Trial Outcomes & Findings for Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (NCT NCT01909934)
NCT ID: NCT01909934
Last Updated: 2025-09-19
Results Overview
ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)
Results posted on
2025-09-19
Participant Flow
Participants took part in the study at various investigative sites globally from 23 January 2014 to 29 August 2024.
Participants with a diagnosis of relapsed or refractory systemic anaplastic large cell lymphoma were enrolled to receive brentuximab vedotin 1.8 milligrams per kilogram (mg/kg).
Participant milestones
| Measure |
Brentuximab Vedotin 1.8 mg/kg
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
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Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Brentuximab Vedotin 1.8 mg/kg
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
25
|
|
Overall Study
Withdrawal of Informed Consent
|
1
|
|
Overall Study
Reason Not Specified
|
1
|
Baseline Characteristics
Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
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Age, Continuous
|
56.4 years
STANDARD_DEVIATION 16.70 • n=99 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
Croatia
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2 Participants
n=99 Participants
|
|
Region of Enrollment
Czech Republic
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
Hungary
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
Poland
|
8 Participants
n=99 Participants
|
|
Region of Enrollment
Portugal
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
Romania
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
Turkey
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=99 Participants
|
|
Height
|
166.8 centimeters (cm)
STANDARD_DEVIATION 10.40 • n=99 Participants
|
|
Weight
|
75.2 kilograms (kg)
STANDARD_DEVIATION 20.73 • n=99 Participants
|
|
Body Mass Index (BMI)
|
26.9 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 6.39 • n=99 Participants
|
PRIMARY outcome
Timeframe: Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)Population: Intent-to-Treat Population included all participants enrolled in the study.
ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
|
Objective Response Rate (ORR)
|
64 percentage of participants
Interval 49.0 to 77.0
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SECONDARY outcome
Timeframe: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)Population: Intent-to-Treat Population included all participants enrolled in the study. Only responders were analyzed for this outcome measure.
DOR was defined as the time between initial response and documented tumor progression in the subset of participants who achieved an objective response, either CR or PR. DOR per IRF was based upon the radiological assessment of measured lesions from an independent review facility. DOR was censored on the date of the last disease assessment documenting absence of progressive disease (PD) for participants who were lost to follow-up, withdrew consent, started a new anticancer therapy other than stem cell transplant (SCT), or discontinued treatment due to undocumented PD after the last adequate disease assessment.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=32 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
|
Duration of Response (DOR) Per IRF
|
NA months
Interval 19.71 to
Median and upper limit of confidence interval (CI) were not estimable as most of the responders were censored.
|
SECONDARY outcome
Timeframe: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)Population: Intent-to-Treat Population included all participants enrolled in the study.
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS per IRF is based upon the radiological assessment from an independent review facility.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
|
Progression-free Survival (PFS) Per IRF
|
20.9 months
Interval 4.17 to
Upper limit of 95% CI was not estimable due to insufficient number of participants with events up to data cut-off date: 4 May 2021.
|
SECONDARY outcome
Timeframe: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)Population: Intent-to-Treat Population included all participants enrolled in the study.
CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
|
Complete Remission Rate (CRR) Per IRF
|
30 percentage of participants
Interval 18.0 to 45.0
|
SECONDARY outcome
Timeframe: Until disease progression, death, or end of study (Up to approximately 10.7 years)Population: Intent-to-Treat Population included all participants enrolled in the study.
OS is defined as the time from start of study treatment to date of death due to any cause.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
|
Overall Survival (OS)
|
67.6 months
Interval 17.68 to
Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Until disease progression, death, or end of study (Up to approximately 10.7 years)Population: Intent-to-Treat Population included all participants enrolled in the study.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
|
Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin
|
28 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days post last dose of study drug (Up to approximately 1 year)Population: Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
An adverse event (AE): any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to medicinal product. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Serious TEAEs: defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is a medically important event.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher)
TEAEs
|
94 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher)
Serious TEAEs
|
32 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher)
Drug-Related TEAEs
|
70 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher)
TEAEs by Severity (Grade 3 or Higher)
|
58 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusionPopulation: Pharmacokinetic (PK) Population included participants who received at least 1 dose of brentuximab vedotin and have PK concentration data available. Number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
|
|---|---|
|
Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion
Cycle 1, Day 1
|
35 micrograms per liter (µg/L)
Geometric Coefficient of Variation 35
|
|
Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion
Cycle 3, Day 1
|
38 micrograms per liter (µg/L)
Geometric Coefficient of Variation 25
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusionPopulation: PK Population included participants who received at least 1 dose of brentuximab vedotin and have PK concentration data available. Number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
|
Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody
Cycle 1, Day 1
|
33 µg/L
Geometric Coefficient of Variation 29
|
|
Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody
Cycle 3, Day 1
|
38 µg/L
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusionPopulation: PK Population included participants who received at least 1 dose of brentuximab vedotin and have PK concentration data available. Number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
|
Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE)
Cycle 1, Day 1
|
0.25 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 87
|
|
Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE)
Cycle 3, Day 1
|
0.29 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 88
|
SECONDARY outcome
Timeframe: Up to 16 cycles (each cycle = 21 days)Population: Immunogenicity-evaluable Population included all participants who received at least 1 dose of brentuximab vedotin and had a baseline and at least 1 post-baseline sample available for evaluation for the presence of ATA and NAb. Overall number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=44 Participants
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
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|---|---|
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Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin
ATA Positive
|
30 percentage of participants
|
|
Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin
Neutralizing ATA Positive
|
0.0 percentage of participants
|
Adverse Events
Brentuximab Vedotin 1.8 mg/kg
Serious events: 16 serious events
Other events: 37 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 participants at risk
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
|
|---|---|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic large cell lymphoma T- and null-cell types
|
4.0%
2/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Vascular disorders
Aortic stenosis
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Nervous system disorders
Autonomic neuropathy
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Cardiac disorders
Cardiac failure acute
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Nervous system disorders
Central nervous system haemorrhage
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
General disorders
Death
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
2/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
2/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Infections and infestations
Epididymitis
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
General disorders
General physical health deterioration
|
4.0%
2/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Haematemesis
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Nervous system disorders
Ischaemic stroke
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Infections and infestations
Pneumonia
|
4.0%
2/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.0%
1/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
Other adverse events
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=50 participants at risk
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.0%
7/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
5/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
4/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Constipation
|
8.0%
4/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
4/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.0%
4/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
8/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
General disorders
Fatigue
|
12.0%
6/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.0%
3/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
General disorders
Malaise
|
6.0%
3/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
3/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
5/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.0%
4/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.0%
8/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
General disorders
Oedema peripheral
|
6.0%
3/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
3/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Nervous system disorders
Paraesthesia
|
6.0%
3/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.0%
3/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.0%
9/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
General disorders
Pyrexia
|
18.0%
9/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.0%
3/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
4/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
4/50 • All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER