Peripheral T Cell Lymphoma, Transformed Mycosis Fungoides
Conditions
Brief summary
This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies. Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood. Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.
Interventions
DRUGAFM13
weekly intravenous infusions of 200mg
Sponsors
Affimed GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Histologically confirmed CD30-positive PTCL (most subtypes allowed) or TMF per the revised World Health Organization 2016 classification (Swerdlow, 2016) by central assessment. * Cohorts A and B (PTCL cohorts): measurable by the modified Lugano Classification (Cheson, 2014); measurable disease of ≥1.5 cm diameter by computed tomography (CT), assessed locally for eligibility. Note: fluorodeoxyglucose (FDG) avid disease by positron emission tomography (PET) recommended, if possible. * Cohort C (TMF cohort): measurable by the Olsen Criteria (Olsen, 2011) including at least 1 cutaneous lymphoma lesion ≥2 cm in diameter, assessed locally for eligibility. * Patients must have relapsed or refractory disease AND the following: * Cohorts A and B (PTCL): patients must have received at least 1 prior line of systemic therapy. For patients with systemic ALCL, patients must have failed or be intolerant to brentuximab vedotin \[BV\]; Adcetris® * Cohort C (TMF): patients must have received at least 1 prior line of systemic therapy; and have exhausted systemic therapies with regular approval for their disease Main
Exclusion criteria
* Patients with the following subtypes of lymphoma: T-cell prolymphocytic leukemia; T-cell large granular lymphocytic leukemia; Chronic lymphoproliferative disorder of NK cells; Aggressive NK-cell leukemia; Extranodal NK-/T-cell lymphoma; Indolent T-cell lymphoproliferative disorder of the GI tract: * Has had an allogenic tissue hematopoietic cell/solid organ transplant within the last 3 years. Note: Patients who have had a transplant \>3 years ago are eligible as long as there are no signs/symptoms of graft versus host disease (GvHD). * Requirement for systemic immunosuppressive therapy, e.g. GvHD therapy, \<12 weeks prior to the first dose of study drug. * Prior treatment with AFM13
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate Assessed by Independent Review Committee Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate Assessed by Investigator Based on CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | 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). |
| Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | 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). |
| Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | 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). |
| Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | 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). |
| Duration of Overall Response Assessed by Independent Review Committee Based on CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | 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). |
| Duration of Overall Response Assessed by Investigator Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | 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. |
| Duration of Overall Response Assessed by Investigator Based on CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | 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. |
| Overall Response Rate Assessed by Investigator Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | 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). |
| Maximum Measured Concentration (Cmax) of AFM13 | 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. | Maximum measured concentration (Cmax) of the AFM13 in serum. Geometric coefficient of variation is given in percentages. |
| Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞) | 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. | 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. |
| Volume of Distribution at Steady State (Vss) of AFM13 | 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. | Volume of distribution at steady state (Vss) of the AFM13. Geometric coefficient of variation is given in percentages. |
| The Terminal Half-life (t1/2) of AFM13 | 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. | The terminal half-life (t1/2) of the AFM13. Geometric coefficient of variation is given in percentages. |
| European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | At baseline and final study visit, up to 199 weeks. | 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. |
| European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D) | From baseline until final study visit, up to 199 weeks. | 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. |
| Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment | Pre-dose Day 1 on cycle 1 and end of treatment, up to approximately 46 months. | Number of subjects who had treatment (AFM13) and developed anti-drug antibodies (ADA). |
| Number of Subjects With Treatment Related Adverse Event | From the date of first treatment until the date of the last treatment + 37 days, up to 199 weeks. | Number of subjects who had treatment (AFM13) related Adverse Events. |
Countries
Australia, France, Germany, Italy, Poland, Russia, South Korea, Spain, Turkey (Türkiye), United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL). | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Allogenic transplant | 1 |
| Overall Study | Death | 6 |
| Overall Study | Disease progression | 82 |
| Overall Study | Investigator decision | 6 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cohort A |
|---|---|
| Age, Continuous | 61.1 Years STANDARD_DEVIATION 13.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 75 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 52 / 108 |
| other Total, other adverse events | 95 / 108 |
| serious Total, serious adverse events | 44 / 108 |
Outcome results
Primary
Overall Response Rate Assessed by Independent Review Committee Based on PET-CT
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Overall Response Rate Assessed by Independent Review Committee Based on PET-CT | 32.4 percentage |
p-value: 0.051Exact binomial test
Secondary
Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | 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 |
| Cohort A | 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
Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT | Complete response rate (CR rate) | 12.0 percentage |
| Cohort A | Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT | Partial response rate (PR rate) | 20.4 percentage |
Secondary
Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | 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 |
| Cohort A | 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 |
| Cohort A | 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 |
p-value: 0.537Exact binomial test
Secondary
Duration of Overall Response Assessed by Independent Review Committee Based on CT
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).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A | Duration of Overall Response Assessed by Independent Review Committee Based on CT | 5.3 months |
Secondary
Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT
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).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A | Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT | 2.3 months |
Secondary
Duration of Overall Response Assessed by Investigator Based on CT
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A | Duration of Overall Response Assessed by Investigator Based on CT | 6.3 months |
Secondary
Duration of Overall Response Assessed by Investigator Based on PET-CT
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A | Duration of Overall Response Assessed by Investigator Based on PET-CT | 3.3 months |
Secondary
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort A | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Baseline | No pain or discomfort | 41 Participants |
| Cohort A | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Baseline | Moderate pain or discomfort | 55 Participants |
| Cohort A | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Baseline | Extreme pain or discomfort | 9 Participants |
| Cohort A | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Baseline | Missing | 3 Participants |
| Cohort A | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Final Study Visit | No pain or discomfort | 19 Participants |
| Cohort A | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Final Study Visit | Moderate pain or discomfort | 38 Participants |
| Cohort A | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Final Study Visit | Extreme pain or discomfort | 5 Participants |
| Cohort A | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Final Study Visit | Missing | 46 Participants |
Secondary
European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D) | -9.16 score on a scale | Standard Deviation 25.46 |
Secondary
Maximum Measured Concentration (Cmax) of AFM13
Maximum measured concentration (Cmax) of the AFM13 in serum. Geometric coefficient of variation is given in percentages.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Maximum Measured Concentration (Cmax) of AFM13 | Cycle 1 - day 29 | 24435 Nanogram/milliliter | Geometric Coefficient of Variation 364 |
| Cohort A | Maximum Measured Concentration (Cmax) of AFM13 | Cycle 1 - day 1 | 26232 Nanogram/milliliter | Geometric Coefficient of Variation 270 |
Secondary
Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment
Number of subjects who had treatment (AFM13) and developed anti-drug antibodies (ADA).
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A | Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment | 21 Participants |
Secondary
Number of Subjects With Treatment Related Adverse Event
Number of subjects who had treatment (AFM13) related Adverse Events.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A | Number of Subjects With Treatment Related Adverse Event | 105 Participants |
Secondary
Overall Response Rate Assessed by Investigator Based on CT
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Overall Response Rate Assessed by Investigator Based on CT | 30.6 percentage |
p-value: 0.112Exact binomial test
Secondary
Overall Response Rate Assessed by Investigator Based on PET-CT
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Overall Response Rate Assessed by Investigator Based on PET-CT | 32.4 percentage |
p-value: 0.051Exact binomial test
Secondary
The Terminal Half-life (t1/2) of AFM13
The terminal half-life (t1/2) of the AFM13. Geometric coefficient of variation is given in percentages.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | The Terminal Half-life (t1/2) of AFM13 | Cycle 1 - day 1 | 20.7 hour | Geometric Coefficient of Variation 35.9 |
| Cohort A | The Terminal Half-life (t1/2) of AFM13 | Cycle 1 - day 29 | 19.6 hour | Geometric Coefficient of Variation 47.4 |
Secondary
Volume of Distribution at Steady State (Vss) of AFM13
Volume of distribution at steady state (Vss) of the AFM13. Geometric coefficient of variation is given in percentages.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | Volume of Distribution at Steady State (Vss) of AFM13 | 5.1 Liter | Geometric Coefficient of Variation 58.4 |