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 Bortezomib, Ifosfamide, and Vinorelbine Tartrate in Treating Young Patients With Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Therapy (NCT00381940), a na phase 2 study. The primary outcome is Complete Response (CR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00381940 |
| Phase | Phase 2 |
| Condition | Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 26 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Children and young adults with Hodgkin lymphoma that had recurred or had not responded to previous therapy. The listed conditions include several Hodgkin lymphoma subtypes and stages, but detailed eligibility criteria are not reported in the registry record. The primary endpoint population was patients evaluable for tumor response; the record says three enrolled patients were excluded from that population for specified reasons.
Intervention
A treatment combination of bortezomib, ifosfamide, and vinorelbine tartrate, with filgrastim support. The treatment description specifies intravenous administration on particular cycle days, with filgrastim continuing until blood counts recovered or peripheral blood stem cells were harvested. The registry record does not report the complete duration of treatment for each participant.
Comparator
There was no concurrent comparator group. The trial is listed as single-group, with allocation recorded as not applicable and masking listed as none. It therefore does not provide a randomized, like-for-like comparison against another regimen or a control group.
Primary question
The primary endpoint was the number of evaluable participants who achieved complete response after 2 cycles of treatment. Complete response required a substantial reduction in measured nodal masses or return to normal size, together with negative nuclear medicine imaging. The response count and its uncertainty are not reported in the registry record.
Statistically, this is a question about the frequency of complete response in a defined, treated group at a specified assessment time. A single-group response count can describe what happened among participants meeting the endpoint’s evaluation criteria, but it cannot by itself estimate how outcomes would have differed under another treatment. Without a comparator, differences from historical experience would also require a separate, clearly specified reference and assumptions that are not reported in the registry record.
The record lists 26 enrolled participants, while the primary endpoint description states that three enrolled participants were excluded from the tumor-response analysis. One was ineligible, one was removed after one dose of bortezomib, and one received only part of the intended bortezomib dosing because of a pharmacy error. These exclusions matter because the primary question concerns the evaluable population rather than every enrolled participant. The response result for that population is not reported in the registry record, so the observed frequency and its precision cannot be described.
3. Trial Design
This was a phase II, single-group study sponsored by the National Cancer Institute. The registry record lists the trial as completed, with a start in 2007-01 and primary completion in 2008-06. Enrollment was 26. The population was pediatric patients and young adults with recurrent or refractory Hodgkin lymphoma, as described in the official title and study summary.
All participants were assigned to the treatment regimen described in the record: ifosfamide, vinorelbine tartrate, and bortezomib, alongside filgrastim support. The regimen description gives ifosfamide intravenously over days 1-4, vinorelbine intravenously on days 1 and 5, bortezomib intravenously on days 1, 4, and 8, and filgrastim beginning on day 6. Treatment repeats, but the number of cycles or the complete treatment duration is not reported in the registry record.
Allocation is listed as not applicable, the model as single-group, and masking as none. These design features mean there was no randomized allocation and no masked treatment assignment. Accordingly, the treatment group cannot be compared with an internal control group, and this record does not support an estimate of a between-group treatment effect. The study can be read as a single-arm description of response and safety outcomes in the participants assessed.
The primary outcome was complete response after 2 cycles of treatment. The endpoint was defined by tumor-size change or return to normal size in conjunction with negative nuclear medicine imaging. Secondary outcomes listed in the record include grade 3 or 4 toxicity, overall response rate, induction success, successful peripheral blood stem cell harvest, and biological markers. Although the record lists six outcome measures, it does not report the statistical analysis results for them. Details such as eligibility rules beyond the population description, the planned sample-size rationale, and stopping or interim procedures are not reported in the registry record.
For interpretation, the single-group structure is central: an observed response proportion would describe outcomes in this treated cohort, not prove that the regimen caused those outcomes or was better than an alternative. The endpoint’s evaluable population also differs from the enrollment total because three participants were excluded from response evaluation for reasons stated in the 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 | Treatment (Ifosfamide, Vinorelbine, Bortezomib) |
|---|---|
| STARTED | 26 |
| COMPLETED | 21 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | Treatment (Ifosfamide, Vinorelbine, Bortezomib) |
|---|---|
| Lack of Efficacy | 3 |
| Protocol Violation | 1 |
| Ineligible | 1 |
Analysis population for the primary outcome, as defined in the registry: Analysis population includes all patients evaluable for tumor response. Three enrolled patients are excluded: 1 ineligible, 1 who was removed from treatment after 1 dose of bortezomib, and 1 who received only 1/3 dose of bortezomib in cycle 1 and part of cycle 2 due to pharmacy error.
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 | Treatment (Ifosfamide, Vinorelbine, Bortezomib) |
|---|---|---|
| Participants analysed | 26 | |
| Age, Continuous | years | 15.9 (SD 2.6) |
| Age, Categorical: <=18 years | Participants | 23 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 12 |
| Sex: Female, Male: Male | Participants | 14 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 |
| Race (NIH/OMB): White | Participants | 18 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 22 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 23 |
| Region of Enrollment: Australia | participants | 1 |
| Region of Enrollment: Canada | participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Complete Response (CR), measured over After 2 cycles of treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with complete response after 2 cycles of treatment. The record defines complete response as at least 80% reduction in the sum of the products of the perpendicular diameters of each nodal mass, or return to normal size, together with negative nuclear medicine imaging. Thus, the endpoint combines an assessment of tumor dimensions with imaging evidence; satisfying only the size criterion would not meet the full definition.
A binary response endpoint is useful for summarizing how many people in a defined assessment population meet a prespecified response definition at a particular time. The count can be converted into a proportion for interpretation, with a confidence interval describing the precision of that estimate. The response count and confidence interval are not reported in the registry record, so neither the observed proportion nor its precision can be stated.
The population is described as all patients evaluable for tumor response, rather than everyone enrolled. Three enrolled participants were excluded: one was ineligible, one was removed after one bortezomib dose, and one received only 1/3 dose of bortezomib in cycle 1 and part of cycle 2 because of a pharmacy error. This makes the analysis population definition important to understanding any response result; how the excluded participants would have been counted under another analysis approach is not reported in the registry record.
In general, response endpoints offer a defined clinical measure for an early-phase study, but they do not alone establish comparative benefit. This endpoint is assessed after a fixed treatment period, so it does not describe duration of response or time until progression. Those outcomes and their results are not reported in the primary endpoint description.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies complete response after 2 cycles as the primary endpoint, but does not report the number of complete responses, the corresponding proportion, or an uncertainty interval. Therefore, the primary response finding cannot be quantified from the registry record. The endpoint definition is detailed, but a definition is not a result: it specifies what would count as complete response, not how many participants met that criterion.
The study was single-group and unmasked, with no concurrent comparator. Even if a response count were available, it would describe the evaluable participants receiving the regimen. It would not provide a randomized estimate of how the regimen compares with another treatment. Any causal interpretation or comparison with outcomes from other settings would require additional evidence and assumptions that are not reported in the registry record.
The response analysis excludes three enrolled participants for reasons described in the record: ineligibility, removal after one dose of bortezomib, and a pharmacy error leading to partial dosing. Exclusion can affect the interpretation of an outcome when the analysis population differs from all enrolled participants. The record identifies who was excluded and why, but does not report an alternative analysis including them, a sensitivity analysis, or a missing-data method. The impact of the exclusions on the response estimate therefore cannot be assessed.
The record lists safety information for 25 participants at risk. Four participants were reported as having a serious adverse event, and 18 were reported as having another adverse event. The listed serious adverse event terms include hypokalemia at 8.0%, and abdominal pain, nausea, vomiting, fatigue, and anaphylaxis at 4.0% each. These are safety descriptions, not estimates of comparative risk: there is no control group in this trial. The registry record does not report deaths in the safety group.
Planning illustrations associated with the posted results use a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. They are described as based on fractions of the observed effect, rather than as the trial’s own design rationale. The record does not report a trial-specific sample-size justification. Such planning quantities are not observed power and do not replace the missing response result or its uncertainty.
Overall, the record describes the intended endpoint, the analysis population, treatment, and some adverse-event findings, but does not provide a primary efficacy estimate or inferential analysis. The absence of a reported response result means readers cannot judge the magnitude or statistical precision of the primary outcome from this record alone. No conclusion about comparative efficacy follows from the trial design or the listed safety counts.
9. Statistical Methods Explained
The primary outcome is a binary measure: each participant either met the registry definition of complete response at the assessment after 2 cycles or did not. A count is the direct summary for such an outcome. A proportion expresses that count relative to the population assessed, while an uncertainty interval communicates how much precision the estimate has. The response count, proportion, and interval are not reported in the registry record, so no numerical efficacy estimate can be interpreted.
What does a confidence interval convey?
In general, a confidence interval gives a range of values compatible with the observed data under a statistical procedure and its assumptions. A narrow interval indicates greater precision than a wide interval, although precision is not the same as freedom from bias. For a single-group binary endpoint, the interval would describe uncertainty around the response frequency in the analyzed population. It would not establish a treatment effect relative to another regimen, because this study has no concurrent comparator. No interval is reported for the primary outcome in the registry record.
Why does the analysis population matter?
The record defines the primary endpoint population as patients evaluable for tumor response and notes that three enrolled participants were excluded. Their stated reasons were ineligibility, removal from treatment after one bortezomib dose, and partial bortezomib dosing in cycle 1 and part of cycle 2 because of a pharmacy error. An estimate based on evaluable participants answers a question about that selected group. An estimate based on all enrolled participants could answer a different question, depending on how non-evaluable outcomes were handled. The registry record does not report an all-enrolled analysis or explain how missing endpoint assessments were treated.
In general, excluding participants can affect an estimate if those excluded differ in outcome prospects from those retained. That possibility does not establish that the result was biased; it means the population definition and exclusions need to be considered when interpreting the estimate. Because the response estimate itself is not reported, the magnitude of any such impact cannot be assessed from the registry record.
What can the design estimate?
A single-group study can describe outcomes observed in the treated group. It does not include a randomized control group from which to estimate a treatment contrast. In general, a comparison with an external or historical benchmark is vulnerable to differences in participant selection, outcome assessment, follow-up, and other aspects of care. No such benchmark or comparative analysis is reported in the registry record. The trial is also listed as unmasked, so the record does not indicate masked treatment assignment or outcome assessment.
The phase II label identifies the study phase, but it does not by itself reveal the planned statistical decision rule, target response threshold, or intended sample-size rationale. Those details are not reported in the registry record. A phase label should not be used to infer a protocol or a particular analysis method.
How should planning illustrations be read?
In general, a sample-size calculation is a planning exercise that describes the number of participants needed under specified assumptions about an effect, variability, significance level, power, allocation, and analysis method. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe effects to detect as stated fractions of the observed effect. The record also specifies that non-time-to-event planning quantities are participants per arm, while time-to-event quantities are total event counts using the Schoenfeld approach.
These planning assumptions are distinct from the design of this single-group trial and do not document why its enrollment was chosen. The actual numerical planning outputs are not stated in the registry record described for this analysis. Such illustrations are not observed power: observed power is not a substitute for presenting an effect estimate and its uncertainty. A planning calculation also cannot repair the absence of a reported primary response count.
What is over-dispersion in general?
Over-dispersion means that observed variability exceeds what a statistical model assumes. In general, ignoring it can make uncertainty appear smaller than it is, which can affect interval estimates and tests. It is particularly relevant when counts or clustered observations are analyzed using models that assume less variability. The primary endpoint is a participant-level binary response count, and the registry record does not report a model, an over-dispersion assessment, or any analysis of this kind. No claim about the use or relevance of a particular model can therefore be made for the trial analysis.
What analysis results are available?
The registry record lists six outcome measures and lists no analyses. It does not report a statistical analysis plan, test statistics, p-values, adjusted estimates, confidence intervals, or handling of repeated or multiple outcomes. These omissions limit what can be inferred about how the outcomes were analyzed. General statistical principles can explain what such methods would mean, but they cannot establish which methods were used in this study. The most defensible reading is to distinguish the endpoint definitions and safety counts that are reported from efficacy estimates and inferential results that are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary complete-response outcome and secondary outcomes covering toxicity, overall response, induction success, successful peripheral blood stem cell harvest, and biological markers. It does not report a statistical analysis plan describing how these outcomes were prioritized, whether any outcome hierarchy was used, or how multiplicity was addressed. When several outcomes are examined, general statistical practice recognizes that the chance of at least one apparently unusual result can increase if many tests are conducted. Whether that issue affected this study cannot be determined without the analyses and plan.
The primary response population is defined as participants evaluable for tumor response. Three enrolled participants were excluded, with the reasons stated in the record. This is important for distinguishing enrollment from endpoint analysis. The registry record does not report an intention-to-treat analysis, an alternative analysis of all enrolled participants, or sensitivity analyses evaluating the exclusions.
Missing-data methods are not reported in the registry record. It does not specify whether missing response assessments were treated as non-response, excluded, imputed, or handled in another way. The exclusion description explains some non-evaluability, but does not establish a general rule for all missing or incomplete endpoint data. The extent of missing outcome data beyond the three stated exclusions is not reported in the registry record.
The record also does not report interim analyses, monitoring rules, stopping criteria, or methods for adjusting statistical inference. These features should not be inferred from the phase II designation. Without an analysis plan and outcome-level results, readers cannot determine which comparisons were intended, how missingness was addressed, or how the reported outcomes relate to any prespecified inferential framework.
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 |
|---|---|---|---|
| Treatment (Ifosfamide, Vinorelbine, Bortezomib) | 4 | 25 | 16.0% |
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 |
|---|---|
| Treatment (Ifosfamide, Vinorelbine, Bortezomib) | 18 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment (Ifosfamide, Vinorelbine, Bortezomib) |
|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | 2 of 25 |
| Abdominal pain | Gastrointestinal disorders | 1 of 25 |
| Nausea | Gastrointestinal disorders | 1 of 25 |
| Vomiting | Gastrointestinal disorders | 1 of 25 |
| Fatigue | General disorders | 1 of 25 |
| Anaphylaxis | Immune system disorders | 1 of 25 |
| Anorexia | Metabolism and nutrition disorders | 1 of 25 |
| Dehydration | Metabolism and nutrition disorders | 1 of 25 |
| Depressed level of consciousness | Nervous system disorders | 1 of 25 |
| Neuralgia | Nervous system disorders | 1 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment (Ifosfamide, Vinorelbine, Bortezomib) |
|---|---|---|
| Infections and infestations - Other, specify | Infections and infestations | 7 of 25 |
| Neutrophil count decreased | Investigations | 6 of 25 |
| White blood cell decreased | Investigations | 5 of 25 |
| Anemia | Blood and lymphatic system disorders | 4 of 25 |
| Lymphocyte count decreased | Investigations | 4 of 25 |
| Febrile neutropenia | Blood and lymphatic system disorders | 3 of 25 |
| Death NOS | General disorders | 3 of 25 |
| Platelet count decreased | Investigations | 3 of 25 |
| Hypokalemia | Metabolism and nutrition disorders | 3 of 25 |
| Catheter related infection | Infections and infestations | 2 of 25 |
Serious events with the highest arm-level rate: hypokalemia (8.0%), abdominal pain (4.0%), nausea (4.0%), vomiting (4.0%), fatigue (4.0%).
The safety record lists 25 participants at risk for the treatment group. Four participants were reported as having a serious adverse event, and 18 were reported as having another adverse event. These figures describe participants affected, not necessarily the total number of separate events; one participant may have experienced more than one event. The record does not give event-level counts for the listed terms.
The serious adverse event terms with reported percentages are hypokalemia at 8.0%, and abdominal pain, nausea, vomiting, fatigue, and anaphylaxis at 4.0% each. These percentages are reported as listed; the record does not specify within this summary whether participants could contribute to multiple terms. The serious adverse event percentages should therefore be read as term-specific descriptions, not combined into a total or interpreted as mutually exclusive categories.
Serious adverse events and other adverse events are different reporting categories. The participant counts should not be added together to infer a number of unique participants affected, because overlap between categories is not reported. Deaths are not reported in the registry record. The safety data are from a single treatment group, so they do not establish how the frequency of adverse events compares with another regimen or with no treatment. They also do not, on their own, establish a causal relationship between an event and a particular drug.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II, single-group study evaluated a regimen of bortezomib with ifosfamide and vinorelbine tartrate in children and young adults with recurrent or refractory Hodgkin lymphoma. It specifies complete response after 2 cycles as the primary endpoint and defines the imaging and tumor-size criteria. It also describes the treatment schedule and reports selected safety information.
The primary efficacy result is not reported in the registry record. Consequently, the response frequency, its uncertainty, and the distribution of outcomes among participants cannot be described. A stated endpoint definition is not evidence that any particular number or proportion achieved the endpoint. The record’s outcome list also does not itself show the results for the secondary outcomes.
Even a reported response frequency in this design would describe the treated cohort, not establish a comparative treatment effect. There was no randomized comparator group, and the study was unmasked. The observed outcomes could not be separated from other explanations by a within-trial treatment contrast. The record does not report an external comparison or the assumptions needed to interpret one.
The safety counts indicate that serious and other adverse events were reported among participants at risk, with several serious-event terms listed and their percentages. They are not comparative risk estimates and do not establish causation. Because overlap between categories and event terms is not described, the counts should not be combined to infer a total number of unique participants or events. Deaths are not reported in the registry record.
The appropriate conclusion is therefore limited: the registry record documents the study design, the defined primary endpoint, the response-analysis exclusions, and selected adverse-event reporting. It does not provide the primary response result, a statistical analysis plan, or comparative evidence. These gaps prevent assessment of the magnitude and precision of the primary outcome and limit interpretation of the listed safety information to the descriptive report.
13. Why This Trial Matters Statistically
This trial illustrates why a result cannot be interpreted from an endpoint definition alone. The primary outcome is specified with a clear assessment time and response criteria, but the registry record does not report the response count or an uncertainty estimate. Without those results, readers cannot judge the observed frequency or its precision, regardless of how carefully the endpoint is described.
It also demonstrates the distinction between an evaluable analysis population and enrollment. The record reports 26 enrolled participants and states that three were excluded from the response-evaluable population, with reasons. A reader needs to know which participants contribute to an outcome and how non-evaluable participants were handled before interpreting a response proportion. The record does not report an alternative analysis or a missing-data strategy, so the sensitivity of the endpoint result to those choices is unknown.
The single-group design is another important statistical feature. It can describe outcomes in participants receiving the regimen, but it cannot create a randomized comparison that isolates a treatment contrast. This is not a criticism of the endpoint; it is a limit on the questions the design can answer. Statistical interpretation should match the design rather than treating a within-group outcome as comparative evidence.
Finally, the record distinguishes outcome measures from outcome analyses. Several secondary outcomes are listed, but analyses are not listed, and no analysis plan is reported. Planning illustrations based on stated assumptions are not trial-specific sample-size justification and are not observed power. Together, these points show why a careful statistical reading considers the estimand, analysis population, design, uncertainty, and reporting completeness—not just the treatment names or outcome labels.
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 primary limitation for interpretation is that the primary response result is not reported in the registry record. No complete-response count, proportion, confidence interval, or test result is available. The same record lists several secondary outcomes without reporting their results, which prevents a broader assessment of the outcomes named for the study.
The design is single-group, unmasked, and has no concurrent comparator. It can describe outcomes among participants who received the regimen, but it cannot estimate a randomized difference between treatments. The record does not describe an external comparison that might offer context. It also does not report enough detail to assess how outcomes were adjudicated or whether assessments were independently reviewed.
The primary endpoint analysis excludes three enrolled participants. The record gives reasons for each exclusion, including partial dosing caused by a pharmacy error, but does not report an alternative analysis including those participants or a sensitivity analysis. It does not state a general missing-data approach. Therefore, the consequences of restricting the analysis to response-evaluable participants cannot be evaluated from the registry record.
Other design and analysis details are not reported in the registry record, including the trial-specific sample-size justification, statistical analysis plan, multiplicity procedures, interim analyses, and stopping rules. The treatment description indicates that treatment repeats but does not provide the complete duration in the registry record of the record. These omissions limit assessment of how the planned design relates to enrollment and how the outcome analyses were intended to be interpreted.
The safety report is also descriptive. It provides participant counts and selected serious adverse-event terms, but not a comparator, event-level detail, or an account of overlap among terms and categories. Deaths are not reported in the registry record. These limits mean the listed safety information should not be treated as a comparative or causal estimate.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Bortezomib, Ifosfamide, and Vinorelbine Tartrate in Treating Young Patients With Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Therapy — NCT00381940.
- Registry record last updated 2021-03-24; status last verified 2021-03.
- Results first posted 2014-04-10.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This completed phase II study enrolled 26 participants and evaluated a single treatment group of children and young adults with recurrent or refractory Hodgkin lymphoma. The regimen included bortezomib, ifosfamide, vinorelbine tartrate, and filgrastim support. Allocation was not applicable and masking was listed as none.
The primary endpoint was complete response after 2 cycles, defined by tumor-size criteria together with negative nuclear medicine imaging. The response analysis excluded three enrolled participants for reasons specified in the record. The primary response result and its statistical uncertainty are not reported in the registry record.
Safety reporting lists 25 participants at risk, with four participants having a serious adverse event and 18 having another adverse event. Selected serious-event terms and percentages are reported, while deaths are not reported in the registry record. The record lists secondary outcomes but no analyses, and does not report the statistical analysis plan, missing-data methods, or multiplicity procedures. The single-group design supports descriptive interpretation, not a randomized comparison.