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 A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma (NCT04038359), a randomized phase 2 study. The primary outcome is Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04038359 |
| Phase | Phase 2 |
| Condition | Indolent Non-Hodgkin Lymphoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 103 |
| Arms in the primary outcome | n/a |
| Lead sponsor | SecuraBio |
| Results posted | Yes |
2. Clinical Question
Population
Participants with indolent non-Hodgkin lymphoma (iNHL) were eligible for the study. The registry record reports enrollment of 103 participants. The primary endpoint description defines a modified intent-to-treat analysis set as participants who received at least 1 dose of duvelisib; a per-protocol set excludes participants with protocol violations judged to significantly affect the study outcome. Numerical primary-endpoint results for either population are not reported in the registry record.
Intervention
One arm received duvelisib 25 milligrams twice daily continuously for 10 weeks, followed by a repeating schedule of 2 weeks off and 2 weeks on in each subsequent 4-week cycle. This arm therefore began with continuous dosing before introducing planned treatment breaks.
Comparator
The other arm received duvelisib 25 milligrams twice daily in a repeating schedule of 2 weeks on and 2 weeks off. Both groups received the same named drug, while their schedules differed in whether dosing began continuously or intermittently.
Primary question
The primary endpoint was overall response rate (ORR), defined as the percentage of participants achieving complete response or partial response under the 2007 revised International Working Group criteria, assessed up to 14 months. The clinical question is whether response outcomes differed between the two dosing schedules. The registry record does not report numerical ORR estimates, confidence intervals, or a numerical comparison between the arms, so the size and precision of any difference cannot be described from this record.
3. Trial Design
This was a Phase 2, randomized, open-label, parallel-group study comparing 2 intermittent dosing schedules of duvelisib in participants with indolent non-Hodgkin lymphoma. The registry record gives enrollment as 103 and status as completed. Randomization assigns participants to study groups by chance, which is intended to support a fair comparison at baseline; the method used to generate or implement the random allocation is not reported in the registry record. Open-label means the study was not masked, but the record does not describe how that might have affected outcome assessment or clinical management.
The arms differed in their dosing sequences. The continuous-and-intermittent arm used duvelisib 25 milligrams twice daily continuously for 10 weeks, followed by 2 weeks off and 2 weeks on in each subsequent 4-week cycle. The intermittent arm used duvelisib 25 milligrams twice daily for 2 weeks on and 2 weeks off. The registry record does not report adherence, dose interruptions beyond the schedules, treatment exposure, or reasons for changes in treatment.
The primary endpoint was ORR by the 2007 revised IWG criteria, with assessment up to 14 months. Listed secondary outcomes include progression-free survival, response at specific timepoints, duration of response, overall survival, lymph node response rate, time to first response, time to treatment failure, and ORR according to 2014 Lugano criteria. The registry record does not report the detailed assessment schedule or the statistical analysis plan for these outcomes.
Because this is a comparison of dosing schedules of the same drug, the central design contrast is the timing of planned treatment breaks, not a comparison of duvelisib with no treatment or with a different drug. The record does not report a control group without duvelisib. It also does not report the basis for the chosen enrollment, any sample-size justification, interim analyses, or stopping rules.
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 | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| STARTED | 52 | 51 |
| Received At Least 1 Dose of Study Drug | 51 | 51 |
| COMPLETED | 32 | 36 |
| NOT COMPLETED | 20 | 15 |
Reasons for not completing this period:
| Reason | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| Consent Withdrawn Prior to Receiving Study Drug | 1 | 0 |
| Death | 8 | 7 |
| Lost to Follow-up | 3 | 0 |
| Participant Moved | 1 | 0 |
| Withdrawal by Subject | 4 | 3 |
| Physician Decision | 3 | 2 |
| Adverse Event | 0 | 2 |
| Progressive Disease | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Per-protocol (PP) Analysis Set: all participants in the mITT analysis set who did not violate the protocol in a way that would significantly affect the study outcome. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure.
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: All-Treated (AT) Analysis Set: All participants who receive at least 1 dose of duvelisib.
| Characteristic | Unit | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing | Total |
|---|---|---|---|---|
| Participants analysed | 51 | 51 | 102 | |
| Age, Continuous | years | 60.5 (SD 12.15) | 63.9 (SD 11.40) | 62.2 (SD 11.85) |
| Sex: Female, Male: Female | Participants | 28 | 27 | 55 |
| Sex: Female, Male: Male | Participants | 23 | 24 | 47 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 48 | 50 | 98 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 14 | 9 | 23 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 36 | 42 | 78 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria, measured over Up to 14 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
Overall response rate measures the proportion of participants who achieve either complete response or partial response under specified disease-response criteria. In this study, the criteria were the 2007 revised International Working Group criteria, and the assessment timeframe was up to 14 months. The record defines complete response as disappearance of all evidence of disease and partial response as regression of measurable disease with no new sites.
ORR is used to describe whether participants meet a prespecified response definition during the assessment period. It is a binary outcome at the participant level: each participant is classified according to whether a qualifying complete or partial response was achieved, and the group rate is expressed as a percentage. It does not, by itself, describe how long a response lasts, whether disease later progresses, or survival. The registry lists duration of response, progression-free survival, and overall survival separately as secondary outcomes.
For a comparison of dosing schedules, response rates can describe whether the observed frequency of qualifying responses differs between groups. Interpretation depends on the estimates and their uncertainty, as well as on how response was assessed and which analysis population was used. Numerical ORR results and confidence intervals are not reported in the registry record, so neither the observed response rates nor the precision of their comparison can be stated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies ORR by the 2007 revised IWG criteria as the primary endpoint, assessed up to 14 months. However, it does not report the numerical ORR in either arm, confidence intervals, or a statistical comparison. Consequently, the posted record does not establish the observed direction or magnitude of an arm difference, nor how precisely any difference was estimated. A statistical interpretation of the primary endpoint must therefore remain focused on what was measured and what is missing from the reported results.
A confidence interval communicates uncertainty around an estimate. For a response percentage, it helps show how compatible the observed data are with a range of underlying response rates, subject to the analysis assumptions. A confidence interval is not a guarantee that the true value lies within its limits, and it should be read alongside the point estimate and the study design. Since the numerical confidence intervals are not reported in the registry record, precision cannot be evaluated for this endpoint.
The trial was randomized, which supports an arm-to-arm comparison, but randomization does not eliminate uncertainty or solve limitations in outcome measurement and reporting. The record describes the study as open-label. It does not report whether response assessors were independent or masked, how response assessments were scheduled, or how incomplete assessments were handled. Those details matter when interpreting response outcomes, but they should not be inferred from the trial title or endpoint definition.
The registry lists secondary outcomes covering response at specific timepoints, duration of response, progression-free survival, overall survival, lymph node response rate, time to first response, time to treatment failure, and ORR by 2014 Lugano criteria. The existence of these listed outcomes does not establish that results were reported or that they can be compared. Numerical secondary-outcome results are not reported in the registry record. The record also lists no analysis records. This limits assessment of how endpoint estimates were calculated, which comparisons were emphasized, and whether analyses followed a prespecified statistical plan.
Safety information should be interpreted separately from the primary response endpoint. The posted serious adverse event counts and listed event terms describe events recorded in the arms; they do not establish that an event was caused by the drug or that differences between arms are statistically reliable. The death counts are not accompanied by cause or attribution information in the record. These limitations preclude drawing causal conclusions from the counts alone.
The design information and endpoint definitions clarify the intended comparison, but the absence of numerical response results is a central interpretive limitation. No claim about which schedule had a higher response rate, whether the rates were similar, or whether any difference was statistically significant can be made from the registry record. Such conclusions would require the arm-specific estimates, their uncertainty, and the analysis details.
9. Statistical Methods Explained
The statistical methods can be understood by separating the trial question, the outcome definition, the analysis population, and the uncertainty around any estimate. The registry record identifies a randomized, parallel-group comparison and a binary response endpoint. It does not provide numerical primary-endpoint results or a detailed statistical analysis plan, so the general concepts below explain how such results are commonly interpreted without asserting which specific procedures this study used.
What does randomization contribute?
In a randomized study, allocation by chance is intended to make treatment groups comparable, on average, with respect to measured and unmeasured characteristics at the point of assignment. This helps make an observed group difference more interpretable as a consequence of assignment to the different schedules, provided follow-up, outcome assessment, and analysis are also handled appropriately. Randomization does not guarantee exact balance in a particular study, and it does not remove uncertainty from estimates. The registry record does not report the randomization sequence method, allocation concealment procedures, or baseline characteristics needed to assess the realized balance.
The parallel-group structure means the schedules were assigned to separate groups rather than each participant receiving both schedules in sequence. The two schedules share the same drug and dose as described, but differ in the timing of planned dosing and breaks. As a result, interpretation concerns the schedules as studied; it should not be extended to other dosing patterns not described in the record.
How should a response percentage be understood?
ORR is a proportion-based endpoint. Participants are classified according to whether they achieved complete or partial response under the stated criteria during the assessment timeframe. A response rate summarizes the frequency of that outcome in a group. It does not represent the average amount of tumor change, the duration of response, or the probability of survival. Those are distinct questions, and the registry lists several related outcomes separately.
For a group response rate, uncertainty arises because the observed participants are only a sample from a broader population of interest. A confidence interval expresses the uncertainty associated with the estimate under a statistical model and its assumptions. Wider intervals generally indicate less precision, while narrower intervals indicate more precision; neither width can be assessed without the numerical interval. The registry record identifies a 95% confidence interval as the endpoint dispersion measure, but does not report its limits or the corresponding response estimates.
What do analysis populations mean?
The endpoint description identifies a modified intent-to-treat analysis set comprising all participants who received at least 1 dose of duvelisib. It also describes a per-protocol analysis set as participants in the modified intent-to-treat set who did not violate the protocol in a way that would significantly affect the study outcome. These populations can answer different analytic questions. An analysis focused on participants who received treatment describes outcomes among those who began study drug, while a per-protocol analysis restricts attention according to protocol adherence. Such restriction may affect comparability because adherence and protocol deviations can be related to participant characteristics or outcomes.
The registry wording for the number analyzed is incomplete, and arm-specific denominators for the primary endpoint are not reported in the registry record. It is therefore not possible to determine which population underlies any numerical response result or whether both populations were analyzed. No particular approach to missing response assessments should be assumed.
Why do analysis details matter?
A statistical analysis plan can specify the estimand, analysis population, handling of missing outcomes, confidence interval method, and test used for an arm comparison. It may also describe adjustment for baseline factors or planned sensitivity analyses. These choices affect what a reported estimate means and how robust it is to assumptions. The registry record does not report these details. It also lists no analysis records, which is a reporting gap rather than proof that no analyses were conducted.
When a primary outcome has more than one possible category, such as complete response, partial response, or no qualifying response, a plan may define how categories are combined. In this record, ORR is explicitly defined as the percentage achieving complete or partial response. The record does not provide arm-specific counts in those categories or show how missing or unevaluable assessments were classified.
What is multiplicity?
Multiplicity arises when several outcomes, timepoints, or comparisons are examined. Repeated testing can increase the chance of finding an apparently notable result by chance if each test is interpreted separately. Methods for addressing multiplicity can include a prespecified hierarchy, adjustment of significance levels, or cautious interpretation of secondary analyses. The registry lists multiple secondary outcomes, but it does not report a multiplicity strategy or the statistical testing hierarchy. It would be inappropriate to infer a correction method or the status of any secondary finding.
What does the planning illustration mean?
The record describes a planning illustration based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. Planning illustrations estimate the sample size that might be needed under chosen assumptions; they are not observed power and do not demonstrate that a study had a particular probability of detecting its actual effect. The stated illustration also considers fractions of the observed effect. Without the numerical observed effect and corresponding planning estimates in the registry record, no sample-size value or detectable difference can be interpreted. The record does not report that these assumptions were the study's original design assumptions.
For time-to-event outcomes, methods often account for the number and timing of events, censoring, and follow-up, rather than treating all participants as if they had the same observation time. The record lists time-to-event outcomes, but does not report their event counts, estimates, or analysis methods. General considerations about those methods cannot substitute for the missing outcome results.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary ORR endpoint and multiple secondary outcomes, including survival, response at specific timepoints, duration of response, lymph node response rate, and time-to-event measures. Examining multiple outcomes or timepoints can create multiplicity: if each result is treated as a separate confirmatory test, the chance of at least one chance-positive result can increase. A prespecified testing hierarchy or adjustment can address this concern, while descriptive reporting can make clear that findings are exploratory. The registry record does not report a multiplicity strategy, test hierarchy, or statistical analysis plan.
The record lists no analysis records. This should be read as a limitation in the registry reporting, not as evidence that the investigators performed no analyses. Numerical estimates for the primary endpoint are not reported in the registry record, and numerical secondary-outcome results are not included in the registry record. Without those results, there is no basis for evaluating the direction, magnitude, uncertainty, or consistency of outcome findings.
The primary endpoint description identifies a modified intent-to-treat set of participants who received at least 1 dose of duvelisib and a per-protocol set that excludes certain protocol violations. The record does not report the arm-specific number analyzed for the primary endpoint, the analysis population actually used for a numerical result, or how protocol deviations were determined.
Missing-data methods are not reported in the registry record. It is not clear how participants without an evaluable response assessment were handled, whether missingness differed by arm, or whether sensitivity analyses were conducted. These details can affect a proportion-based endpoint because the classification of unevaluable participants changes the denominator or outcome assignment. No assumptions about those procedures should be made from the endpoint definition alone.
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 |
|---|---|---|---|
| Duvelisib, Continuous and Intermittent Dosing | 13 | 51 | 25.5% |
| Duvelisib, Intermittent Dosing | 16 | 51 | 31.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Duvelisib, Continuous and Intermittent Dosing | 8 of 51 |
| Duvelisib, Intermittent Dosing | 7 of 51 |
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 |
|---|---|
| Duvelisib, Continuous and Intermittent Dosing | 49 of 51 |
| Duvelisib, Intermittent Dosing | 50 of 51 |
Most frequent serious adverse event terms
| Event term | Organ system | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | 3 of 51 | 3 of 51 |
| COVID-19 | Infections and infestations | 2 of 51 | 1 of 51 |
| Pneumonia | Infections and infestations | 1 of 51 | 1 of 51 |
| Sepsis | Infections and infestations | 1 of 51 | 1 of 51 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0 of 51 | 2 of 51 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 0 of 51 | 2 of 51 |
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 51 | 0 of 51 |
| Anaemia | Blood and lymphatic system disorders | 0 of 51 | 1 of 51 |
| Cardiac arrest | Cardiac disorders | 1 of 51 | 0 of 51 |
| Cardiac failure | Cardiac disorders | 0 of 51 | 1 of 51 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 10 of 51 | 17 of 51 |
| Diarrhoea | Gastrointestinal disorders | 17 of 51 | 10 of 51 |
| Alanine aminotransferase increased | Investigations | 15 of 51 | 8 of 51 |
| Aspartate aminotransferase increased | Investigations | 15 of 51 | 6 of 51 |
| Pyrexia | General disorders | 9 of 51 | 9 of 51 |
| COVID-19 | Infections and infestations | 8 of 51 | 10 of 51 |
| Nausea | Gastrointestinal disorders | 7 of 51 | 8 of 51 |
| Fatigue | General disorders | 7 of 51 | 5 of 51 |
| Rash | Skin and subcutaneous tissue disorders | 4 of 51 | 6 of 51 |
| Anaemia | Blood and lymphatic system disorders | 4 of 51 | 5 of 51 |
Serious events with the highest arm-level rate: covid-19 pneumonia (5.9%), covid-19 (3.9%), dyspnoea (3.9%), pleural effusion (3.9%), febrile neutropenia (2.0%).
The registry reports serious adverse events affecting 13 participants in the continuous-and-intermittent dosing arm and 16 participants in the intermittent dosing arm; 51 participants are listed at risk in each arm. These are counts of participants affected, not event rates recalculated from the available information. The listed serious event terms include COVID-19 pneumonia at 5.9%, COVID-19 at 3.9%, dyspnoea at 3.9%, pleural effusion at 3.9%, febrile neutropenia at 2.0%, and anaemia at 2.0%.
Event-term percentages should not be added to estimate an overall serious-event percentage. In general, a participant may experience more than one event term, and the registry record does not clarify whether terms overlap. The figures describe events reported in the record; they do not establish causation or comparative risk. The record also lists 8 deaths in the continuous-and-intermittent arm and 7 in the intermittent arm, without cause or attribution details in the information. These counts alone do not establish that deaths were related to treatment or that the schedules differed in safety.
12. What the Result Does, and Does Not, Mean
The study was designed to compare two intermittent dosing schedules of duvelisib in participants with indolent non-Hodgkin lymphoma. One schedule began with continuous dosing for 10 weeks before moving to planned 2-week breaks and dosing periods; the other used 2 weeks on and 2 weeks off. The primary endpoint was ORR under the 2007 revised IWG criteria, assessed up to 14 months. These registry entries establish the comparison and the outcome definition, but they do not supply the primary response findings.
Numerical ORR estimates, confidence intervals, and an arm-to-arm statistical comparison are not reported in the registry record. Therefore, the record cannot show which schedule had the higher observed response rate, whether the estimates were close, or how precisely they were measured. It also cannot establish whether any difference was statistically significant or clinically important. Absence of a reported numerical result is not evidence that the arms had equal outcomes.
The listed secondary outcomes broaden the questions the study could address, including duration of response, progression-free survival, overall survival, and time to treatment failure. Their listing does not provide their results. Likewise, serious adverse event counts and death counts are descriptive observations and do not by themselves establish cause or a comparative treatment effect.
The record does not report the statistical analysis plan, missing-data procedures, detailed response-assessment process, or multiplicity approach. These omissions limit evaluation of how the endpoints were analyzed and how robust any results would be to analytic choices. The stated sample-size assumptions are described as a planning illustration, not as observed power or proof that the trial could detect a particular effect.
Accordingly, the defensible conclusion from the registry record is about the study's design and reporting: it randomized participants between two described schedules and identified a response endpoint, but the numerical primary outcome results needed to judge the observed comparison are not reported in the registry record. No treatment recommendation or claim of benefit follows from the design description or safety counts alone.
13. Why This Trial Matters Statistically
This study is statistically notable because it compares schedules of the same drug rather than comparing a drug with an untreated group or another drug. That makes the timing of planned treatment periods and breaks the central design distinction. Such a comparison can be informative only when the outcome estimates are reported clearly and interpreted in light of their uncertainty and analysis population.
The primary outcome is a percentage based on a defined response threshold. This kind of endpoint is easy to state, but its interpretation depends on the criteria used, the timing of assessment, the denominator, and the treatment of participants without an evaluable assessment. The registry specifies the 2007 revised IWG criteria and an assessment timeframe up to 14 months, while the numerical result and key analysis details are not reported in the registry record.
The trial also lists several clinically distinct secondary outcomes. Response frequency, response duration, disease progression, and survival are not interchangeable measures. Reporting these outcomes with clear analysis methods helps readers understand what each can and cannot answer. A multiplicity plan is especially relevant when multiple outcomes and timepoints are considered, but such a plan is not reported in the registry record.
Finally, the distinction between planning assumptions and observed results matters. A sample-size planning illustration can explore how design choices relate to a target effect, but it does not establish the study's observed power or replace outcome estimates. Here, the central statistical limitation is that the numerical primary-endpoint result is not reported in the registry record. The study design can be described, but the comparative response evidence cannot be evaluated from the available registry information.
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 main trial-specific limitation is that numerical primary-endpoint results are not reported in the registry record. Arm-specific response estimates, confidence intervals, response counts, and a statistical comparison are absent from the information. As a result, the primary comparison cannot be quantified or judged for precision.
The record does not report the actual analysis population used for the primary endpoint or arm-specific numbers analyzed. Although it defines modified intent-to-treat and per-protocol populations, the wording about the number analyzed is incomplete. The handling of missing or unevaluable response assessments is not reported, nor are sensitivity analyses or details of protocol deviations.
The study is described as open-label, but the record does not report whether response assessment was independently reviewed or masked. It also does not describe the assessment schedule, randomization procedures, allocation concealment, baseline characteristics, adherence, or treatment exposure. These omissions restrict assessment of potential sources of bias and the comparability of the groups as analyzed.
The registry lists multiple secondary outcomes, but their numerical results and the approach to multiplicity are not reported in the information. The statistical analysis plan, interim analyses, and study-specific sample-size justification are also not reported in the registry record. The sample-size assumptions listed are a planning illustration, not evidence of observed power. Safety counts do not include causal attribution details, and the death counts are not accompanied by causes in the record. Each of these limits how far conclusions can extend beyond the study design itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma — NCT04038359.
- Registry record last updated 2024-09-19; status last verified 2024-09.
- Results first posted 2024-09-19.
- 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
NCT04038359 is a completed Phase 2, randomized, open-label, parallel-group study of duvelisib in indolent non-Hodgkin lymphoma, with registry enrollment of 103 participants. It compared duvelisib 25 milligrams twice daily given continuously for 10 weeks before a repeating 2-weeks-off, 2-weeks-on schedule with duvelisib 25 milligrams twice daily given 2 weeks on and 2 weeks off.
The primary endpoint was ORR under the 2007 revised IWG criteria, assessed up to 14 months. Numerical primary-endpoint results and confidence intervals are not reported in the registry record. Listed secondary outcomes include response, survival, and time-to-event measures. Serious adverse events affected 13 participants in the continuous-and-intermittent arm and 16 in the intermittent arm, with 51 at risk in each; death counts were 8 and 7, respectively. The record does not report the detailed statistical analysis plan, missing-data methods, or multiplicity approach.