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NCT04101331 · REGISTRY CONDITION SEARCH

Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2024-11-05

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate Assessed by Independent Review Committee Based on PET-CT

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outcome · POSTED

Overall Response Rate Assessed by Investigator Based on PET-CT

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outcome · POSTED

Overall Response Rate Assessed by Investigator Based on CT

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outcome · POSTED

Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT

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outcome · POSTED

Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT

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outcome · POSTED

Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT

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outcome · POSTED

Duration of Overall Response Assessed by Independent Review Committee Based on CT

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outcome · POSTED

Duration of Overall Response Assessed by Investigator Based on PET-CT

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outcome · POSTED

Duration of Overall Response Assessed by Investigator Based on CT

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outcome · POSTED

Number of Subjects With Treatment Related Adverse Event

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outcome · POSTED

Maximum Measured Concentration (Cmax) of AFM13

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outcome · POSTED

Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)

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outcome · POSTED

Volume of Distribution at Steady State (Vss) of AFM13

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outcome · POSTED

The Terminal Half-life (t1/2) of AFM13

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outcome · POSTED

European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)

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outcome · POSTED

European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)

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outcome · POSTED

Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    intervention Names
    1. Drug: AFM13
    label
    Cohort A
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort A
    description
    weekly intravenous infusions of 200mg
    name
    AFM13
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
108
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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).
    measure
    Overall Response Rate Assessed by Independent Review Committee Based on PET-CT
    time Frame
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
secondary Outcomes
  1. description
    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).
    measure
    Overall Response Rate Assessed by Investigator Based on PET-CT
    time Frame
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
  2. description
    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).
    measure
    Overall Response Rate Assessed by Investigator Based on CT
    time Frame
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
  3. description
    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).
    measure
    Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT
    time Frame
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
  4. description
    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).
    measure
    Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT
    time Frame
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
  5. description
    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).
    measure
    Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT
    time Frame
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
  6. description
    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).
    measure
    Duration of Overall Response Assessed by Independent Review Committee Based on CT
    time Frame
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
  7. description
    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.
    measure
    Duration of Overall Response Assessed by Investigator Based on PET-CT
    time Frame
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
  8. description
    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.
    measure
    Duration of Overall Response Assessed by Investigator Based on CT
    time Frame
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
  9. description
    Number of subjects who had treatment (AFM13) related Adverse Events.
    measure
    Number of Subjects With Treatment Related Adverse Event
    time Frame
    From the date of first treatment until the date of the last treatment + 37 days, up to 199 weeks.
  10. description
    Maximum measured concentration (Cmax) of the AFM13 in serum. Geometric coefficient of variation is given in percentages.
    measure
    Maximum Measured Concentration (Cmax) of AFM13
    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.
  11. description
    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.
    measure
    Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)
    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.
  12. description
    Volume of distribution at steady state (Vss) of the AFM13. Geometric coefficient of variation is given in percentages.
    measure
    Volume of Distribution at Steady State (Vss) of AFM13
    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.
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      primary nct id
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      id
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      nct id
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      occurrences
      1. context exact
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        exact text
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        start
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      offset unit
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      query cond
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      query disease state id
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      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
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      source kind
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice