Brentuximab Vedotin and Lenalidomide in Treating Patients With Stage IB-IVB Relapsed or Refractory T-Cell Lymphoma: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Brentuximab Vedotin and Lenalidomide in Treating Patients With Stage IB-IVB Relapsed or Refractory T-Cell Lymphoma (NCT03409432), a na phase 2 study. The primary outcome is Overall Response Rate.

2. Clinical Question

The central statistical question is therefore whether the record reports the planned response measure and how precisely it is estimated. It specifies the endpoint and its definition, but not an observed estimate. Without the response count, denominator used for the endpoint, or confidence interval, readers cannot judge the magnitude or precision of the response rate from the registry record.

This is a phase II study, not a randomized comparison. Its single-group structure can describe outcomes among participants receiving the combination, but it cannot by itself separate treatment effects from other explanations for observed outcomes. The record gives an enrollment of 26; it does not state how many participants contributed to the primary endpoint analysis. The clinical question and the evidence available to answer it should therefore be kept distinct: the endpoint is described, while its numerical result is not reported in the registry record.

3. Trial Design

The registry record identifies this as a phase II study of brentuximab vedotin and lenalidomide in relapsed or refractory T-cell lymphomas. It lists a single-group model, no masking, and allocation as not applicable. These features mean the design does not include a randomized control arm or a blinded comparison. The record lists an enrollment of 26, but does not report how many enrolled participants received treatment or were included in each outcome analysis.

Participants in the treatment group are described as receiving brentuximab vedotin intravenously over 30 minutes on day 1 and lenalidomide orally once daily on days 1 through 21. Courses repeat every 21 days for up to 16 courses, in the absence of disease progression or unacceptable toxicity. Laboratory biomarker analysis is also listed as an intervention category, alongside the two drugs.

The primary outcome is overall response rate, defined as the proportion achieving complete or partial response using the Global Response Score. Its timeframe is up to 2 years. Secondary outcomes include adverse events according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0, overall survival, and progression-free survival. The record lists four outcome measures, but does not report analysis details for them.

The registry status is completed, and the listed primary completion date is 2025-07-16. A completed status does not itself establish that all planned analyses or results are reported. The record does not report the rationale for the enrollment target, eligibility details beyond the broad disease descriptions, follow-up completeness, or a statistical analysis plan. In particular, it does not describe how response assessments were scheduled, how missing assessments were handled, or which analysis population was used.

Because the design has one treatment group, outcomes can be described within that group but not interpreted as a randomized contrast against another treatment. Differences between this group and patients in other studies could reflect differences in patient selection, disease characteristics, follow-up, or assessment methods; the record does not supply a controlled comparison to address those possibilities.

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

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Overall Response Rate, measured over Up to 2 years.

Overall response rate is the proportion of patients who achieve either complete response or partial response. The registry record says that response and progression are defined using the Global Response Score, and gives a timeframe of up to 2 years. It describes the result as a percentage of participants and specifies a 95% confidence interval as the dispersion measure.

Response rate is used in clinical research as a way to summarize whether participants meet prespecified criteria for tumor response during an assessment period. Combining complete and partial responses into one endpoint gives a single proportion, but does not make the two response categories identical. The record does not provide the separate counts in either category, the observed overall response rate, or its confidence interval.

A confidence interval expresses the uncertainty around an estimated response proportion under the statistical method used. Its width depends on the data and method; without the interval or the underlying response count and analysis denominator, the precision of the estimate cannot be evaluated. The actual confidence-interval method is not reported in the registry record.

The endpoint is a proportion, not a time-to-event measure. It does not by itself describe how long responses last, when they occur, or how outcomes compare with a different treatment. Response duration is not reported as a primary endpoint in the record. Overall survival and progression-free survival are listed as secondary outcomes, but their numerical results are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods determine how trial observations become estimates and how much uncertainty accompanies those estimates. The registry record identifies an overall response rate endpoint and a 95% confidence interval, but it does not report the observed rate, interval limits, or method used to calculate the interval. The explanations below describe general statistical concepts and do not imply that a particular method was used in this trial.

What does a response proportion represent?

A response proportion is formed by counting participants who meet the response definition and relating that count to an analysis denominator. Here, the definition includes complete or partial response according to the Global Response Score. Interpretation depends on both the response count and the denominator. The enrollment of 26 is reported, but the number assessed for response and the analysis denominator are not reported in the registry record. Enrollment should not be substituted for an outcome denominator unless the analysis explicitly supports that choice.

For a proportion, the denominator is especially important when some participants lack an assessment, discontinue follow-up, or otherwise do not contribute to the endpoint. Different rules for such cases can yield different estimates. The registry record does not say whether missing response assessments were treated as nonresponse, excluded, or handled another way. No such rule can be assumed.

What does a confidence interval add?

In general, a confidence interval gives a range of values compatible with the data under a specified statistical method and its assumptions. It conveys sampling uncertainty around an estimate; it is not a guarantee that the true value lies in the interval, nor does it account automatically for bias, measurement error, or limitations in the study design. A narrower interval generally indicates greater precision under the method, while a wider interval indicates more uncertainty. The actual interval is not reported in the registry record, so neither its width nor the estimate’s precision can be assessed.

Confidence intervals for proportions can be calculated using different methods, and those methods may behave differently, particularly when the number of observations is limited or a proportion is near a boundary. The registry record specifies a 95% confidence interval but does not identify the calculation method. It is therefore not possible to evaluate method-specific assumptions or reproduce the reported interval from the registry information.

Why does the single-group design matter?

A single-group study can estimate an outcome among treated participants, provided outcome data and analysis rules are reported. It does not directly estimate a treatment contrast against a contemporaneous control group. General comparisons with external experience can be affected by differences in eligibility, disease mix, outcome assessment, follow-up, and other factors. Those differences are not resolved by calculating a confidence interval around a single-group response proportion. The record lists allocation as not applicable and describes a single-group model, so a randomized comparison is not part of the documented design.

No masking is reported. In general, lack of masking can matter when outcome assessment involves judgment, because knowledge of treatment assignment may affect assessment or reporting. The registry record does not provide details about independent review or safeguards for response assessment. The Global Response Score is named, but further assessment procedures are not reported.

How should planning illustrations be understood?

General sample-size planning asks how many participants or events might be needed to detect a specified effect under chosen assumptions. The planning assumptions described for the posted calculations refer to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of an observed effect. For time-to-event calculations, the stated quantity is a total number of events; for other calculations, it is participants per arm.

Those calculations are planning illustrations, not observed results and not the trial’s documented design justification. The record does not report the sponsor’s sample-size rationale or the inputs needed to assess the illustrations in detail. A planning calculation cannot establish that a completed study had a particular probability of detecting an effect. It is not observed power, and its assumptions should not be mistaken for a statistical plan used in the trial.

What can be said about other outcomes?

The record lists adverse events, overall survival, and progression-free survival as secondary outcomes. In general, time-to-event outcomes account for both whether an event occurs and the time until it occurs, with censoring possible when follow-up ends before an event is observed. The record does not provide survival estimates, event definitions beyond the outcome names, follow-up summaries, or analysis methods. No survival curve, hazard estimate, or comparison can be described from the registry record.

The record lists four outcome measures and zero analyses. That entry does not explain the analysis status or mean that no analyses occurred; the registry record does not clarify its interpretation. It also does not report adjustment methods, interim analyses, subgroup analyses, or a prespecified hierarchy among outcomes. These omissions restrict assessment of how results were selected and how uncertainty should be interpreted.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Treatment (Brentuximab Vedotin, Lenalidomide)")
n      <- c(26)
events <- c(9)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Treatment (Brentuximab Vedotin, Lenalidomide)  26  9  34.6  17.2  55.7  19.4  53.8  19.4  54.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists four outcome measures, including overall response rate and the secondary outcomes of adverse events, overall survival, and progression-free survival. It does not report an outcome hierarchy, multiplicity adjustment, or a statistical analysis plan. When several outcomes are examined, general statistical practice distinguishes a prespecified primary question from additional analyses; assessing many results can increase the chance of finding an apparently notable result by chance. Whether or how that issue was addressed in this trial is not reported in the registry record.

Missing-data rules and analysis populations are also not reported. The record gives an enrollment of 26, but does not specify how many participants were included in the primary endpoint analysis, how response assessments that were absent or unevaluable were handled, or whether the analysis followed an intention-to-treat or another population definition. These details affect the meaning of a response proportion because both the numerator and denominator depend on analysis rules.

The registry record does not describe interim analyses, stopping rules, or methods for incomplete follow-up on survival outcomes. It lists zero analyses, but does not explain what that registry entry signifies. No conclusion about whether analyses were performed, how many were performed, or whether their results were adjusted for multiplicity can be drawn from that entry alone.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: colitis (3.8%), dyspnea (3.8%), fever (3.8%), fracture (3.8%), lung infection (3.8%).

The treatment group’s adverse-event record lists 7 participants affected by serious adverse events among 26 at risk. The other adverse-event category lists 26 affected among 26 at risk. These are separate registry categories; the record does not explain their precise relationship or provide event-level timing and duration. The figures should not be treated as evidence that the treatment caused the events.

Six serious-event terms are listed, each with a frequency of 3.8%: colitis, dyspnea, fever, fracture, lung infection, and portal vein thrombosis. The registry record does not specify whether these terms count participants or event occurrences, whether individuals could appear in multiple categories, or how the listed terms relate to the total affected by serious adverse events. They should not be added together or interpreted as a complete account of safety.

The record also lists 16 deaths. It does not report their causes, timing, relationship to treatment, or the follow-up period associated with this count. The presence of a death count alone does not establish treatment-related mortality. Adverse-event interpretation generally requires context about severity, timing, attribution, exposure, and follow-up; those details are not reported in the registry record.

13. What the Result Does, and Does Not, Mean

The registry record describes a phase II, single-group study of brentuximab vedotin with lenalidomide and specifies overall response rate as the primary endpoint. It defines response as complete or partial response using the Global Response Score, with assessment over a timeframe of up to 2 years. The record does not report the observed response rate or its 95% confidence interval. Thus, the endpoint definition is available, but the numerical primary result and its precision are not.

The trial design also shapes what an observed response estimate could mean. In a single-group study, a response proportion describes outcomes in the treated group; it is not a randomized estimate of the difference between the combination and another treatment. It cannot by itself identify the effect attributable to the combination. That limitation holds regardless of whether a response estimate is large or small.

The adverse-event record gives counts for serious and other adverse events and lists deaths and several serious-event terms. These figures are useful as recorded safety information, but they do not establish causality. The registry record does not give enough context about timing, attribution, follow-up, or the death circumstances to support stronger interpretations. Nor does it report numerical results for the listed overall survival or progression-free survival outcomes.

Accordingly, the record supports a description of the study question, treatment regimen, design, endpoint definition, and reported adverse-event counts. It does not support a numerical assessment of the primary response outcome, its uncertainty, or comparative efficacy. Missing analysis details—including endpoint denominators, missing-data handling, and statistical methods—further limit interpretation. These are limits of what is reported in the registry record, not evidence for or against a treatment effect.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between a clearly described research question and a fully interpretable result. The registry record names a primary endpoint, defines the response categories, identifies the assessment framework, and states the timeframe. Yet it does not report the response estimate or its confidence interval. Without those, readers cannot judge either the observed response proportion or its precision.

The single-group design is another important feature. It can describe outcomes among participants receiving the regimen, but it does not create a randomized comparison. A within-group outcome and a between-group treatment effect answer different questions. This distinction is essential when interpreting phase II evidence and when considering comparisons with other studies, where patient selection and assessment methods may differ.

The safety information also illustrates why counts require context. The record lists serious and other adverse-event categories, serious-event terms, and deaths, but does not report attribution or detailed timing. Statistical summaries can describe recorded events; they cannot, by themselves, establish their cause. Clear definitions, denominators, follow-up, and analysis populations are needed for readers to understand what event frequencies represent.

Finally, the record’s omissions about missing data, analysis methods, and multiplicity matter because these choices influence how endpoints are estimated and interpreted. The documented enrollment and endpoint definitions are not substitutes for those details. Reading the record carefully means distinguishing what it specifies from what remains unreported, without turning design information or safety counts into conclusions about efficacy or causation.

15. 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 does not report the primary endpoint result, its 95% confidence interval, or the analysis denominator. It therefore does not permit an assessment of the magnitude or precision of the overall response rate. Although enrollment is listed as 26, the record does not establish that every enrolled participant was included in the response analysis.

Several elements needed to understand response ascertainment are also absent: the schedule of assessments, handling of unevaluable or missing assessments, analysis population, and confidence-interval method. The Global Response Score is named, but the record does not describe the assessment process or whether any independent review was used.

The single-group design has no concurrent control group, so it cannot provide a randomized treatment comparison. The record does not report details that would support an adjusted or external comparison. It also does not state a sample-size justification, interim-analysis plan, or strategy for multiplicity. The planning assumptions associated with illustrative calculations are not the trial’s reported design rationale.

For safety, the record lists affected counts, six serious-event terms, and deaths, but does not describe event timing, treatment attribution, event recurrence, or circumstances of death. Overall survival and progression-free survival are listed as secondary outcomes without numerical results or analysis details. These reporting gaps constrain interpretation of both benefits and harms and should not be filled by assumptions.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Brentuximab Vedotin and Lenalidomide in Treating Patients With Stage IB-IVB Relapsed or Refractory T-Cell Lymphoma — NCT03409432.
• Registry record last updated 2026-08-13; status last verified 2026-08.
• Results first posted 2026-08-13.
• 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.

19. Record Summary

The registry record describes a completed phase II, single-group study of brentuximab vedotin and lenalidomide for relapsed or refractory T-cell lymphoma. It lists an enrollment of 26, no masking, and allocation as not applicable. Treatment is described as brentuximab vedotin intravenously on day 1 and lenalidomide orally on days 1 through 21, repeating every 21 days for up to 16 courses, subject to progression or unacceptable toxicity.

The primary outcome is overall response rate, defined as complete or partial response using the Global Response Score over up to 2 years. The observed response rate and confidence interval are not reported in the registry record. Secondary outcomes include adverse events, overall survival, and progression-free survival. The record lists serious and other adverse-event counts, six serious-event terms at 3.8% each, and 16 deaths, without reporting the contextual details needed to establish causality or interpret timing. Analysis populations, missing-data methods, and a statistical analysis plan are not reported.