0/295 (0.00%)  0
Surgical and medical procedures     
Surgical and medical procedures - Other, specify †  0/287 (0.00%)  0 1/295 (0.34%)  1
Vascular disorders     
Hematoma †  1/287 (0.35%)  1 0/295 (0.00%)  0
Hypertension †  1/287 (0.35%)  1 3/295 (1.02%)  3
Hypotension †  11/287 (3.83%)  11 1/295 (0.34%)  1
Thromboembolic event †  6/287 (2.09%)  6 4/295 (1.36%)  4
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02166463    
Other Study ID Numbers: NCI-2014-01223
NCI-2014-01223 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
s15-00950
AHOD1331 ( Other Identifier: Children's Oncology Group )
AHOD1331 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2014
First Posted: June 18, 2014
Results First Submitted: February 14, 2023
Results First Posted: May 31, 2023
Last Update Posted: December 21, 2023