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 IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma (NCT01491841), a non-randomized phase 1 study. The primary outcome is Maximum Tolerated Dose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01491841 |
| Phase | Phase 1 |
| Condition | Non-Hodgkin's Lymphoma |
| Allocation | Non-Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 33 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Anne Beaven, MD |
| Results posted | Yes |
2. Clinical Question
Population
Patients with relapsed or refractory B cell non-Hodgkin lymphoma. The registry record lists 33 participants enrolled overall and describes three dose cohorts for the primary endpoint.
Intervention
Bendamustine and rituximab were combined with pixantrone, with pixantrone dose escalation across sequential cohorts. Pegfilgrastim was also included in the regimen descriptions.
Comparator
There was no randomized control group. The study used sequential dose cohorts, not a like-for-like comparison of treatment groups.
Primary question
What maximum tolerated dose of pixantrone could be identified for this combination using dose-limiting toxicities as the assessment criterion?
This was a phase I study of a combination regimen for people whose B cell non-Hodgkin lymphoma had relapsed or was refractory. Bendamustine and rituximab were kept at static doses in the planned design, while the pixantrone dose was escalated between sequential cohorts. The registry describes the intended dose levels as 55mg/m2, 85mg/m2, and 115mg/m2.
The primary question concerns dose finding and toxicity, rather than whether the combination improves outcomes relative to another treatment. The record says that dose-limiting toxicities during the first 2 cycles were to guide determination of the maximum tolerated dose. The registry describes a standard 3+3 design, but the detailed implementation and any deviations are not reported in the registry record.
Overall response, progression-free survival, toxicity, and overall survival are listed as secondary outcomes. These outcomes could address activity and safety, but numerical results for them are not reported in the registry record. The planned phase II did not proceed as planned after pixantrone was withdrawn from the US. Consequently, the record describes a phase I dose-escalation question, not a completed randomized assessment of comparative benefit.
3. Trial Design
The registry lists this as a phase I, non-randomized, unmasked, sequential study. It reports enrollment of 33 participants and lists non-Hodgkin lymphoma as the condition. The design description focuses on escalating pixantrone doses while maintaining static doses of bendamustine and rituximab. Because allocation was not randomized and there was no stated control arm, the dose cohorts should not be interpreted as treatment groups in a comparative efficacy trial.
The planned pixantrone levels were 55mg/m2, 85mg/m2, and 115mg/m2, in sequential cohorts dependent on acceptable toxicity at each dose level. Bendamustine was described at 120mg/m2 and rituximab at 375mg/m2, each administered on Day 1 of each cycle. Pixantrone was administered last on Day 1, 4-6 hours after bendamustine. Pegfilgrastim, 6mg, was scheduled for Day 2 of each cycle. These are the registry’s regimen descriptions, not evidence that every participant received every listed dose or completed treatment.
The summary describes a standard 3+3 design and says dose-limiting toxicities in the first 2 cycles were to inform the maximum tolerated dose. The primary endpoint population description says dose escalation was performed in 3 cohorts and lists 7 people in each cohort. The adverse-event groups list 7 people at risk for the 55mg/m^2 cohort, 7 for the 85mg/m^2 cohort, and 8 for the 115mg/m^2 cohort. These group counts are not reconciled with each other or with overall enrollment in the registry record.
The registry lists a 4 years timeframe for the primary endpoint and marks the study completed. Its summary also says phase II did not proceed as planned because of withdrawal of pixantrone from the US. The detailed analysis plan, actual escalation decisions, and any protocol deviations are 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.
Overall Study
| Stage | Bendamustine + Rituximab + Pixantrone |
|---|---|
| STARTED | 33 |
| COMPLETED | 22 |
| NOT COMPLETED | 11 |
Reasons for not completing this period:
| Reason | Bendamustine + Rituximab + Pixantrone |
|---|---|
| Screen Failure | 10 |
| Withdrawal by Subject | 1 |
Analysis population for the primary outcome, as defined in the registry: Over the course of 4 years, dose escalation was performed in 3 cohorts. Cohort 1 (Phase 1: Pixantrone, 55mg/m\^2) enrolled 7 people; Cohort 2 (Phase 1: Pixantrone, 85mg/m\^2) enrolled 7 people; Cohort 3 (Phase 1: Pixantrone, 115 mg/m\^2) enrolled 7 people.
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 | Bendamustine + Rituximab + Pixantrone |
|---|---|---|
| Participants analysed | 33 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 19 |
| Age, Categorical: >=65 years | Participants | 14 |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 23 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 33 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 31 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 33 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose, measured over 4 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | milligrams per meter squared |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is maximum tolerated dose, expressed in milligrams per meter squared. It is a dose-finding endpoint: the study sought to identify the pixantrone dose level that could be administered with the bendamustine and rituximab regimen under the specified toxicity rules. This differs from an endpoint such as overall response, which describes tumor response, or survival, which measures time until an event.
The registry defines dose-limiting toxicity using severity and duration. It includes any grade 3 non-hematologic toxicity lasting longer than 48 hours despite proper supportive care, any grade 4 non-hematologic toxicity, or any grade 3 or 4 hematologic toxicity lasting longer than 7 days. Alopecia and febrile neutropenia were excluded from the DLT definition. Any NCI CTC v4.03 grade 5 toxicity, meaning death, was considered a DLT. Assessments were performed weekly during cycles 1 and 2.
In general, early-cycle toxicity criteria are used in dose-escalation studies to guide decisions about whether a dose level is tolerable enough to continue escalation or select as the maximum tolerated dose. The record states that DLTs were the assessment criteria, but it does not report the observed DLT counts by dose, the escalation decisions, or the resulting maximum tolerated dose. The endpoint’s numerical result is therefore not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a phase I dose-escalation study, but it does not report the numerical result of its primary endpoint. Although maximum tolerated dose is named as the endpoint and the record specifies the dose levels and DLT criteria, no selected MTD is stated. Without that result, the posted information does not establish which pixantrone dose was identified as the maximum tolerated dose, or whether a dose was selected at all.
The record lists overall enrollment of 33. The primary endpoint description lists 7 people in each of three cohorts, while the adverse-event groups list 7, 7, and 8 people at risk. These counts do not align completely, and the registry does not explain the discrepancy. They should be read as figures attached to different record descriptions, not combined into a new total or treated as a single reconciled analysis population.
The adverse-event entries describe serious events, other events, and deaths by dose group. They show that serious events were recorded in the 55mg/m^2 and 115mg/m^2 groups, while the 85mg/m^2 group lists no participants affected by serious events. The groups each list participants affected by other events, and the listed death counts are substantial relative to the group sizes. These counts do not establish that treatment caused an event or death. The registry does not provide an attribution analysis or clinical context sufficient for causal interpretation.
The serious-event terms with the largest listed percentages include febrile neutropenia, hypercalcemia, and neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify, each at 14.3%. Left ventricular systolic dysfunction, acute kidney injury, and hypotension are each listed at 12.5%. Those percentages are registry entries; no further breakdown or uncertainty estimate is reported.
Overall response, progression-free survival, toxicity, and overall survival are named as secondary outcomes, but numerical outcome results are not reported in the registry record. There are no posted analyses listed. As a result, the record supports a description of the design and recorded safety counts, but not a quantitative conclusion about response, survival, or comparative treatment effects. The study was non-randomized and had no like-for-like control comparison, so differences between dose cohorts would not by themselves establish a causal dose effect.
The registry says phase II did not proceed as planned after pixantrone was withdrawn from the US. Thus, the absence of phase II results is consistent with the stated development history, but the record does not provide further details about that decision. The available information is not enough to assess the precision of the primary endpoint estimate, the completeness of follow-up, or the robustness of any efficacy analysis.
9. Statistical Methods Explained
What does a sequential dose-escalation design do?
In general, a sequential dose-escalation study assigns successive groups to increasing dose levels rather than randomizing participants among concurrent treatment arms. The next dose decision depends on toxicity observed at the current level. This approach is suited to early dose finding, where the central aim is to characterize tolerability and select a dose for further study, not to estimate comparative efficacy against a control.
The registry describes a standard 3+3 design and says pixantrone would be escalated in sequential cohorts if toxicity at the current level was acceptable. The actual decision rules used, the number treated at each dose, and any changes to the planned escalation are not reported in the registry record. The primary endpoint description lists 7 participants for each of three cohorts, whereas the safety record lists 8 at risk in the highest-dose group. The record does not explain this difference, so the planned design description should not be mistaken for a complete account of implementation.
How is the maximum tolerated dose defined?
The endpoint is based on dose-limiting toxicity, with assessments made weekly during cycles 1 and 2. The record’s criteria distinguish toxicities by grade, type, and duration. For example, the definition includes grade 3 non-hematologic toxicity lasting longer than 48 hours despite supportive care, and grade 3 or 4 hematologic toxicity lasting longer than 7 days. It excludes alopecia and febrile neutropenia, while any grade 5 toxicity is considered a DLT.
In general, a toxicity rule creates a common basis for dose-escalation decisions, but the result depends on the observed events and the specified decision algorithm. The record describes the criterion and timeframe but does not report DLT counts by cohort or the final MTD. It is therefore not possible to verify the dose-selection decision from the posted information.
What can the safety counts tell readers?
Safety counts describe how many participants in a group were recorded as having an event. The registry lists participants at risk and participants affected by serious and other events for each pixantrone group. These are descriptive summaries; they do not, by themselves, show whether an event was caused by the regimen. Interpretation also depends on event definitions, follow-up, attribution, repeated events, and completeness of reporting. Those details are not fully reported in the registry record.
The listed deaths are counts in the adverse-event group summaries. A death count is important to report, but without details about timing, cause, disease status, and attribution, it cannot be interpreted as a treatment-related death count. The registry does not report those details in the information available for this study.
How should planning illustrations be understood?
The sample-size assumptions describe planning illustrations based on the observed effect, not the original design of this phase I trial. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. For time-to-event settings, the stated planning quantity is the total number of events; other settings use participants per arm.
In general, a planning illustration asks how much information might be needed under its stated assumptions. It is not a report of the number enrolled, a reconstruction of the trial’s design, or evidence that the study had a particular probability of detecting an effect. Such figures must not be described as observed power. Here, the study itself was non-randomized and sequential, and the record does not list an analysis comparing two randomized arms. The registry does not report that these planning assumptions were used to design the trial.
What is missing for statistical interpretation?
The registry lists five outcome measures and no posted analyses. It does not report numerical results for the MTD endpoint or the secondary outcomes. The detailed statistical analysis plan, analysis populations, treatment of missing observations, and any adjustment for multiple outcomes are not reported in the registry record. In general, those details help readers understand which participants contributed to each result, how uncertainty was quantified, and how a set of outcome tests should be interpreted. Their absence limits the conclusions that can be drawn from this record.
No confidence interval, standard error, or other estimate of precision is reported for the primary endpoint. In general, a confidence interval communicates the range of values compatible with the data under a statistical model; its width reflects precision. Without an estimate and an uncertainty measure, readers cannot assess how precisely the MTD was established. Likewise, without reported outcome estimates, there is no basis for inferring a treatment effect from the named secondary endpoints.
10. Multiplicity, Missing Data and Analysis Populations
The registry names several secondary outcomes in addition to the primary maximum tolerated dose endpoint: overall response, progression-free survival, toxicity, and overall survival. It does not report whether any multiplicity strategy was planned, such as prioritizing outcomes, adjusting significance thresholds, or treating secondary analyses as exploratory. A formal statistical analysis plan is not reported in the registry record.
In general, testing multiple outcomes creates more opportunities for apparently notable findings by chance if each test is interpreted independently. A prespecified testing strategy can clarify which results are confirmatory and how to interpret a family of comparisons. Without a reported plan or posted analyses, the status and interpretation of any secondary analyses cannot be assessed. The registry lists no analyses, and no numerical results for these outcomes are reported.
Missing-data methods and analysis populations are also not reported in the registry record. In general, readers need to know which participants were included in each endpoint analysis, how incomplete follow-up or unevaluable outcomes were handled, and whether the analysis followed the planned population definitions. These details matter even in an early-phase dose-finding study because they affect the denominator and the interpretation of toxicity and outcome counts.
The study’s cohort counts are not fully reconciled: the primary endpoint population description lists 7 people in each cohort, while the highest-dose adverse-event group lists 8 at risk. The record does not explain whether this reflects different analysis populations, a reporting discrepancy, or another reason. No resolution should be inferred. The overall enrollment count is also not presented as a reconciled endpoint-specific analysis population.
Finally, the registry does not describe interim analyses, stopping rules beyond the summary of the dose-escalation approach, or any corrections for repeated looks at accumulating data. These aspects are not reported in the registry record. Their absence limits assessment of the decision process but does not establish that any particular analysis was or was not 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 |
|---|---|---|---|
| Pixantrone, 55mg/m^2 | 3 | 7 | 42.9% |
| Pixantrone, 85mg/m^2 | 0 | 7 | 0.0% |
| Pixantrone, 115mg/m^2 | 2 | 8 | 25.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pixantrone, 55mg/m^2 | 6 of 7 |
| Pixantrone, 85mg/m^2 | 7 of 7 |
| Pixantrone, 115mg/m^2 | 8 of 8 |
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 |
|---|---|
| Pixantrone, 55mg/m^2 | 7 of 7 |
| Pixantrone, 85mg/m^2 | 7 of 7 |
| Pixantrone, 115mg/m^2 | 8 of 8 |
Most frequent serious adverse event terms
| Event term | Organ system | Pixantrone, 55mg/m^2 | Pixantrone, 85mg/m^2 | Pixantrone, 115mg/m^2 |
|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 7 | 0 of 7 | 1 of 8 |
| Left ventricular systolic dysfunction | Cardiac disorders | 0 of 7 | 0 of 7 | 1 of 8 |
| Hypercalcemia | Metabolism and nutrition disorders | 1 of 7 | 0 of 7 | 0 of 8 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 7 | 0 of 7 | 0 of 8 |
| Acute kidney injury | Renal and urinary disorders | 0 of 7 | 0 of 7 | 1 of 8 |
| Hypotension | Vascular disorders | 0 of 7 | 0 of 7 | 1 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pixantrone, 55mg/m^2 | Pixantrone, 85mg/m^2 | Pixantrone, 115mg/m^2 |
|---|---|---|---|---|
| Fatigue | General disorders | 5 of 7 | 2 of 7 | 6 of 8 |
| Nausea | Gastrointestinal disorders | 4 of 7 | 1 of 7 | 3 of 8 |
| Anemia | Blood and lymphatic system disorders | 2 of 7 | 0 of 7 | 5 of 8 |
| Platelet count decreased | Investigations | 2 of 7 | 0 of 7 | 5 of 8 |
| Anorexia | Metabolism and nutrition disorders | 4 of 7 | 2 of 7 | 1 of 8 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 3 of 7 | 1 of 7 | 3 of 8 |
| Vomiting | Gastrointestinal disorders | 2 of 7 | 0 of 7 | 4 of 8 |
| Neutrophil count decreased | Investigations | 1 of 7 | 1 of 7 | 4 of 8 |
| Constipation | Gastrointestinal disorders | 3 of 7 | 1 of 7 | 1 of 8 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 7 | 0 of 7 | 5 of 8 |
Serious events with the highest arm-level rate: febrile neutropenia (14.3%), hypercalcemia (14.3%), neoplasms benign, malignant and unspecified (incl cysts and polyps) - other, specify (14.3%), left ventricular systolic dysfunction (12.5%), acute kidney injury (12.5%).
The adverse-event summaries give, for each pixantrone dose group, the number at risk and the number affected by serious events, other events, and deaths. For the 55mg/m^2 group, 7 participants were at risk, 3 were affected by serious events, 7 by other events, and 6 deaths were listed. For the 85mg/m^2 group, the corresponding counts were 7, 0, 7, and 7. For the 115mg/m^2 group, they were 8, 2, 8, and 8.
These are descriptive counts, not evidence that the regimen caused the events or deaths. The record does not provide event attribution, timing, cause of death, or a detailed account of follow-up. It also does not explain why the highest-dose safety group lists 8 at risk while the primary endpoint description lists 7 in that cohort.
The listed serious-event terms include febrile neutropenia, hypercalcemia, and neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify, each reported at 14.3%. Left ventricular systolic dysfunction, acute kidney injury, and hypotension are each reported at 12.5%. These percentages should be read as registry entries, not as comparative evidence between doses. The record does not provide uncertainty intervals or further context for these term-level figures.
12. What the Result Does, and Does Not, Mean
The record describes an early-phase investigation of dose escalation for pixantrone combined with bendamustine and rituximab. Its primary purpose was to use specified dose-limiting toxicity criteria to identify a maximum tolerated dose. That is a dose-finding question, not a direct test of whether the regimen is more effective than another treatment.
The registry does not report the numerical MTD result. It also does not report numerical results for the listed secondary outcomes of overall response, progression-free survival, toxicity, and overall survival. Therefore, the posted information does not establish a selected dose, quantify response or survival, or estimate comparative efficacy. The absence of those results in the registry record should not be converted into a claim that an outcome did or did not occur.
The adverse-event summaries show recorded serious events, other events, and deaths in the dose groups. Those figures are relevant descriptions of what the registry reports, but they do not establish causation. The record lacks information needed to distinguish treatment-related events from events related to lymphoma, other conditions, or other causes. Dose groups were sequential rather than randomized, so raw differences between groups would also be vulnerable to differences in participants and timing, even if outcome estimates were available.
The registry states that phase II did not proceed as planned because pixantrone was withdrawn from the US. This explains why the record does not describe a completed phase II component, but it does not supply results from one. The study’s non-randomized phase I design cannot support a controlled treatment-effect conclusion on its own.
In general, a complete interpretation of a dose-finding study considers the observed DLTs, the escalation decisions, the selected dose, and uncertainty around that selection. Those results are not reported in the registry record. The responsible reading is therefore limited to the stated design, endpoint definition, cohort descriptions, and posted safety counts, with the primary endpoint outcome and secondary efficacy results remaining unreported.
13. Why This Trial Matters Statistically
This trial is statistically distinctive because its stated primary question is about dose selection rather than a treatment-versus-control effect. A phase I sequential design makes the relationship between toxicity observations and dose decisions central. The registry describes the DLT definition and planned pixantrone levels, allowing readers to understand the intended decision framework even though the endpoint result itself is not reported.
The record also illustrates why design details and analysis populations matter. Overall enrollment is listed as 33, the primary endpoint description lists 7 participants in each of three cohorts, and the adverse-event listing gives 8 participants at risk in the highest-dose group. Since these counts are not reconciled, readers cannot assume that every count refers to the same population or that a single denominator applies to all outcomes.
The non-randomized, sequential allocation is another key statistical feature. Cohorts are not concurrent randomized arms, so their outcome counts cannot be treated as a fair comparative estimate of dose effects. In general, comparisons across sequential groups can reflect differences in participants, follow-up, or circumstances as well as dose. No adjusted analysis or comparative result is reported in the registry record.
Finally, the record names secondary outcomes but does not report their results or a multiplicity plan. This distinction matters because a list of intended outcomes is not itself evidence of an observed effect. The stated withdrawal of pixantrone from the US and the decision not to proceed with phase II are part of the study context, while the primary MTD result and efficacy findings remain unreported. Together, these features make careful separation of planned questions, descriptive safety data, and demonstrated statistical results especially important.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A major limitation of the registry record is that it does not report the numerical primary endpoint result. The maximum tolerated dose is named, and the criteria used to assess dose-limiting toxicity are described, but the observed DLT counts and dose-selection outcome are absent. The listed secondary outcomes likewise have no numerical results in the registry record.
The cohort counts are not internally reconciled across descriptions. The primary endpoint population text lists 7 participants in each of three cohorts, while the adverse-event group for the highest dose lists 8 at risk. Overall enrollment is listed as 33, but the registry does not explain how that total relates to the cohort counts or endpoint-specific populations. This prevents a clear accounting of who contributed to each reported safety summary.
The study was non-randomized, unmasked, and sequential. Consequently, the dose cohorts are not randomized comparison groups, and differences in their event counts cannot establish comparative effects. The registry does not report adjusted analyses, uncertainty estimates, or detailed participant characteristics that could support a fuller assessment.
Additional information relevant to interpretation is not reported in the registry record, including the detailed statistical analysis plan, handling of missing data, analysis populations, event attribution, causes and timing of deaths, and any multiplicity approach. The exact escalation decisions and any deviations from the planned 3+3 approach are also not described. The registry states that phase II did not proceed as planned because pixantrone was withdrawn from the US, but it does not provide further detail about the decision. These limitations constrain interpretation of the posted record; they do not determine what may have been reported elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma — NCT01491841.
- Registry record last updated 2020-03-04; status last verified 2020-03.
- Results first posted 2019-06-14.
- 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
The registry describes a completed, non-randomized, unmasked, sequential phase I study of bendamustine, rituximab, and pixantrone in relapsed or refractory B cell non-Hodgkin lymphoma. It lists overall enrollment of 33 and planned pixantrone dose levels of 55mg/m2, 85mg/m2, and 115mg/m2. The primary endpoint was maximum tolerated dose, assessed through dose-limiting toxicities during cycles 1 and 2.
The registry does not report the numerical MTD result or numerical results for the listed secondary outcomes. Safety summaries report serious events, other events, and deaths by dose group, but do not establish causation. Cohort counts differ between the primary endpoint and adverse-event descriptions and are not reconciled. The registry states that phase II did not proceed as planned after pixantrone was withdrawn from the US.