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 Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma (NCT00972478), a na phase 1, phase 2 study. The primary outcome is Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00972478 |
| Phase | Phase 1, Phase 2 |
| Condition | Ann Arbor Stage II Non-Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 83 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with newly diagnosed diffuse large B-cell lymphoma at Ann Arbor Stage II, Stage III, or Stage IV were the intended population. The record describes Phase I eligible patients for the primary endpoint as those receiving any amount of the assigned dose during Cycle 1, or those who developed a dose-limiting toxicity. The endpoint population is therefore defined around assigned dose and toxicity during the initial cycle, rather than simply all people enrolled.
Intervention
The treatment combined oral vorinostat with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, a regimen identified as R-CHOP. Vorinostat was given once daily on days 1-5 or 1-9 according to dose level. The other treatment schedule and the dose-level distinction are described in the record; a full dosing rationale is not reported in the registry record.
Comparator
There was no randomized control group. The registry describes a single-group model, and allocation is listed as not applicable. Phase I and Phase II are different parts of the trial, not randomized treatment arms that can automatically be treated as equivalent groups. The record cautions that the arms are not a like-for-like control comparison.
Primary question
The Phase I primary question was what daily oral dose of vorinostat, in combination with R-CHOP, met the stated safety criterion: 3/10 or fewer patients with dose-limiting toxicities during Cycle 1. Toxicities were to be drug-related and graded under CTCAE Version 4.0. The primary endpoint is a dose-safety question, not a direct comparison of treatment efficacy with another regimen. A primary endpoint result is not reported in the registry record.
3. Trial Design
This was a Phase I/II trial for patients with newly diagnosed Stage II, Stage III, or Stage IV diffuse large B-cell lymphoma. The registry identifies the study model as single group, with no allocation and no masking. Enrollment is listed as 83. The sponsor is the National Cancer Institute. The recorded study start is 2010-11-15, primary completion is 2015-12-30, and status is active, not recruiting.
The regimen combined vorinostat with rituximab and chemotherapy drugs: cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone. In the described treatment schedule, vorinostat was taken orally once daily on days 1-5 or 1-9 according to dose level. Rituximab, cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate were administered on day 3; prednisone was taken orally once daily on days 3-7. Treatment repeated every 21 days. The record also lists laboratory biomarker analysis as an intervention.
The Phase I primary endpoint concerned the safe dose of vorinostat with R-CHOP. Its assessment window was 21 days, corresponding to Cycle 1. The record describes a dose-limiting toxicity threshold of 3/10 or fewer patients and specifies that the toxicity should be drug-related. Phase II outcomes listed in the record include overall survival, response rate defined as complete response plus partial response, and toxicity.
The record does not report random assignment, a concurrent control group, or masking. It also does not report the rationale for the planned enrollment, the dose-escalation procedure, or a detailed statistical analysis plan. The Phase I and Phase II cohorts should therefore not be read as randomized groups suitable for a direct comparative treatment-effect estimate.
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 | Ph I: R-CHOP+Vorinostat (400mg D1-9) | Ph II: R-CHOP+Vorinostat |
|---|---|---|
| STARTED | 11 | 72 |
| Eligible and Began Protocol Therapy | 9 | 63 |
| COMPLETED | 4 | 34 |
| NOT COMPLETED | 7 | 38 |
Reasons for not completing this period:
| Reason | Ph I: R-CHOP+Vorinostat (400mg D1-9) | Ph II: R-CHOP+Vorinostat |
|---|---|---|
| Adverse Event | 3 | 16 |
| Withdrawal by Subject | 1 | 8 |
| Progression/Relapse | 0 | 2 |
| Death | 0 | 2 |
| Not protocol specified | 1 | 1 |
| Ineligible | 1 | 7 |
| Not start protocol treatment | 1 | 2 |
Analysis population for the primary outcome, as defined in the registry: Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 (1 Cycle = 21 days) or whom developed a dose-limiting toxicity (DLT).
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.
Population: Eligible patients who began protocol therapy
| Characteristic | Unit | Ph I: R-CHOP+Vorinostat (400mg D1-9) | Ph II: R-CHOP+Vorinostat | Total |
|---|---|---|---|---|
| Participants analysed | 9 | 63 | 72 | |
| Age, Continuous | years | 66.9 (46.4 to 83.8) | 64.1 (19.6 to 80.8) | 64.2 (19.6 to 83.8) |
| Sex: Female, Male: Female | Participants | 3 | 27 | 30 |
| Sex: Female, Male: Male | Participants | 6 | 36 | 42 |
| Race/Ethnicity, Customized: White | participants | 9 | 54 | 63 |
| Race/Ethnicity, Customized: Black | participants | 0 | 3 | 3 |
| Race/Ethnicity, Customized: Asian | participants | 0 | 5 | 5 |
| Race/Ethnicity, Customized: Unknown | participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Hispanic | participants | 3 | 4 | 7 |
| Race/Ethnicity, Customized: Non-Hispanic | participants | 6 | 59 | 65 |
6. Primary Endpoint
The registry lists the primary outcome as Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I), measured over 21 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg PO Once daily Days 1-9 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the safe dose of vorinostat when given with R-CHOP, expressed in milligrams taken orally once daily on days 1-9. The record defines a dose as meeting the safety criterion when 3/10 or fewer patients have dose-limiting toxicities. Toxicities are assessed during Cycle 1, described as 21 days, and must be drug-related, with possible, probable, or definite attribution. The record says toxicity grading uses the NCI Common Terminology Criteria for Adverse Events Version 4.0.
This endpoint is used in Phase I dose-finding because a combination regimen needs a dose that can be carried forward while taking early toxicity into account. It is not an endpoint of comparative effectiveness: it does not, by itself, estimate whether the combination improves outcomes relative to another treatment. The registry’s endpoint population includes Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 or those who developed a dose-limiting toxicity. That definition is important when interpreting the denominator, since the endpoint population is not necessarily identical to everyone enrolled.
The registry record does not report the primary endpoint result, including which dose met the criterion. Consequently, the posted information does not establish the selected safe dose or the uncertainty around that selection.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a Phase I/II investigation of vorinostat combined with R-CHOP in newly diagnosed advanced-stage diffuse large B-cell lymphoma. Its design is single group, without masking or random allocation. The primary Phase I objective is dose safety during Cycle 1, while the listed Phase II outcomes include overall survival, response rate, and toxicity. These objectives address different questions: early dose-limiting toxicity helps characterize tolerability at a dose level, whereas survival and response describe clinical outcomes over a longer course of observation.
The central limitation for interpreting efficacy is that the registry record does not report a primary dose-safety result or results for the listed Phase II outcomes. A named endpoint is not itself an observed finding. Without the outcome values, estimates of precision, and analysis details, no conclusion about response or survival can be drawn from the registry information summarized in the record. The stated rationale that the combination may affect cancer cells is part of the study description, not evidence of an observed treatment effect.
The adverse-event summary contains safety counts for two reported groups. For the Phase I R-CHOP plus vorinostat group labeled 400mg D1-9, 5 of 9 participants at risk are listed as having a serious adverse event. For the Phase II R-CHOP plus vorinostat group, 44 of 63 are listed as affected. The record also lists other adverse events in 9 of 9 and 63 of 63 participants, respectively. These summaries describe the posted safety data; they do not establish that events were caused by a specific drug, nor do they supply a randomized comparison.
The serious-event terms reported most often include platelet count decreased at 44.4%, febrile neutropenia at 34.9%, anemia at 33.3%, sepsis at 33.3%, neutrophil count decreased at 33.3%, and white blood cell decreased at 22.2%. They provide information about the types of serious events recorded, but the registry summary does not provide their event-specific participant counts or further details about timing and attribution. The percentages should be read as registry summaries, not as comparative risks against an untreated or alternative-treatment group.
The enrollment figure of 83 does not by itself identify how many participants contributed to each endpoint or analysis. The adverse-event groups have their own reported at-risk counts, and the primary endpoint has a specific Phase I analysis population. Details of missing observations, endpoint analysis populations beyond that definition, and statistical methods for the Phase II outcomes are not reported in the registry record. The results therefore support a limited description of recorded safety summaries and trial intent, not a complete assessment of dose selection or efficacy.
9. Statistical Methods Explained
Several statistical ideas help distinguish the questions this study was designed to address from the results that can be interpreted. The registry describes Phase I and Phase II components, but a phase label does not replace the analysis details needed to understand an estimate. The record names outcomes and gives some safety summaries; a detailed statistical plan and outcome analyses are not reported in the registry record.
What does a dose-safety endpoint measure?
A dose-safety endpoint applies a defined rule to toxicity observations at a dose level. In this record, the rule is 3/10 or fewer patients with dose-limiting toxicity during Cycle 1. The rule gives a decision criterion for identifying a dose considered acceptable under the study definition. It does not mean that every patient experiences the same risk, and it does not measure response or survival. The interpretation depends on the toxicity definition, the observation window, and the patients included in the denominator.
The record specifies that dose-limiting toxicities must be drug-related, with possible, probable, or definite attribution, and that grading uses CTCAE Version 4.0. These details clarify how events are classified. They do not reveal which dose met the threshold: that result is not reported in the registry record. Nor does the record report the dose-finding algorithm or how uncertainty across dose levels was handled.
Why does the single-group design matter?
In a randomized comparative trial, allocation is used to make groups more comparable with respect to both measured and unmeasured characteristics, on average. This trial is identified as single group, with allocation not applicable and no masking. Thus, the registry does not describe randomized assignment to a control treatment. The Phase I and Phase II cohorts are not necessarily interchangeable, and comparisons between their summaries can be influenced by differences in cohort purpose, eligibility, follow-up, dose, or data collection. The registry specifically cautions that the groups are not a like-for-like control comparison.
Without a concurrent comparison group, an observed outcome in participants receiving the combination cannot isolate the effect of vorinostat from the effects of the other regimen components, the underlying course of illness, or other influences. This is a general design limitation, not a claim that a particular bias occurred. It means that response and survival observations, if reported, would need to be interpreted as outcomes in the treated study population rather than as a randomized estimate of treatment benefit.
What can safety counts and percentages tell the reader?
Counts give the number of participants affected within a stated group, while percentages express the reported proportion in that group. Both are useful, but counts are especially important when the group is small because a change in only a few participants can materially alter a percentage. The registry lists 5 of 9 affected by serious adverse events in the Phase I group labeled 400mg D1-9, and 44 of 63 in the Phase II group. These are descriptive summaries. They are not a comparison of treatment strategies, and they do not establish causation.
Adverse-event terms also need careful interpretation. The listed percentages for platelet count decreased, febrile neutropenia, anemia, sepsis, neutrophil count decreased, and white blood cell decreased describe reported serious-event terms. A participant may experience more than one event, so event terms should not be treated as mutually exclusive categories unless the record explicitly says so. The registry record does not specify whether these percentages count participants or events for each term, or provide event-specific denominators. Those details should not be inferred.
How should uncertainty be understood?
In general, a confidence interval describes a range of values compatible with the observed data under a statistical model and a stated confidence procedure. It communicates precision as well as the estimated effect. A narrow interval indicates greater precision than a wide one, while neither guarantees that the model or study design is free from bias. The registry record does not report confidence intervals for the outcomes, so the precision of the posted adverse-event percentages cannot be fully assessed from the record alone.
In general, over-dispersion occurs when observed variability is greater than a statistical model expects. When present, a model that ignores it may understate uncertainty. Whether over-dispersion is relevant depends on the specific outcome and model. The registry record does not report the outcome models or diagnostics, so no conclusion about over-dispersion in this trial is possible.
What does the sample-size illustration represent?
General planning calculations can illustrate the number of participants per arm needed to detect a specified fraction of an observed effect under stated assumptions. In this record, the planning illustration is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such values are hypothetical planning quantities, not observed trial results, and not observed power. The record also states that time-to-event planning values refer to total events, while other values refer to participants per arm.
These illustrations should not be read as the trial’s own design justification. The record does not report that the trial was randomized between two comparable arms, and it explicitly warns that the groups are not a like-for-like comparison. It also does not report the original sample-size rationale. A planning calculation based on an observed effect can be sensitive to the effect estimate used and cannot repair limitations in the underlying design.
More broadly, statistical interpretation requires attention to the outcome definition, target population, analysis set, amount of missing data, and uncertainty. The registry describes a specific Phase I population for the primary endpoint but does not give the analysis populations or missing-data handling for the other outcomes. Since no analyses are listed in the record, the named secondary outcomes cannot be treated as reported findings.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary Phase I dose-safety endpoint and Phase II outcomes that include overall survival, response rate defined as complete response plus partial response, and toxicity. Considering several outcomes raises the general issue of multiplicity: when many hypotheses are examined, the chance of finding at least one apparently notable result by chance can increase. Whether and how to address that issue depends on which outcomes were formally tested, their prespecified status, and the analysis plan. Those details are not reported in the registry record.
The record lists no analyses. It does not report statistical tests, confidence intervals, a hierarchy among secondary outcomes, adjustments for multiple comparisons, or rules for selecting which results to emphasize. Therefore, the listed outcomes should be understood as planned or registered outcome topics, not as evidence that a particular effect was observed or statistically established.
Missing-data methods and analysis populations are also not reported for the Phase II outcomes. The primary endpoint population is described as Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 or those who developed a dose-limiting toxicity. The record does not explain how participants with incomplete toxicity assessment, withdrawal, or other missing endpoint information were handled. It also does not report the analysis populations for overall survival or response rate. These omissions make it difficult to determine how the enrolled population relates to any eventual outcome estimate.
In general, missing-data methods matter because people with incomplete follow-up may differ from those with complete data. The consequences depend on why data are missing and on the method used; no particular pattern or method should be assumed for this trial. The enrollment total alone cannot resolve these questions. The registry record does not report sensitivity analyses or other procedures for evaluating the effect of missing observations.
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 |
|---|---|---|---|
| Ph I: R-CHOP+Vorinostat (400mg D1-9) | 5 | 9 | 55.6% |
| Ph II: R-CHOP+Vorinostat | 44 | 63 | 69.8% |
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 |
|---|---|
| Ph I: R-CHOP+Vorinostat (400mg D1-9) | 9 of 9 |
| Ph II: R-CHOP+Vorinostat | 63 of 63 |
Most frequent serious adverse event terms
| Event term | Organ system | Ph I: R-CHOP+Vorinostat (400mg D1-9) | Ph II: R-CHOP+Vorinostat |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 3 of 9 | 22 of 63 |
| Platelet count decreased | Investigations | 4 of 9 | 16 of 63 |
| Neutrophil count decreased | Investigations | 3 of 9 | 16 of 63 |
| Anemia | Blood and lymphatic system disorders | 3 of 9 | 13 of 63 |
| White blood cell decreased | Investigations | 2 of 9 | 10 of 63 |
| Sepsis | Infections and infestations | 3 of 9 | 8 of 63 |
| Lung infection | Infections and infestations | 1 of 9 | 4 of 63 |
| Lymphocyte count decreased | Investigations | 1 of 9 | 4 of 63 |
| Dehydration | Metabolism and nutrition disorders | 1 of 9 | 4 of 63 |
| Hypokalemia | Metabolism and nutrition disorders | 2 of 9 | 3 of 63 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ph I: R-CHOP+Vorinostat (400mg D1-9) | Ph II: R-CHOP+Vorinostat |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 9 of 9 | 52 of 63 |
| Fatigue | General disorders | 8 of 9 | 45 of 63 |
| Nausea | Gastrointestinal disorders | 8 of 9 | 43 of 63 |
| White blood cell decreased | Investigations | 8 of 9 | 40 of 63 |
| Neutrophil count decreased | Investigations | 7 of 9 | 35 of 63 |
| Platelet count decreased | Investigations | 8 of 9 | 32 of 63 |
| Diarrhea | Gastrointestinal disorders | 7 of 9 | 31 of 63 |
| Lymphocyte count decreased | Investigations | 7 of 9 | 26 of 63 |
| Constipation | Gastrointestinal disorders | 5 of 9 | 26 of 63 |
| Anorexia | Metabolism and nutrition disorders | 6 of 9 | 23 of 63 |
Serious events with the highest arm-level rate: platelet count decreased (44.4%), febrile neutropenia (34.9%), anemia (33.3%), sepsis (33.3%), neutrophil count decreased (33.3%).
The registry’s serious adverse-event summary separates two groups. In the Phase I group labeled R-CHOP+Vorinostat (400mg D1-9), 9 participants are listed as at risk and 5 as affected. In the Phase II R-CHOP+Vorinostat group, 63 are listed as at risk and 44 as affected. The record also lists other adverse events in 9 of 9 and 63 of 63 participants, respectively. These are descriptive counts within the reported groups, not results from a randomized comparison.
The serious-event terms listed include platelet count decreased (44.4%), febrile neutropenia (34.9%), anemia (33.3%), sepsis (33.3%), neutrophil count decreased (33.3%), and white blood cell decreased (22.2%). These percentages should not be interpreted as treatment-versus-control differences. The registry record does not give event-specific counts, timing, duration, or detailed attribution for these terms. It also does not report deaths in these adverse-event group summaries.
Serious adverse events are not necessarily synonymous with dose-limiting toxicities. The primary endpoint uses a specific Cycle 1 definition and requires drug-related attribution; the adverse-event summaries are a separate safety presentation. They should not be substituted for the primary dose-safety result, which is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a Phase I/II study was conducted to investigate vorinostat in combination with rituximab and chemotherapy in newly diagnosed Stage II, Stage III, or Stage IV diffuse large B-cell lymphoma. It identifies a Phase I primary endpoint based on dose-limiting toxicity during Cycle 1 and lists overall survival, response rate, and toxicity among the Phase II outcomes. It also posts group-level adverse-event summaries and selected serious-event percentages.
Those details do not establish which vorinostat dose met the protocol’s stated safety criterion. The primary endpoint result is not reported in the registry record. The Phase II outcome names do not provide observed response or survival estimates, and no outcome analyses are listed. Thus, the record does not support a conclusion about the magnitude or precision of response or survival outcomes.
The adverse-event counts and percentages describe events recorded in the study groups. They cannot, by themselves, show that a particular drug caused an event or that the combination has more or fewer events than an alternative treatment. The study has no randomized control group in the registry description, and the record explicitly says its groups are not a like-for-like control comparison. Any contrast between Phase I and Phase II summaries would not have the safeguards of a randomized comparison.
In general, statistical evidence is strongest when the study design, endpoint definition, analysis population, and uncertainty estimate all align with the question being asked. Here, the endpoint definition is available for the Phase I dose-safety question, but its result and associated uncertainty are not. The record does not report detailed methods for the Phase II outcomes, missing-data handling, or the analysis plan. These gaps prevent a full evaluation of precision and potential bias.
The appropriate reading is therefore bounded: the record describes the study’s purpose, treatment schedule, endpoint definitions, and posted safety summaries. It does not provide enough outcome information to determine whether the combination changed survival or response, or to establish a comparative treatment effect. That distinction is about the evidence available in the registry record, not a judgment about the treatment or the clinical decisions made for individual patients.
13. Why This Trial Matters Statistically
This trial illustrates why design and endpoint definitions matter when reading early-phase oncology research. The Phase I question is explicitly about dose safety: a dose is judged against a threshold for dose-limiting toxicity during Cycle 1. That is distinct from asking whether a regimen improves response or survival. Keeping those questions separate prevents a safety endpoint from being mistaken for evidence of efficacy.
The record also illustrates the limits of interpreting single-group data. Descriptive event counts can characterize what was recorded among participants receiving the regimen, but without a randomized comparator they do not estimate how outcomes differ from another treatment. The record makes this limitation explicit for the groups it reports. This distinction remains important even when outcome percentages appear precise, because precision does not remove confounding or other design limitations.
A further statistical lesson is that an outcome listed in a registry is not the same as an outcome result. The primary dose-safety endpoint and several Phase II outcomes are named, but analyses are not listed and the primary result is not reported in the registry record. Readers need the observed estimates, denominators, analysis populations, and uncertainty to assess what the data show. When those elements are absent, a clear account of what remains unknown is more informative than an unsupported conclusion.
Finally, the posted adverse-event summaries show why counts, denominators, event definitions, and attribution all matter. Group-level serious-event counts and event-term percentages provide useful descriptive safety information, but they do not answer every safety question. In particular, they do not replace the endpoint’s specific dose-limiting toxicity rule or provide a controlled comparison. Careful separation of these statistical roles helps avoid overstating what a registry summary can establish.
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 identifies the study as single group, with allocation not applicable and no masking. It does not describe a randomized control arm. As a result, the posted safety summaries cannot be interpreted as causal comparisons between treatment strategies. The record also cautions against treating the reported groups as like-for-like controls, so contrasts between their counts or percentages require particular restraint.
The main Phase I endpoint is defined, but its result is not reported in the registry record. The record does not identify which dose met the safety criterion or provide an uncertainty estimate for dose selection. The Phase II outcomes are listed, but analyses and outcome estimates are not reported. Consequently, the available registry information does not permit assessment of response or survival results.
Enrollment is listed as 83, while adverse-event summaries give separate at-risk counts for the Phase I and Phase II groups. The record does not explain how those group counts relate to all enrolled participants, nor does it report reasons for differences in analysis populations. The primary endpoint population is defined, but comparable population definitions are not provided for the listed Phase II outcomes.
Detailed statistical methods are not reported in the registry record. In particular, the record does not specify analysis models, handling of missing data, multiplicity procedures, or the rationale for planned enrollment. It does not provide event-specific participant counts, timing, duration, or detailed attribution for the serious adverse-event terms. These limitations restrict assessment of precision, completeness, and the relationship between adverse events and individual treatment components.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma — NCT00972478.
- Registry record last updated 2026-10-22; status last verified 2026-09.
- Results first posted 2016-10-31.
- 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 is a Phase I/II, single-group trial of vorinostat combined with rituximab and chemotherapy in patients with newly diagnosed Stage II, Stage III, or Stage IV diffuse large B-cell lymphoma. The registry lists enrollment of 83, no allocation, and no masking. Treatment includes vorinostat with R-CHOP; the schedule describes repeated treatment every 21 days.
The Phase I primary endpoint is the safe vorinostat dose under a Cycle 1 dose-limiting toxicity criterion of 3/10 or fewer patients. Listed Phase II outcomes include overall survival, response rate, and toxicity. The registry posts serious adverse-event summaries for Phase I and Phase II groups, but the primary endpoint result and analyses of the listed outcomes are not reported in the registry record.
The design does not provide a randomized comparison, and the registry cautions that the groups are not like-for-like controls. Therefore, the posted safety data are descriptive and do not establish comparative effects. Statistical analysis details, missing-data methods, and the sample-size rationale are not reported in the registry record.