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 Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma (NCT03789240), a na phase 2 study. The primary outcome is Proportion of Participants Who Achieve Positron Emission Tomography (PET) - Negative Complete Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03789240 |
| Phase | Phase 2 |
| Condition | Follicular Lymphoma, Non-Hodgkin's Lymphoma, NHL |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 33 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
People with follicular lymphoma who have not previously received treatment for their disease. The registry describes follicular lymphoma as a disease involving abnormal B-cells that commonly accumulate in lymph nodes, though other parts of the body may also be affected.
Intervention
Response-adapted treatment with copanlisib and rituximab. The registry describes intravenous administration in 28-day cycles, with the schedule varying across treatment cycles. The listed dose level is 60mg of copanlisib and 375mg/m^2 of rituximab.
Comparator
There is no separate comparator group. The study is listed as single-group, with allocation recorded as NA and masking as none. Consequently, the registry record does not describe a randomized treatment comparison.
Primary question
What proportion of participants achieve a PET-negative complete response after induction therapy with copanlisib and rituximab? The response is assessed within 2 months of induction therapy completion, up to 13 months since start of therapy.
The study concerns untreated follicular lymphoma, a form of non-Hodgkin's lymphoma. Its stated objective is to assess whether the drug combination is effective at slowing the growth of the disease, while the primary endpoint focuses more specifically on PET-negative complete response after induction therapy. That endpoint is a response measure, not a direct measure of how long a participant remains free of progression or how long they live.
The registry also lists secondary outcomes covering response, safety, and longer-term follow-up. These include objective response rate, continuous complete response at 30 months, complete molecular remission, duration of response, time to next treatment, progression-free survival, and overall survival. Their inclusion indicates that the study record encompasses more than the primary response question, but the registry record does not report results for these outcomes.
Because the study has one group and no control arm, its primary question is descriptive: how often PET-negative complete response is observed among participants treated in this study. It cannot, by itself, establish how that response rate compares with another treatment or with outcomes in an untreated group.
3. Trial Design
This is a phase 2, single-group study of response-adapted therapy with copanlisib and rituximab in untreated follicular lymphoma. The registry lists an enrollment of 33 and identifies the National Cancer Institute (NCI) as sponsor. Allocation is recorded as NA, and masking is listed as none. The record therefore describes no randomized, masked, parallel control comparison.
The treatment description calls for intravenous study drugs in 28-day cycles, for up to 13 cycles. Copanlisib is infused over about 1 hour and rituximab over several hours. The schedule varies by cycle: one cycle includes 3 weekly doses of copanlisib; the next includes 3 weekly copanlisib doses and 4 weekly rituximab doses; other cycles include 2-3 weekly copanlisib doses and 1 rituximab dose. The arm description also identifies a copanlisib window cycle before induction. Further details of the induction schedule are not fully reported in the registry record.
Screening and follow-up procedures described in the record include medical and cancer history, physical examination, symptom and daily-activity review, blood and urine testing, bone marrow sampling, and imaging of the chest, abdomen, and pelvis. Some imaging uses a radioactive tracer. During treatment, some tests are repeated, and participants may provide cheek swabs or saliva samples or have a tumor sample taken. Some participants are described as having follow-up visits after treatment.
The registry lists a study start of 2019-08-22, primary completion of 2025-09-24, and status active, not recruiting. These are record entries, not evidence that all follow-up or outcome analyses are complete. The registry record does not report a separate sample-size justification, a planned interim-analysis schedule, or a detailed statistical analysis plan.
With one treatment group, the study can describe response and safety outcomes in the enrolled group. It does not provide a randomized estimate of the treatment's effect relative to a control. Differences from outcomes in other studies would not constitute a like-for-like randomized comparison.
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 | Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab |
|---|---|
| STARTED | 33 |
| COMPLETED | 28 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab |
|---|---|
| Switched to alternative treatment | 4 |
| Physician Decision | 1 |
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 | Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab |
|---|---|---|
| Participants analysed | 33 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 23 |
| Age, Categorical: >=65 years | Participants | 10 |
| Age, Continuous | years | 55 (24 to 80) |
| Sex: Female, Male: Female | Participants | 16 |
| Sex: Female, Male: Male | Participants | 17 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 31 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 |
| Race (NIH/OMB): White | Participants | 23 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 33 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Participants Who Achieve Positron Emission Tomography (PET) - Negative Complete Response, measured over Within 2 months of induction therapy completion, up to 13 months since start of therapy.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | proportion of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the proportion of participants who achieve a PET-negative complete response after induction therapy with copanlisib and rituximab. The response is assessed within 2 months of induction therapy completion, up to 13 months since start of therapy. The registry states that the response rate is to be reported with a 95% confidence interval.
Complete response is defined using the 2014 Lugano classification. In the registry description, a complete response requires a Deauville score of 1-3 on PET and no evidence of disease in the bone marrow, with or without a residual mass. Thus, the endpoint combines findings from PET imaging and bone marrow assessment rather than relying on a single symptom or laboratory result.
As a proportion, this endpoint describes how commonly the specified response was observed in the study group by the stated assessment period. A confidence interval conveys statistical uncertainty around that estimate: generally, it represents a range of values compatible with the observed data under the method's assumptions. It does not remove uncertainty about selection, measurement, or other features of a single-group study.
The endpoint is used to characterize response to induction therapy. It is not itself a measure of response duration, time to progression, need for subsequent treatment, or overall survival. The registry lists several of those as secondary outcomes, but does not report their results. It also does not report the primary endpoint's observed proportion or confidence interval, so the size and precision of the response estimate cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a phase 2 study in which the primary outcome is a PET-negative complete response after induction therapy. It gives the response definition and assessment window, but no observed response count, proportion, or 95% confidence interval. Therefore, no conclusion about the frequency of this response in the study group can be drawn from the outcome information reported in the registry record.
The planned assessment is tied to a specific clinical and imaging definition: the 2014 Lugano criteria, including a Deauville score of 1-3 on PET and no evidence of disease in bone marrow, with or without a residual mass. A response estimate would describe the proportion meeting that definition at the specified time. It would not establish how long the response lasts. The registry lists duration of response, continuous complete response at 30 months, and other time-related outcomes separately, but their results are not reported in the registry record.
Even if a response proportion were available, its interpretation would be limited by the single-group design. Without a control group, the study cannot estimate a randomized contrast against another treatment or against no study treatment. A response observed during treatment is a descriptive result for participants in the study; it does not, on its own, show that treatment caused the response or that the response rate is higher than it would have been under another approach.
A 95% confidence interval, if reported, would help show the precision of the response proportion. In general, a narrower interval indicates a more precise estimate under the statistical method used, while a wider interval indicates greater uncertainty. The interval would not address all sources of uncertainty, such as differences between the study participants and other populations, outcome assessment, or the absence of a control group. No interval is reported for the primary endpoint in the registry record.
The registry lists 33 as enrollment, but does not report the number assessed for the primary endpoint, the number with missing response assessments, or the analysis population. Those details matter because a proportion depends on both the response count and the denominator used. The record's stated enrollment cannot be assumed to be the endpoint denominator.
The study also reports safety counts in the registry record. These figures describe adverse events in the listed dose-level group; they do not supply a comparison with an untreated or alternative-treatment group. Safety counts and response outcomes answer different questions and should not be combined into a claim about benefit or harm relative to another option.
In short, the record establishes the design and definition of the primary outcome but does not report the outcome result. Interpretations about response frequency, precision, comparative efficacy, or longer-term benefit are therefore not supported by the registry information reported.
9. Statistical Methods Explained
Statistical methods are the rules used to turn observed participant data into estimates and uncertainty measures. The registry specifies that the primary response rate is to be reported with a 95% confidence interval, but detailed computational choices for that interval are not reported in the registry record. No primary outcome analysis is listed in the record.
What does a proportion measure?
General explanation: a proportion is the number of participants meeting a defined outcome divided by the number included in the relevant analysis. For a response endpoint, the numerator consists of participants meeting the response definition, while the denominator is the group used for the analysis. The denominator may depend on prespecified analysis-population rules and on whether outcome information is available. The registry record does not state the primary endpoint's observed numerator, denominator, or analysis population, so no response proportion can be interpreted from the posted results.
The outcome definition matters because a proportion is meaningful only when the qualifying event and assessment period are clear. In this study, the event is PET-negative complete response under the stated Lugano criteria, and the assessment period is within 2 months of induction therapy completion, up to 13 months since start of therapy. Any interpretation should remain attached to that definition and timeframe rather than treating the endpoint as a general measure of disease control.
What does a confidence interval add?
General explanation: a confidence interval expresses the statistical uncertainty around an estimated quantity. For a response proportion, it provides a range of values compatible with the observed data under the interval method's assumptions. It is not a guarantee that the true value lies within the particular interval, and it does not measure bias from study design or missing data. The registry says a 95% confidence interval will accompany the response rate, but the interval method and the resulting interval are not reported in the registry record.
Precision is influenced by the amount of information in the analysis and by the observed response pattern. A smaller or more uncertain dataset generally yields less precise estimates, but the exact precision cannot be assessed without the response count, analysis denominator, and interval. The registry's enrollment entry alone does not establish the number analyzed for the primary endpoint.
Why does the single-group design matter?
General explanation: a single-group study estimates outcomes observed among participants receiving the study regimen. A randomized comparison can estimate a difference between assigned groups under the conditions of that trial; a single-group study cannot provide that same controlled contrast. Participants may differ from people in external studies in eligibility, follow-up, outcome assessment, or other factors. Thus, comparing a single-group response estimate with results from another source would not be equivalent to a randomized comparison.
Here, allocation is recorded as NA, masking as none, and the model as single-group. The registry does not identify a comparator group. The primary outcome can therefore be described as a response proportion for this study group if and when results are reported, but it cannot quantify a comparative treatment effect from the design information recorded.
What do the listed secondary outcomes represent?
The registry names outcomes spanning response, safety, and time-to-event questions. Objective response rate concerns achievement of at least a partial response. Continuous complete response at 30 months and complete molecular remission are distinct response-related outcomes with their own definitions. Duration of response, time to next treatment, progression-free survival, and overall survival concern the timing of events over follow-up. These are not interchangeable measures. The record lists the outcomes but does not report their numerical results, event definitions beyond the names, analysis methods, or handling of censoring in the registry record.
General explanation: time-to-event analyses can account for differing follow-up by using the time until an event or censoring, where censoring means the event was not observed during a participant's available follow-up. The statistical interpretation depends on the event definition, follow-up, and assumptions. Those analysis details are not reported in the registry record. No results for these secondary endpoints should be inferred from their listing.
How should planning illustrations be distinguished from trial results?
General explanation: sample-size planning calculations explore how many participants might be needed under stated assumptions to detect a chosen effect with a specified statistical framework. Such calculations are planning illustrations, not evidence that an effect was observed, and not a measure of the probability that the study's result is correct. The registry record does not report its own sample-size justification or a full statistical plan. No numerical planning result or observed treatment effect is reported in the registry record, so those quantities cannot be assessed from the record.
In general, power is a design property tied to assumptions about the effect, variability, significance threshold, and analysis. It is not an observed result. Any planning scenario based on an observed effect would also depend on the estimate used and would not replace a prespecified design justification. No observed primary response estimate is available in the registry record to anchor such an interpretation.
Overall, the registry identifies the primary outcome and the intended confidence-interval reporting, while leaving the analysis population, missing-data approach, exact interval method, and detailed methods for secondary outcomes unreported. Those omissions limit reproducibility and prevent assessment of whether the reported analysis, if added later, follows prespecified choices.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rit | 33 | 0 | 0.0% | 0.0% to 10.6% | 0.0% to 10.4% | 0.1% to 10.3% |
R code and output
arm <- c("Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rit")
n <- c(33)
events <- c(0)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rit 33 0 0.0 0.0 10.6 0.0 10.4 0.1 10.311. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and multiple secondary outcomes. When a study assesses several outcomes, multiplicity is a general statistical concern: the more questions tested, the greater the chance that at least one apparently notable finding may arise by chance if each is assessed separately. Methods such as prespecified outcome hierarchies or adjustment procedures can address particular multiplicity goals, but no such approach is reported in the registry record. The record also does not report a testing hierarchy or explain whether secondary outcomes are intended as descriptive or confirmatory.
The registry lists 10 outcome measures and zero analyses. It does not provide numerical outcome results for the primary or secondary endpoints. Therefore, there are no posted analysis estimates from which to evaluate multiplicity handling or statistical significance. The outcome list alone does not establish how the study planned to interpret multiple results.
Missing data are also relevant to proportion endpoints. If some participants lack an evaluable response assessment, the estimated proportion can depend on how those participants are treated and on which participants enter the analysis denominator. The registry record does not report missing primary endpoint assessments, an imputation method, or rules for including participants with incomplete information. The enrollment entry should not be taken as the primary-endpoint denominator.
The analysis population is not reported in the registry record. It is therefore unclear from the record whether the intended response analysis includes all enrolled participants, only those who start or complete induction, or another defined group. The study's statistical analysis plan and any interim-analysis procedures are also not reported in the registry record. Without these details, the transparency and reproducibility of any eventual estimate cannot be fully assessed.
General explanation: a clear analysis plan ordinarily states which outcomes are primary, how the analysis population is defined, how missing outcomes are handled, and whether multiplicity adjustments are used. These choices can affect interpretation, but none should be inferred when absent from the registry record.
12. 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 |
|---|---|---|---|
| Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab | 12 | 33 | 36.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab | 3 of 33 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab | 31 of 33 |
Most frequent serious adverse event terms
| Event term | Organ system | Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab |
|---|---|---|
| Infections and infestations - Other, specify: COVID-19 | Infections and infestations | 3 of 33 |
| Bacteremia | Infections and infestations | 2 of 33 |
| Lung infection | Infections and infestations | 2 of 33 |
| Allergic reaction | Immune system disorders | 1 of 33 |
| Catheter related infection | Infections and infestations | 1 of 33 |
| Enterocolitis infectious | Infections and infestations | 1 of 33 |
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 33 |
| Immune system disorders - Other, specify | Immune system disorders | 1 of 33 |
| Infections and infestations - Other, specify: COVID 19 | Infections and infestations | 1 of 33 |
| Infections and infestations - Other, specify: Viral Infection, other | Infections and infestations | 1 of 33 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab |
|---|---|---|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 20 of 33 |
| Nausea | Gastrointestinal disorders | 14 of 33 |
| Mucositis oral | Gastrointestinal disorders | 13 of 33 |
| Diarrhea | Gastrointestinal disorders | 10 of 33 |
| Infusion related reaction | Infections and infestations | 9 of 33 |
| Superficial thrombophlebitis | Vascular disorders | 7 of 33 |
| Alanine aminotransferase increased | Investigations | 6 of 33 |
| Aspartate aminotransferase increased | Investigations | 6 of 33 |
| Neutrophil count decreased | Investigations | 6 of 33 |
| Upper respiratory infection | Infections and infestations | 5 of 33 |
Serious events with the highest arm-level rate: infections and infestations - other, specify: covid-19 (9.1%), bacteremia (6.1%), lung infection (6.1%), allergic reaction (3.0%), catheter related infection (3.0%).
The registry reports adverse-event figures for the listed dose level: 60mg of copanlisib and 375mg/m^2 of rituximab. It records serious adverse events affecting 12 of 33 participants and other adverse events affecting 31 of 33 participants. The record also lists 3 deaths. These are counts in the registry record, not comparisons with another group.
The listed serious-event terms include COVID-19 under infections and infestations - Other, specify, reported as 9.1%; bacteremia, 6.1%; lung infection, 6.1%; allergic reaction, 3.0%; catheter related infection, 3.0%; and enterocolitis infectious, 3.0%. These term-specific percentages should be read as registry-reported figures. The record does not provide additional detail in the information reported about timing, recurrence, severity grading, or causal attribution for these terms.
Serious and other adverse-event categories are different summaries, and their counts should not be added together. The registry does not report whether the same participant experienced events in both categories or multiple events of a given type. The listed deaths should not be presumed to be caused by treatment; causal attribution is not reported in the registry record.
These safety counts describe what was recorded in the study group. Without a control group and fuller event-level context, they do not establish comparative risk. The registry also lists an outcome concerning adverse events leading to discontinuation of induction therapy, but does not report its result.
13. What the Result Does, and Does Not, Mean
The registry record defines a specific response outcome and describes the treatment schedule and study design. It does not report the observed primary response proportion, its 95% confidence interval, or results for the listed secondary outcomes. The main statistical message is therefore about what the study is designed to measure, not what response result it found.
If reported, the primary endpoint would describe the proportion of the study group meeting the PET-negative complete-response definition within the specified assessment window. It would not by itself describe how durable that response is, whether disease progression is delayed, or whether survival changes. The registry lists separate outcomes for duration of response, progression-free survival, time to next treatment, and overall survival, but no results for these are reported in the registry record.
The single-group structure also defines what can be concluded. The study has no separate control arm in the registry record, so an observed response rate would not be a randomized comparison with another regimen or with no study treatment. It would describe outcomes among participants in this study, without isolating the effect of treatment from other influences.
Likewise, adverse-event counts describe recorded events in the study group; they do not establish how risks compare with an alternative. The registry lists serious and other adverse-event counts and selected serious-event terms, but does not report causal attribution in the information available. Counts should not be interpreted as proof that treatment caused each event.
In general, a confidence interval can communicate precision around an estimate, but it cannot resolve limitations arising from lack of a control group, incomplete reporting, or possible missing outcome data. Here, the primary confidence interval is intended for reporting but is not present in the registry record. The endpoint denominator, analysis population, and missing-data methods are also not reported.
Accordingly, the registry information supports a description of the trial's question, design, endpoint definition, and recorded safety figures. It does not support a claim that the regimen is effective or ineffective, a comparative treatment claim, or an inference about longer-term outcomes.
14. Why This Trial Matters Statistically
This study is statistically notable for the contrast between a clearly defined response endpoint and the limited outcome information reported in the registry record. The endpoint specifies PET-negative complete response using the 2014 Lugano classification, with a defined assessment window and intended 95% confidence interval. Those details identify what an eventual estimate is meant to represent.
At the same time, the single-group design is central to interpreting any response estimate. A proportion from one treatment group can describe observed outcomes in that group, but it cannot provide the same evidence as a randomized comparison. This distinction is important whenever response rates are considered alongside results from other studies or treatment settings.
The record also illustrates why an endpoint's analysis details matter. The response proportion depends on the analysis denominator and on how participants without an evaluable assessment are handled. The registry record does not report these choices or the resulting response count and estimate. Without them, neither the outcome frequency nor its statistical precision can be evaluated.
Several secondary outcomes broaden the questions the study intends to address, covering molecular response, adverse events, response duration, later treatment, progression, and survival. These outcomes have different meanings and statistical requirements. Their presence does not mean that results are available, and the registry record does not report how multiplicity across outcomes is handled.
Finally, the listed safety counts offer descriptive information but do not provide a comparative risk estimate. Taken together, the record is useful for identifying the trial's design, endpoint, and intended outcome scope, while also showing the limits of interpretation when outcome analyses and key statistical methods are not reported.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record identifies a single-group study without a control arm. As a result, it cannot establish a randomized contrast for the primary response endpoint or for the safety outcomes. Any response proportion, if reported, would describe the study group rather than estimate a treatment difference against a comparator.
The primary outcome result is not reported in the registry record. No response count, denominator, proportion, or confidence interval is available. The analysis population and handling of participants without an evaluable response assessment are also not reported, limiting assessment of the endpoint's precision and potential sensitivity to missing data.
The record lists multiple secondary outcomes but does not report their results or detailed analysis methods. It does not state a multiplicity strategy, interim-analysis plan, or full statistical analysis plan. The listed outcome names alone do not establish event definitions, censoring rules, analysis populations, or the order in which findings would be interpreted.
The intervention description gives a cycle-based schedule, while the arm description does not fully specify the induction regimen. The registry record also does not report whether participants completed treatment or how treatment exposure varied. These gaps limit detailed interpretation of treatment delivery alongside outcomes.
The safety information is descriptive and lacks a control group. The record does not provide causal attribution for the listed events, and the information reported does not establish timing or recurrence. The counts should therefore not be treated as comparative risks or as evidence that each event was treatment-related.
Finally, the record lists enrollment and study status, but those entries do not supply outcome-analysis denominators or demonstrate that follow-up and analyses are complete. The registry record does not report a sample-size justification. These limitations constrain what can be concluded from the available information, independently of the clinical importance of the question.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma — NCT03789240.
- Registry record last updated 2026-03-03; status last verified 2026-02.
- Results first posted 2026-03-03.
- 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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19. Record Summary
The registry record describes NCT03789240, a phase 2, single-group study of response-adapted copanlisib and rituximab in untreated follicular lymphoma. The National Cancer Institute (NCI) is listed as sponsor. The record lists enrollment of 33, no masking, and allocation as NA.
The primary endpoint is the proportion achieving PET-negative complete response under the 2014 Lugano classification, assessed within 2 months of induction therapy completion, up to 13 months since start of therapy. The response rate is intended to be reported with a 95% confidence interval. The registry record does not report the primary outcome result or any outcome analyses.
The listed secondary outcomes include response, molecular remission, adverse events, duration of response, time to next treatment, progression-free survival, and overall survival. Safety figures are reported for the listed dose level, including serious and other adverse-event counts and selected serious-event terms. The study status is active, not recruiting, with primary completion listed as 2025-09-24. Detailed analysis methods, the analysis population, missing-data handling, and sample-size justification are not reported in the registry record.