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 Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH (NCT04251065), a na phase 2 study. The primary outcome is Complete Response Rate (CRR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04251065 |
| Phase | Phase 2 |
| Condition | Refractory T-Cell Lymphoma, Relapsed T-Cell Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Fondazione Italiana Linfomi - ETS |
| Results posted | Yes |
2. Clinical Question
Population
Patients with CD38-positive PTCL-NOS, AITL, or other nodal lymphomas of TFH cell origin that were relapsed or refractory after at least one and no more than two previous lines of therapy. The registry record lists enrollment of 8. Further details about the patients’ baseline characteristics are not reported in the registry record.
Intervention
The study evaluated D-GDP: daratumumab combined with gemcitabine, cisplatin, and dexamethasone. The primary objective concerned complete response after 4 courses. The registry describes an open-label treatment approach; additional details about dose and treatment delivery are not reported in the registry record.
Comparator
There was no concurrent comparison group. The study is described as single-group, with allocation listed as not applicable. Thus, the study does not directly compare D-GDP with another regimen or with a control condition. Comparisons with other treatments cannot be made as randomized, like-for-like contrasts from this design.
Primary question
The primary question was whether patients achieved complete remission, assessed using Lugano response criteria after the first 4 cycles of D-GDP. If treatment stopped early, efficacy was to be assessed at the end-of-treatment visit. A patient without a response assessment was to be considered a non-responder. The registry record does not report the observed complete response count or rate.
3. Trial Design
This is a phase II, open-label, multicenter, single-group study of D-GDP. The registry lists allocation as not applicable and masking as none. With no concurrent control arm, the design describes outcomes among people receiving the study regimen but does not provide a randomized comparison with another treatment. The record lists enrollment of 8.
The study population was specified as patients with relapsed or refractory CD38-positive PTCL-NOS, AITL, or other nodal lymphomas of TFH cell origin after at least one and no more than two previous lines of therapy. The planned primary efficacy assessment was complete response after 4 courses; early discontinuation was addressed by assessment at the end-of-treatment visit. The registry describes the study as single-stage, but the decision rules or stage boundaries are not reported in the registry record.
The recorded start date is 2020-09-03, and the primary completion date is 2021-12-22. The current status is terminated. The reason for termination, recruitment details, and whether the listed enrollment reflects a planned or achieved target are not reported in the registry record. The sponsor is Fondazione Italiana Linfomi - ETS.
The registry lists 8 outcome measures and 0 analyses. It names overall response rate, overall survival, progression-free survival, and frequency of relevant toxicities among the secondary outcomes. Results for these outcomes and the statistical analysis plan are not reported in the registry record.
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.
Overall Study
| Stage | One Arm |
|---|---|
| STARTED | 8 |
| COMPLETED | 2 |
| NOT COMPLETED | 6 |
Reasons for not completing this period:
| Reason | One Arm |
|---|---|
| Death | 2 |
| Lack of Efficacy | 3 |
| Death | 1 |
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.
| Characteristic | Unit | One Arm |
|---|---|---|
| Participants analysed | 8 | |
| Age, Continuous | years | 64.5 (62.0 to 72.5) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 8 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Disease status at study entry: Relapse | Participants | 5 |
| Disease status at study entry: Refractory | Participants | 3 |
| Systemic B symptoms: Absent | Participants | 4 |
| Systemic B symptoms: Present | Participants | 4 |
| Ann Arbor Stage: III | Participants | 1 |
| Ann Arbor Stage: IV | Participants | 7 |
| ECOG Performance Status: 0 | Participants | 4 |
| ECOG Performance Status: 1 | Participants | 4 |
| Bone marrow involvement: Negative | Participants | 4 |
| Bone marrow involvement: Positive | Participants | 4 |
| Number extra-nodal sites: 1 | Participants | 2 |
| Number extra-nodal sites: 2 | Participants | 2 |
| Number extra-nodal sites: 3 | Participants | 2 |
| Number extra-nodal sites: 4 | Participants | 1 |
| Number extra-nodal sites: 5 | Participants | 1 |
| Type of the 1st Line Treatment: 6 cy CHOEP + 1 cy DHAP + ASCT | Participants | 1 |
| Type of the 1st Line Treatment: 6 cy CHOP+DHAP+ASCT | Participants | 2 |
| Type of the 1st Line Treatment: CHOEP | Participants | 1 |
| Type of the 1st Line Treatment: 6cy CHOEP + ARA-C + ABMT | Participants | 1 |
| Type of the 1st Line Treatment: CHOP | Participants | 1 |
| Type of the 1st Line Treatment: COEP | Participants | 1 |
| Type of the 1st Line Treatment: CHOEP +HSCT | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Complete Response Rate (CRR), measured over the endpoint will be assessed from the start date of therapy to the end of the first four cycles of therapy (cycles of 21 days)..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the complete response rate, defined in the registry as the percentage of patients in complete remission according to Lugano response criteria. The assessment was planned after the first 4 cycles of D-GDP, with an end-of-treatment assessment for patients who discontinued early. The record describes complete radiological response using features that include no new lesions and regression of organ enlargement to normal; it also gives criteria concerning extralymphatic sites and bone marrow morphology.
A response rate is a binary-outcome summary: each assessed patient is classified according to whether the defined response occurred, and the rate describes the proportion classified as responders in the analysis population. The registry specifies that patients without a response assessment for any reason are considered non-responders. This rule makes missing assessments part of the endpoint classification rather than excluding those patients by default, although the number of missing assessments is not reported in the registry record.
General statistical context: complete response is used as an efficacy endpoint because it captures a defined depth of response, rather than any response. That definition makes consistent assessment important. The observed complete response count, rate, denominator used in analysis, and uncertainty interval are not reported in the registry record, so the endpoint’s result cannot be quantified from the available record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the study question and endpoint but does not report the observed complete response result. The complete response count, rate, and confidence interval are not reported in the registry record. Consequently, the posted results do not establish how often complete response occurred in the study group or how precisely that rate was estimated.
The listed enrollment is 8. With a study group of this size, an individual outcome can materially affect a response-rate estimate. General statistical context: a confidence interval communicates uncertainty around an estimate; a wide interval indicates that the data are compatible with a broad range of underlying response rates. No interval for complete response is reported, so precision cannot be assessed directly.
The design is single-group and open-label. It can describe outcomes observed during treatment, but without a concurrent comparator it cannot separate the contribution of the regimen from other explanations, such as the natural course of illness, patient selection, or differences in assessment. These are general limitations of interpreting uncontrolled treatment outcomes, not findings about what happened to participants in this study. The registry record does not report an adjusted or comparative efficacy analysis.
The secondary outcomes named in the registry include overall response rate, overall survival, progression-free survival, and frequency of relevant toxicities. Their results, assessment details, and analysis methods are not reported in the registry record. In particular, no survival estimates or follow-up duration are available in the recorded information, so these outcomes cannot be interpreted statistically from the record.
The status is terminated, but the reason is not reported in the registry record. Termination alone does not reveal whether the study stopped because of recruitment, safety, efficacy, operational issues, or another cause. Nor does it establish whether the primary endpoint was fully assessed. The record also does not report whether any planned analyses were changed or whether results were reviewed during the study.
Overall, the available information supports a description of the design, planned endpoint, and limited enrollment, but not a conclusion about the magnitude or reliability of an efficacy result. Any interpretation of benefit, lack of benefit, or comparison with alternative care would require outcome data and evidence beyond the information reported in this record.
9. Statistical Methods Explained
The registry describes a phase II, open-label, single-group study with a binary primary endpoint. The endpoint classifies patients according to complete response under the stated criteria. The registry lists the outcome unit as participants and the outcome type as counts of participants with an event. In this context, the event is the complete response being measured. The observed count and corresponding rate are not reported in the registry record.
General statistical context: for a binary endpoint, the basic estimate is the share of the analysis population classified as having the outcome. Interpretation depends on knowing both the numerator and the denominator, as well as how unassessed participants were handled. The protocol description specifies that participants without a response assessment are classified as non-responders. The count of participants lacking assessment and the analysis denominator are not reported in the registry record.
An estimate from a small study group is inherently uncertain. General statistical context: a confidence interval describes a range of values compatible with the data under the method’s assumptions. It is not a guarantee that the true response rate lies within a particular interval. The width of an interval depends on the amount of information and the observed outcome pattern. The registry record does not report a confidence interval or the method used to calculate one for the primary endpoint.
The study has no concurrent comparator. General statistical context: random allocation helps balance measured and unmeasured factors, on average, between treatment groups. A single-group study does not offer that protection and cannot estimate a randomized treatment contrast. Its outcomes can be described for the enrolled group, but they cannot by themselves establish that observed outcomes were caused by treatment. The registry does not report a comparator-based analysis.
The open-label design means the study is not described as masked. General statistical context: knowledge of treatment assignment can affect aspects of care, reporting, or assessment, depending on how outcomes are collected. Objective response criteria can help standardize assessment, but they do not remove every possible source of bias. Details about independent review, assessor masking, and procedures for resolving disagreement are not reported in the registry record.
The primary endpoint uses Lugano response criteria and is assessed after treatment cycles, with an end-of-treatment assessment in case of early discontinuation. General statistical context: a clearly timed assessment helps define when an outcome is measured and can reduce ambiguity about follow-up. However, the registry record does not report the observed assessment schedule for participants, the number completing planned assessments, or any deviations from the planned timing.
The response definition has an explicit rule for unavailable assessments: those patients are treated as non-responders. This approach avoids counting unassessed patients as responders, but it does not reveal why assessments were missing or how many were missing. General statistical context: missing-data rules can influence an estimate, particularly if missingness is related to a patient’s health or outcome. The registry record does not report missingness by reason or any sensitivity analysis testing alternative assumptions.
Some statistical concepts that may accompany trial summaries need careful distinction. A significance level is a preselected threshold used in a testing procedure; a p-value describes how unusual the data would be under a specified null model and its assumptions. Neither is a measure of clinical importance. The registry record does not report the primary hypothesis test, significance threshold, p-value, or inferential procedure for the primary endpoint.
The record’s sample-size description states that planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect specified as a fraction of the observed effect. It also states that time-to-event illustrations give total events, while other illustrations give participants per arm. These are described as planning illustrations, not the study’s own design; the trial itself is single-group. Such planning values are not observed power and do not substitute for an analysis of the study results. The registry record does not report the study’s own sample-size justification or design assumptions.
The registry lists 0 analyses. The statistical analysis plan, analysis populations, treatment of protocol deviations, model specifications, and any interim analysis procedures are not reported in the registry record. General statistical context: a model can adjust for measured characteristics or account for features such as censoring, but model choice depends on the outcome and prespecified question. No particular model or adjustment should be inferred where it is not documented.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures and names overall response rate, overall survival, progression-free survival, and frequency of relevant toxicities among the secondary outcomes. It does not report which outcomes, if any, were assigned confirmatory status, how hypotheses were ordered, or whether a multiplicity adjustment was planned. The registry also lists 0 analyses, and no outcome-specific statistical testing procedures are reported.
General statistical context: when several outcomes or hypotheses are examined, the chance of at least one apparently notable result can increase if each is assessed independently. Prespecifying a hierarchy or using an adjustment can address that issue, but the appropriate approach depends on the study aims. The record does not document whether such a strategy was used. Without it and without reported outcome results, the secondary outcomes should not be treated as evidence of a confirmed effect.
For the primary endpoint, the registry explicitly says that patients without a response assessment are considered non-responders. The number of patients without assessment, reasons for missing assessment, and any sensitivity analyses are not reported in the registry record. The record does not report how missing data were handled for the secondary outcomes.
Analysis populations, such as whether all enrolled patients were included in the primary analysis or whether exclusions were applied, are not reported in the registry record. The record also does not describe handling of protocol deviations or eligibility issues. These omissions limit assessment of whether the planned endpoint definition was applied consistently and whether the analysis population matched the intended population.
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 |
|---|---|---|---|
| One Arm | 8 | 8 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| One Arm | 8 of 8 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| One Arm | 8 of 8 |
Most frequent serious adverse event terms
| Event term | Organ system | One Arm |
|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 1 of 8 |
| septic shock multiorgan failure | Infections and infestations | 1 of 8 |
| Acute myocardial infarction | Cardiac disorders | 1 of 8 |
| Heart failure | Cardiac disorders | 1 of 8 |
| Hepatorenal syndrome | Hepatobiliary disorders | 1 of 8 |
| Thenth rib fracture | Musculoskeletal and connective tissue disorders | 1 of 8 |
| COVID-19 | Infections and infestations | 1 of 8 |
| EBV infection | Infections and infestations | 1 of 8 |
| Pneumonia | Infections and infestations | 1 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | One Arm |
|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 5 of 8 |
| Thrombocytopenia | Blood and lymphatic system disorders | 5 of 8 |
| General disorder | General disorders | 4 of 8 |
| Infections | Infections and infestations | 4 of 8 |
| Other | General disorders | 3 of 8 |
| Anemia | Blood and lymphatic system disorders | 2 of 8 |
| Leukopenia | Blood and lymphatic system disorders | 2 of 8 |
| Gastrointestinal disorder | Gastrointestinal disorders | 2 of 8 |
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 8 |
| Cardiac disorder | Cardiac disorders | 1 of 8 |
Serious events with the highest arm-level rate: pulmonary embolism (12.5%), septic shock multiorgan failure (12.5%), acute myocardial infarction (12.5%), heart failure (12.5%), hepatorenal syndrome (12.5%).
The registry reports one adverse-event group. Its fields list 8 participants at risk and 8 with serious adverse events, 8 at risk and 8 with other adverse events, and 8 deaths. The top serious adverse-event terms are pulmonary embolism, septic shock multiorgan failure, acute myocardial infarction, heart failure, hepatorenal syndrome, and Thenth rib fracture; each is listed as 12.5%.
These entries should be read as registry-reported safety information, not as proof that the treatment caused an event. The record does not report the event-level details needed to determine timing, duration, severity grading, clinical course, or attribution. It also does not explain the relationship between the deaths and the listed adverse events, or provide the follow-up context for the death count. The denominator and counting rules for each listed serious-event term are not described in the record.
General statistical context: adverse-event counts describe what was recorded in a study group, while causal attribution requires careful clinical and comparative assessment. With no concurrent control group, the figures cannot establish whether event frequency differs from another treatment or from the underlying risk in a comparable population. The safety information is important to report, but the available entries alone do not support broader comparative conclusions.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II, open-label, single-group study of D-GDP was conducted in a defined population with relapsed or refractory CD38-positive peripheral T-cell lymphomas. It also specifies complete response as the primary endpoint and explains how patients without a response assessment were to be classified. These details clarify the intended question and the endpoint rule.
The record does not report the observed complete response count or rate, so it cannot show the magnitude of the primary outcome. It also does not report a confidence interval or primary analysis. Without these results, it is not possible to assess the precision of an efficacy estimate or determine whether the observed data were compatible with a broad or narrow range of response rates.
Even if a response result were available, the single-group design would not establish a causal comparison with another regimen. General statistical context: outcomes observed in a treatment group can reflect treatment as well as patient characteristics, care decisions, assessment, and the course of disease. A randomized comparison is designed to support a different inference. No such comparison is reported for this study.
The listed enrollment is 8, and the study status is terminated. The reason for termination and the completeness of endpoint follow-up are not reported in the registry record. Those details limit interpretation of the study’s progress but do not, on their own, explain why it ended or what its results would have been under a different design.
The safety fields include adverse events and deaths, but the record does not provide enough context to assign causality or compare risks. The reasonable statistical conclusion is therefore limited: the registry describes the trial and records safety counts, but does not report the primary efficacy result or the analyses needed to draw broader conclusions about treatment effects.
13. Why This Trial Matters Statistically
This study illustrates how design features shape the questions a trial can answer. A single-group phase II design can describe outcomes in a selected population receiving a specified regimen. It cannot directly estimate a randomized contrast against another option. That distinction is important when readers encounter response or safety figures and are tempted to interpret them as comparative effects.
The primary endpoint is a defined binary outcome, complete response under Lugano criteria. The registry also specifies a rule for patients without response assessment, classifying them as non-responders. This makes the endpoint operationally clear, while also highlighting why the number and reasons for unassessed patients matter when interpreting the estimate. Those missing-assessment details are not reported.
The listed enrollment is 8, and the study is terminated. In a study with this enrollment, estimates can be imprecise; the registry does not report the complete response estimate or an uncertainty interval that would allow its precision to be examined. It also does not report the reason for termination, so that status cannot be used to infer an efficacy, safety, or operational explanation.
Statistically, the case emphasizes the difference between a planned endpoint and a reported result. A clear endpoint definition does not itself reveal the observed outcome, and a listed sample-size planning approach does not substitute for outcome data. The registry’s record of 0 analyses further means that inferential methods are not documented in the posted information. Careful interpretation requires keeping those design, reporting, and analysis gaps distinct.
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.
Several limitations specific to this study constrain interpretation. It is open-label and single-group, with no concurrent comparator. The design therefore cannot directly distinguish outcomes associated with D-GDP from outcomes that might also occur under another treatment or through other influences. Masking is listed as none, and further information about independent response assessment is not reported in the registry record.
The listed enrollment is 8. The primary endpoint result, its denominator, and an uncertainty interval are not reported, so the size and precision of the complete response estimate cannot be evaluated. Although the registry defines how unassessed patients would be classified, it does not report how many lacked assessment or why. The reason for termination is also not reported.
The statistical analysis plan, analysis populations, hypothesis-testing approach, and missing-data analyses are not reported in the registry record. The record lists 0 analyses, and secondary-outcome results are not reported. It is therefore not possible to assess the handling of multiple outcomes, follow-up for survival endpoints, or whether reported analyses followed a prespecified plan.
Additional information about participant characteristics, treatment delivery, response assessment procedures, and adverse-event attribution is not reported. These gaps prevent evaluation of how representative the enrolled group was, whether assessments were conducted consistently, and how the reported safety fields relate to treatment exposure. The registry record supports a description of the trial, but not a full assessment of its efficacy or safety findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH — NCT04251065.
- Registry record last updated 2025-03-28; status last verified 2022-11.
- Results first posted 2025-03-28.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT04251065 is a phase II, open-label, multicenter, single-group study sponsored by Fondazione Italiana Linfomi - ETS. It evaluated daratumumab with gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory CD38-positive PTCL-NOS, AITL, and other nodal lymphomas of TFH cell origin. The registry lists enrollment of 8 and a terminated status.
The primary endpoint is complete response rate, assessed after the first 4 cycles, with an end-of-treatment assessment for early discontinuation. Patients without a response assessment were to be considered non-responders. The recorded start date is 2020-09-03, and primary completion is dated 2021-12-22.
The registry lists overall response rate, overall survival, progression-free survival, and relevant toxicities among secondary outcomes. The observed primary efficacy result, analysis methods, and reason for termination are not reported in the registry record.