Trial Outcomes & Findings for Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma (NCT NCT01578967)
NCT ID: NCT01578967
Last Updated: 2021-12-07
Results Overview
Percentage of patients who convert to PET negative disease post consolidation. This is defined by PET with Deauville \<=2. The Deauville 5-point scoring system is a five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG Positron emission tomography: Score 1: No uptake above the background Score 2: Uptake ≤ mediastinum Score 3: Uptake \> mediastinum but ≤ liver Score 4: Uptake moderately increased compared to the liver at any site Score 5: Uptake markedly increased compared to the liver at any site Score X: New areas of uptake unlikely to be related to lymphoma
COMPLETED
NA
41 participants
12 months
2021-12-07
Participant Flow
Participant milestones
| Measure |
ABVD Followed by Brentuximab Vedotin
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
ABVD Followed by Brentuximab Vedotin
n=40 Participants
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|
|
Stage
IIA
|
28 Participants
n=93 Participants
|
|
Age, Continuous
|
29 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=93 Participants
|
|
Stage
I
|
2 Participants
n=93 Participants
|
|
Stage
IIB
|
10 Participants
n=93 Participants
|
|
Risk
Favorable
|
18 Participants
n=93 Participants
|
|
Risk
UnFavorable
|
22 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: One patient was not evaluable due to change in diagnosis during ABVD treatment (HL --\> gray zone lymphoma). There was one death due to sepsis and hepatic failure, a very rare but known complication of brentuximab vedotin. Leaving 39 evaluable patients
Percentage of patients who convert to PET negative disease post consolidation. This is defined by PET with Deauville \<=2. The Deauville 5-point scoring system is a five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG Positron emission tomography: Score 1: No uptake above the background Score 2: Uptake ≤ mediastinum Score 3: Uptake \> mediastinum but ≤ liver Score 4: Uptake moderately increased compared to the liver at any site Score 5: Uptake markedly increased compared to the liver at any site Score X: New areas of uptake unlikely to be related to lymphoma
Outcome measures
| Measure |
ABVD Followed by Brentuximab Vedotin
n=39 Participants
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 4
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 5
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|---|---|
|
Percentage of Patients With Positron Emission Tomography (PET) Negative Disease
|
37 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: One patient was not evaluable due to change in diagnosis during ABVD treatment (HL --\> gray zone lymphoma). There was one death due to sepsis and hepatic failure, a very rare but known complication of brentuximab vedotin. Leaving 39 evaluable patients
Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
Outcome measures
| Measure |
ABVD Followed by Brentuximab Vedotin
n=39 Participants
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 4
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 5
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|---|---|
|
Number of Participant Who Achieved a Complete Response
|
37 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 4 subjects had a partial response (PR) (Deauville score of 3)
Conversion rate to Complete Response after brentuximab vedotin in patients with partial response at the end of ABVD therapy. Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least 2 perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.
Outcome measures
| Measure |
ABVD Followed by Brentuximab Vedotin
n=4 Participants
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 4
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 5
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|---|---|
|
Conversion Rate to Complete Response. Number of Participants Who Had a Partial Response Post ABVD Who Converted to a Complete Response.
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsDefined as the percentage of participants who did not show relapse/progression or death from any cause occurred at 3 years after the time from ABVD treatment start. Relapse/progression is measured using the Revised Response Criteria for Malignant Lymphoma and is defined as the following: appearance of any new lesion \> 1.5 centimeters (cm) in any axis during or at the end of therapy; at least a 50% increase from nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions; or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis. In addition, lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was positron emission tomography (PET) positive before therapy
Outcome measures
| Measure |
ABVD Followed by Brentuximab Vedotin
n=40 Participants
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 4
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 5
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|---|---|
|
3 Year Progression Free Survival Rate
|
92 percentage of patients progression free
Interval 77.0 to 97.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsDefined as the percentage of participants who did not show relapse/progression at 3 years after the time from ABVD treatment start. Relapse/progression is measured using the Revised Response Criteria for Malignant Lymphoma and is defined as the following: appearance of any new lesion \> 1.5 centimeters (cm) in any axis during or at the end of therapy; at least a 50% increase from nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions; or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis. In addition, lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was positron emission tomography (PET) positive before therapy
Outcome measures
| Measure |
ABVD Followed by Brentuximab Vedotin
n=40 Participants
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 4
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 5
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|---|---|
|
3 Year Time to Progression Rate
|
92 percentage of patients progression free
Interval 77.0 to 97.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Please note all grade 4 or higher events were experienced by one patient. The patient developed fever and hepatic dysfunction after 1 dose of Brentuximab Vedotin (BV). Patient also developed pancreatitis and eventually died of sepsis.
Number of adverse events attributed to Brentuximab Vedotin with a grade 3 or higher. Toxicity assessed via the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.The higher the grade the more severe the adverse event.
Outcome measures
| Measure |
ABVD Followed by Brentuximab Vedotin
n=40 Participants
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 4
n=40 Participants
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
Grade 5
n=40 Participants
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|---|---|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
White blood cell decreased
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Neutropenia
|
3 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Infections and infestations
|
1 Number of events
|
0 Number of events
|
1 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Alanine aminotransferase increased
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Anemia
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Ascites
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Aspartate aminotransferase increased
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Blood bilirubin increased
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Creatinine increased
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Hepatic failure
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Hyperglycemia
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Hypophosphatemia
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Lipase increased
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Pancreatitis
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Peripheral sensory neuropathy
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Platelet count decreased
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Pleural effusion
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Rash maculo-papular
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Renal and urinary disorders
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Sepsis
|
0 Number of events
|
0 Number of events
|
1 Number of events
|
|
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Syncope
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
Adverse Events
ABVD Followed by Brentuximab Vedotin
Serious adverse events
| Measure |
ABVD Followed by Brentuximab Vedotin
n=41 participants at risk
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/41 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/41 • 2 years
|
|
Infections and infestations
Catheter related infection
|
2.4%
1/41 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/41 • 2 years
|
|
Vascular disorders
Hypotension
|
2.4%
1/41 • 2 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.4%
1/41 • 2 years
|
|
Infections and infestations
Lung infection
|
4.9%
2/41 • 2 years
|
|
Infections and infestations
Meningitis
|
2.4%
1/41 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.4%
1/41 • 2 years
|
|
Nervous system disorders
Transient ischemic attacks
|
2.4%
1/41 • 2 years
|
Other adverse events
| Measure |
ABVD Followed by Brentuximab Vedotin
n=41 participants at risk
Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
4.9%
2/41 • 2 years
|
|
Investigations
Alanine Aminotransferase Increased
|
43.9%
18/41 • 2 years
|
|
Investigations
Alkaline Phosphatase Increased
|
14.6%
6/41 • 2 years
|
|
Immune system disorders
Allergic Reaction
|
4.9%
2/41 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
4.9%
2/41 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
41.5%
17/41 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
58.5%
24/41 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
26.8%
11/41 • 2 years
|
|
Psychiatric disorders
Anxiety
|
9.8%
4/41 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.1%
7/41 • 2 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
36.6%
15/41 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.9%
2/41 • 2 years
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other, Specify
|
7.3%
3/41 • 2 years
|
|
Investigations
Blood Bilirubin Increased
|
9.8%
4/41 • 2 years
|
|
Eye disorders
Blurred Vision
|
4.9%
2/41 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
12.2%
5/41 • 2 years
|
|
General disorders
Chills
|
22.0%
9/41 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
41.5%
17/41 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.7%
13/41 • 2 years
|
|
Investigations
Creatinine Increased
|
7.3%
3/41 • 2 years
|
|
Psychiatric disorders
Depression
|
7.3%
3/41 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
31.7%
13/41 • 2 years
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.3%
3/41 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
2/41 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.5%
8/41 • 2 years
|
|
General disorders
Edema Limbs
|
14.6%
6/41 • 2 years
|
|
General disorders
Fatigue
|
82.9%
34/41 • 2 years
|
|
General disorders
Fever
|
22.0%
9/41 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
19.5%
8/41 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Specify
|
7.3%
3/41 • 2 years
|
|
General disorders
General Disorders And Administration Site Conditions - Other, Specify
|
7.3%
3/41 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
4.9%
2/41 • 2 years
|
|
Nervous system disorders
Headache
|
24.4%
10/41 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.9%
2/41 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.9%
2/41 • 2 years
|
|
Vascular disorders
Hot Flashes
|
4.9%
2/41 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
34.1%
14/41 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.9%
2/41 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.8%
4/41 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
4/40 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
2/40 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.5%
3/40 • 2 years
|
|
General disorders
Infusion Related Reaction
|
5.0%
2/40 • 2 years
|
|
General disorders
Injection Site Reaction
|
7.5%
3/40 • 2 years
|
|
Psychiatric disorders
Insomnia
|
25.0%
10/40 • 2 years
|
|
Investigations
Lymphocyte Count Decreased
|
7.5%
3/40 • 2 years
|
|
General disorders
Malaise
|
22.5%
9/40 • 2 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
17.5%
7/40 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
8/40 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
15.0%
6/40 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
77.5%
31/40 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.0%
2/40 • 2 years
|
|
Investigations
Neutrophil Count Decreased
|
80.0%
32/40 • 2 years
|
|
General disorders
Non-Cardiac Chest Pain
|
7.5%
3/40 • 2 years
|
|
General disorders
Pain
|
27.5%
11/40 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.5%
5/40 • 2 years
|
|
Cardiac disorders
Palpitations
|
5.0%
2/40 • 2 years
|
|
Infections and infestations
Papulopustular Rash
|
5.0%
2/40 • 2 years
|
|
Nervous system disorders
Paresthesia
|
7.5%
3/40 • 2 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
77.5%
31/40 • 2 years
|
|
Investigations
Platelet Count Decreased
|
7.5%
3/40 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
7.5%
3/40 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.5%
9/40 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
15.0%
6/40 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
47.5%
19/40 • 2 years
|
|
Infections and infestations
Sinusitis
|
5.0%
2/40 • 2 years
|
|
Infections and infestations
Skin Infection
|
12.5%
5/40 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
10.0%
4/40 • 2 years
|
|
Nervous system disorders
Syncope
|
5.0%
2/40 • 2 years
|
|
Infections and infestations
Upper Respiratory Infection
|
10.0%
4/40 • 2 years
|
|
Renal and urinary disorders
Urinary Frequency
|
5.0%
2/40 • 2 years
|
|
Renal and urinary disorders
Urinary Tract Pain
|
5.0%
2/40 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
2/40 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
10/40 • 2 years
|
|
Investigations
Weight Gain
|
12.5%
5/40 • 2 years
|
|
Investigations
Weight Loss
|
5.0%
2/40 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
2/40 • 2 years
|
|
Investigations
White Blood Cell Decreased
|
60.0%
24/40 • 2 years
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60