Trial · NCT04101331
Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
NCT04101331, Phase 2, Completed, Affimed GmbH; results first posted 2023-06-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides. Trials, record NCT04101331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04101331
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
- NCT number
- NCT04101331
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- Affimed GmbH
- Conditions
- Peripheral T Cell Lymphoma, Transformed Mycosis Fungoides
- Interventions
- AFM13
- First posted
- 2019-09-24
- Last updated
- 2024-11-05
- Results first posted
- 2023-06-05
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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). | 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. | percentage | NUMBER |
| SECONDARY | 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). | 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. | percentage | NUMBER |
| SECONDARY | 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). | 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. | percentage | NUMBER |
| SECONDARY | 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). | 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. | percentage | NUMBER |
| SECONDARY | 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). | 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. | percentage | NUMBER |
| SECONDARY | 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). | All subjects of the full analysis set (FAS) who had a response in PET assessed by IRC. | months | MEDIAN |
| SECONDARY | 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). | All subjects of the full analysis set (FAS) who had a response in CT assessed by IRC. | months | MEDIAN |
| SECONDARY | 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). | All subjects of the full analysis set (FAS) who had a response in PET-CT assessed by investigator. | months | MEDIAN |
| SECONDARY | 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). | All subjects of the full analysis set (FAS) who had a response in CT assessed by investigator. | months | MEDIAN |
| SECONDARY | 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. | The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate Assessed by Independent Review Committee Based on PET-CT | Cohort A | 32.4 | 95% Confidence Interval 23.7 to 42.1 | percentage | |
| Overall Response Rate Assessed by Investigator Based on PET-CT | Cohort A | 32.4 | 95% Confidence Interval 23.7 to 42.1 | percentage | |
| Overall Response Rate Assessed by Investigator Based on CT | Cohort A | 30.6 | 95% Confidence Interval 22.1 to 40.2 | percentage | |
| Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT | Cohort A | Complete response rate (CR rate) | 12.0 | 95% Confidence Interval 6.6 to 19.7 | percentage |
| Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT | Cohort A | Partial response rate (PR rate) | 20.4 | 95% Confidence Interval 13.2 to 29.2 | percentage |
| Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT | Cohort A | Overall response rate (ORR) | 25.0 | 95% Confidence Interval 17.2 to 34.3 | percentage |
| Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT | Cohort A | Complete response rate (CR rate) | 7.4 | 95% Confidence Interval 3.3 to 14.1 | percentage |
| Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT | Cohort A | Partial response rate (PR rate) | 17.6 | 95% Confidence Interval 10.9 to 26.1 | percentage |
| Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT | Cohort A | 2.3 | 95% Confidence Interval 1.9 to 8.7 | months | |
| Duration of Overall Response Assessed by Independent Review Committee Based on CT | Cohort A | 5.3 | 95% Confidence Interval 1.9 to 6.9 | months |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 108 | |
| Overall Study | COMPLETED | Cohort A | 3 | |
| Overall Study | NOT COMPLETED | Cohort A | 105 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Cohort A | 13 | 108 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A | 12 | 108 | |
| other | Nausea | Gastrointestinal disorders | Cohort A | 11 | 108 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A | 11 | 108 | |
| other | Vomiting | Gastrointestinal disorders | Cohort A | 8 | 108 | |
| other | Dyspepsia | Gastrointestinal disorders | Cohort A | 6 | 108 | |
| other | Rash | Skin and subcutaneous tissue disorders | Cohort A | 17 | 108 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Cohort A | 10 | 108 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Cohort A | 7 | 108 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A | 16 | 108 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 52 | 108 |
| Total, other adverse events | Cohort A | 95 | 108 |
| Total, serious adverse events | Cohort A | 44 | 108 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04101331
GET https://conductscience.org/api/trials/v1/NCT04101331/results?page=2