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 Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma (NCT04676360), a na phase 2 study. The primary outcome is Overall Response Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04676360 |
| Phase | Phase 2 |
| Condition | Relapsed Plasmablastic Lymphoma, Refractory Plasmablastic Lymphoma, Anaplastic Lymphoma Kinase Positive Large B-Cell Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Jacob Soumerai, MD |
| Results posted | Yes |
2. Clinical Question
Population
People with relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma. The registry record gives enrollment of 10; it does not report the analyzed population or the number enrolled with each condition.
Intervention
Belantamab mafodotin, an antibody-drug conjugate. The record describes intravenous administration on day 1 of a 21-day cycle, with treatment intended on an outpatient basis.
Comparator
No comparator group is listed. This is a single-group study, and allocation is listed as NA. The study therefore does not provide a concurrent control comparison.
Primary question
What proportion of participants achieved a partial response or complete response according to the 2014 Lugano criteria, measured up to 2 years? The registry record does not report the primary response result.
The clinical question is about observed tumor response in two uncommon lymphoma populations enrolled in the same study. The registry description frames the study as assessing the safety and effectiveness of belantamab mafodotin in relapsed or refractory plasmablastic lymphoma and ALK+ large B-cell lymphoma. Its primary outcome is a participant count for overall response rate, defined using partial response or complete response under the stated criteria.
Combining two diagnoses in one small, single-group study means the overall response question does not automatically describe either diagnosis separately. The registry record does not report how many participants had each condition, nor does it give diagnosis-specific response results. It also does not state the characteristics of the participants beyond the conditions and relapse or refractory status described in the study title and record.
Because no comparator is listed, the central question is not whether response is more frequent than under another treatment or than with no study treatment. It is a question about the response observed among participants treated in this study. The response result, its uncertainty, and the number of participants included in its calculation are not reported in the registry record. As a result, the clinical question can be identified, but the posted information does not provide an answer to it.
3. Trial Design
This is a phase 2 study of belantamab mafodotin in relapsed or refractory plasmablastic lymphoma and ALK+ large B-cell lymphoma. The listed model is single group, allocation is NA, and masking is none. No comparator arm is listed, so the design is not a randomized comparison. The registry record lists enrollment of 10 participants.
The intervention description identifies belantamab mafodotin as the study drug. The arm description states that it is administered intravenously on day 1 of a 21-day cycle and that treatment is intended to be delivered on an outpatient basis. The registry record does not report additional details about treatment duration, dose modification, discontinuation rules, or adherence.
The primary outcome is overall response rate, defined as the proportion of participants achieving partial or complete response under the 2014 Lugano criteria, measured up to 2 years. Secondary outcomes listed are complete response rate, progression-free survival, overall survival, and participants with treatment-related adverse events assessed by CTCAE v5.0. The record lists five outcome measures but no analyses.
The study start date is 2021-07-01, and the primary completion date is 2023-11-27. The status is terminated. The reason for termination is not reported in the registry record, so the status alone does not explain whether the planned enrollment, follow-up, or analysis was completed.
A single-group design can describe outcomes observed among treated participants, but it cannot directly isolate an intervention effect from the course of disease, participant selection, or other influences. Without a concurrent control group, differences from another treatment or from an untreated course cannot be estimated within this design. The registry record does not report further design details, including the planned sample-size justification, the statistical analysis plan, interim analyses, or the analysis population.
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 | (BELANTAMAB MAFODOTIN |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
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 | (BELANTAMAB MAFODOTIN |
|---|---|---|
| Participants analysed | 10 | |
| Age, Categorical: <=18 years | Participants | 1 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 |
| Age, Categorical: >=65 years | Participants | 2 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 7 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 8 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Response Rate, measured over Measured up to 2 years.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is overall response rate, expressed as the proportion of participants who achieved either partial response or complete response according to the 2014 Lugano criteria. The stated assessment period is measured up to 2 years. The registry record describes the endpoint as a count of participants and defines response by those two categories.
A response endpoint provides a direct summary of how many participants meet a predefined threshold for tumor response during the specified assessment period. It differs from a time-to-event endpoint, such as progression-free survival, because the primary measure is whether a participant meets the response definition rather than the time until an event. The registry also lists complete response rate separately as a secondary outcome, allowing that more specific response category to be considered separately if results are reported.
The interpretation of a response proportion depends on the denominator, the response assessment rules, and how missing or unevaluable assessments are handled. Those analysis details are not reported in the registry record. Nor does the record give the number who achieved partial or complete response, the total number assessed for response, or an uncertainty interval. Therefore, the endpoint can be described from its definition, but its observed value and precision cannot be assessed from the posted registry results.
In general, response criteria standardize how a response is classified, but they do not by themselves show whether an observed response is attributable to treatment. That distinction is especially relevant in a single-group study without a concurrent comparator.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a phase 2, single-group study with enrollment of 10 participants and a primary endpoint of overall response rate. It lists the endpoint definition and assessment period but does not report the primary response result. The record also lists zero analyses. Consequently, the posted information does not establish how many participants achieved a partial or complete response, what response proportion was observed, or how precisely that proportion was estimated.
This absence of an endpoint result is not equivalent to a result of zero responses. It means the response outcome is not reported in the registry record. There is no basis in the posted information to describe the treatment as having a particular response rate, to compare response between the two diagnoses, or to assess whether the response endpoint met a prespecified threshold. The registry record does not report such a threshold.
The single-group design matters to interpretation. Any response result, if reported, would describe participants in this study; without a concurrent comparison group, it would not by itself estimate a comparative treatment effect. A reader could not use this design to distinguish the influence of treatment from other factors that may affect observed outcomes. The enrollment of 10 also means that each participant's outcome could have substantial influence on a participant-count endpoint, though the actual response count is unavailable.
The registry lists several secondary outcomes: complete response rate, progression-free survival, overall survival, and treatment-related adverse events assessed by CTCAE v5.0. Their detailed results and analyses are not reported in the registry record. The adverse-event information does include counts of participants affected by serious and other adverse events, along with selected serious event terms. These safety counts are descriptive and do not fill the gap in the primary response result.
The record status is terminated, but the reason for termination is not reported in the registry record. Termination alone does not indicate why the study ended, whether follow-up was complete, or whether all planned analyses were conducted. The primary completion date is 2023-11-27, but that date does not supply a response estimate or explain the termination.
Any precision assessment would require a response estimate and its denominator, as well as a confidence interval or other uncertainty measure. Neither the response count nor a confidence interval is reported. In general, a confidence interval describes the range of values compatible with the observed data under the analysis assumptions; it is not a guarantee that the true value lies within that range. In this case, there is no posted response estimate around which to interpret such an interval.
The appropriate statistical reading is therefore limited: the record specifies the population, intervention, design, and primary endpoint, and it reports selected safety counts. It does not report the primary efficacy outcome or analyses. No conclusion about the magnitude, direction, or precision of the response result can be drawn from the registry information.
9. Statistical Methods Explained
The design determines which statistical questions can be answered. This study is listed as single group, with allocation NA and masking none. In general, a single-group study can summarize outcomes among participants receiving the intervention. It does not create a concurrent reference group, so it cannot estimate a randomized between-group contrast. A before-and-after or external comparison would require additional data and assumptions; the registry record does not report such an analysis.
What does the primary endpoint count?
The primary outcome is overall response rate, described as the proportion of participants who achieved partial response or complete response according to the 2014 Lugano criteria. Its timeframe is measured up to 2 years. For a binary endpoint, each participant is classified according to whether the outcome occurred under the endpoint definition. In general, the response proportion is interpreted alongside the number evaluated and the rule for handling participants without an evaluable assessment. Those denominator and missing-data rules are not reported in the registry record.
The response result itself is also not reported. There is no posted response count, proportion, or interval estimate to explain. The record lists zero analyses, so it does not provide an analysis output for the primary endpoint. This lack of a reported result should not be interpreted as evidence that no response occurred.
Why does the design affect interpretation?
Random allocation, when used, can support a comparison by creating groups intended to be comparable at baseline. Here, no such allocation or comparator is listed. A result from the study would therefore be a description of the treated group, not a randomized estimate of how outcomes differ under an alternative treatment. General statistical interpretation also depends on the population recruited, follow-up, and outcome assessment; details beyond those stated in the record are not reported.
Masking is listed as none. In general, lack of masking can affect how outcomes are assessed or reported, especially when judgments are involved. The registry identifies response criteria but does not report whether response assessments were independently reviewed or how assessment procedures were implemented. No further claims about the effect of masking on this study's results can be made from the record.
How should uncertainty be understood?
A confidence interval is a general way to express the statistical uncertainty around an estimate. For a participant proportion, it reflects the limited information available in the observed number of participants and the assumptions of the interval method. A narrow interval generally indicates greater precision than a wide interval, but an interval does not establish causality or eliminate potential bias. The registry record does not report an interval for the primary endpoint, and no response estimate is available to contextualize one.
The enrollment is 10. In general, when a binary outcome is measured in a small group, the observed proportion can be sensitive to the outcomes of individual participants and can be estimated imprecisely. This is a design-level consideration, not a calculation of the study's response result. Since the response count and analysis denominator are not reported, the actual uncertainty cannot be quantified from the record.
What do the safety counts describe?
The record lists 10 participants at risk for serious adverse events and 6 affected, and it lists 10 participants at risk for other adverse events and 10 affected. These are participant counts. A participant count does not necessarily communicate the total number of event episodes, their timing, duration, severity distribution, or relationship to treatment. Those details are not reported in the registry record.
The serious adverse-event terms listed include tumor lysis syndrome; blood and lymphatic system disorders - other, specify; eye disorders - other, specify; gastrointestinal disorders - other, specify; disease progression; and infections and infestations - other, specify. Each listed term is accompanied by 10.0%. The registry record does not give further details about event episodes or indicate how terms may overlap within participants. The selected terms should not be treated as a complete account of all clinical events.
What is not available about the analysis?
The statistical analysis plan, sample-size justification, interim analyses, analysis populations, and missing-data methods are not reported in the registry record. General methods for a binary endpoint could include a proportion estimate and an interval, but the record does not identify the method used or provide results. Likewise, the record lists secondary outcomes but does not give their analysis methods or numerical results.
The posted sample-size illustrations are planning calculations rather than observed trial outcomes. In general, such illustrations depend on assumptions about the effect to detect, significance level, allocation, and statistical model; they do not measure the probability that a completed study has detected a true effect. The stated illustration assumptions use two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. That hypothetical two-arm setup is not the listed single-group trial design. No resulting planning values are reported in the registry record, and such a calculation cannot substitute for the missing response outcome or serve as observed power.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and several secondary outcomes, but the statistical analysis plan is not reported in the registry record. It does not describe whether the study planned to adjust for multiple statistical tests, prioritize secondary outcomes, or use a testing sequence. When several outcomes are assessed, general statistical practice distinguishes the primary question from additional exploratory questions; testing many outcomes can increase the chance of observing an apparently unusual result by chance. Whether or how that issue was addressed in this study is not reported.
The record lists five outcome measures and zero analyses. It names overall response rate as the primary endpoint and lists complete response rate, progression-free survival, overall survival, and treatment-related adverse events as secondary outcomes. Numerical results for these endpoints, other than the listed safety counts, are not reported in the registry record. The record also does not describe any interim analyses or stopping boundaries.
Missing-data handling is not reported. For the primary response endpoint, the record does not state how participants without a response assessment, with incomplete follow-up, or otherwise unevaluable would be handled. The denominator used for the response proportion and the analysis population are also not reported. In general, different approaches to missing outcome data can produce different estimates, so this information is important for interpreting a reported endpoint result.
The registry status is terminated, but the reason and the consequences for follow-up or analyses are not reported in the registry record. It is therefore not possible to determine from the status alone whether missingness arose, whether the planned follow-up was completed, or whether all intended outcomes were analyzed. No assumptions about missing outcomes or unreported analyses should be substituted for the absent details.
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 |
|---|---|---|---|
| (BELANTAMAB MAFODOTIN | 6 | 10 | 60.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| (BELANTAMAB MAFODOTIN | 7 of 10 |
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 |
|---|---|
| (BELANTAMAB MAFODOTIN | 10 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | (BELANTAMAB MAFODOTIN |
|---|---|---|
| Tumor lysis syndrome | Blood and lymphatic system disorders | 1 of 10 |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | 1 of 10 |
| Eye disorders - Other, specify | Eye disorders | 1 of 10 |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | 1 of 10 |
| Disease progression | General disorders | 1 of 10 |
| Infections and infestations - Other, specify | Infections and infestations | 1 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | (BELANTAMAB MAFODOTIN |
|---|---|---|
| Fatigue | General disorders | 8 of 10 |
| Nausea | Gastrointestinal disorders | 5 of 10 |
| Platelet count decreased | Investigations | 5 of 10 |
| Anemia | Blood and lymphatic system disorders | 5 of 10 |
| Fever | General disorders | 5 of 10 |
| Edema limbs | General disorders | 4 of 10 |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | 4 of 10 |
| Vomiting | Gastrointestinal disorders | 4 of 10 |
| Eye disorders - Other, specify | Eye disorders | 4 of 10 |
| Headache | Nervous system disorders | 4 of 10 |
Serious events with the highest arm-level rate: tumor lysis syndrome (10.0%), blood and lymphatic system disorders - other, specify (10.0%), eye disorders - other, specify (10.0%), gastrointestinal disorders - other, specify (10.0%), disease progression (10.0%).
The registry record lists 10 participants at risk for serious adverse events, with 6 affected. It also lists 10 participants at risk for other adverse events, with 10 affected. These are counts of participants, not counts of individual event episodes. The record separately lists deaths as 7; it does not report timing, cause, or attribution for those deaths.
The selected serious adverse-event terms are tumor lysis syndrome; blood and lymphatic system disorders - other, specify; eye disorders - other, specify; gastrointestinal disorders - other, specify; disease progression; and infections and infestations - other, specify. Each term is listed with 10.0%. The registry record does not give further event-level detail or clarify whether one participant could contribute to more than one listed term. The terms therefore should not be added or interpreted as mutually exclusive categories.
These figures are descriptive safety information from a single-group study. They do not, on their own, establish that an event was caused by the intervention, nor do they provide a comparison with another treatment. The record does not report the event-level details, duration of exposure, or a comparative safety analysis needed for broader interpretation. Treatment-related adverse events are listed as a secondary outcome assessed by CTCAE v5.0, but the corresponding analysis is not reported.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase 2, single-group study examined belantamab mafodotin in relapsed or refractory plasmablastic lymphoma and ALK+ large B-cell lymphoma. It identifies overall response rate as the primary endpoint and defines response as partial or complete response under the 2014 Lugano criteria, measured up to 2 years. It also gives the listed intervention schedule and selected safety information.
It does not report the primary response result. There is no response count, response proportion, or precision estimate in the registry record. The absence of a posted result is not the same as a finding of no responses, and it does not justify an efficacy conclusion in either direction. The record also does not report diagnosis-specific outcomes, so no separate response conclusion can be drawn for either condition.
The single-group design means that any observed outcome would describe the study participants, without a concurrent control group for comparison. It cannot by itself show how outcomes would have differed under another treatment or in the absence of the study intervention. The enrollment of 10 and the absence of a reported analysis also limit how much can be inferred from the posted information.
The safety record reports participant counts for serious and other adverse events and lists selected serious event terms. These counts describe what was recorded in the registry; they do not establish causation or provide a complete comparative safety assessment. The listed deaths are not accompanied by details on timing or cause.
The record is marked terminated, but the reason for termination and its effect on outcome collection are not reported. Thus, the statistical meaning is bounded by what the registry actually reports: study design and endpoint definitions, enrollment and status, and selected safety counts. It does not provide the primary outcome analysis needed to quantify response or its uncertainty.
13. Why This Trial Matters Statistically
Statistically, this study is notable for the contrast between a clearly defined primary endpoint and the absence of a reported primary result. The endpoint is specified as the proportion achieving partial or complete response under the 2014 Lugano criteria, measured up to 2 years. That definition identifies what the study sought to measure, but without the observed response count and denominator, it cannot be translated into an estimate.
The design also shapes the questions that can be answered. A single-group study can describe outcomes among participants receiving the intervention, but it lacks a concurrent comparator for estimating a treatment contrast. The registry record lists two lymphoma conditions and enrollment of 10, yet does not report how participants were distributed between diagnoses or provide diagnosis-specific outcome data. Any overall summary would therefore need careful interpretation even if a response result were available.
The safety information illustrates the value and limits of descriptive counts. The registry reports participants affected by serious and other adverse events and lists selected serious event terms. Those counts document reported events, but they do not establish attribution, comparative risk, or the pattern of event timing and severity. A complete statistical reading would need the analysis details and event-level context, which are not reported.
The terminated status is another reason to distinguish a study record from an outcome analysis. The reason for termination is not reported, and the status does not reveal whether all intended follow-up or analyses were completed. The record's most important statistical limitation is therefore not merely small enrollment or a single-group design: it is that the central response outcome and its uncertainty are not reported. Clear endpoint definitions are useful, but they cannot replace outcome data.
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 registry record identifies enrollment of 10, but does not report the number analyzed for the primary outcome or the number with each diagnosis. Because the study combines relapsed or refractory plasmablastic lymphoma and ALK+ large B-cell lymphoma, the overall study description does not show whether outcomes differed by diagnosis. No condition-specific response estimates are reported.
The study is listed as single group, with allocation NA and masking none. There is no listed concurrent comparator, which limits interpretation to outcomes observed in the study rather than a direct comparative treatment effect. The registry record does not report further details about response assessment procedures, independent review, treatment exposure, or follow-up completeness.
The primary response result and its precision are not reported. The record does not provide the response count, analysis denominator, confidence interval, or method for handling unevaluable participants. The analysis population and missing-data approach are also not reported. Although several secondary outcomes are named, their results and analyses are not reported in the registry record.
The status is terminated, but the reason for termination is not reported. The record does not explain whether termination affected enrollment, follow-up, or analysis completion. The safety information is limited to participant counts and selected event terms; details about event episodes, timing, attribution, and overlap are not reported. These limitations prevent a fuller assessment of efficacy, precision, safety patterns, and the consequences of study termination.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma — NCT04676360.
- Registry record last updated 2026-03-13; status last verified 2026-03.
- Results first posted 2026-03-13.
- 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
NCT04676360 is a phase 2, single-group study of belantamab mafodotin in relapsed or refractory plasmablastic lymphoma and ALK+ large B-cell lymphoma. Allocation is listed as NA, masking as none, enrollment as 10, and status as terminated. The study start date is 2021-07-01, and the primary completion date is 2023-11-27.
The primary endpoint is overall response rate, defined as partial or complete response under the 2014 Lugano criteria and measured up to 2 years. The registry record lists secondary outcomes for complete response rate, progression-free survival, overall survival, and treatment-related adverse events assessed by CTCAE v5.0. It lists zero analyses and does not report the primary response result.
For safety, the record lists 6 participants affected by serious adverse events among 10 at risk, 10 affected by other adverse events among 10 at risk, and 7 deaths. The reason for termination, the primary analysis, and details of missing data and analysis populations are not reported in the registry record.