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A Study of Brentuximab Vedotin in Relapsed or Refractory Non-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: NCT01421667
Recruitment Status : Completed
First Posted : August 23, 2011
Results First Posted : October 13, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Interventions Drug: brentuximab vedotin
Drug: rituximab
Enrollment 176
Recruitment Details Aug 2011 - Jun 2015
Pre-assignment Details Four additional patients enrolled, but withdrew prior to receiving treatment.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ B-Cell NHL, BV CD30u DLBCL, BV CD30+ DLBCL, BV+R
Hide Arm/Group Description Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL) Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u) Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL)
Period Title: Overall Study
Started 35 68 53 16
Completed 35 [1] 66 [2] 51 [3] 15 [4]
Not Completed 0 2 2 1
Reason Not Completed
Withdrawal by Subject             0             1             2             1
Lost to Follow-up             0             1             0             0
[1]
Completed per protocol due to death [24] or study termination by sponsor [11]
[2]
Completed per protocol due to death [45] or study termination by sponsor [21]
[3]
Completed per protocol due to death [33] or study termination by sponsor [18]
[4]
Completed per protocol due to death [7] or study termination by sponsor [8]
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ B-Cell NHL, BV CD30u DLBCL, BV CD30+ DLBCL, BV+R Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 35 68 53 16 172
Hide Baseline Analysis Population Description
All participants who received treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
64
(33 to 83)
57
(16 to 85)
65
(21 to 91)
62
(22 to 78)
63
(16 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
Female
8
  22.9%
29
  42.6%
27
  50.9%
4
  25.0%
68
  39.5%
Male
27
  77.1%
39
  57.4%
26
  49.1%
12
  75.0%
104
  60.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
Hispanic or Latino
3
   8.6%
3
   4.4%
7
  13.2%
1
   6.3%
14
   8.1%
Not Hispanic or Latino
32
  91.4%
65
  95.6%
46
  86.8%
15
  93.8%
158
  91.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
American Indian or Alaska Native
0
   0.0%
1
   1.5%
1
   1.9%
0
   0.0%
2
   1.2%
Asian
1
   2.9%
3
   4.4%
4
   7.5%
0
   0.0%
8
   4.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.9%
0
   0.0%
1
   0.6%
Black or African American
5
  14.3%
6
   8.8%
4
   7.5%
0
   0.0%
15
   8.7%
White
29
  82.9%
55
  80.9%
41
  77.4%
15
  93.8%
140
  81.4%
More than one race
0
   0.0%
3
   4.4%
2
   3.8%
1
   6.3%
6
   3.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pathological Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
Diffuse Large B-Cell Lymphoma (DLBCL) 0 43 53 16 112
Epstein-Barr Virus-Associated DLBCL of Elderly 0 5 0 0 5
Follicular Lymphoma 0 3 0 0 3
Gray Zone Lymphoma 0 6 0 0 6
Primary Mediastinal B-Cell Lymphoma 0 6 0 0 6
Post-Transplant Lymphoproliferative Disorder 0 3 0 0 3
Plasmablastic Lymphoma 0 1 0 0 1
T-Cell Rich B-Cell Lymphoma 0 1 0 0 1
Angioimmunoblastic T-cell Lymphoma 13 0 0 0 13
Peripheral T-Cell Lymphoma Not Otherwise Specified 22 0 0 0 22
Transformed Disease from Prior Non-Hodgkin Lymphoma  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
Yes 1 14 11 5 31
No 34 54 42 11 141
Disease Stage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
Stage I 2 4 1 1 8
Stage II 2 12 7 3 24
Stage III 13 17 11 6 47
Stage IV 14 31 33 6 84
Unknown 4 4 1 0 9
Bulky Disease (≥5 cm on at least one baseline index lesion)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
Yes 5 27 35 4 71
No 30 41 18 12 101
Eastern Cooperative Oncology Group Performance Status (ECOG)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
0 7 25 10 9 51
1 23 35 31 7 96
2 5 7 12 0 24
3-5 0 0 0 0 0
Missing 0 1 0 0 1
[1]
Measure Description: 0 = Normal activity; 1 = Symptoms but ambulatory; 2 = In bed <50% of the time; 3 = In bed >50% of the time; 4 = 100% bedridden; 5 = Dead
% CD30 Expression by Visual Immunohistochemistry (vIHC)   [1] 
Median (Full Range)
Unit of measure:  Percentage
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
15
(0 to 95)
35
(0 to 100)
0
(0 to 10)
50
(1 to 100)
8
(0 to 100)
[1]
Measure Description: Percent CD30 expression by standard immunohistochemistry assessed visually by central laboratory (vIHC)
Refractory to Frontline Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
Yes 25 51 34 10 120
No 10 15 19 6 50
Missing/Unknown 0 2 0 0 2
Disease Status Relative to Most Recent Prior Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 68 participants 53 participants 16 participants 172 participants
Refractory 22 55 37 9 123
Relapsed 13 12 16 7 48
Missing 0 1 0 0 1
1.Primary Outcome
Title Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy
Hide Description Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ Other B-Cell NHL, BV CD30+ DLBCL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
Overall Number of Participants Analyzed 34 19 48 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41
(24.6 to 59.3)
26
(9.1 to 51.2)
44
(29.5 to 58.8)
31
(18.7 to 45.1)
2.Primary Outcome
Title Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
Hide Description Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment with brentuximab vedotin plus rituximab.
Arm/Group Title CD30+ DLBCL, BV+R
Hide Arm/Group Description:
Part B - CD30-positive diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
Any TEAE 16
TEAE Related to Study Drug 15
TEAE With Severity Grade >/=3 9
Discontinued Treatment Due to Adverse Event 2
Serious Adverse Event 3
Serious Adverse Event Related to Study Drug 3
Deaths (Within 30 Days of Last Dose) 1
Chemistry Laboratory Abnormalities >/=Grade 3 1
Hematology Laboratory Abnormalities >/=Grade 3 7
3.Secondary Outcome
Title Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab
Hide Description Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment with brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.
Arm/Group Title CD30+ DLBCL, BV+R
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50
(21.1 to 78.9)
4.Secondary Outcome
Title Complete Remission (CR) Rate by Investigator
Hide Description Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ Other B-Cell NHL, BV CD30+ DLBCL, BV CD30u DLBCL, BV CD30+ DLBCL, BV+R
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 34 19 48 52 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24
(10.7 to 41.2)
16
(3.4 to 39.6)
19
(8.9 to 32.6)
12
(4.4 to 23.4)
17
(2.1 to 48.4)
5.Secondary Outcome
Title Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
Hide Description Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment with brentuximab vedotin monotherapy and achieved a CR or PR.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ Other B-Cell NHL, BV CD30+ DLBCL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 14 5 21 16
Median (Full Range)
Unit of Measure: months
7.6
(1.3 to 36.1)
1.6
(1.4 to 34)
4.7
(0 to 22.7)
4.7
(0.5 to 11.6)
6.Secondary Outcome
Title Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
Hide Description Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment with brentuximab vedotin monotherapy and achieved CR
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ Other B-Cell NHL, BV CD30+ DLBCL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 3 9 6
Median (Full Range)
Unit of Measure: months
NA [1] 
(1.8 to NA)
7.2
(1.6 to 34)
NA [1] 
(2.2 to NA)
11.6
(1.4 to 11.6)
[1]
Not reached because too few events
7.Secondary Outcome
Title Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
Hide Description Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ Other B-Cell NHL, BV CD30+ DLBCL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 34 19 48 52
Median (Full Range)
Unit of Measure: months
2.5
(0.3 to 37.4)
2.9
(0.6 to 36.3)
4.0
(0.6 to 24.0)
1.4
(0.4 to 15.6)
8.Secondary Outcome
Title Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression
Hide Description Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ Other B-Cell NHL, BV CD30+ DLBCL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 34 19 48 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Complete Remission (CR)
24
(10.7 to 41.2)
16
(3.4 to 39.6)
19
(8.9 to 32.6)
12
(4.4 to 23.4)
Partial Remission (PR)
18
(6.8 to 34.5)
11
(1.3 to 33.1)
25
(13.6 to 39.6)
19
(9.6 to 32.5)
Disease Control Rate (CR+PR+SD)
59
(40.7 to 75.4)
63
(38.4 to 83.7)
69
(53.7 to 81.3)
42
(28.7 to 56.8)
9.Secondary Outcome
Title Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
Hide Description Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment with brentuximab vedotin monotherapy.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ B-Cell NHL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 35 68 53
Measure Type: Number
Unit of Measure: participants
Any TEAE 32 66 52
TEAE Related to Study Drug 28 62 39
TEAE With Severity Grade >/=3 23 52 37
Discontinued Treatment Due To Adverse Event 6 7 4
Serious Adverse Event 15 34 22
Serious Adverse Event Related to Study Drug 5 15 7
Deaths (Within 30 Days of Last Dose) 3 5 6
Chemistry Laboratory Abnormalities >/= Grade 3 8 16 10
Hematology Laboratory Abnormalities >/= Grade 3 11 31 21
10.Secondary Outcome
Title Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)
Hide Description End of infusion concentration of ADC following the first dose of brentuximab vedotin
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were treated with brentuximab vedotin monotherapy and had Ceoi of ADC results.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ B-Cell NHL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 63 50
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
35.6
(25%)
40.0
(29%)
40.1
(43%)
11.Secondary Outcome
Title Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)
Hide Description Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were treated with brentuximab vedotin monotherapy and had Ctrough of ADC results.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ B-Cell NHL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 25 44 34
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
0.44
(113%)
0.91
(119%)
0.86
(94%)
12.Secondary Outcome
Title Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)
Hide Description Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were treated with brentuximab vedotin monotherapy and had Cmax of MMAE results.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ B-Cell NHL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 35 68 51
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
4.71
(63%)
4.66
(88%)
3.95
(74%)
13.Secondary Outcome
Title Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
Hide Description Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were treated with brentuximab vedotin monotherapy and had Tmax of MMAE results.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ B-Cell NHL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 35 68 51
Median (Full Range)
Unit of Measure: days
1.90
(0.88 to 6.89)
1.91
(0.91 to 20.90)
1.94
(0.93 to 19.8)
14.Secondary Outcome
Title Baseline Soluble CD30 Expression
Hide Description Serum concentration of soluble CD30 before first dose of brentuximab vedotin
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were treated with brentuximab vedotin monotherapy and had baseline sCD30 expression results.
Arm/Group Title CD30+ T-Cell NHL, BV CD30+ B-Cell NHL, BV CD30u DLBCL, BV
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 64 46
Median (Full Range)
Unit of Measure: ng/mL
1005.4
(89.4 to 26426.6)
229.4
(33.2 to 21277.7)
140.4
(53.4 to 1695.9)
Time Frame Up to 3 years
Adverse Event Reporting Description TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
 
Arm/Group Title CD30+ NHL (T-Cell and B-Cell), BV CD30u DLBCL, BV CD30+ DLBCL, BV+R
Hide Arm/Group Description Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive non-Hodgkin lymphomas (NHL), including T-cell lymphomas and B-cell lymphomas, as well as diffuse large B-cell lymphoma (DLBCL) Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in Part C with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u) Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients in Part B with diffuse large B-cell lymphoma (DLBCL)
All-Cause Mortality
CD30+ NHL (T-Cell and B-Cell), BV CD30u DLBCL, BV CD30+ DLBCL, BV+R
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CD30+ NHL (T-Cell and B-Cell), BV CD30u DLBCL, BV CD30+ DLBCL, BV+R
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/103 (47.57%)   22/53 (41.51%)   3/16 (18.75%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  3/103 (2.91%)  2/53 (3.77%)  1/16 (6.25%) 
Neutropenia  1  3/103 (2.91%)  0/53 (0.00%)  0/16 (0.00%) 
Thrombocytopenia  1  3/103 (2.91%)  0/53 (0.00%)  0/16 (0.00%) 
Anemia  1  1/103 (0.97%)  1/53 (1.89%)  0/16 (0.00%) 
Leukopenia  1  2/103 (1.94%)  0/53 (0.00%)  0/16 (0.00%) 
Cardiac disorders       
Sinus tachycardia  1  0/103 (0.00%)  1/53 (1.89%)  1/16 (6.25%) 
Cardiac arrest  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Tachycardia  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Gastrointestinal disorders       
Diarrhea  1  2/103 (1.94%)  3/53 (5.66%)  0/16 (0.00%) 
Nausea  1  4/103 (3.88%)  1/53 (1.89%)  0/16 (0.00%) 
Vomiting  1  3/103 (2.91%)  1/53 (1.89%)  0/16 (0.00%) 
Abdominal pain  1  1/103 (0.97%)  1/53 (1.89%)  0/16 (0.00%) 
Abdominal pain upper  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Gastric ulcer hemorrhage  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Gastritis  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Gastrointestinal hemorrhage  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Jejunal perforation  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Pancreatitis  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Small intestinal obstruction  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
General disorders       
Pyrexia  1  9/103 (8.74%)  0/53 (0.00%)  0/16 (0.00%) 
Asthenia  1  0/103 (0.00%)  2/53 (3.77%)  0/16 (0.00%) 
Chest pain  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Multi-organ failure  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Pain  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Systemic inflammatory response syndrome  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Immune system disorders       
Graft versus host disease  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Infections and infestations       
Pneumonia  1  8/103 (7.77%)  3/53 (5.66%)  0/16 (0.00%) 
Sepsis  1  4/103 (3.88%)  2/53 (3.77%)  0/16 (0.00%) 
Urinary tract infection  1  2/103 (1.94%)  1/53 (1.89%)  0/16 (0.00%) 
Cellulitis  1  2/103 (1.94%)  0/53 (0.00%)  0/16 (0.00%) 
Breast cellulitis  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Central nervous system abscess  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Clostridium difficile colitis  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Escherichia urinary tract infection  1  0/103 (0.00%)  0/53 (0.00%)  1/16 (6.25%) 
Herpes zoster disseminated  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Infection  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Lung infection  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Mastoiditis  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Meningoencephalitis herpetic  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Peritonitis  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Pneumocystis jirovecii pneumonia  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Pneumonia bacterial  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Skin infection  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Staphylococcal bacteremia  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Investigations       
Lipase increased  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Liver function test abnormal  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  4/103 (3.88%)  1/53 (1.89%)  0/16 (0.00%) 
Hyponatremia  1  1/103 (0.97%)  1/53 (1.89%)  1/16 (6.25%) 
Decreased appetite  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Failure to thrive  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Hypercalcemia  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Hyperglycemia  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Hypokalemia  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Hypomagnasemia  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Tumor lysis syndrome  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Pain in extremity  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Diffuse large B-cell lymphoma  1  6/103 (5.83%)  6/53 (11.32%)  0/16 (0.00%) 
Angioimmunoblastic T-cell lymphoma  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
B-cell lymphoma  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Malignant pleural effusion  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Non-Hodgkin's lymphoma  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Peripheral T-cell lymphoma unspecified  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Nervous system disorders       
Dizziness  1  2/103 (1.94%)  0/53 (0.00%)  0/16 (0.00%) 
Headache  1  2/103 (1.94%)  0/53 (0.00%)  0/16 (0.00%) 
Amnesia  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Brain mass  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Encephalopathy  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Seizure  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Psychiatric disorders       
Confusional state  1  3/103 (2.91%)  0/53 (0.00%)  0/16 (0.00%) 
Delirium  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Hallucination, visual  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Mental status changes  1  0/103 (0.00%)  0/53 (0.00%)  1/16 (6.25%) 
Renal and urinary disorders       
Acute kidney injury  1  5/103 (4.85%)  0/53 (0.00%)  0/16 (0.00%) 
Nephrolithiasis  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Renal failure  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Renal impairment  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pleural effusion  1  2/103 (1.94%)  1/53 (1.89%)  0/16 (0.00%) 
Respiratory failure  1  2/103 (1.94%)  0/53 (0.00%)  1/16 (6.25%) 
Acute respiratory distress syndrome  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Bronchostenosis  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Dyspnea  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Dyspnea exertional  1  0/103 (0.00%)  1/53 (1.89%)  0/16 (0.00%) 
Hypoxia  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Mediastinal mass  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Oropharyngeal pain  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Pneumonia aspiration  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Pulmonary alveolar hemorrhage  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Rash maculo-papular  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Skin lesion  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Toxic epidermal necrolysis  1  0/103 (0.00%)  0/53 (0.00%)  1/16 (6.25%) 
Vascular disorders       
Superior vena cava syndrome  1  1/103 (0.97%)  0/53 (0.00%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CD30+ NHL (T-Cell and B-Cell), BV CD30u DLBCL, BV CD30+ DLBCL, BV+R
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   96/103 (93.20%)   48/53 (90.57%)   15/16 (93.75%) 
Blood and lymphatic system disorders       
Anemia  1  19/103 (18.45%)  8/53 (15.09%)  0/16 (0.00%) 
Neutropenia  1  31/103 (30.10%)  13/53 (24.53%)  6/16 (37.50%) 
Thrombocytopenia  1  8/103 (7.77%)  5/53 (9.43%)  1/16 (6.25%) 
Cardiac disorders       
Tachycardia  1  5/103 (4.85%)  3/53 (5.66%)  1/16 (6.25%) 
Gastrointestinal disorders       
Abdominal distension  1  6/103 (5.83%)  4/53 (7.55%)  1/16 (6.25%) 
Abdominal pain  1  14/103 (13.59%)  8/53 (15.09%)  2/16 (12.50%) 
Constipation  1  19/103 (18.45%)  15/53 (28.30%)  2/16 (12.50%) 
Diarrhea  1  33/103 (32.04%)  9/53 (16.98%)  4/16 (25.00%) 
Nausea  1  28/103 (27.18%)  17/53 (32.08%)  8/16 (50.00%) 
Vomting  1  19/103 (18.45%)  11/53 (20.75%)  6/16 (37.50%) 
General disorders       
Asthenia  1  10/103 (9.71%)  3/53 (5.66%)  1/16 (6.25%) 
Chills  1  11/103 (10.68%)  3/53 (5.66%)  4/16 (25.00%) 
Fatigue  1  43/103 (41.75%)  17/53 (32.08%)  4/16 (25.00%) 
Edema peripheral  1  11/103 (10.68%)  4/53 (7.55%)  2/16 (12.50%) 
Pyrexia  1  22/103 (21.36%)  12/53 (22.64%)  5/16 (31.25%) 
Infections and infestations       
Upper respiratory tract infection  1  10/103 (9.71%)  5/53 (9.43%)  3/16 (18.75%) 
Urinary tract infection  1  2/103 (1.94%)  7/53 (13.21%)  0/16 (0.00%) 
Investigations       
Weight decreased  1  12/103 (11.65%)  6/53 (11.32%)  0/16 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  23/103 (22.33%)  9/53 (16.98%)  0/16 (0.00%) 
Dehydration  1  7/103 (6.80%)  2/53 (3.77%)  0/16 (0.00%) 
Hypokalemia  1  12/103 (11.65%)  6/53 (11.32%)  0/16 (0.00%) 
Hypomagnesemia  1  10/103 (9.71%)  2/53 (3.77%)  0/16 (0.00%) 
Hyponatremia  1  5/103 (4.85%)  4/53 (7.55%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  10/103 (9.71%)  1/53 (1.89%)  1/16 (6.25%) 
Back pain  1  9/103 (8.74%)  3/53 (5.66%)  0/16 (0.00%) 
Pain in extremity  1  4/103 (3.88%)  3/53 (5.66%)  3/16 (18.75%) 
Nervous system disorders       
Dizziness  1  6/103 (5.83%)  5/53 (9.43%)  2/16 (12.50%) 
Dysgeusia  1  6/103 (5.83%)  3/53 (5.66%)  0/16 (0.00%) 
Headache  1  13/103 (12.62%)  6/53 (11.32%)  3/16 (18.75%) 
Hypoesthesia  1  7/103 (6.80%)  2/53 (3.77%)  1/16 (6.25%) 
Peripheral motor neuropathy  1  7/103 (6.80%)  2/53 (3.77%)  0/16 (0.00%) 
Peripheral sensory neuropathy  1  33/103 (32.04%)  14/53 (26.42%)  6/16 (37.50%) 
Psychiatric disorders       
Anxiety  1  10/103 (9.71%)  3/53 (5.66%)  1/16 (6.25%) 
Insomnia  1  14/103 (13.59%)  7/53 (13.21%)  3/16 (18.75%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  17/103 (16.50%)  2/53 (3.77%)  3/16 (18.75%) 
Dyspnea  1  13/103 (12.62%)  4/53 (7.55%)  1/16 (6.25%) 
Oropharyngeal pain  1  7/103 (6.80%)  2/53 (3.77%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  7/103 (6.80%)  3/53 (5.66%)  3/16 (18.75%) 
Night sweats  1  8/103 (7.77%)  8/53 (15.09%)  1/16 (6.25%) 
Pruritus  1  13/103 (12.62%)  5/53 (9.43%)  4/16 (25.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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
Name/Title: Chief Medical Officer
Organization: Seattle Genetics, Inc.
Phone: 855-473-2436
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01421667     History of Changes
Other Study ID Numbers: SGN35-012
First Submitted: August 19, 2011
First Posted: August 23, 2011
Results First Submitted: June 21, 2016
Results First Posted: October 13, 2016
Last Update Posted: November 28, 2016