Trial Outcomes & Findings for Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas (NCT NCT02388490)
NCT ID: NCT02388490
Last Updated: 2024-09-23
Results Overview
The primary endpoint was the ORR based on the revised criteria or modified Severity Weighted Assessment Tool (SWAT) criteria in the case of cutaneous lymphomas.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
One-year
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
Brentuximab Vedotin
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin was administered by IV infusion, given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg, q 3 weeks.
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|---|---|
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Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
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25
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
Baseline characteristics by cohort
| Measure |
Brentuximab Vedotin
n=25 Participants
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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Age, Continuous
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67 years
n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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25 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Region of Enrollment
South Korea
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25 participants
n=5 Participants
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PRIMARY outcome
Timeframe: One-yearPopulation: Revised tumor response criteria for lymphoma(Revised Cheson) or revised SWAT and assessed by MRI except a pregnant patient whose response evaluation can be assessed by CT scan: Complete Response (CR), Disappearance of all evidence of the disease; Partial Response (PR), Regression of measurable disease and no new lesions. The SPD of the largest 6 major nodules should decrease by ≥ 50%, and there should be no increase in the size of other nodules; Overall Response (OR) = CR + PR.
The primary endpoint was the ORR based on the revised criteria or modified Severity Weighted Assessment Tool (SWAT) criteria in the case of cutaneous lymphomas.
Outcome measures
| Measure |
Brentuximab Vedotin
n=25 Participants
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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To Evaluate the Overall Response Rate (ORR) of Brentuximab Vedotin in EBV- and CD30-positive Lymphomas
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12 Participants
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SECONDARY outcome
Timeframe: From the first dose of brentuximab vedotin to up to 30 days after the last dose, a total of up to approximately 366 daysPopulation: Among 25 patients, treatment-related serious adverse reactions were observed in 9 patients.
AEs/SAEs occurring during the study period defined by CTCAE version 4.03
Outcome measures
| Measure |
Brentuximab Vedotin
n=25 Participants
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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To Evaluate the Safety Profile
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9 Participants
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SECONDARY outcome
Timeframe: One-yearPopulation: Clinical outcomes of brentuximab vedotin treatment according to lymphoma subtype and CD30 expression.
PFS as defined as the time from the date of initiation until the date of first documented progression. Revised tumor response criteria for lymphoma(Revised Cheson) or revised SWAT and assessed by MRI except a pregnant patient whose response evaluation can be assessed by CT scan: Progression is defined using these criteria, as observation of a new lesion or an increase of 50% or more from the nadir in a previously involved site.
Outcome measures
| Measure |
Brentuximab Vedotin
n=25 Participants
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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To Calculate Progression-free Survival (PFS) Time
All
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6.1 months
Interval 2.8 to 13.5
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To Calculate Progression-free Survival (PFS) Time
Mature T/NK cell
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6.1 months
Interval 0.0 to 13.9
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To Calculate Progression-free Survival (PFS) Time
Mature B cell
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3.0 months
Interval 0.5 to 5.5
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To Calculate Progression-free Survival (PFS) Time
CD 30 expression < 10%
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5.5 months
Interval 0.0 to 15.3
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To Calculate Progression-free Survival (PFS) Time
10% <= CD 30 expression < 50%
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9.7 months
Interval 0.0 to 24.3
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To Calculate Progression-free Survival (PFS) Time
50% <= CD 30 expression
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6.1 months
Interval 0.0 to 14.6
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SECONDARY outcome
Timeframe: From the first dose Up to the time of data cut-off.Population: The duration of response was assessed in 12 patients who had objective responses.
The duration of response was assessed in 12 patients who had objective responses. The response continued even after the completion of the planned 16 cycles of brentuximab vedotin administration in three of these 12 patients (25%) at the time of data cut-off.
Outcome measures
| Measure |
Brentuximab Vedotin
n=12 Participants
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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To Calculate the Duration of Response
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10 months
Interval 4.2 to 21.0
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SECONDARY outcome
Timeframe: From first dose to end of data collectionOS as defined as the time from the date of first dose until death due to any cause. The median overall survival was obtained, but the upper value of 95% Confidence Interval was not reached at the time of data cut-off. Therefore the longest OS was 30.4 months, the follow-up duration up to the date of data cut-off.
Outcome measures
| Measure |
Brentuximab Vedotin
n=25 Participants
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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To Calculate Overall Survival (OS) Time
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15.6 months
Interval 6.1 to 30.4
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OTHER_PRE_SPECIFIED outcome
Timeframe: One-yearPopulation: The level of soluble CD30 (sCD30) was determined using an enzyme-linked immunosorbent assay.
Exploratory. The level of soluble CD30 (sCD30) was determined using an enzyme-linked immunosorbent assay.
Outcome measures
| Measure |
Brentuximab Vedotin
n=25 Participants
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
CD30 expression < 10% · CR
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2 Participants
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The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
CD30 expression < 10% · PR
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4 Participants
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The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
CD30 expression < 10% · Non-CR and Non-PR
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7 Participants
|
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The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
10% <= CD30 expression < 50% · CR
|
3 Participants
|
|
The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
10% <= CD30 expression < 50% · PR
|
0 Participants
|
|
The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
10% <= CD30 expression < 50% · Non-CR and Non-PR
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2 Participants
|
|
The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
50% <= CD30 expression · CR
|
0 Participants
|
|
The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
50% <= CD30 expression · PR
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3 Participants
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The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
50% <= CD30 expression · Non-CR and Non-PR
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4 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: On the date of screening visit.Population: The median value of soluble CD30 (sCD30) was obtained.
The level of soluble CD30 (sCD30) was determined using an enzyme-linked immunosorbent assay. The specimen were collected on the date of screening visit.
Outcome measures
| Measure |
Brentuximab Vedotin
n=25 Participants
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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Exploratory.
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99.03 ng/mL
Interval 2.67 to 2155.78
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to the date of data cut-offThe ORR in the groups with high sCD30 (≥ 99.03 ng/mL) and low sCD30 (\<99.03 ng/mL) were determined up to the date of data cut-off.
Outcome measures
| Measure |
Brentuximab Vedotin
n=25 Participants
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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The ORR in the Groups With High sCD30 (≥ 99.03 ng/mL) and Low sCD30 (<99.03 ng/mL).
The ORR in the groups with high sCD30 (1-<10%)
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13 Participants
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The ORR in the Groups With High sCD30 (≥ 99.03 ng/mL) and Low sCD30 (<99.03 ng/mL).
The ORR in the groups with intermediate sCD30 (10-<50%)
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5 Participants
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The ORR in the Groups With High sCD30 (≥ 99.03 ng/mL) and Low sCD30 (<99.03 ng/mL).
The ORR in the groups with low sCD30 (>=50%)
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7 Participants
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Adverse Events
Brentuximab Vedotin
Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brentuximab Vedotin
n=25 participants at risk
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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Musculoskeletal and connective tissue disorders
Fracture
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
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Skin and subcutaneous tissue disorders
Herpes zoster
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12.0%
3/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
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Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
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Psychiatric disorders
Anorexia
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
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Blood and lymphatic system disorders
Anemia
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
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Blood and lymphatic system disorders
Cytopenia
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
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Renal and urinary disorders
Hematuria
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
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Infections and infestations
Fungal infection
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
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Respiratory, thoracic and mediastinal disorders
Pneumonia
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
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Endocrine disorders
General weakness
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4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neck mass
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
Other adverse events
| Measure |
Brentuximab Vedotin
n=25 participants at risk
This group was consisted of patients with EBV-positive and CD30- positive non-Hodgkin lymphomas with various levels of CD30 in the relapsed or refractory setting and designed to evaluate the activity of brentuximab vedotin in the patients.
Brentuximab vedotin: Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
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|---|---|
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Nervous system disorders
Peripheral neutropathy
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48.0%
12/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
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Immune system disorders
Neutropenia
|
36.0%
9/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.0%
4/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.0%
4/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.0%
3/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Psychiatric disorders
Fatigue
|
12.0%
3/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Psychiatric disorders
Decreased appetite
|
8.0%
2/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Pruitus
|
8.0%
2/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Gastrointestinal disorders
Hyperglycemia
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Gastrointestinal disorders
Epigastric discomfort
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Nervous system disorders
Asthenia
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Nail change
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Renal and urinary disorders
Urinary retention
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Ear and labyrinth disorders
Sore throat
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
|
Endocrine disorders
Thirst
|
4.0%
1/25 • From the day of first IP administration to 30 days after the last IP administration(till PD or unacceptable toxicity), an average of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place