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ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas (ECHELON-2)

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: NCT01777152
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : July 30, 2019
Last Update Posted : November 30, 2021
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Anaplastic Large-Cell Lymphoma
Non-Hodgkin Lymphoma
T-Cell Lymphoma
Interventions Drug: brentuximab vedotin
Drug: doxorubicin
Drug: prednisone
Drug: vincristine
Drug: cyclophosphamide
Enrollment 452
Recruitment Details Jan2013-Nov2016
Pre-assignment Details  
Arm/Group Title A+CHP CHOP
Hide Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Period Title: Overall Study
Started 226 226
Completed [1] 131 116
Not Completed 95 110
Reason Not Completed
Withdrawal by Subject             22             16
Lost to Follow-up             3             5
Death             68             89
Not eligible, no study drug received             1             0
Change of diagnosis             1             0
[1]
Completed due to study closure by sponsor
Arm/Group Title A+CHP CHOP Total
Hide Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles Total of all reporting groups
Overall Number of Baseline Participants 226 226 452
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 226 participants 452 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
157
  69.5%
156
  69.0%
313
  69.2%
>=65 years
69
  30.5%
70
  31.0%
139
  30.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 226 participants 226 participants 452 participants
58
(18 to 85)
58
(18 to 83)
58
(18 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 226 participants 452 participants
Female
93
  41.2%
75
  33.2%
168
  37.2%
Male
133
  58.8%
151
  66.8%
284
  62.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 226 participants 452 participants
Hispanic or Latino
10
   4.4%
4
   1.8%
14
   3.1%
Not Hispanic or Latino
186
  82.3%
193
  85.4%
379
  83.8%
Unknown or Not Reported
30
  13.3%
29
  12.8%
59
  13.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 226 participants 226 participants 452 participants
Asian
45
  19.9%
54
  23.9%
99
  21.9%
Black or African American
12
   5.3%
6
   2.7%
18
   4.0%
Native Hawaiian or Other Pacific Islander
1
   0.4%
0
   0.0%
1
   0.2%
White
139
  61.5%
142
  62.8%
281
  62.2%
Other
3
   1.3%
2
   0.9%
5
   1.1%
Unknown
26
  11.5%
22
   9.7%
48
  10.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 226 participants 226 participants 452 participants
United States
70
  31.0%
57
  25.2%
127
  28.1%
Japan
20
   8.8%
23
  10.2%
43
   9.5%
South Korea
17
   7.5%
23
  10.2%
40
   8.8%
Italy
17
   7.5%
20
   8.8%
37
   8.2%
France
18
   8.0%
18
   8.0%
36
   8.0%
Germany
15
   6.6%
12
   5.3%
27
   6.0%
Spain
15
   6.6%
11
   4.9%
26
   5.8%
Czechia
10
   4.4%
12
   5.3%
22
   4.9%
United Kingdom
7
   3.1%
14
   6.2%
21
   4.6%
Australia
6
   2.7%
8
   3.5%
14
   3.1%
Denmark
9
   4.0%
5
   2.2%
14
   3.1%
Israel
8
   3.5%
4
   1.8%
12
   2.7%
Hungary
4
   1.8%
5
   2.2%
9
   2.0%
Taiwan, Province Of China
5
   2.2%
4
   1.8%
9
   2.0%
Poland
2
   0.9%
5
   2.2%
7
   1.5%
Canada
3
   1.3%
3
   1.3%
6
   1.3%
Romania
0
   0.0%
2
   0.9%
2
   0.4%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 226 participants 226 participants 452 participants
Grade 0
85
  37.6%
93
  41.2%
178
  39.4%
Grade 1
90
  39.8%
86
  38.1%
176
  38.9%
Grade 2
51
  22.6%
47
  20.8%
98
  21.7%
[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. One participant (ECOG=0) was assessed after start of treatment.
1.Primary Outcome
Title Progression-free Survival Per Independent Review Facility (IRF)
Hide Description The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.
Arm/Group Title A+CHP CHOP
Hide Arm/Group Description:
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Number of Participants Analyzed 226 226
Median (Inter-Quartile Range)
Unit of Measure: months
48.20 [1] 
(8.87 to NA)
20.80 [2] 
(4.70 to NA)
[1]
Insufficient number of participants experienced events
[2]
Insufficient number of participants with events
2.Secondary Outcome
Title Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
Hide Description The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes only patients with systemic anaplastic large cell lymphoma (sALCL).
Arm/Group Title A+CHP CHOP
Hide Arm/Group Description:
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Number of Participants Analyzed 162 154
Median (Inter-Quartile Range)
Unit of Measure: months
55.66 [1] 
(15.61 to NA)
32.03 [1] 
(4.57 to NA)
[1]
Insufficient number of participants experienced events
3.Secondary Outcome
Title Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
Hide Description The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Time Frame Up to 8.34 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.
Arm/Group Title A+CHP CHOP
Hide Arm/Group Description:
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Number of Participants Analyzed 226 226
Measure Type: Count of Participants
Unit of Measure: Participants
153
  67.7%
126
  55.8%
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description The time from randomization to death due to any cause.
Time Frame Up to 90 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.
Arm/Group Title A+CHP CHOP
Hide Arm/Group Description:
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Number of Participants Analyzed 226 226
Median (Full Range)
Unit of Measure: Months
NA [1] 
(0.0 to 86.5)
NA [1] 
(0.1 to 90.0)
[1]
The median and 75th percentile of OS was not reached in either treatment arm. The 25th percentile of OS in the A+CHP arm was 40.9 months as compared with 17.5 months in the CHOP arm.
5.Secondary Outcome
Title Objective Response Rate (ORR) Per IRF at End of Treatment
Hide Description The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Time Frame Up to 8.34 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.
Arm/Group Title A+CHP CHOP
Hide Arm/Group Description:
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Number of Participants Analyzed 226 226
Measure Type: Count of Participants
Unit of Measure: Participants
188
  83.2%
163
  72.1%
6.Secondary Outcome
Title Incidence of Adverse Events (AEs)
Hide Description Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Time Frame Up to 8.28 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.
Arm/Group Title A+CHP CHOP
Hide Arm/Group Description:
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Number of Participants Analyzed 223 226
Measure Type: Count of Participants
Unit of Measure: Participants
Any treatment-emergent AE
221
  99.1%
221
  97.8%
Blinded study treatment-related AE
201
  90.1%
193
  85.4%
CHP treatment-related AE
198
  88.8%
205
  90.7%
Any serious adverse event (SAE)
87
  39.0%
87
  38.5%
Blinded study treatment-related SAE
58
  26.0%
45
  19.9%
CHP treatment-related SAE
62
  27.8%
53
  23.5%
Treatment discontinuations due to AE
14
   6.3%
15
   6.6%
Treatment discontinuations due to blinded study treatment-related AE
10
   4.5%
10
   4.4%
Treatment discontinuations due to CHP treatment-related AE
8
   3.6%
7
   3.1%
7.Secondary Outcome
Title Incidence of Laboratory Abnormalities
Hide Description Number of participants who experienced a Grade 3 or higher laboratory toxicity.
Time Frame Up to 8.28 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.
Arm/Group Title A+CHP CHOP
Hide Arm/Group Description:
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Number of Participants Analyzed 223 226
Measure Type: Count of Participants
Unit of Measure: Participants
Any Chemistry Test
25
  11.2%
23
  10.2%
Alanine Aminotransferase High
3
   1.3%
1
   0.4%
Albumin Low
2
   0.9%
3
   1.3%
Alkaline Phosphatase High
1
   0.4%
0
   0.0%
Calcium Low
1
   0.4%
1
   0.4%
Glucose High
8
   3.6%
6
   2.7%
Phosphate Low
4
   1.8%
3
   1.3%
Potassium High
0
   0.0%
2
   0.9%
Potassium Low
3
   1.3%
2
   0.9%
Sodium High
1
   0.4%
0
   0.0%
Sodium Low
4
   1.8%
6
   2.7%
Urate High
5
   2.2%
2
   0.9%
Any Hematology Test
68
  30.5%
78
  34.5%
Absolute Neutrophil Count Low
17
   7.6%
19
   8.4%
Hemoglobin High
1
   0.4%
0
   0.0%
Hemoglobin Low
9
   4.0%
13
   5.8%
Leukocytes Low
12
   5.4%
21
   9.3%
Lymphocytes High
0
   0.0%
1
   0.4%
Lymphocytes Low
52
  23.3%
61
  27.0%
Neutrophils Low
17
   7.6%
19
   8.4%
Platelets Low
1
   0.4%
1
   0.4%
Time Frame Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months
Adverse Event Reporting Description

Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment.

Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
 
Arm/Group Title A+CHP CHOP A+CHP Subgroup
Hide Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles Includes only participants in A+CHP arm who were randomized but did not receive treatment.
All-Cause Mortality
A+CHP CHOP A+CHP Subgroup
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   67/223 (30.04%)   89/226 (39.38%)   1/3 (33.33%) 
Hide Serious Adverse Events
A+CHP CHOP A+CHP Subgroup
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   89/223 (39.91%)   90/226 (39.82%)   0/0 
Blood and lymphatic system disorders       
Febrile neutropenia † 1  32/223 (14.35%)  26/226 (11.50%)  0/0 
Neutropenia † 1  8/223 (3.59%)  6/226 (2.65%)  0/0 
Anaemia † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Leukopenia † 1  1/223 (0.45%)  3/226 (1.33%)  0/0 
Lymphadenopathy † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Lymphopenia † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Thrombocytopenia † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Pancytopenia † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Cardiac disorders       
Atrial fibrillation † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Cardiac arrest † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Sinus tachycardia † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Supraventricular tachycardia † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Tachycardia † 1  1/223 (0.45%)  2/226 (0.88%)  0/0 
Ventricular fibrillation † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Arrhythmia † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Cardiac failure acute † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Cardiogenic shock † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Eye disorders       
Retinal vein occlusion † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Gastrointestinal disorders       
Diarrhoea † 1  4/223 (1.79%)  3/226 (1.33%)  0/0 
Abdominal pain † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Constipation † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Duodenal ulcer haemorrhage † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Duodenitis haemorrhagic † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Enterocolitis † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Inguinal hernia strangulated † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Intestinal perforation † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Nausea † 1  1/223 (0.45%)  4/226 (1.77%)  0/0 
Upper gastrointestinal haemorrhage † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Vomiting † 1  1/223 (0.45%)  3/226 (1.33%)  0/0 
Colitis † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Gastric ulcer † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Haematemesis † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Intestinal obstruction † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Lower gastrointestinal haemorrhage † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Odynophagia † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Oesophagitis † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Small intestinal obstruction † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Stomatitis † 1  0/223 (0.00%)  2/226 (0.88%)  0/0 
Subileus † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Ulcerative gastritis † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
General disorders       
Pyrexia † 1  9/223 (4.04%)  8/226 (3.54%)  0/0 
Asthenia † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Extravasation † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Hyperthermia † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Mucosal inflammation † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Non-cardiac chest pain † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Death † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Multiple organ dysfunction syndrome † 1  0/223 (0.00%)  3/226 (1.33%)  0/0 
Hepatobiliary disorders       
Hepatic function abnormal † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Cholangitis † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Infections and infestations       
Pneumonia † 1  11/223 (4.93%)  3/226 (1.33%)  0/0 
Sepsis † 1  5/223 (2.24%)  4/226 (1.77%)  0/0 
Cellulitis † 1  2/223 (0.90%)  0/226 (0.00%)  0/0 
Clostridium difficile colitis † 1  2/223 (0.90%)  0/226 (0.00%)  0/0 
Device related infection † 1  2/223 (0.90%)  0/226 (0.00%)  0/0 
Influenza † 1  2/223 (0.90%)  0/226 (0.00%)  0/0 
Neutropenic infection † 1  2/223 (0.90%)  1/226 (0.44%)  0/0 
Pneumocystis jirovecii pneumonia † 1  2/223 (0.90%)  0/226 (0.00%)  0/0 
Urinary tract infection † 1  2/223 (0.90%)  0/226 (0.00%)  0/0 
Abscess soft tissue † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Anal fistula infection † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Bacterial pyelonephritis † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Bacterial sepsis † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Bronchopulmonary aspergillosis † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Catheter site cellulitis † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Clostridium difficile infection † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Cytomegalovirus infection † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Enterocolitis infectious † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Epstein-Barr virus infection † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
H1N1 influenza † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Infection † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Injection site infection † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Lymph gland infection † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Otitis externa † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Perirectal abscess † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Respiratory syncytial virus infection † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Septic shock † 1  1/223 (0.45%)  2/226 (0.88%)  0/0 
Soft tissue infection † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Staphylococcal infection † 1  1/223 (0.45%)  2/226 (0.88%)  0/0 
Erysipelas † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Escherichia sepsis † 1  0/223 (0.00%)  2/226 (0.88%)  0/0 
Groin abscess † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Laryngitis † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Neutropenic sepsis † 1  0/223 (0.00%)  3/226 (1.33%)  0/0 
Skin infection † 1  0/223 (0.00%)  2/226 (0.88%)  0/0 
Staphylococcal sepsis † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Streptococcal sepsis † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Viral upper respiratory tract infection † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Diabetic foot infection † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Injury, poisoning and procedural complications       
Splenic rupture † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Hip fracture † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Spinal compression fracture † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Investigations       
Weight decreased † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
CSF volume decreased † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Metabolism and nutrition disorders       
Tumour lysis syndrome † 1  3/223 (1.35%)  0/226 (0.00%)  0/0 
Dehydration † 1  2/223 (0.90%)  3/226 (1.33%)  0/0 
Decreased appetite † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Fluid overload † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Hypokalaemia † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Hyperuricaemia † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Hyponatraemia † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Type 2 diabetes mellitus † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Musculoskeletal and connective tissue disorders       
Bone pain † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Pain in extremity † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Muscular weakness † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Vertebral column mass † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Papillary thyroid cancer † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Peripheral T-cell lymphoma unspecified † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Tumour haemorrhage † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Anaplastic large cell lymphoma T- and null-cell types † 1  0/223 (0.00%)  11/226 (4.87%)  0/0 
Cancer pain † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Metastases to central nervous system † 1  0/223 (0.00%)  2/226 (0.88%)  0/0 
Transitional cell carcinoma † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Tumour associated fever † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Cutaneous T-cell lymphoma † 1  2/223 (0.90%)  1/226 (0.44%)  0/0 
Myelodysplastic syndrome † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Neoplasm malignant † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
T-cell type acute leukaemia † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Nervous system disorders       
Peripheral sensory neuropathy † 1  2/223 (0.90%)  0/226 (0.00%)  0/0 
Dizziness † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Headache † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Peripheral motor neuropathy † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Seizure † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Syncope † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Autonomic neuropathy † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Cerebral infarction † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Hydrocephalus † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Paraesthesia † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Product Issues       
Device issue † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Psychiatric disorders       
Mental status changes † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Confusional state † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Renal and urinary disorders       
Acute kidney injury † 1  3/223 (1.35%)  0/226 (0.00%)  0/0 
Haematuria † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Renal failure † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Urinary retention † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Oliguria † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Respiratory, thoracic and mediastinal disorders       
Pneumonitis † 1  5/223 (2.24%)  0/226 (0.00%)  0/0 
Respiratory failure † 1  3/223 (1.35%)  2/226 (0.88%)  0/0 
Pulmonary embolism † 1  2/223 (0.90%)  6/226 (2.65%)  0/0 
Acute respiratory failure † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Cough † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Dyspnoea † 1  2/223 (0.90%)  0/226 (0.00%)  0/0 
Haemoptysis † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Pleural effusion † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Pneumonia aspiration † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Pulmonary cavitation † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Acute respiratory distress syndrome † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Skin and subcutaneous tissue disorders       
Rash † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Rash maculo-papular † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Blister † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Vascular disorders       
Deep vein thrombosis † 1  3/223 (1.35%)  2/226 (0.88%)  0/0 
Embolism † 1  1/223 (0.45%)  0/226 (0.00%)  0/0 
Hypotension † 1  1/223 (0.45%)  1/226 (0.44%)  0/0 
Thrombophlebitis superficial † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
Orthostatic hypotension † 1  0/223 (0.00%)  1/226 (0.44%)  0/0 
1
Term from vocabulary, MedDRA (21.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A+CHP CHOP A+CHP Subgroup
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   220/223 (98.65%)   218/226 (96.46%)   0/0 
Blood and lymphatic system disorders       
Neutropenia † 1  87/223 (39.01%)  81/226 (35.84%)  /0 
Anaemia † 1  64/223 (28.70%)  49/226 (21.68%)  /0 
Thrombocytopenia † 1  21/223 (9.42%)  14/226 (6.19%)  /0 
Leukopenia † 1  18/223 (8.07%)  13/226 (5.75%)  /0 
Febrile neutropenia † 1  16/223 (7.17%)  9/226 (3.98%)  /0 
Endocrine disorders       
Hypothyroidism † 1  12/223 (5.38%)  11/226 (4.87%)  /0 
Gastrointestinal disorders       
Nausea † 1  114/223 (51.12%)  91/226 (40.27%)  /0 
Constipation † 1  98/223 (43.95%)  94/226 (41.59%)  /0 
Diarrhoea † 1  93/223 (41.70%)  55/226 (24.34%)  /0 
Vomiting † 1  60/223 (26.91%)  37/226 (16.37%)  /0 
Stomatitis † 1  28/223 (12.56%)  27/226 (11.95%)  /0 
Abdominal pain † 1  26/223 (11.66%)  22/226 (9.73%)  /0 
Gastrooesophageal reflux disease † 1  22/223 (9.87%)  16/226 (7.08%)  /0 
Abdominal pain upper † 1  23/223 (10.31%)  10/226 (4.42%)  /0 
Dyspepsia † 1  17/223 (7.62%)  12/226 (5.31%)  /0 
Haemorrhoids † 1  8/223 (3.59%)  12/226 (5.31%)  /0 
General disorders       
Fatigue † 1  83/223 (37.22%)  80/226 (35.40%)  /0 
Pyrexia † 1  86/223 (38.57%)  74/226 (32.74%)  /0 
Oedema peripheral † 1  40/223 (17.94%)  36/226 (15.93%)  /0 
Asthenia † 1  35/223 (15.70%)  20/226 (8.85%)  /0 
Mucosal inflammation † 1  15/223 (6.73%)  14/226 (6.19%)  /0 
Chest pain † 1  14/223 (6.28%)  8/226 (3.54%)  /0 
Malaise † 1  8/223 (3.59%)  12/226 (5.31%)  /0 
Infections and infestations       
Upper respiratory tract infection † 1  18/223 (8.07%)  12/226 (5.31%)  /0 
Nasopharyngitis † 1  10/223 (4.48%)  12/226 (5.31%)  /0 
Urinary tract infection † 1  12/223 (5.38%)  9/226 (3.98%)  /0 
Investigations       
Weight decreased † 1  54/223 (24.22%)  43/226 (19.03%)  /0 
Alanine aminotransferase increased † 1  11/223 (4.93%)  0/226 (0.00%)  /0 
Metabolism and nutrition disorders       
Decreased appetite † 1  53/223 (23.77%)  47/226 (20.80%)  /0 
Hypokalaemia † 1  29/223 (13.00%)  24/226 (10.62%)  /0 
Diabetes mellitus † 1  14/223 (6.28%)  13/226 (5.75%)  /0 
Hypercholesterolaemia † 1  10/223 (4.48%)  12/226 (5.31%)  /0 
Hyperlipidaemia † 1  9/223 (4.04%)  13/226 (5.75%)  /0 
Hyperglycaemia † 1  11/223 (4.93%)  9/226 (3.98%)  /0 
Hyperuricaemia † 1  11/223 (4.93%)  9/226 (3.98%)  /0 
Musculoskeletal and connective tissue disorders       
Back pain † 1  44/223 (19.73%)  43/226 (19.03%)  /0 
Arthralgia † 1  31/223 (13.90%)  20/226 (8.85%)  /0 
Myalgia † 1  27/223 (12.11%)  21/226 (9.29%)  /0 
Pain in extremity † 1  23/223 (10.31%)  21/226 (9.29%)  /0 
Bone pain † 1  15/223 (6.73%)  12/226 (5.31%)  /0 
Neck pain † 1  11/223 (4.93%)  8/226 (3.54%)  /0 
Nervous system disorders       
Peripheral sensory neuropathy † 1  112/223 (50.22%)  108/226 (47.79%)  /0 
Headache † 1  37/223 (16.59%)  36/226 (15.93%)  /0 
Dizziness † 1  32/223 (14.35%)  24/226 (10.62%)  /0 
Paraesthesia † 1  13/223 (5.83%)  19/226 (8.41%)  /0 
Dysgeusia † 1  13/223 (5.83%)  15/226 (6.64%)  /0 
Peripheral motor neuropathy † 1  8/223 (3.59%)  18/226 (7.96%)  /0 
Psychiatric disorders       
Insomnia † 1  52/223 (23.32%)  49/226 (21.68%)  /0 
Anxiety † 1  30/223 (13.45%)  13/226 (5.75%)  /0 
Depression † 1  16/223 (7.17%)  15/226 (6.64%)  /0 
Reproductive system and breast disorders       
Benign prostatic hyperplasia † 1  9/223 (4.04%)  14/226 (6.19%)  /0 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  37/223 (16.59%)  44/226 (19.47%)  /0 
Dyspnoea † 1  39/223 (17.49%)  33/226 (14.60%)  /0 
Oropharyngeal pain † 1  21/223 (9.42%)  19/226 (8.41%)  /0 
Skin and subcutaneous tissue disorders       
Alopecia † 1  58/223 (26.01%)  56/226 (24.78%)  /0 
Night sweats † 1  46/223 (20.63%)  63/226 (27.88%)  /0 
Rash † 1  27/223 (12.11%)  21/226 (9.29%)  /0 
Pruritus † 1  22/223 (9.87%)  15/226 (6.64%)  /0 
Dry skin † 1  10/223 (4.48%)  17/226 (7.52%)  /0 
Vascular disorders       
Hypertension † 1  71/223 (31.84%)  68/226 (30.09%)  /0 
Hypotension † 1  15/223 (6.73%)  14/226 (6.19%)  /0 
1
Term from vocabulary, MedDRA (21.0)
†
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: Chief Medical Officer
Organization: Seagen Inc.
Phone: (855)473-2436
EMail: medinfo@seagen.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT01777152    
Other Study ID Numbers: SGN35-014
2012-002751-42 ( EudraCT Number )
First Submitted: January 23, 2013
First Posted: January 28, 2013
Results First Submitted: July 10, 2019
Results First Posted: July 30, 2019
Last Update Posted: November 30, 2021