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 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202) (NCT02998476), a non-randomized phase 2 study. The primary outcome is Objective Response Rate Based on Lugano Classification Criteria in Group A.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02998476 |
| Phase | Phase 2 |
| Condition | Lymphoma |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Incyte Corporation |
| Results posted | Yes |
2. Clinical Question
Population
People with relapsed or refractory diffuse large B-cell lymphoma were enrolled. The full analysis set is defined as all enrolled subjects who received at least 1 dose of INCB050465. The record does not report further eligibility details or the number enrolled in each group.
Intervention
The intervention was parsaclisib, also identified as INCB050465. This was a Phase 2 safety and efficacy study. The record does not give dosing details in the information reported for this analysis.
Comparator
The study distinguished Group A, whose subjects had no prior BTK inhibitor treatment, from Group B, whose subjects had prior BTK inhibitor treatment. These groups were not randomized treatment arms and do not constitute a like-for-like control comparison.
Primary question
The primary endpoint was objective response rate in Group A, defined as the percentage of subjects with a complete or partial response under Lugano Classification criteria, as determined by IRC. The registry record does not report the observed response rate or its 95% confidence interval.
The study’s broad purpose was to assess parsaclisib safety and efficacy in subjects with relapsed or refractory diffuse large B-cell lymphoma. The primary endpoint focused specifically on Group A, defined by absence of prior BTK inhibitor treatment. Group B was defined by prior BTK inhibitor treatment, and safety was assessed in both groups. The distinction between groups is therefore based on treatment history, not random assignment to parsaclisib or a control treatment. The record does not report a separate primary efficacy question for Group B.
The response assessment was scheduled every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months. This describes the assessment schedule, not the number of responses or the duration of follow-up actually observed for any participant. The registry record does not report the primary endpoint estimate, the number of participants with complete or partial responses, or a comparison with another treatment.
3. Trial Design
CITADEL-202 was a Phase 2, multicenter, international, open-label study of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma. The registry lists the allocation as non-randomized, masking as none, and the model as parallel. Enrollment was 60. The study is recorded as completed; its start date was 2017-03-02 and its primary completion date was 2019-02-22.
The parallel groups were defined by prior BTK inhibitor exposure. Group A included subjects who had not previously been treated with a BTK inhibitor; Group B included subjects who had. Both groups received parsaclisib. Because the groups were not randomized and had different prior-treatment histories, they should not be interpreted as a treatment arm and a control arm or as a direct causal comparison. The record does not report group-specific enrollment totals beyond the adverse-event populations.
The primary efficacy outcome was objective response rate in Group A, assessed using Lugano Classification criteria and determined by IRC. Safety was assessed in Group A and Group B. Secondary outcomes listed for Group A included duration of response, progression-free survival, and overall survival; a safety outcome covering both groups was also listed. The registry lists five outcome measures, but does not report statistical analyses for them in the record reviewed.
Enrollment and completion dates describe study administration, not the timing of outcome assessments for every subject. The primary endpoint assessment schedule extended every 9 weeks through Week 27 and every 18 weeks thereafter until progression, up to 26 months. Actual follow-up duration, follow-up completeness, and the number assessed at each time point are not reported in the registry record. The study’s sample-size justification and detailed statistical analysis plan are also not reported in the registry 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.
Before assignment: 55 participants included in the treatment group A who were not previously treated with a BTK inhibitor and received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW. 5 Participants were enrolled in group B who were previously treated with a BTK inhibitor. and received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW.
Overall Study
| Stage | Group A Parsaclisib (no Prior BTK Inhibitor) | Group B Parsaclisib (Prior BTK Inhibitor) |
|---|---|---|
| STARTED | 55 | 5 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 55 | 5 |
Reasons for not completing this period:
| Reason | Group A Parsaclisib (no Prior BTK Inhibitor) | Group B Parsaclisib (Prior BTK Inhibitor) |
|---|---|---|
| Lost to Follow-up | 1 | 0 |
| Participants transferred to rollover study INCB50465-801 | 2 | 0 |
| Withdrawal by Subject | 1 | 2 |
| Death | 45 | 2 |
| Other | 6 | 1 |
Analysis population for the primary outcome, as defined in the registry: The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465
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 | Group A Parsaclisib (no Prior BTK Inhibitor) | Group B Parsaclisib (Prior BTK Inhibitor) | Total |
|---|---|---|---|---|
| Participants analysed | 55 | 5 | 60 | |
| Age, Continuous | years | 69.6 (SD 12.62) | 68.4 (SD 12.97) | 69.5 (SD 12.54) |
| Sex: Female, Male: Female | Participants | 22 | 0 | 22 |
| Sex: Female, Male: Male | Participants | 33 | 5 | 38 |
| Race/Ethnicity, Customized: White/Caucasian | Participants | 42 | 5 | 47 |
| Race/Ethnicity, Customized: Black or African American | Participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: Asian | Participants | 3 | 0 | 3 |
| Race/Ethnicity, Customized: Other | Participants | 6 | 0 | 6 |
| Race/Ethnicity, Customized: Missing | Participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: Not Hispanic or Latino | Participants | 37 | 5 | 42 |
| Race/Ethnicity, Customized: Not Reported | Participants | 10 | 0 | 10 |
| Race/Ethnicity, Customized: Unknown | Participants | 7 | 0 | 7 |
| Race/Ethnicity, Customized: Missing | Participants | 1 | 0 | 1 |
| ECOG: 0 | Participants | 12 | 1 | 13 |
| ECOG: 1 | Participants | 34 | 3 | 37 |
| ECOG: 2 | Participants | 9 | 1 | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Objective Response Rate Based on Lugano Classification Criteria in Group A, measured over Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage |
| Endpoint classification | not reduced to a single comparison |
Objective response rate is the percentage of subjects who achieve either a complete response or a partial response according to the specified response criteria. In this study, responses were defined using Lugano Classification criteria for lymphomas and determined by IRC. The endpoint was assessed in Group A, the group without prior BTK inhibitor treatment.
General statistical context: a response-rate endpoint reduces each participant’s response assessment to a response or no response for the purpose of estimating a proportion. It can describe how often a defined response was observed in the assessed population, but it does not by itself describe how long a response lasts, whether disease progresses later, or how outcomes compare with an untreated or alternative-treatment group. Those questions require other outcomes or an appropriate comparison design.
The planned assessment schedule was every 9 weeks through Week 27 and every 18 weeks thereafter until disease progression, up to 26 months. The registry defines the full analysis set as all enrolled subjects who received at least 1 dose of INCB050465. However, it does not report the observed objective response rate, its 95% confidence interval, or the response counts. Consequently, the endpoint’s numerical result and precision cannot be described from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed Phase 2 study with 60 enrolled subjects and reports safety counts for two groups defined by prior BTK inhibitor treatment. It does not report the primary efficacy estimate: the objective response rate in Group A, defined by complete or partial response under Lugano Classification criteria and determined by IRC. The corresponding 95% confidence interval is not reported in the registry record. Without the estimate and interval, the magnitude and precision of the primary endpoint cannot be evaluated from this record.
The absence of a reported efficacy estimate is not evidence that the response rate was zero, nor does it establish that the endpoint was not measured. It means only that the result is not reported in the registry record. Similarly, although duration of response, progression-free survival, and overall survival in Group A are listed as secondary outcomes, their numerical results are not reported in the information recorded. The record lists safety as assessed by the percentage of subjects with adverse events in both groups, but it does not give a complete outcome-level account of all adverse-event types or their timing.
The two groups do not provide a randomized comparison. Group membership was determined by prior BTK inhibitor exposure, and both groups received parsaclisib. Any difference between group outcomes could reflect differences in treatment history or other factors, as well as chance; the record does not establish a causal effect of prior BTK inhibitor exposure or of parsaclisib through a between-group comparison. The Group A endpoint also cannot be treated as an estimate for all enrolled subjects, because it was specifically defined for Group A.
The safety counts describe participants with events in the reported risk populations. In Group A, 39 of 55 were affected by serious adverse events and 41 of 55 were affected by other adverse events. In Group B, the corresponding counts were 2 of 5 and 3 of 5. The registry also reports deaths of 45 in Group A and 3 in Group B. These figures do not establish that an event was caused by parsaclisib, and the death counts alone do not identify cause or timing. The small Group B risk population should be kept in view when reading its counts; no comparative inference follows from these descriptive data.
9. Statistical Methods Explained
The registry record identifies the study as non-randomized, open-label, and parallel. It names the primary outcome and its assessment criteria, but does not report the statistical procedures used to estimate the outcome, construct its confidence interval, or handle missing observations. The concepts below are general statistical explanations; they should not be read as claims about methods used in this study unless those methods are explicitly stated in the registry record.
What does an objective response rate estimate?
General: for a binary response outcome, each participant is classified according to whether a qualifying response occurred. The response rate is the proportion classified as having a complete or partial response among the defined analysis population. Here, the registry specifies Group A and Lugano Classification criteria, with response determined by IRC. The numerical proportion, response counts, and confidence interval are not reported in the registry record.
A confidence interval expresses uncertainty around an estimated quantity under the method used to construct it. It is not a guarantee that the true value lies within the interval, and it does not measure the probability that an individual participant will respond. The registry identifies a 95% confidence interval as the endpoint’s dispersion measure, but does not report its limits or the method used to calculate it. Without those results, neither the estimate’s precision nor the range of values compatible with the analysis can be assessed.
Why does the study design matter?
General: random assignment can help balance measured and unmeasured baseline characteristics between treatment groups, on average. In a non-randomized study, treatment history or other participant characteristics may differ across groups. CITADEL-202’s groups were defined by prior BTK inhibitor treatment, and both received parsaclisib. They therefore do not form a randomized treatment-versus-control comparison. Their outcomes may be described separately, but differences between them cannot be attributed to prior treatment history or to a treatment effect without additional design and analysis information.
Open-label means masking was listed as none. General: when treatment assignment is known, assessment or reporting can potentially be influenced by knowledge of treatment, depending on the outcome and assessment process. The primary response outcome was determined by IRC, but the full designation and procedures for IRC are not reported in the registry record. No further conclusion about safeguards against assessment bias can be drawn from the information recorded.
How should the planned sample-size illustrations be understood?
General: a sample-size calculation depends on assumptions about the effect to detect, the significance level, allocation, and statistical model. The planning assumptions stated for the illustrations use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For time-to-event outcomes, the illustration concerns the total number of events using the Schoenfeld approach; for other outcomes, it concerns participants per arm. These are planning illustrations, not observed power and not evidence that the trial was designed using those assumptions.
The registry record does not report the trial’s own sample-size justification. The described illustration assumptions do not establish the original design rationale, the target effect, or the operating characteristics of the actual study. No calculated participant or event totals are reported in the record reviewed, so none can be inferred from these assumptions.
Why does over-dispersion matter in general?
General: over-dispersion occurs when the observed variability in data exceeds what a statistical model assumes. If it is ignored, standard errors can be too small and confidence intervals too narrow, making estimates appear more precise than warranted. This consideration is particularly relevant for some count outcomes, but the registry record does not report a count-based primary endpoint or a model for the primary response-rate analysis. It also does not report whether over-dispersion was assessed or whether any adjustment was used. It would therefore be inappropriate to claim that this issue affected the study’s analysis.
What analysis details are unavailable?
The statistical analysis plan, the specific confidence-interval procedure, covariate adjustment, subgroup analyses, interim analyses, and missing-data methods are not reported in the registry record. The record lists no statistical analyses. It does not state how subjects with unevaluable response assessments were handled or whether any sensitivity analyses were conducted. These omissions limit the ability to reproduce or appraise the inferential analysis, but they do not establish that the procedures were absent from the full study documentation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint of objective response rate in Group A and secondary outcomes of duration of response, progression-free survival, and overall survival in Group A, along with safety assessed in both groups. Considering multiple endpoints can raise a multiplicity question: when several statistical claims are tested, the chance of at least one apparently notable result can increase. General: procedures such as prespecifying a hierarchy or adjusting inference can address some multiplicity concerns. The registry record does not report whether any such approach was planned or used, and it lists no statistical analyses.
The record does not report interim analyses, a testing hierarchy, or whether secondary outcomes were intended for formal hypothesis testing or descriptive reporting. It is therefore not possible to determine from the registry record how multiple outcomes were handled or whether any adjustment was made. No inferential conclusion about the secondary outcomes should be presumed from their listing alone.
The full analysis set is defined as all enrolled subjects who received at least 1 dose of INCB050465. The registry does not report how missing, incomplete, or unevaluable endpoint assessments were treated, how many subjects contributed data to each efficacy outcome, or whether missingness was examined. General: missing-data handling can affect an estimate when the likelihood of missing assessment is related to response or other participant characteristics. The available information does not support a claim about the direction or size of any such effect.
Details of exclusions after enrollment, protocol deviations, and analysis populations for secondary outcomes are not reported in the registry record. The definition of the full analysis set is useful, but does not alone explain how every outcome-specific analysis was conducted.
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 |
|---|---|---|---|
| Group A Parsaclisib (no Prior BTK Inhibitor) | 39 | 55 | 70.9% |
| Group B Parsaclisib (Prior BTK Inhibitor) | 2 | 5 | 40.0% |
| Total | 41 | 60 | 68.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Group A Parsaclisib (no Prior BTK Inhibitor) | 45 of 55 |
| Group B Parsaclisib (Prior BTK Inhibitor) | 3 of 5 |
| Total | 48 of 60 |
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 |
|---|---|
| Group A Parsaclisib (no Prior BTK Inhibitor) | 41 of 55 |
| Group B Parsaclisib (Prior BTK Inhibitor) | 3 of 5 |
| Total | 44 of 60 |
Most frequent serious adverse event terms
| Event term | Organ system | Group A Parsaclisib (no Prior BTK Inhibitor) | Group B Parsaclisib (Prior BTK Inhibitor) | Total |
|---|---|---|---|---|
| Pyrexia | General disorders | 5 of 55 | 0 of 5 | 5 of 60 |
| Hypercalcaemia | Metabolism and nutrition disorders | 4 of 55 | 0 of 5 | 4 of 60 |
| Abdominal pain | Gastrointestinal disorders | 3 of 55 | 0 of 5 | 3 of 60 |
| General physical health deterioration | General disorders | 3 of 55 | 0 of 5 | 3 of 60 |
| Aspartate aminotransferase increased | Investigations | 2 of 55 | 0 of 5 | 2 of 60 |
| Febrile neutropenia | Blood and lymphatic system disorders | 2 of 55 | 0 of 5 | 2 of 60 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 2 of 55 | 0 of 5 | 2 of 60 |
| Urinary tract infection | Infections and infestations | 2 of 55 | 0 of 5 | 2 of 60 |
| Urosepsis | Infections and infestations | 2 of 55 | 0 of 5 | 2 of 60 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 55 | 0 of 5 | 1 of 60 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group A Parsaclisib (no Prior BTK Inhibitor) | Group B Parsaclisib (Prior BTK Inhibitor) | Total |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 11 of 55 | 0 of 5 | 11 of 60 |
| Diarrhoea | Gastrointestinal disorders | 10 of 55 | 0 of 5 | 10 of 60 |
| Cough | Respiratory, thoracic and mediastinal disorders | 9 of 55 | 0 of 5 | 9 of 60 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 7 of 55 | 1 of 5 | 8 of 60 |
| Constipation | Gastrointestinal disorders | 5 of 55 | 0 of 5 | 5 of 60 |
| Decreased appetite | Metabolism and nutrition disorders | 5 of 55 | 0 of 5 | 5 of 60 |
| Fatigue | General disorders | 4 of 55 | 1 of 5 | 5 of 60 |
| Neutrophil count decreased | Investigations | 5 of 55 | 0 of 5 | 5 of 60 |
| Pyrexia | General disorders | 5 of 55 | 0 of 5 | 5 of 60 |
| Abdominal pain | Gastrointestinal disorders | 4 of 55 | 0 of 5 | 4 of 60 |
Serious events with the highest arm-level rate: enterocolitis (20.0%), pneumocystis jirovecii pneumonia (20.0%), staphylococcal infection (20.0%), pyrexia (9.1%), hypercalcaemia (7.3%).
The safety record gives affected-subject counts within stated risk populations. In Group A, 55 subjects were at risk for the reported event categories; 39 were affected by serious adverse events and 41 by other adverse events. In Group B, 5 were at risk; 2 were affected by serious adverse events and 3 by other adverse events. Across the total group, 60 were at risk, 41 were affected by serious adverse events, and 44 by other adverse events. These are participant counts, not event counts or rates per unit of follow-up.
The record also lists deaths of 45 in Group A, 3 in Group B, and 48 overall. It does not report causes or timing of death in this information. A death count does not establish that death was caused by the study drug, and the listed adverse-event counts likewise do not establish causation. The risk populations and event counts should be read as descriptive safety information rather than a comparison of treatments.
Listed serious-event terms include enterocolitis, Pneumocystis jirovecii pneumonia, and staphylococcal infection, each reported as 20.0%; pyrexia, 9.1%; hypercalcaemia, 7.3%; and abdominal pain, 5.5%. The denominator and event-counting details for these percentages are not reported in the registry record. They should not be combined or interpreted as mutually exclusive categories.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a Phase 2 study of parsaclisib was conducted in relapsed or refractory diffuse large B-cell lymphoma and is marked completed. It records 60 enrolled subjects, a primary response-rate outcome for Group A, and safety information for Group A and Group B. The primary endpoint was defined using complete or partial response under Lugano Classification criteria, determined by IRC.
What the record does not establish is the numerical primary efficacy result. The objective response rate and its 95% confidence interval are not reported in the registry record. Without them, readers cannot assess the observed response frequency or how precisely it was estimated. The listed secondary efficacy outcomes also lack numerical results in the information recorded. This absence should not be mistaken for a null result or a failure to measure the outcomes.
The study design also limits what can be concluded from comparing groups. Group A and Group B were defined by prior BTK inhibitor exposure, were not randomized, and both received parsaclisib. They are not a control group and treatment group. Differences in their outcomes, if reported elsewhere, would not by themselves show that prior exposure caused the difference or that parsaclisib caused an outcome. The safety counts are descriptive and do not establish drug-relatedness.
General: interpreting a clinical study requires both an estimate and its uncertainty, a clear analysis population, and a design that supports the intended comparison. Here, the registry identifies the endpoint and population definition, but does not report the primary estimate, confidence-interval limits, detailed analysis methods, or missing-data handling. The findings that can be stated from the record are therefore limited to its design, endpoint definition, and reported safety counts; efficacy magnitude and comparative effects cannot be inferred.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how an endpoint and a participant grouping need to be distinguished. The primary efficacy question concerned objective response rate in Group A, whose subjects had not previously received a BTK inhibitor. Group B was defined by prior BTK inhibitor treatment, but it was not a randomized comparator. The groups’ labels describe treatment history, not competing study treatments.
That distinction matters because a numerical difference between non-randomized groups can reflect differences in who entered each group, as well as chance. A design without random assignment does not support treating group contrasts as if they were controlled treatment effects. The registry record reports safety information for both groups but does not provide a primary efficacy estimate or statistical analyses that would support a comparative inference.
The record also illustrates why an endpoint definition is not the same as an endpoint result. It specifies a response criterion, assessment schedule, and analysis-set definition, but does not report the objective response rate or its 95% confidence interval. Without these, statistical precision and the size of the observed response proportion cannot be evaluated. The listed secondary outcomes do not fill that gap because their numerical results are not reported in the registry record.
Finally, safety counts have to be interpreted with their denominators and context. Group A and Group B have different risk populations, and the record does not establish that reported events were caused by parsaclisib. Descriptive counts can characterize what was recorded, but they do not independently establish comparative risk. These design and reporting distinctions are central to reading clinical evidence carefully.
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.
Several trial-specific limitations follow from the information reported in the registry record. The primary endpoint is defined, but the objective response rate and 95% confidence interval are not reported. The numerical efficacy results for the listed secondary outcomes are also not reported. Consequently, the efficacy findings and their precision cannot be assessed from this record.
The study was non-randomized and open-label, with groups defined by prior BTK inhibitor exposure. Both groups received parsaclisib, so there is no randomized control group in the described design. The groups are not a like-for-like comparison, and their outcomes cannot isolate the effect of parsaclisib or prior BTK inhibitor treatment. The registry does not report group-specific baseline characteristics that might help describe differences in their participant profiles.
Although the full analysis set is defined, outcome-specific analysis populations, missing-data procedures, and the number assessed at each scheduled time point are not reported in the registry record. The statistical analysis plan, confidence-interval method, covariate adjustment, interim analyses, and sample-size justification are also not reported. The registry lists no statistical analyses, leaving the inferential details unavailable.
Safety information is presented as affected-subject counts, but the record does not provide causes or timing for the deaths. The denominator and event-counting details for the listed serious-event percentages are not reported. These limitations constrain interpretation of the safety summaries and prevent a causal reading of the counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202) — NCT02998476.
- Registry record last updated 2025-08-22; status last verified 2025-08.
- Results first posted 2020-04-24.
- 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
NCT02998476, CITADEL-202, is recorded as a completed Phase 2, multicenter, international, open-label, non-randomized, parallel study of parsaclisib in relapsed or refractory diffuse large B-cell lymphoma. Enrollment was 60. The study began on 2017-03-02, and primary completion was 2019-02-22.
Group A included subjects without prior BTK inhibitor treatment; Group B included subjects with prior BTK inhibitor treatment. The primary endpoint was objective response rate in Group A, based on complete or partial response under Lugano Classification criteria as determined by IRC. The registry record does not report the primary endpoint estimate or its 95% confidence interval. It reports affected-subject safety counts and deaths, but does not establish event causation. Statistical analyses, the sample-size justification, and detailed missing-data methods are not reported in the registry record.