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 for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma (NCT01635283), a na phase 2 study. The primary outcome is Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01635283 |
| Phase | Phase 2 |
| Condition | Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Jonsson Comprehensive Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with low-grade glioma, including conditions listed as adult diffuse astrocytoma, adult mixed glioma, adult oligodendroglioma, recurrent adult brain tumor, and adult oligoastrocytoma. The registry record lists enrollment as 5. Its primary endpoint description refers to low-grade glioma patients and defines the relevant status as completing the maximum time allowed on study without tumor recurrence or progression.
Intervention
The intervention was a tumor lysate-pulsed autologous dendritic cell vaccine. The treatment description says patients received the vaccine on days 0, 14, and 28. Laboratory biomarker analysis is also listed as an intervention, but the registry record does not report the resulting biomarker findings.
Comparator
The study is recorded as a single-group trial with no allocation. Its primary endpoint description says the trial patients’ progression-free survival curve was compared with that of control patients matched for tumor grade, recurrence number, IDH1 status, and 1p/19q status. The record does not give the control group’s size or outcome data, and the study is not recorded as a randomized comparison.
Primary question
The primary question was progression-free survival after treatment with the autologous vaccine. The endpoint description says assessment began at the baseline date of surgery and continued to MRI evidence of tumor progression through study completion, up to 44 months. The registry record does not report a numerical progression-free survival estimate, a treatment effect, or an analysis result.
3. Trial Design
This was a phase II clinical trial recorded as completed. The registry lists a single-group model and allocation as not applicable; masking was none. Enrollment is recorded as 5. These design features mean the listed study group received the intervention, rather than being assigned through a randomized comparison within the trial.
The treatment group is described as receiving autologous glioma tumor lysate-pulsed autologous dendritic cells on days 0, 14, and 28. The intervention list also includes laboratory biomarker analysis. The registry identifies Jonsson Comprehensive Cancer Center as the sponsor. The recorded start date is 2012-01-10, and primary completion is recorded as 2016-05-13.
The primary endpoint was progression-free survival. The record describes assessment from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months. It also says a Kaplan-Meier curve for the trial patients was created and compared with a curve for control patients matched on tumor grade, recurrence number, IDH1 status, and 1p/19q status. However, outcome values for those controls and details about how matching was carried out are not reported in the registry record.
Overall survival and anti-tumor immune responses are listed as secondary outcomes. The registry record does not provide estimates or analysis results for these outcomes. It lists 3 outcome measures and 0 analyses. The record therefore describes the study’s purpose and endpoint approach, but does not give the numerical findings needed to assess the endpoint or secondary outcomes.
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.
Before assignment: Study enrollment patients must satisfy inclusion criteria, screening evaluations (vital signs, history, physical, neurological exams, Karnofsky Performance Scale, brain MRI , urinalysis, complete blood count, differential, platelets, coagulation tests), underwent leukapheresis, and had suitable Dendritic Cell (DC) Vaccine manufactured for them.
Overall Study
| Stage | Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells) |
|---|---|
| STARTED | 5 |
| COMPLETED | 1 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells) |
|---|---|
| Tumor Progression | 3 |
| Lost to Follow-up | 1 |
Analysis population for the primary outcome, as defined in the registry: Completed the maximum time allowed on study without being affected by Tumor Recurrence or Progression.
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 (Tumor Lysate-pulsed Autologous Dendritic Cells) |
|---|---|---|
| Participants analysed | 5 | |
| Age, Continuous | years | 46.2 (SD 21.95) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 3 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate, measured over Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was progression-free survival (PFS). In general, PFS describes the time until disease progression or death, according to the trial’s specified event definition. This registry record describes the endpoint in relation to MRI evidence of tumor progression, with assessment beginning at the baseline date of surgery and continuing through study completion, up to 44 months. Its population description refers to patients who completed the maximum time allowed on study without tumor recurrence or progression.
The record says a Kaplan-Meier curve was created for the trial patients and compared with a curve for control patients matched for tumor grade, recurrence number, IDH1 status, and 1p/19q status. A time-to-event endpoint can use information from participants who have not had a recorded event by their last assessment, rather than treating their follow-up as though progression had occurred. In general, that feature makes it possible to describe event timing when follow-up differs among participants.
The endpoint is clinically relevant to a study focused on slowing tumor growth, but the registry record does not report a PFS estimate, the number of progression events, a confidence interval, or a comparison result. It also does not report additional operational details such as censoring rules or how deaths were handled for this endpoint. The endpoint description alone therefore explains what the study intended to measure, not what the measured outcome was.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a phase II, single-group study of an autologous dendritic cell vaccine pulsed with autologous tumor lysate. Enrollment is recorded as 5. The primary outcome was PFS, with assessment described from the baseline date of surgery to MRI evidence of progression through study completion, up to 44 months. The record says a Kaplan-Meier curve was created and compared with a matched control curve.
The numerical PFS findings are not reported in the registry record. There is no posted survival estimate, event count, confidence interval, or reported statistical comparison to interpret. Although the record describes a comparison with matched controls, it does not provide the control outcomes or enough information to assess the magnitude or precision of any difference. The study’s single-group, nonrandomized design also means that the treatment group was not assigned against a concurrent randomized control group within the trial.
The listed secondary outcomes are overall survival and anti-tumor immune responses. The registry record does not report numerical results for either outcome. It lists 3 outcome measures and 0 analyses, so it does not supply analysis outputs that would clarify how these outcomes were evaluated or how estimates were derived.
The adverse event information is limited to counts: 0 serious adverse events affected participants among 5 at risk, while other adverse events affected 3 among 5 at risk. The record lists no serious adverse event terms. These counts describe what was entered in the registry; they do not establish the absence of all possible harms, and the record does not provide event descriptions or additional context such as severity, timing, or attribution.
Overall, the posted record supports a description of the design, intervention, endpoint, and recorded adverse event counts. It does not support a quantitative conclusion about PFS or overall survival, nor does it provide enough information to judge the comparative effect of the intervention. Such interpretation requires outcome estimates and their uncertainty, neither of which is reported for the primary endpoint.
9. Statistical Methods Explained
What does a Kaplan-Meier curve describe?
In general, a Kaplan-Meier curve estimates the proportion of participants who remain free of a defined event over time. For this trial, the registry identifies PFS and describes MRI evidence of tumor progression as the endpoint event. Each participant contributes information from the stated assessment origin until an event or the end of their observable follow-up. Participants who have not had a recorded event by their last assessment can be censored at that point, meaning their later event status is not known for the analysis.
Censoring is useful when participants have different follow-up durations, but it relies on assumptions about why follow-up ends. The registry record does not report its censoring rules, the number of censored observations, or whether death counted as a PFS event. Without these details or the curve itself, the endpoint description cannot be used to recover a survival estimate or assess the shape and precision of the estimated curve.
What would a matched comparison mean?
The endpoint description says the trial patients’ PFS curve was compared with a control curve matched for tumor grade, recurrence number, IDH1 status, and 1p/19q status. In general, matching aims to make groups more alike on specified characteristics. It does not itself create random assignment, and it cannot ensure that groups are comparable on characteristics that were not measured or included in the matching process.
The record does not report the control group’s size, its outcome values, the source of the controls, or the method used to match them. It also does not report an effect estimate or uncertainty interval for the comparison. Consequently, the described matching variables are not enough to assess the validity or precision of the comparison. The trial is recorded as single-group, with allocation not applicable, and the study record specifically notes that it is not a randomized comparison.
Why does uncertainty matter?
In general, an estimate describes the observed outcome, while a confidence interval describes the range of values compatible with the data under the method’s assumptions. The interval helps readers distinguish a precise estimate from one that is uncertain. For a time-to-event endpoint, precision depends on factors such as the observed event information and follow-up, not enrollment alone. The registry record does not report a PFS estimate, confidence interval, or event count, so the precision of the primary result cannot be assessed.
Likewise, a significance test, if reported, would address compatibility with a specified null hypothesis under its assumptions; it would not by itself describe the size or clinical importance of an effect. No primary endpoint test result is reported in the registry record. The record also does not give a statistical analysis plan or explain whether estimates were adjusted for any characteristics.
How should planning illustrations be understood?
The registry’s sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustrations are described as targeting a stated fraction of the observed effect. For time-to-event outcomes, the record says the tables give total events; other illustrations are described as participants per arm.
These assumptions are explicitly described as planning illustrations, not as the trial’s own design. The record does not report the trial’s sample-size justification or a numerical observed effect for the primary endpoint. Any planning illustration should therefore be understood as hypothetical rather than as a description of the study’s actual enrollment plan or an observed power calculation. Sample-size planning does not establish whether a trial’s findings are conclusive.
In general, power is a design-stage probability tied to assumptions about an effect, variability, significance threshold, and analysis. It is not a measure of the probability that a finding is true after observing data. The registry’s planning description does not provide sufficient numerical inputs to interpret a specific power calculation for this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures, including PFS as the primary outcome and overall survival and anti-tumor immune responses as secondary outcomes. It lists 0 analyses. Numerical results for the primary and secondary outcomes are not reported in the registry record.
When a study assesses more than one outcome or performs multiple statistical tests, the chance of finding at least one apparently unusual result can increase. In general, a statistical analysis plan may specify whether and how to account for multiple comparisons, or identify a primary analysis that receives priority. The registry record does not report a multiplicity strategy, an analysis plan, or the number of tests performed. It is therefore not possible to determine how multiple outcomes or analyses were handled.
Information about missing data is also not reported in the registry record. The record does not describe participants’ follow-up completeness, withdrawals, reasons for missing assessments, or an approach to missing outcome observations. For a time-to-event analysis, details about censoring and follow-up are important to interpreting the estimate; these are not given.
The analysis population is not reported in the registry record. It does not say whether the primary analysis included everyone enrolled, only participants who received treatment, or another defined group. Although enrollment is recorded as 5, enrollment alone does not identify the population used for an endpoint analysis. These omissions limit assessment of how the outcomes were analyzed and whether the reported results, if any, would represent all enrolled participants.
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 (Tumor Lysate-pulsed Autologous Dendritic Cells) | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells) | 0 of 5 |
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 |
|---|---|
| Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells) | 3 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells) |
|---|---|---|
| Seizure | Nervous system disorders | 2 of 5 |
| Headache | General disorders | 2 of 5 |
| Fatigue | General disorders | 2 of 5 |
| Anemia | Blood and lymphatic system disorders | 1 of 5 |
| Dysphasia | Nervous system disorders | 1 of 5 |
| Visual Distortions | Nervous system disorders | 1 of 5 |
| cognitive slowness | Nervous system disorders | 1 of 5 |
| Fractures | Musculoskeletal and connective tissue disorders | 1 of 5 |
| Myalgia | Musculoskeletal and connective tissue disorders | 1 of 5 |
| Squamous cell carcinomas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 5 |
The registry lists 0 serious adverse events affecting participants among 5 at risk in the treatment group. It lists 3 participants affected by other adverse events among 5 at risk. The serious adverse event terms list is empty. These are the safety counts recorded for the group; no additional event descriptions or numerical detail are reported.
In general, a count of participants affected is not the same as a count of individual event episodes: one participant may experience more than one event. The registry record does not clarify whether its counts refer to people, episodes, or both beyond its group fields, and it does not list the specific other adverse events. It also does not report severity grades, timing, duration, attribution to treatment, or the method used to collect adverse events.
The absence of recorded serious adverse events in this entry should be read narrowly as the registry’s reported count, not as evidence that no serious harm could occur. The record’s limited safety detail and enrollment of 5 constrain how much can be inferred from these counts.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II, single-group study was conducted to evaluate autologous dendritic cells pulsed with autologous tumor lysate in low-grade glioma. It identifies PFS as the primary endpoint and describes a Kaplan-Meier curve comparison with matched controls. It also identifies overall survival and anti-tumor immune responses as secondary outcomes.
However, the registry record does not report the primary endpoint estimate, its uncertainty, a statistical test result, or the matched control outcomes. It therefore does not establish the size or precision of any PFS difference. The descriptions of endpoint and comparison methods are not a substitute for outcome results. The secondary outcome names likewise do not show whether survival or immune responses changed.
The study’s single-group model and lack of random allocation matter when interpreting comparisons. Matching is mentioned in the endpoint description, but matching does not make this a randomized trial. The record does not provide the information needed to assess how the matched controls were selected or whether important differences remained between groups.
The safety entry reports 0 serious adverse events among 5 at risk and other adverse events affecting 3 among 5 at risk. Those counts do not characterize the event types or establish a complete safety profile. The registry also does not report the analysis population, missing-data handling, or multiplicity approach.
Thus, the registry record allows readers to understand the study’s stated aims and basic design, but it does not provide enough numerical outcome evidence for a quantitative assessment of efficacy or comparative benefit. This is a description of what is and is not recorded, not a recommendation about treatment.
13. Why This Trial Matters Statistically
This trial illustrates why a study’s endpoint description and its outcome results must be distinguished. The registry gives a clear time-to-event focus: PFS assessed from the baseline date of surgery to MRI evidence of progression, through study completion, up to 44 months. It also describes a Kaplan-Meier comparison with controls matched on specified tumor characteristics. Yet the record does not report the numerical PFS result or its uncertainty. Without those, readers cannot judge the magnitude or precision of the outcome.
The design also highlights the interpretive limits of nonrandomized comparisons. This was a single-group study with allocation recorded as not applicable. Matching is described, but the record does not provide control-group outcomes or matching details. Readers therefore cannot assess the comparability of the groups or the extent to which a comparison could support causal interpretation.
The registry records enrollment as 5, while listing 0 serious adverse events and other adverse events affecting 3 participants. These entries show how safety counts can be reported, but the missing event descriptions and limited study size restrict what can be inferred about the range and frequency of harms.
Finally, the record lists primary and secondary outcomes but does not report an analysis plan, analysis population, multiplicity approach, or missing-data handling. Those details matter for evaluating how results were selected and calculated. This study is statistically instructive because it makes the distinction between a stated endpoint, a described method, and reported evidence especially important.
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 has important limitations for interpreting this trial. It describes a single-group study with allocation not applicable and masking none; it is not a randomized comparison. Although the primary endpoint description refers to matched controls, the record does not report their number, source, outcomes, or matching procedures. The basis for judging comparability between the trial group and controls is therefore unavailable.
Most importantly, no numerical primary endpoint result is reported. The registry does not give a PFS estimate, event count, confidence interval, or comparison result. Numerical results for the secondary outcomes are also not reported. The record lists 3 outcome measures and 0 analyses, but does not explain how those measures were analyzed.
Other key details are not reported in the registry record: the analysis population, missing-data handling, censoring rules, the treatment of death in the PFS definition, and a statistical analysis plan. The record also does not provide details on the type, severity, timing, or attribution of the other adverse events. These omissions prevent fuller evaluation of the outcome estimates and safety findings.
Enrollment is recorded as 5. The record does not provide a trial-specific sample-size justification, and the sample-size assumptions are described as planning illustrations rather than as the trial’s own design. These features should be kept in mind when interpreting the limited information available; they do not supply missing outcome results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma — NCT01635283.
- Registry record last updated 2020-11-04; status last verified 2016-05.
- Results first posted 2020-11-04.
- 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
NCT01635283 is recorded as a completed phase II, single-group trial of tumor lysate-pulsed autologous dendritic cells for low-grade glioma. Enrollment is recorded as 5. The treatment description lists vaccination on days 0, 14, and 28. The primary endpoint was PFS, assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.
The registry describes comparison with controls matched for tumor grade, recurrence number, IDH1 status, and 1p/19q status, but does not report control outcomes or a numerical PFS result. Overall survival and anti-tumor immune responses are listed as secondary outcomes, without numerical findings. Safety entries report 0 serious adverse events among 5 at risk and other adverse events affecting 3 among 5 at risk.