Trial Outcomes & Findings for Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides (NCT NCT04101331)
NCT ID: NCT04101331
Last Updated: 2024-11-05
Results Overview
Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
Results posted on
2024-11-05
Participant Flow
This study was a Phase II open-label multicenter study to assess the efficacy and safety of AFM13 in subjects with relapsed or refractory CD30-positive peripheral T-cell lymphoma.
All the subjects were screened for CD30 expression. Investigators assessed the subjects, and they were enrolled in the study if they met all inclusion criteria and none of the exclusion criteria.
Participant milestones
| Measure |
Cohort A
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
105
|
Reasons for withdrawal
| Measure |
Cohort A
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Disease progression
|
82
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Investigator decision
|
6
|
|
Overall Study
Death
|
6
|
|
Overall Study
Allogenic transplant
|
1
|
Baseline Characteristics
Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
Baseline characteristics by cohort
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).Population: The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Outcome measures
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Overall Response Rate Assessed by Independent Review Committee Based on PET-CT
|
32.4 percentage
Interval 23.7 to 42.1
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).Population: The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Outcome measures
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Overall Response Rate Assessed by Investigator Based on PET-CT
|
32.4 percentage
Interval 23.7 to 42.1
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).Population: The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Outcome measures
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Overall Response Rate Assessed by Investigator Based on CT
|
30.6 percentage
Interval 22.1 to 40.2
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).Population: The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Complete response and/or partial response by Positron Emission Tomography-Computed Tomography (PET-CT) assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Outcome measures
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT
Complete response rate (CR rate)
|
12.0 percentage
Interval 6.6 to 19.7
|
|
Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT
Partial response rate (PR rate)
|
20.4 percentage
Interval 13.2 to 29.2
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).Population: The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Outcome measures
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT
Overall response rate (ORR)
|
25.0 percentage
Interval 17.2 to 34.3
|
|
Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT
Complete response rate (CR rate)
|
7.4 percentage
Interval 3.3 to 14.1
|
|
Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT
Partial response rate (PR rate)
|
17.6 percentage
Interval 10.9 to 26.1
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).Population: All subjects of the full analysis set (FAS) who had a response in PET assessed by IRC.
Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Positron Emission Tomography-Computed Tomography (PET-CT) by Independent Review Committee (IRC).
Outcome measures
| Measure |
Cohort A
n=35 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT
|
2.3 months
Interval 1.9 to 8.7
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).Population: All subjects of the full analysis set (FAS) who had a response in CT assessed by IRC.
Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Computed Tomography (CT) by Independent Review Committee (IRC).
Outcome measures
| Measure |
Cohort A
n=27 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Duration of Overall Response Assessed by Independent Review Committee Based on CT
|
5.3 months
Interval 1.9 to 6.9
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).Population: All subjects of the full analysis set (FAS) who had a response in PET-CT assessed by investigator.
Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Positron Emission Tomography-Computed Tomography (PET-CT) by the investigator.
Outcome measures
| Measure |
Cohort A
n=35 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Duration of Overall Response Assessed by Investigator Based on PET-CT
|
3.3 months
Interval 1.9 to 8.7
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).Population: All subjects of the full analysis set (FAS) who had a response in CT assessed by investigator.
Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Computed Tomography (CT) by the investigator.
Outcome measures
| Measure |
Cohort A
n=33 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Duration of Overall Response Assessed by Investigator Based on CT
|
6.3 months
Interval 2.0 to 8.7
|
SECONDARY outcome
Timeframe: From the date of first treatment until the date of the last treatment + 37 days, up to 199 weeks.Population: The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
Number of subjects who had treatment (AFM13) related Adverse Events.
Outcome measures
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Number of Subjects With Treatment Related Adverse Event
|
105 Participants
|
SECONDARY outcome
Timeframe: Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.Population: The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.
Maximum measured concentration (Cmax) of the AFM13 in serum. Geometric coefficient of variation is given in percentages.
Outcome measures
| Measure |
Cohort A
n=20 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Maximum Measured Concentration (Cmax) of AFM13
Cycle 1 - day 29
|
24435 Nanogram/milliliter
Geometric Coefficient of Variation 364
|
|
Maximum Measured Concentration (Cmax) of AFM13
Cycle 1 - day 1
|
26232 Nanogram/milliliter
Geometric Coefficient of Variation 270
|
SECONDARY outcome
Timeframe: Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.Population: The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.
Area under concentration (AUC) versus time curve of the AFM13 in serum over time interval from 0 extrapolated to infinity. Geometric coefficient of variation is given in percentages.
Outcome measures
| Measure |
Cohort A
n=18 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)
Cycle 1 - day 1
|
612361 nanogram*hour/milliliter
Geometric Coefficient of Variation 60.3
|
|
Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)
Cycle 1 - day 29
|
749717 nanogram*hour/milliliter
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 29.Population: The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.
Volume of distribution at steady state (Vss) of the AFM13. Geometric coefficient of variation is given in percentages.
Outcome measures
| Measure |
Cohort A
n=13 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Volume of Distribution at Steady State (Vss) of AFM13
|
5.1 Liter
Geometric Coefficient of Variation 58.4
|
SECONDARY outcome
Timeframe: Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.Population: The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.
The terminal half-life (t1/2) of the AFM13. Geometric coefficient of variation is given in percentages.
Outcome measures
| Measure |
Cohort A
n=18 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
The Terminal Half-life (t1/2) of AFM13
Cycle 1 - day 1
|
20.7 hour
Geometric Coefficient of Variation 35.9
|
|
The Terminal Half-life (t1/2) of AFM13
Cycle 1 - day 29
|
19.6 hour
Geometric Coefficient of Variation 47.4
|
SECONDARY outcome
Timeframe: At baseline and final study visit, up to 199 weeks.Population: The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Quality of Life (QoL) as measured by the European QoL 5-dimensional questionnaire (EQ-5D) for Cohorts A. The EQ-5D comprises asks for the current health state in the five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Pain/discomfort scores assessed based on questionnaire. The categories of the response offer three levels pain/discomfort score: "no pain or discomfort" (score of 1), "moderate pain or discomfort" (score of 2), and "extreme pain and discomfort" (score of 3). Scores are presented from baseline to each visit for Cohort A.
Outcome measures
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Baseline · No pain or discomfort
|
41 Participants
|
|
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Baseline · Moderate pain or discomfort
|
55 Participants
|
|
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Baseline · Extreme pain or discomfort
|
9 Participants
|
|
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Baseline · Missing
|
3 Participants
|
|
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Final Study Visit · No pain or discomfort
|
19 Participants
|
|
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Final Study Visit · Moderate pain or discomfort
|
38 Participants
|
|
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Final Study Visit · Extreme pain or discomfort
|
5 Participants
|
|
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Final Study Visit · Missing
|
46 Participants
|
SECONDARY outcome
Timeframe: From baseline until final study visit, up to 199 weeks.Population: The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Quality of Life (QoL) as measured by the European Quality of Life 5-dimensional questionnaire (EQ-5D) for Cohorts A. Visual Analogue Scale scores assessed based on drawn scale from 0(worst imaginable state) to 100(best imaginable state). Subjects chose their health state on scale based on their situation by themselves. A negative outcome indicates a decrease in score compared to the baseline value.
Outcome measures
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)
|
-9.16 score on a scale
Standard Deviation 25.46
|
SECONDARY outcome
Timeframe: Pre-dose Day 1 on cycle 1 and end of treatment, up to approximately 46 months.Population: The safety set consisted of all subjects who received at least one dose of AFM13and had at least one post-baseline safety assessment.
Number of subjects who had treatment (AFM13) and developed anti-drug antibodies (ADA).
Outcome measures
| Measure |
Cohort A
n=108 Participants
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment
|
21 Participants
|
Adverse Events
Cohort A
Serious events: 44 serious events
Other events: 95 other events
Deaths: 52 deaths
Serious adverse events
| Measure |
Cohort A
n=108 participants at risk
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
COVID-19
|
8.3%
9/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
5.6%
6/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Herpes zoster
|
1.9%
2/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Septic shock
|
1.9%
2/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Orchitis
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Periodontitis
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Respiratory tract infection
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Rhinovirus infection
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Soft tissue infection
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Vascular access site infection
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.9%
2/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.6%
5/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
1.9%
2/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
General disorders
Chills
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
General disorders
General physical health deterioration
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
General disorders
Pain
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.8%
3/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Investigations
Hepatic enzyme increased
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Investigations
International normalised ratio increased
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
1.9%
2/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Device Related Sepsis
|
0.93%
1/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Cohort A
n=108 participants at risk
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
12.0%
13/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
12/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
10.2%
11/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.2%
11/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
8/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
6/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.7%
17/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.3%
10/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
7/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.8%
16/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.0%
14/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.0%
13/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
7/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
19.4%
21/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
General disorders
Asthenia
|
8.3%
9/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
General disorders
Chills
|
6.5%
7/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
23.1%
25/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
9/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.4%
8/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.5%
7/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
9/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
9/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.4%
8/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
9.3%
10/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
9/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
7.4%
8/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
6/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.6%
6/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Respiratory Tract Infection
|
5.6%
6/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
6/108 • From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor has the right to review communications for 90 days prior to public release (whereby the sponsor may ask to consider modifications to ensure necessary protection of sponsor's IP). Any publication shall be not made before the first multi-centre publication if the study is a part of a multi-centred clinical trial. Also, if a publication concerns the analyses of data from a multi-centred clinical trial, the communication shall make reference to the relevant multi-centre publication
- Publication restrictions are in place
Restriction type: OTHER