This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides (NCT04101331), a na phase 2 study. The primary outcome is Overall Response Rate Assessed by Independent Review Committee Based on PET-CT.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04101331 |
| Phase | Phase 2 |
| Condition | Peripheral T Cell Lymphoma, Transformed Mycosis Fungoides |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 108 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Affimed GmbH |
| Results posted | Yes |
2. Clinical Question
Population
People with relapsed or refractory CD30-positive peripheral T-cell lymphoma or transformed mycosis fungoides were eligible if they met the study entry criteria. The registry describes the full analysis set as subjects who received at least one dose of AFM13. Cohort A is specifically described as subjects with relapsed or refractory CD30-positive peripheral T-cell lymphoma.
Intervention
AFM13 was given as monotherapy. The study summary describes weekly infusions at a 200mg dose per infusion. AFM13 is described as a tetravalent bispecific chimeric recombinant antibody construct targeting human CD30 and human CD16A.
Comparator
There was no comparator group: the registry records a single-group study and no masking. Participants were assigned to one of 3 study cohorts according to disease type and the magnitude of CD30 expression; the summary states that each cohort received the same treatment. This is not a randomized comparison.
Primary question
The primary question was whether participants achieved an overall response, defined as a complete response and/or partial response by an Independent Review Committee using PET-CT and the modified Lugano Classification Revised Staging System for malignant lymphoma. The registry record does not report the response estimate or its 95% confidence interval, so the magnitude and precision of the primary result cannot be described from the record.
3. Trial Design
This was a phase II, open-label, multicenter study of AFM13 in people with relapsed or refractory CD30-positive peripheral T-cell lymphoma or transformed mycosis fungoides. The registry identifies the design as single-group, with allocation not applicable and masking absent. There was no concurrent control group, so the study was not designed as a randomized comparison of AFM13 with another treatment.
The registry lists enrollment of 108 and records the study as completed. The listed study start was 2019-11-13, and primary completion was 2022-05-11. The sponsor was Affimed GmbH. Participants were to be assigned to one of 3 cohorts according to disease type and the magnitude of CD30 expression; the study summary says all cohorts received weekly AFM13 infusions at 200mg per infusion. The detailed description available for Cohort A identifies relapsed or refractory CD30-positive peripheral T-cell lymphoma. Descriptions of the other cohorts are not reported in the registry record.
The primary endpoint was overall response assessed by an Independent Review Committee based on PET-CT. Tumor assessments were planned every 8 weeks for the first 3 assessments and then every 12 weeks until documented disease progression, up to 28 months. The registry also lists outcomes involving investigator assessment, CT-based assessment, complete and partial response, and duration of response.
The study summary describes a final visit approximately 1 month after the last AFM13 dose, followed by quarterly phone contacts to check overall health status and long-term survival. These follow-up procedures describe the intended study conduct; they do not provide the missing primary response estimate. The registry record does not report a control-group result, a rationale for the enrollment target, or enough cohort detail to characterize every enrolled subgroup.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 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.
Overall Study
| Stage | Cohort A |
|---|---|
| STARTED | 108 |
| COMPLETED | 3 |
| NOT COMPLETED | 105 |
Reasons for not completing this period:
| Reason | Cohort A |
|---|---|
| Adverse Event | 9 |
| Disease progression | 82 |
| Withdrawal by Subject | 1 |
| Investigator decision | 6 |
| Death | 6 |
| Allogenic transplant | 1 |
Analysis population for the primary outcome, as defined in the registry: 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.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Full analysis set (FAS): consist of all subjects who received at least one dose of AFM13.
| Characteristic | Unit | Cohort A |
|---|---|---|
| Participants analysed | 108 | |
| Age, Continuous | Years | 61.1 (SD 13.98) |
| Sex: Female, Male: Female | Participants | 42 |
| Sex: Female, Male: Male | Participants | 66 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 90 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 13 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 15 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 |
| Race (NIH/OMB): White | Participants | 75 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Response Rate Assessed by Independent Review Committee Based on PET-CT, measured over Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months)..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the overall response rate assessed by an Independent Review Committee using PET-CT. Overall response was defined as achieving a complete response and/or a partial response, with classification based on the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). The registry describes the analysis population as the full analysis set, following the intent-to-treat principle and consisting of all subjects who received at least one dose of AFM13.
Overall response combines complete and partial responses into a measure of whether tumor assessment met either response category. Independent review can provide an assessment separate from the investigator's judgment; it does not, by itself, remove the limitations of an open-label, single-group study. PET-CT was the specified basis for the primary assessment, while the registry also lists other response outcomes using investigator assessment or CT.
The registry lists a percentage as the endpoint unit and a 95% confidence interval as the dispersion measure. A confidence interval conveys the statistical uncertainty around an estimated response rate: narrower intervals indicate greater precision, while wider intervals indicate more uncertainty. The primary response value and its confidence interval are not reported in the registry record. Therefore, the response rate's size and precision cannot be interpreted from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically focused response question: whether participants with relapsed or refractory CD30-positive disease achieved complete or partial response on PET-CT, as judged by an Independent Review Committee. However, it does not report the numerical primary endpoint result. Neither an overall response percentage nor its 95% confidence interval is available in the registry record. Without those values, it is not possible to describe the observed response frequency or how precisely it was estimated.
The design also determines what an observed response could establish. This was a single-group, open-label study, not a randomized comparison. Any response estimate would describe outcomes among participants receiving AFM13 under the study's assessment procedures. It would not, on its own, quantify how outcomes compare with a control treatment or establish that AFM13 caused the observed responses. Differences in participant characteristics, disease course, prior treatment, follow-up, or assessment could not be separated from treatment effects using a concurrent randomized contrast because no such contrast is listed.
The endpoint plan includes a 95% confidence interval, which is useful for expressing uncertainty around the estimate. A point estimate alone would not show its precision; conversely, an interval does not correct limitations of study design or establish a causal effect. Since neither estimate nor interval is reported, this interpretation must remain at the level of the planned endpoint rather than the magnitude of the result.
The registry lists 108 participants enrolled, but enrollment is not interchangeable with the primary endpoint analysis population. The stated full analysis set comprised subjects who received at least one dose of AFM13. The number in that set, the number assessed at each visit, and the handling of participants with missing or unevaluable PET-CT assessments are not reported in the registry record. Consequently, the enrolled total alone cannot establish the denominator used for the primary response estimate.
The assessment schedule called for scans every 8 weeks for the first 3 assessments and then every 12 weeks until documented disease progression, up to 28 months. Response is therefore tied to defined imaging and review procedures, as well as to the point at which assessments were available. The record does not supply the result by assessment time, duration of response, or a detailed account of follow-up completeness. Other listed outcomes include response by investigator assessment, CT-based response, and duration of response, but outcome titles do not establish what those results were.
Safety counts are reported separately from the primary response endpoint. They describe recorded adverse-event information for Cohort A, including serious events, other adverse events, and deaths. These counts do not supply a randomized safety contrast, and the registry listing alone does not establish that an event or death was caused by AFM13. The event terms and percentages should therefore be read as descriptive safety reporting, not as comparative estimates of treatment-attributable risk.
9. Statistical Methods Explained
The registry describes an open-label, single-group phase II study. In a single-group design, participants receive the study intervention without a concurrent control group. The primary endpoint can characterize response in the enrolled analysis population, but it cannot provide a randomized estimate of the difference between AFM13 and another treatment. Open-label means masking was absent; the primary endpoint nevertheless used an Independent Review Committee for PET-CT assessment. The registry does not report further details about the committee's procedures or safeguards.
What does the response endpoint represent?
Overall response combines complete response and partial response into a single endpoint. Here, response was to be determined from PET-CT using the modified Lugano Classification Revised Staging System for malignant lymphoma. The endpoint was expressed as a percentage, with a 95% confidence interval specified as the measure of uncertainty. In general, a confidence interval describes a range of values compatible with the data and the statistical procedure used. It addresses sampling uncertainty, not all possible sources of bias or uncertainty in how participants were selected, treated, or assessed.
The registry gives an assessment schedule: every 8 weeks for the first 3 assessments, then every 12 weeks until documented disease progression, up to 28 months. A fixed assessment framework matters because the chance of observing a response can depend on when imaging takes place and whether participants remain assessable. The registry does not report results at individual time points, missing assessment counts, or detailed rules for assigning response when imaging was unavailable.
Who was included in the primary analysis?
The stated full analysis set followed the intent-to-treat principle and included all subjects who received at least one AFM13 dose. The registry does not report the number who received a dose or confirm whether it matched enrollment of 108. In general, defining an analysis population in advance clarifies which participants contribute to an endpoint. A treatment-received criterion is not identical to including everyone enrolled, so the denominator should be taken from the actual analysis report rather than inferred from enrollment.
The registry does not report the statistical estimator used for the response percentage, the confidence-interval construction, or any adjustments. It also does not give a numerical primary result. Those details should not be inferred from the endpoint unit or from the listed confidence level.
How should the study design shape statistical conclusions?
Randomization is a general method for creating treatment groups that are comparable, on average, with respect to both measured and unmeasured factors. There was no randomized comparator in this study. Thus, a response proportion, if reported, would be descriptive of the treated study population and would not directly estimate a between-treatment effect. Historical comparisons can be difficult to interpret because differences in eligibility, disease mix, assessment, follow-up, and supportive care may affect outcomes; the registry does not state that a historical comparison was planned.
In general, open-label assessment can be susceptible to knowledge of treatment assignment. Independent review may provide a separate assessment, but the registry does not describe blinding of the review committee or enough operational detail to judge the extent of any protection against assessment bias. The absence of reported details is not evidence that a specific procedure was or was not used.
What can the sample-size illustrations say?
The planning illustrations are not the study's own design justification and are not observed power. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. Time-to-event illustrations use total events; other illustrations use participants per arm. Those assumptions describe hypothetical planning exercises, not the design of this single-group study. In particular, equal allocation between two arms is not the actual study structure, which had no control arm. The registry does not report its sample-size justification or target power, and the illustration assumptions cannot fill that gap.
General statistical power is the probability that a specified analysis will detect a prespecified effect under its assumptions. It depends on the assumed effect, variability, sample size, design, and analysis. A planning calculation does not establish the probability that this completed study achieved a particular finding, and it does not turn an unreported endpoint into a result. Over-dispersion is a general issue for count outcomes when observed variability exceeds what a simple model assumes; it can make standard errors and confidence intervals too small if ignored. The primary endpoint is a response proportion, and the registry does not report whether an over-dispersion model or any particular model was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures and 4 analyses, but does not report the detailed statistical analysis plan or identify how the analyses correspond to particular endpoints. The primary endpoint is overall response assessed by an Independent Review Committee based on PET-CT. Secondary outcomes include response assessments by investigators, CT-based response, complete and partial response rates, and duration of response. The presence of several outcomes creates a general multiplicity consideration: when many hypotheses are examined, the chance of at least one apparently notable result can increase unless the analysis plan addresses that issue. The registry record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or which outcomes were confirmatory versus exploratory.
The primary analysis population is described as the full analysis set, consisting of all subjects who received at least one dose of AFM13 under an intent-to-treat principle. The record does not report the number analyzed, missing outcome counts, reasons for missingness, or rules for handling participants without evaluable PET-CT assessments. In general, missing data can affect a response estimate when the availability of assessments is related to disease status, treatment, or other participant characteristics. The registry entries are insufficient to determine whether or how that possibility was addressed.
The registry also does not report interim analyses, a missing-data sensitivity analysis, or a statistical plan for incomplete follow-up. These matters are not resolved by the stated endpoint definition or the analysis population description. The enrollment of 108 should not be assumed to be the endpoint denominator without the analysis count. A sample-size rationale and the study's own power target are not reported in the registry record. Planning illustrations based on a hypothetical two-arm design are not evidence of the original design assumptions or of observed power.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Cohort A | 44 | 108 | 40.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort A | 52 of 108 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cohort A | 95 of 108 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort A |
|---|---|---|
| COVID-19 | Infections and infestations | 9 of 108 |
| Pneumonia | Infections and infestations | 6 of 108 |
| Infusion related reaction | Injury, poisoning and procedural complications | 5 of 108 |
| Acute kidney injury | Renal and urinary disorders | 3 of 108 |
| Herpes zoster | Infections and infestations | 2 of 108 |
| Septic shock | Infections and infestations | 2 of 108 |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 2 of 108 |
| Pyrexia | General disorders | 2 of 108 |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 108 |
| COVID-19 pneumonia | Infections and infestations | 1 of 108 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort A |
|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | 25 of 108 |
| Pyrexia | General disorders | 21 of 108 |
| Rash | Skin and subcutaneous tissue disorders | 17 of 108 |
| Anaemia | Blood and lymphatic system disorders | 16 of 108 |
| Neutropenia | Blood and lymphatic system disorders | 14 of 108 |
| Constipation | Gastrointestinal disorders | 13 of 108 |
| Thrombocytopenia | Blood and lymphatic system disorders | 13 of 108 |
| Diarrhoea | Gastrointestinal disorders | 12 of 108 |
| Nausea | Gastrointestinal disorders | 11 of 108 |
| Abdominal pain | Gastrointestinal disorders | 11 of 108 |
Serious events with the highest arm-level rate: covid-19 (8.3%), pneumonia (5.6%), infusion related reaction (4.6%), acute kidney injury (2.8%), herpes zoster (1.9%).
The registry's safety summary for Cohort A lists 108 participants at risk for serious adverse events and 44 affected. It lists 108 at risk for other adverse events and 95 affected, and records 52 deaths. The serious adverse-event terms with the highest listed percentages are COVID-19 at 8.3%, Pneumonia at 5.6%, Infusion related reaction at 4.6%, Acute kidney injury at 2.8%, Herpes zoster at 1.9%, and Septic shock at 1.9%.
These figures are descriptive counts and percentages in the registry's safety reporting. They should not be read as a comparison with another treatment, since the study had no control group. The listing does not establish that a particular event or death was caused by AFM13. The registry does not report in this summary the timing, duration, participant-level overlap among event categories, or a causal assessment for each event. A count of participants affected is also distinct from a count of individual event episodes. Interpret the figures as safety information recorded for this cohort, not as a causal or comparative risk estimate.
12. What the Result Does, and Does Not, Mean
The study was designed to assess AFM13 monotherapy in people with relapsed or refractory CD30-positive peripheral T-cell lymphoma or transformed mycosis fungoides. Its primary outcome was a PET-CT-based overall response assessment by an Independent Review Committee. These design details indicate what question the investigators intended to address and how response was to be classified.
The registry record does not report the numerical primary response rate or its 95% confidence interval. As a result, it is not possible to say from this record how many participants had a complete or partial response, what proportion met the overall response definition, or how precise that estimate was. The outcome titles and assessment plan are not substitutes for the posted endpoint result.
Even if a response estimate were available, the single-group, open-label design would limit what could be concluded. The result would describe the study participants receiving AFM13, not a randomized difference against another treatment. It would not, by itself, establish that AFM13 caused a response or determine how outcomes would compare under a different treatment. Generalization beyond the enrolled population would also require attention to the eligibility criteria, disease composition, and analysis population.
The safety listing records adverse-event counts and deaths but does not establish treatment causality. Nor does it provide a comparative estimate of safety versus another group. The registry's follow-up description and scheduled tumor assessments help explain the intended observation period, but the record does not report detailed follow-up completeness or all endpoint results.
Accordingly, the statistical reading is bounded by what the registry reports: the study design, endpoint definition, stated analysis population, and descriptive safety figures. The primary efficacy result and important analysis details are not reported in the registry record. No conclusion about efficacy or comparative benefit can be drawn from the endpoint definition alone.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how an objective response endpoint is defined and assessed in a single-group phase II study. The primary outcome combines complete and partial response, uses PET-CT, and assigns assessment to an Independent Review Committee using a named lymphoma classification system. Such specifications make clear what constitutes the intended endpoint, while the stated assessment schedule defines when tumor evaluations were planned.
The design also illustrates why the study question and the statistical conclusion must be kept distinct. A single-group response estimate can describe outcomes in the treated study population. Without randomization or a concurrent control group, however, it does not provide a direct estimate of comparative treatment effect. This distinction remains important even when an endpoint has a formal definition and an independent assessment process.
The registry lists a 95% confidence interval as the intended expression of precision, but does not report the interval or the response estimate. This means that neither the result's magnitude nor its statistical precision can be evaluated from the registry record. It also illustrates why an endpoint name, outcome schedule, and enrollment count cannot replace a posted analysis result.
Finally, the registry identifies several other response and duration outcomes, alongside safety information. Multiple outcomes call for clarity about which analyses are primary, which are secondary, and whether multiplicity was addressed. Those details are not reported in the registry record. The safety counts are likewise descriptive without a comparator, and they do not establish event causation. Together, these features make the study useful for considering the limits of inference as well as the endpoint definitions.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central limitation for interpreting efficacy from the registry record is that the primary overall response estimate and its 95% confidence interval are not reported. The record therefore does not permit assessment of the result's magnitude or precision. It also does not give the number of participants included in the full analysis set, the number with evaluable PET-CT, or the handling of missing assessments.
The study was single-group and open-label, with no randomized comparator. A response proportion cannot be interpreted as a comparative treatment effect, and the design does not separate treatment effects from other influences on outcomes. The registry does not report details of blinding for Independent Review Committee assessment or other procedures that might affect the risk of assessment bias.
The registry lists several response and duration outcomes but does not report a detailed statistical analysis plan, testing hierarchy, or multiplicity procedure. It does not report the sample-size justification, the intended power, interim analyses, or missing-data sensitivity analyses. Although the registry specifies the full analysis set's general definition, enrollment of 108 should not be treated as the primary endpoint denominator without the actual analysis count.
Safety information is also limited to descriptive registry figures. A comparator-based safety estimate, event timing, causal attribution, and detailed follow-up completeness are not reported in the registry record. The listed deaths should not be interpreted as treatment-caused based on this information alone. The available Cohort A description is specific to relapsed or refractory CD30-positive peripheral T-cell lymphoma; descriptions of the other cohorts are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides — NCT04101331.
- Registry record last updated 2024-11-05; status last verified 2024-11.
- Results first posted 2023-06-05.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This completed phase II study evaluated AFM13 monotherapy in relapsed or refractory CD30-positive peripheral T-cell lymphoma or transformed mycosis fungoides. The registry describes an open-label, single-group design, enrollment of 108, and weekly infusions at 200mg per infusion. Participants were assigned to one of 3 cohorts based on disease type and the magnitude of CD30 expression.
The primary endpoint was overall response assessed by an Independent Review Committee using PET-CT, with a 95% confidence interval specified. The primary response estimate and interval are not reported in the registry record. The registry lists 17 outcome measures and 4 analyses but does not report the detailed statistical analysis plan. Safety figures include serious adverse events, other adverse events, and deaths; these are descriptive and do not establish causality. With no comparator group, the study does not provide a randomized comparison.