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 Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma (NCT00478062), a na phase 1, phase 2 study. The primary outcome is Immunologic Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00478062 |
| Phase | Phase 1, Phase 2 |
| Condition | Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Results posted | Yes |
2. Clinical Question
Population
Patients who had received first-line therapy for Hodgkin's lymphoma. The registry record reports that the study enrolled one patient before closure due to slow accrual; further details about eligibility criteria are not reported in the registry record.
Intervention
A Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. The record also lists adjuvant therapy as a procedure.
Comparator
There was no separate comparator group. The study is recorded as single-group, with allocation listed as not applicable and no masking.
Primary question
The primary outcome was immunologic response, with a stated timeframe of 9 months. The registry record says the study closed due to slow accrual and no outcome measures were analyzed, so it does not provide an observed response result.
The study's stated purpose was to examine side effects and how well vaccine therapy works after first-line Hodgkin's lymphoma therapy. Statistically, its primary question concerned whether an immune response could be assessed after vaccination; the registry record does not provide a measured response or an analysis of that outcome.
The design cannot compare vaccination with another treatment or with no vaccination. With a single group, any observation would describe participants who received the intervention, rather than estimate a randomized between-group treatment contrast. In this record, even a descriptive outcome estimate is unavailable because no outcome measures were analyzed.
3. Trial Design
The registry describes a phase I/II, single-group study of a Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy for Hodgkin's lymphoma. It lists adjuvant therapy as a procedure. Allocation is recorded as not applicable, and masking as none. There was no like-for-like control group, so the study was not designed as a randomized comparison.
The record lists an enrollment of 1 and states that the study was closed because of slow accrual. Its status is terminated. The recorded start is 2007-04, and the primary completion date is 2008-06. These registry dates describe the study record; they do not establish when an individual participant was assessed.
The primary outcome is titled Immunologic Response, with a timeframe of 9 months. Four outcome measures are recorded, but the registry record says that no data was analyzed for any outcome measure. It reports no outcome analyses. Details such as the planned statistical model, a sample-size justification, interim analyses, and rules for ending the study are not reported in the registry record.
Because the trial stopped after enrolling one patient, its design and observed evidence need to be distinguished. The single-group design describes the intended structure, while the closure and absence of analyzed outcome data mean the registry record cannot furnish an estimate of immunologic response or a comparative treatment effect. The sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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 | Cell Vaccine After Initial Therapy for Hodgkin Lymphoma |
|---|---|
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.
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 | Cell Vaccine After Initial Therapy for Hodgkin Lymphoma |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Immunologic Response, measured over 9 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled Immunologic Response and has a timeframe of 9 months. The registry record does not describe the specific assay, response definition, measurement scale, assessment schedule, or threshold used to classify a response. Those details are not reported in the registry record.
In general, an immune-response endpoint can be used to assess a biological response to an intervention. Such a measure may answer a different question from a clinical outcome: it records an immune measure rather than directly describing a patient's clinical course. The meaning of a particular immune-response endpoint depends on how it is measured and defined, which cannot be determined from the title alone.
Here, the registry record states that the study closed due to slow accrual, with only one patient enrolled, and that no data was analyzed for any outcome measure. Therefore, no primary-endpoint estimate, response count, uncertainty interval, or statistical test is reported. The stated 9-month timeframe does not show that an assessment at that time was completed or analyzed. Without a reported operational definition and analyzed observations, the endpoint's measured value and precision cannot be interpreted.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The principal statistical fact is that the registry record contains no analyzed outcome data. Although the primary outcome is listed as Immunologic Response at 9 months, the record states that the study closed due to slow accrual and that no data was analyzed for any outcome measure. There is therefore no reported estimate of immune response, no interval describing its uncertainty, and no outcome-based test of a hypothesis.
The enrollment is recorded as 1. That limited enrollment and the absence of analyzed outcomes leave no basis in this record for estimating a response frequency, describing variability, or assessing how precisely a population quantity has been estimated. No numerical inference about the primary endpoint can be drawn from a registered endpoint title or timeframe alone.
The study is listed as single-group, with allocation not applicable and no masking. Thus there is no randomized contrast. Even if an outcome had been reported for the intervention group, a single-group observation would not, by itself, distinguish an intervention effect from other explanations for the observed outcome. In this record, there is also no analyzed observation to describe.
The safety record lists one at risk in the cell-vaccine group and zero affected for serious adverse events, other adverse events, and deaths. No serious adverse-event terms are listed. These entries are limited safety summaries, not estimates that establish the absence of risk. The record does not report a detailed safety analysis or event-specific exposure information beyond those entries.
The trial status is terminated, and slow accrual is the recorded reason for closure. This explains why the planned study did not produce analyzed outcome measures in the registry record; it does not itself indicate whether the vaccine did or did not produce an immune response. Any interpretation should remain focused on the absence of analyzable results, rather than treating the absence of reported outcomes as an observed clinical or biological effect.
The record does not report a statistical analysis plan, an analysis population definition, or a sample-size justification. No sponsor analysis is reported for outcomes. Consequently, there is no sponsor result to compare with any recalculation, and no basis for interpreting planning quantities as evidence about a treatment effect.
9. Statistical Methods Explained
The registry record does not report outcome analyses. The statistical concepts below are general explanations for interpreting the kinds of information that would ordinarily accompany a clinical trial result; they are not descriptions of analyses conducted in this study.
What does an outcome estimate describe?
In general, an estimate condenses observed data into a quantity relevant to the study question. For an immune-response endpoint, the estimate would depend on the recorded measurements and the prespecified response definition. A point estimate alone does not show how much uncertainty remains. A confidence interval is a range of values compatible with the data under the analysis assumptions; a wider interval usually indicates less precision. No estimate or confidence interval for Immunologic Response is reported in this record.
The endpoint title and its 9-month timeframe do not specify the analysis. For example, the record does not report whether response was to be treated as a category, a continuous measurement, or another type of outcome. It also does not report how a missing assessment would be handled or which participants would be included in an analysis. Those choices can affect both the estimate and its interpretation.
Why does the single-group structure matter?
In general, a single-group study can describe outcomes among participants receiving an intervention, if outcomes are collected and analyzed. It cannot directly estimate a randomized difference between intervention and control groups when no control group exists. A comparison with historical experience or an external benchmark would require an explicit source and method; neither is reported in the registry record. Here, there is no analyzed outcome estimate even for the single group.
Allocation is listed as not applicable and masking as none. A lack of masking can matter in general when measurements or assessments involve judgment, because knowledge of treatment may influence how observations are collected or interpreted. The registry record does not describe the immune-response measurement procedure, so the relevance of that concern to this endpoint cannot be assessed. This general point is not evidence that bias occurred in this study.
What can significance testing establish?
In general, a hypothesis test evaluates how compatible the observed data are with a specified null hypothesis under model assumptions. A p-value is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. Statistical significance also does not establish that an estimate is precise. No p-value, hypothesis test, or analyzed effect estimate is reported for the study's outcomes, so no test-based conclusion can be drawn.
Model assumptions matter because a statistical calculation is only as informative as the data and assumptions supporting it. For example, a model for counts may need to account for over-dispersion—variation greater than the model allows—when that feature is present. This is a general concept, not a claim that over-dispersion was relevant. The record does not provide outcome data or an analysis model from which to assess distributional assumptions.
How should planning illustrations be understood?
In general, sample-size calculations explore how many participants or events might be needed under stated design assumptions to detect a specified effect with a chosen significance level and power. They are planning illustrations, not observed outcomes and not a measure of the probability that a completed study has demonstrated an effect. The registry record's planning assumptions specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is described as a stated fraction of an observed effect. For time-to-event calculations, the assumptions refer to a total number of events, while other calculations refer to participants per arm.
Those assumptions do not describe the actual single-group design recorded for this study: the trial has no two-arm allocation and enrolled one patient. The record does not report an analyzed observed effect to anchor such a planning illustration. Accordingly, any planning quantity should not be interpreted as a result from this trial, as observed power, or as evidence that the study tested a particular effect successfully. The protocol's own sample-size justification is not reported in the registry record.
More broadly, no statistical plan, interim-analysis method, or stopping rule is reported. The recorded closure reason is slow accrual. It is not appropriate to infer that an unreported statistical boundary or interim finding led to termination. The available record supports a narrow interpretation: it documents a planned immune-response outcome and a terminated single-group study, but no analyzed outcome results.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists four outcome measures, but it does not report analyses for any of them. The primary outcome is titled Immunologic Response; the titles and definitions of the other outcome measures are not included in the record. No multiplicity adjustment or hierarchy among outcomes is reported in the registry record.
In general, testing several outcomes can increase the chance of obtaining at least one apparently notable result by chance if each is assessed independently without adjustment. Researchers may address this through a prespecified primary outcome, a testing hierarchy, or an adjustment method. The appropriate approach depends on the study's aims and analysis plan. No such strategy is reported for this trial, and the absence of analyzed outcomes means there are no reported outcome tests to interpret.
Missing-data rules and analysis populations are also not reported in the registry record. In general, missing observations can affect estimates when the people or assessments missing differ systematically from those observed. Analysis-population definitions specify which enrolled participants contribute to a particular analysis. These details matter for interpreting a result, but no outcome analysis is available, and the record does not state whether an endpoint assessment was missing, not collected, or simply not analyzed.
The record states that the study closed because of slow accrual and that no data was analyzed for any outcome measure. It does not report imputation, sensitivity analyses, or a method for handling incomplete follow-up. No conclusions about the effect of missing data or the representativeness of an analysis population can therefore be drawn.
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 |
|---|---|---|---|
| Cell Vaccine After Initial Therapy for Hodgkin Lymphoma | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cell Vaccine After Initial Therapy for Hodgkin Lymphoma | 0 of 1 |
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 |
|---|---|
| Cell Vaccine After Initial Therapy for Hodgkin Lymphoma | 0 of 1 |
The safety entries are limited to one at risk in the cell-vaccine group. The record lists zero affected for serious adverse events, zero affected for other adverse events, and zero deaths. No serious adverse-event terms are listed.
These zeros mean that the registry safety summary records no affected participants in those categories; they should not be read as proof that an intervention has no risk. The record also states that only one patient was enrolled and that the study closed due to slow accrual. With such limited recorded exposure, the safety entries cannot characterize uncommon events or provide a precise estimate of event frequency.
In general, an adverse-event count depends on how events were defined, collected, and followed over time. The registry record does not give event-specific descriptions, observation time, severity details, or a fuller account of safety monitoring. It also does not list serious-event terms. Thus, the figures support only a description of what the registry safety summary reports, not a broad claim about safety or a comparison with another treatment.
12. What the Result Does, and Does Not, Mean
The registry record documents a phase I/II, single-group study of a Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy for Hodgkin's lymphoma. Its primary outcome is Immunologic Response, with a stated timeframe of 9 months. The study was terminated after slow accrual, with one patient enrolled, and the record says no data was analyzed for any outcome measure.
These registry entries mean that the posted record does not establish an immune-response result. It gives no outcome estimate, uncertainty interval, or statistical test from which to judge the direction, magnitude, or precision of a response. The lack of an analyzed result is not evidence that there was no immune response; it is an absence of a reported analysis.
The single-group structure also limits what could be concluded even if a group outcome were available. Without a comparator, a treatment contrast against an alternative cannot be estimated directly. This record contains no reported outcome estimate for the intervention group either, so it supports neither a comparative conclusion nor a descriptive response estimate.
The safety summary records zero affected for serious adverse events, other adverse events, and deaths, among one at risk. Those entries describe the registry summary but do not establish that risk is absent or quantify safety precisely. The record does not supply detailed event descriptions or a broader safety analysis.
In general, trial registration and outcome reporting answer different questions: a registered plan identifies intended measures, while analyzed results describe observations and uncertainty. Here, the registered primary measure and timeframe are documented, but the record explicitly states that outcome data were not analyzed. Readers should therefore treat this entry as a record of a terminated study without analyzed efficacy or endpoint results, not as evidence for or against the vaccine's effect.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the difference between a registered outcome and an analyzed result. The registry identifies Immunologic Response as the primary outcome and gives a 9-month timeframe, but it also states that no outcome measures were analyzed. The endpoint's presence in the record does not supply a measured value or evidence about the outcome.
It also illustrates the limits imposed by study size and design. The record describes a single-group study and an enrollment of 1. A single-group structure does not provide a randomized control contrast, and this record has no analyzed group outcome to summarize. Statistical methods cannot recover a treatment comparison or endpoint estimate when the required comparison or analyzed observations are absent.
The status and closure reason are important context for interpreting the record. It is marked terminated, and slow accrual is given as the reason for closure. That is different from a trial being stopped because of an outcome analysis; no interim analysis or statistical stopping rule is reported in the registry record.
The entry also helps distinguish planning calculations from trial evidence. General sample-size planning uses assumptions about effect size, significance level, allocation, and model. Such calculations are not observed power and cannot replace outcome data. In this case, the record supplies planning assumptions but no analyzed outcome effect to interpret as an observed result.
For biostatistical interpretation, a transparent statement of what is missing is as important as describing a positive or negative result. The record supports conclusions about the study's design, termination, enrollment, and lack of analyzed outcomes. It does not support an inference about immune response or comparative efficacy.
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 is explicit: the study closed due to slow accrual, with one patient enrolled, and no data was analyzed for any outcome measure. There is consequently no reported primary-endpoint estimate or analysis of the other registered outcomes.
The study is single-group, with allocation listed as not applicable and no masking. A control comparison is not available. Even a reported single-group outcome would not, on its own, establish a comparative treatment effect; in this registry record, no analyzed outcome is available at all.
The primary endpoint is named Immunologic Response, but the measurement method, response definition, scale, and assessment details are not reported in the registry record. The stated 9-month timeframe does not establish that an assessment was completed. Eligibility criteria beyond the broad population description, follow-up details, missing-data rules, analysis populations, statistical methods, and sample-size justification are also not reported.
The safety summary lists zero affected for serious adverse events, other adverse events, and deaths, with one at risk. The limited enrollment and lack of further event detail prevent a broad assessment of safety or event frequency. No serious adverse-event terms are listed.
Finally, the registry record does not report an interim-analysis approach or a statistical stopping rule. Slow accrual is the recorded reason for closure, and no additional reason should be inferred from the absence of analyzed outcomes. These limitations define what the record can support: a description of a terminated study and its lack of outcome analyses, rather than an estimate of benefit, harm, or immune response.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma — NCT00478062.
- Registry record last updated 2018-02-28; status last verified 2016-10.
- Results first posted 2018-02-28.
- 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
The registry describes a phase I/II, single-group study of a Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy for Hodgkin's lymphoma. Allocation is listed as not applicable, and masking as none. The primary outcome is Immunologic Response at 9 months.
The study is marked terminated. The record gives slow accrual as the reason for closure, lists an enrollment of 1, and states that no data was analyzed for any outcome measure. Four outcome measures are recorded, but no outcome analyses are reported. Safety entries list one at risk and zero affected for serious adverse events, other adverse events, and deaths.
Accordingly, the registry record provides no analyzed estimate of immune response, no comparative treatment effect, and no outcome-based statistical conclusion.