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 Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL) (NCT01520922), a na phase 2 study. The primary outcome is Number of Participants With Overall Response (OR), as Assessed by the Investigator.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01520922 |
| Phase | Phase 2 |
| Condition | Chronic Lymphocytic Leukemia (CLL), Leukaemia, Lymphocytic, Chronic |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 99 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
People with untreated or relapsed chronic lymphocytic leukaemia (CLL) who met the study’s eligibility criteria. The primary endpoint population is described as the as-treated population: participants who received at least one dose of both ofatumumab and bendamustine.
Intervention
A combination of ofatumumab and bendamustine. The study was open label and allowed up to 6 cycles of treatment. The planned treatment schedule differed according to whether CLL was untreated or relapsed.
Comparator
There was no concurrent control group. The study is described as single group, and the registry record does not report a randomized comparison with another treatment or with no treatment.
Primary question
How many participants had an investigator-assessed overall response during the period from starting study treatment until 3 months after the last dose? Overall response includes complete response, complete response with incomplete bone marrow recovery, partial response, and nodular partial response.
The study addresses response and safety in a mixed population that included untreated and relapsed CLL. Those clinical settings are represented within the same study, but the available record does not provide enough detail to interpret them as separate, controlled comparisons. The treatment combination, rather than either drug alone, is the intervention under study.
The primary outcome is a count of participants meeting response criteria, not a direct comparison of treatment groups. In a single-group study, response can describe what was observed among treated participants, but it cannot by itself show how outcomes would have differed under another treatment or without treatment. The registry record does not report the number achieving the primary endpoint, so the observed response level and its precision cannot be assessed from the posted results.
3. Trial Design
This was a Phase II, open-label, multi-centre, single-group study of ofatumumab plus bendamustine for untreated or relapsed CLL. The registry lists an enrollment of 99 and a completed status. The study began in 2012-03, with primary completion in 2013-02. The record does not describe a randomized allocation or masking; masking is listed as none.
Participants who met eligibility criteria entered a treatment phase and were planned to receive 3 cycles of the combination. Each cycle was scheduled every 28 days. Eligibility to continue was assessed after the third cycle. Participants with at least stable disease and acceptable toxicity could receive up to 3 further cycles, for a maximum of 6. The study summary states that participants with progressive disease at or after the start of Cycle 4 were to stop further study treatment and enter follow-up.
The planned regimen depended on prior CLL treatment status. For untreated CLL, the registry describes up to 6 monthly intravenous infusions of ofatumumab and up to 6 cycles of intravenous bendamustine. The listed untreated regimen starts ofatumumab at 300 mg on Day 1 and 1000 mg on Day 8 of Cycle 1, followed by 1000 mg on Day 1 of subsequent cycles; bendamustine is listed at 90 mg/m2 on Days 1 and 2 of each cycle. The regimen description for relapsed CLL is incomplete in the registry record, so its full dosing schedule is not reported.
The single-group design can describe outcomes and adverse events among treated participants, but it does not isolate the effect of the combination from the course of disease, participant selection, or other influences. Although safety summaries are separated under 70mg/m^2 and 90mg/m^2 bendamustine labels, the record does not establish those summaries as a randomized, like-for-like 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.
Before assignment: Participants (par.) who met eligibility criteria at Screening were then allocated to one of the following populations: par. with previously untreated CLL or par. with relapsed CLL. A total of 99 par. were enrolled and 97 par. entered the treatment period. Study results do not include the 2 par. that were not treated in this study
Treatment Phase
| Stage | Ofatumumab + Bendamustine 90 mg/m^2 | Ofatumumab + Bendamustine 70 mg/m^2 |
|---|---|---|
| STARTED | 44 | 53 |
| COMPLETED | 39 | 45 |
| NOT COMPLETED | 5 | 8 |
Reasons for not completing this period:
| Reason | Ofatumumab + Bendamustine 90 mg/m^2 | Ofatumumab + Bendamustine 70 mg/m^2 |
|---|---|---|
| Physician Decision | 2 | 1 |
| Progression | 0 | 2 |
| Adverse Event | 3 | 5 |
Follow up
| Stage | Ofatumumab + Bendamustine 90 mg/m^2 | Ofatumumab + Bendamustine 70 mg/m^2 |
|---|---|---|
| STARTED | 44 | 45 |
| COMPLETED | 44 | 44 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Ofatumumab + Bendamustine 90 mg/m^2 | Ofatumumab + Bendamustine 70 mg/m^2 |
|---|---|---|
| Lost to Follow-up | 0 | 1 |
Survival Follow-up
| Stage | Ofatumumab + Bendamustine 90 mg/m^2 | Ofatumumab + Bendamustine 70 mg/m^2 |
|---|---|---|
| STARTED | 21 | 40 |
| COMPLETED | 20 | 40 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | Ofatumumab + Bendamustine 90 mg/m^2 | Ofatumumab + Bendamustine 70 mg/m^2 |
|---|---|---|
| Withdrawal by Subject | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: As-treated subjects (ATS) Population: all participants who received at least one dose of both study drugs (ofatumumab and bendamustine). OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.
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 | Ofatumumab + Bendamustine 90 mg/m^2 | Ofatumumab + Bendamustine 70 mg/m^2 | Total |
|---|---|---|---|---|
| Participants analysed | 44 | 53 | 97 | |
| Age, Continuous | Years | 63.2 (SD 10.11) | 66.5 (SD 9.28) | 65.0 (SD 9.76) |
| Gender: Female | Participants | 15 | 17 | 32 |
| Gender: Male | Participants | 29 | 36 | 65 |
| Race/Ethnicity, Customized: White - White/Caucasian/European Heritage | Participants | 42 | 53 | 95 |
| Race/Ethnicity, Customized: White - Arabic/North African Heritage | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: African American/African Heritage | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Overall Response (OR), as Assessed by the Investigator, measured over From the start of study treatment until 3 months after the last dose of study treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with an investigator-assessed overall response. The outcome description defines response as achieving complete response, complete response with incomplete bone marrow recovery, partial response, or nodular partial response. Assessment is described after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine. The stated timeframe runs from the start of study treatment until 3 months after the last dose.
Response criteria are useful in a treatment study because they translate clinical and laboratory findings into prespecified categories. The registry says response was assessed using the International Workshop for CLL updated National Cancer Institute-sponsored Working Group guidelines from 2008. In broad terms, the listed categories distinguish complete remission-type findings from partial improvement and from partial response with persistent bone-marrow nodules. The precise criteria include changes in lymphocyte counts, lymph node and organ findings, blood counts, and bone marrow findings.
The endpoint is a count, not a time-to-event measure or a continuous laboratory value. The count is meaningful only alongside its analysis population and the criteria and assessment times used. The primary population is described as participants who received at least one dose of both study drugs. The registry record does not report the count with an overall response, nor does it give an accompanying estimate of uncertainty in the posted primary results. Therefore the observed response frequency and its precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies a clinically defined primary outcome but does not report its observed result. It is therefore not possible to describe how many participants met the overall-response definition, or how precise that estimate was, from the posted primary results. The endpoint definition alone is not evidence that a response occurred in any particular number of participants.
The study enrolled 99 participants and is described as a Phase II, open-label, single-group investigation. These design features frame what the results can establish. A single-group study can report outcomes observed after treatment, but it does not supply a concurrent untreated or alternative-treatment group for estimating what would have happened under a different strategy. Consequently, any response observed in the treated population would be descriptive rather than a randomized estimate of comparative treatment effect.
Open-label assessment can also matter for outcomes that involve investigator judgment. The registry identifies the investigator as the assessor and names response guidelines, but it does not report masking. Without masking, knowledge of treatment may be available during assessment. That design feature does not prove that assessments were biased; it is a consideration when judging the possibility of assessment effects.
The response definition includes assessments after 3 cycles, after 6 cycles, and after the last dose, while further treatment depended on disease status and toxicity after the initial cycles. Thus, treatment exposure could differ among participants. The record states that participants with at least stable disease and acceptable toxicity after 3 cycles could continue, and those with progressive disease from the start of Cycle 4 onward were to discontinue treatment. The available primary outcome description does not report how many participants reached each assessment or how incomplete assessments were handled.
The posted safety information lists serious adverse event counts by bendamustine dose label and gives percentages for selected serious event terms. Those summaries can describe events recorded in the treated groups, but they do not replace a controlled comparison of safety. The number of participants affected, the event-term percentages, and any missing safety observations should be interpreted in relation to the group denominators and the registry’s reporting conventions. Death counts are not reported in the registry record.
Planning illustrations based on an observed effect are not observed power and are not a result of the trial’s original design justification. The record does not report the trial’s sample-size justification. Nor does it report a primary endpoint estimate, a clearly specified interval method, or a comparative treatment effect. These omissions limit both the descriptive assessment of response and any broader inference about treatment effects.
9. Statistical Methods Explained
The primary outcome is binary at the participant level: each participant either meets the overall-response definition or does not, based on the investigator’s assessment. The reported endpoint is a count of participants with response. In general, a binary outcome is often summarized by a count and a proportion, because the count alone does not communicate the share of the analyzed population that experienced the outcome. No primary response count or proportion is reported in the registry record.
What does an interval estimate add?
In general, a confidence interval expresses the uncertainty around an estimate under a statistical model. It gives a range of values compatible with the data and method, rather than a guarantee that the true value lies within that range. For a response proportion, the interval helps distinguish a relatively precise estimate from one that remains uncertain because the number of observations is limited. The registry endpoint description begins to refer to a 95% exact method, but the description is incomplete; the interval method is not reported clearly enough to characterize. The posted primary result and its precision are not reported in the registry record.
Why does the single-group design matter?
In a single-group study, response summaries describe participants who received the study combination. There is no concurrent control group against which to compare response, safety, or time-to-event outcomes. General statistical methods can estimate uncertainty around a single-group response rate, but they cannot create the missing counterfactual comparison. Any planning calculations framed around two arms are illustrations under their stated assumptions, not evidence that the clinical study randomized participants between two arms.
The registry identifies the study as single group, with allocation listed as not applicable and no masking. It also lists safety groups by bendamustine dose label. Those labels should not be read as proof of randomized allocation or as establishing a fair comparison between dose groups. The record does not report a randomized dose comparison, and the study is specifically flagged as not being a randomized comparison.
What does over-dispersion mean in general?
Over-dispersion is a general concern for count outcomes when the variability in the data is greater than a chosen statistical model expects. If a model assumes less variability than the data contain, its uncertainty estimates can be too small. This concept is relevant to count data in general, but the primary outcome in this study is reported as a participant count with a binary response definition, and the registry record does not report an over-dispersion adjustment or a model for the primary outcome. No such analysis should be inferred.
How should sample-size illustrations be read?
The registry’s planning assumptions describe illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumed effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the assumptions describe total event counts; for other outcomes, they describe participants per arm for 80% or 90% power. These are planning illustrations, not observed power, and the equal-allocation assumption does not alter the registry’s description of the clinical study as single group. The record does not report that these assumptions were the trial’s own sample-size justification.
In general, power is a design quantity: it describes the chance a specified analysis would detect an assumed effect under stated conditions. It is not a measure of whether a completed study’s findings are true, nor does it show that an observed effect is reliable. A planning illustration using an effect estimated from observed data is especially distinct from a prospectively justified sample size. No numerical planning output is reported in the record details used for this interpretation.
What can be learned from the time-to-event outcomes?
The listed secondary outcomes include time to response, duration of response, progression-free survival, overall survival, time to progression, and time to next therapy. In general, Kaplan-Meier methods estimate the probability of remaining event-free over time while accounting for participants whose follow-up ends before an event is observed. A time-to-event result depends on the definition of the event, the follow-up period, and the handling of censoring. The registry lists these outcomes, but the corresponding result estimates and analysis details are not reported in the registry record summarized for the primary endpoint.
Methods should be interpreted only to the extent that they are described. The record does not report a complete statistical analysis plan for the primary endpoint, the missing-data procedure, or whether any interim analyses were planned or conducted. These details cannot be inferred from the Phase II label, the outcome definitions, or the planning assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 28 outcome measures and 2 analyses. Several secondary outcomes concern response, survival, progression, and subsequent therapy. When a study examines multiple outcomes or multiple analyses, there can be more opportunities for apparently notable findings to arise by chance. In general, multiplicity procedures can control error rates across a defined family of tests, but the registry record does not report whether any such procedure was planned or used. The count of outcome measures alone does not show that all were formally tested or that they shared a single testing family.
The primary endpoint is described as a count of participants with overall response, assessed by the investigator in the as-treated population. This population includes participants who received at least one dose of both study drugs. The record does not report a broader analysis-population hierarchy or describe how participants with partial treatment exposure, protocol deviations, or unavailable assessments were classified for the primary analysis.
Missing-data handling is not reported in the registry record. In general, incomplete outcome assessment can affect a response summary if participants without an evaluable response are handled differently from those with an observed response. The available information does not establish whether missing assessments were excluded, counted as no response, or addressed by another method; none of those approaches should be assumed.
The registry record also does not report whether interim analyses were planned or conducted, what statistical testing plan governed the primary and secondary outcomes, or whether adjustments were made for repeated assessments after 3 cycles, after 6 cycles, and after the last dose. These omissions matter when interpreting the strength and selectivity of reported findings. Since the primary endpoint result itself is not reported, it is not possible to assess the analysis population’s observed response count or the effect of any missing data on that result.
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 |
|---|---|---|---|
| Ofatumumab + Bendamustine 70mg/m^2 | 25 | 53 | 47.2% |
| Ofatumumab + Bendamustine 90mg/m^2 | 20 | 44 | 45.5% |
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 |
|---|---|
| Ofatumumab + Bendamustine 70mg/m^2 | 49 of 53 |
| Ofatumumab + Bendamustine 90mg/m^2 | 40 of 44 |
Most frequent serious adverse event terms
| Event term | Organ system | Ofatumumab + Bendamustine 70mg/m^2 | Ofatumumab + Bendamustine 90mg/m^2 |
|---|---|---|---|
| Pyrexia | General disorders | 3 of 53 | 3 of 44 |
| Febrile neutropenia | Blood and lymphatic system disorders | 4 of 53 | 1 of 44 |
| Neutropenia | Blood and lymphatic system disorders | 3 of 53 | 2 of 44 |
| Anaemia | Blood and lymphatic system disorders | 1 of 53 | 3 of 44 |
| Pneumonia | Infections and infestations | 3 of 53 | 0 of 44 |
| Acute kidney injury | Renal and urinary disorders | 2 of 53 | 1 of 44 |
| Acute coronary syndrome | Cardiac disorders | 2 of 53 | 0 of 44 |
| Cardio-respiratory arrest | Cardiac disorders | 2 of 53 | 0 of 44 |
| Inguinal hernia | Gastrointestinal disorders | 1 of 53 | 1 of 44 |
| Infusion related reaction | Injury, poisoning and procedural complications | 0 of 53 | 2 of 44 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ofatumumab + Bendamustine 70mg/m^2 | Ofatumumab + Bendamustine 90mg/m^2 |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 32 of 53 | 20 of 44 |
| Nausea | Gastrointestinal disorders | 16 of 53 | 19 of 44 |
| Thrombocytopenia | Blood and lymphatic system disorders | 12 of 53 | 7 of 44 |
| Rash | Skin and subcutaneous tissue disorders | 7 of 53 | 12 of 44 |
| Pyrexia | General disorders | 8 of 53 | 10 of 44 |
| Fatigue | General disorders | 8 of 53 | 7 of 44 |
| Diarrhoea | Gastrointestinal disorders | 7 of 53 | 5 of 44 |
| Headache | Nervous system disorders | 6 of 53 | 6 of 44 |
| Constipation | Gastrointestinal disorders | 5 of 53 | 6 of 44 |
| Infusion related reaction | Injury, poisoning and procedural complications | 8 of 53 | 3 of 44 |
Serious events with the highest arm-level rate: febrile neutropenia (7.5%), anaemia (6.8%), pyrexia (6.8%), neutropenia (5.7%), pneumonia (5.7%).
The registry lists serious adverse event summaries for Ofatumumab + Bendamustine 70mg/m^2 and Ofatumumab + Bendamustine 90mg/m^2. The first group has 53 participants at risk and 25 affected by serious adverse events; the second has 44 participants at risk and 20 affected. The record also lists other adverse events affecting 49 of 53 participants and 40 of 44 participants, respectively. These are counts of participants, not counts of separate event episodes.
The selected serious adverse event terms are reported as percentages: febrile neutropenia, 7.5%; anaemia, 6.8%; pyrexia, 6.8%; neutropenia, 5.7%; pneumonia, 5.7%; and infusion related reaction, 4.5%. These term percentages describe the registry’s listed summaries; the record does not provide enough detail to determine whether participants could contribute to more than one term or how repeated events were handled.
Counts and percentages should be read with their group denominators and the reporting categories in mind. The dose-labelled safety summaries do not establish a randomized comparison between dose groups. Death counts are not reported in the registry record. These summaries describe reported safety events; they do not by themselves establish causation or provide a controlled estimate of comparative risk.
12. What the Result Does, and Does Not, Mean
The study is a Phase II, open-label, single-group investigation of ofatumumab plus bendamustine in untreated or relapsed CLL. Its stated primary outcome is an investigator-assessed count of participants with overall response, using named response categories and a specified assessment period. The registry record does not report the primary response count or an estimate of its precision, so the level of response observed in the study cannot be characterized from the posted primary results.
Even if a response count were available, a single-group result would describe outcomes among treated participants rather than establish how the combination compares with another treatment or with no treatment. Without a concurrent control group, differences attributable to treatment cannot be separated from other influences through a randomized comparison. The record also does not establish a randomized comparison between the dose-labelled safety groups.
The serious adverse event summaries provide descriptive counts by dose label and percentages for selected event terms. They do not determine whether an event was caused by treatment, and they do not constitute a controlled estimate of comparative safety. The record’s lack of reported death counts and incomplete detail about some analysis methods also limits interpretation of the safety profile.
The listed secondary outcomes cover response and several time-to-event questions, but their results are not reported in the record information. Nor are the statistical analysis plan, missing-data handling, or multiplicity approach reported. Those details are important for understanding how estimates were obtained and how much confidence to place in patterns across several outcomes.
In short, the record defines what the study intended to evaluate and describes its design and some safety summaries. It does not report the primary efficacy result needed to quantify observed overall response. It cannot establish a comparative treatment effect, and the absent analysis details prevent a full assessment of uncertainty and robustness.
13. Why This Trial Matters Statistically
This study illustrates why the endpoint definition and the design must be read together. Overall response is defined using named clinical response categories and an investigator assessment, but the study has no concurrent comparator. A response count in this setting would be informative as a description of treated participants; by itself, it would not estimate the contrast between the combination and another treatment strategy.
The population includes untreated and relapsed CLL, and the treatment description depends on prior treatment status. Combining those settings in a single-group study can make the overall summary difficult to interpret as representing one uniform clinical context. The registry record does not report enough complete subgroup result information to assess outcomes separately by treatment history. Nor does the incomplete relapsed-treatment schedule allow the full regimen to be described from the record.
Safety reporting also demonstrates the importance of denominators and design. The record gives affected-participant counts in groups carrying different bendamustine dose labels, but it does not describe a randomized comparison between them. Treating those groups as though they were equivalent apart from dose would go beyond the design information reported. The serious event terms are useful descriptive signals, yet they do not by themselves quantify comparative risk or establish attribution.
Finally, the registry record distinguishes endpoint definitions from results. It describes what overall response means and how it was assessed, but does not report the primary result. This gap is statistically important: without the observed count and its uncertainty, readers cannot judge the response estimate’s magnitude or precision. The trial remains useful as an example of the limits of drawing comparative conclusions from a single-group design and of the need for complete outcome and analysis reporting.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central limitation for interpreting efficacy is that the primary endpoint result is not reported in the registry record. The record describes the response definition, timeframe, and analysis population, but does not give the number of participants with overall response or a clearly reported estimate of precision. The statistical evidence for the primary outcome therefore cannot be evaluated from the posted primary results.
The study was open label and single group, with no randomized concurrent control. This prevents a direct estimate of comparative efficacy and leaves observed outcomes open to influences other than treatment. The registry lists safety summaries under two bendamustine dose labels, but does not establish those as randomized, comparable groups. A like-for-like dose comparison is not supported by the stated design.
The study includes participants with untreated or relapsed CLL, while the treatment plan differs by prior treatment status. The description of the relapsed regimen is truncated, and subgroup outcome results are not reported in the record information used. The overall study description therefore does not resolve how findings might differ across those clinical groups.
Assessment was investigator-based, and masking is listed as none. This does not demonstrate biased assessment, but knowledge of treatment can be relevant when the endpoint involves judgment. The registry record also does not report the missing-data approach, full analysis plan, multiplicity procedures, or interim-analysis details. The primary population is described, but the handling of participants without evaluable outcome data is not.
Finally, the record does not report the trial’s sample-size justification. Planning illustrations based on an observed effect do not substitute for that rationale and should not be treated as observed power. These limitations constrain interpretation of both efficacy and safety and prevent firm conclusions about comparative effects.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL) — NCT01520922.
- Registry record last updated 2017-01-19; status last verified 2016-11.
- Results first posted 2013-12-16.
- 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
NCT01520922 is a completed Phase II, open-label, multi-centre, single-group study of ofatumumab plus bendamustine in untreated or relapsed chronic lymphocytic leukaemia. The registry lists enrollment of 99, a start in 2012-03, and primary completion in 2013-02. Treatment was planned for 3 cycles initially, with up to 3 additional cycles for participants meeting continuation criteria.
The primary outcome is the investigator-assessed number of participants with overall response, in an as-treated population that received at least one dose of both drugs. Overall response includes complete response, complete response with incomplete bone marrow recovery, partial response, and nodular partial response. The primary result is not reported in the registry record.
Serious adverse event summaries are listed for groups labelled 70mg/m^2 and 90mg/m^2 bendamustine. The design does not support treating these labels as a randomized comparison. The record does not report a full statistical analysis plan, missing-data procedures, or multiplicity approach.