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NCT04101331 · STUDY IN CONTEXT

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

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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).

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.

→

secondary · POSTED

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).

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.

→

secondary · POSTED

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).

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.

→

secondary · POSTED

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).

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.

→

secondary · POSTED

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).

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.

→

secondary · POSTED

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).

All subjects of the full analysis set (FAS) who had a response in PET assessed by IRC.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

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

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT04101331
qol key
qol-0014
source section id
NCT04101331-om-0014
source outcome index
14
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
measure definition
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.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT04101331
qol key
qol-0015
source section id
NCT04101331-om-0015
source outcome index
15
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)
measure definition
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.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT04101331
trial label
Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0000
    source section id
    NCT04101331-om-0000
    source outcome index
    0
    endpoint
    Overall Response Rate Assessed by Independent Review Committee Based on PET-CT
    endpoint definition
    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 origin
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0001
    source section id
    NCT04101331-om-0001
    source outcome index
    1
    endpoint
    Overall Response Rate Assessed by Investigator Based on PET-CT
    endpoint definition
    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 origin
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0002
    source section id
    NCT04101331-om-0002
    source outcome index
    2
    endpoint
    Overall Response Rate Assessed by Investigator Based on CT
    endpoint definition
    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 origin
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0003
    source section id
    NCT04101331-om-0003
    source outcome index
    3
    endpoint
    Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT
    endpoint definition
    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 origin
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0004
    source section id
    NCT04101331-om-0004
    source outcome index
    4
    endpoint
    Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT
    endpoint definition
    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 origin
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0005
    source section id
    NCT04101331-om-0005
    source outcome index
    5
    endpoint
    Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT
    endpoint definition
    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 origin
    Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All subjects of the full analysis set (FAS) who had a response in PET assessed by IRC.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04101331-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04101331-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04101331-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04101331-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04101331-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04101331-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    harm key
    EG000
    source section id
    NCT04101331-ae
    event group key
    EG000
    event group label
    Cohort A
    serious affected
    44
    serious at risk
    108
    other affected
    95
    other at risk
    108
    frequency threshold
    5
    collection period
    From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
    event definition
    The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    qol key
    qol-0014
    source section id
    NCT04101331-om-0014
    source outcome index
    14
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
    measure definition
    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.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-mycosis-fungoides-recurrent-270902ab
    nct id
    NCT04101331
    qol key
    qol-0015
    source section id
    NCT04101331-om-0015
    source outcome index
    15
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)
    measure definition
    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.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice