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 Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia (NCT01361711), a na phase 2 study. The primary outcome is Best Response as Defined by the iwCLL2008 (International Workshop on Chronic Lymphocytic Leukemia 2008).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01361711 |
| Phase | Phase 2 |
| Condition | Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Northwestern University |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerns people with previously untreated symptomatic chronic lymphocytic leukemia (CLL). The listed conditions include Stage I, Stage II, Stage III, and Stage IV CLL. Enrollment is 53. The registry record does not give further eligibility details in the available trial description, so the exact characteristics of the enrolled population cannot be fully assessed from this information.
Intervention
The treatment combines alemtuzumab and ofatumumab, both listed as biological interventions. The arm description says alemtuzumab is given subcutaneously three times a week in weeks 1-18. Ofatumumab is given intravenously over 4-6 hours on day 1 of weeks 3, 5, 7, 9, 11, 13, 15, and 17. Biopsy is also listed as a procedure; the registry description does not specify its role in the treatment schedule.
Comparator
There is one treatment group and no concurrent comparator arm. Allocation is listed as NA, and the trial model is single group. A secondary outcome names a comparison with a historical control study of alemtuzumab-rituximab, but the record does not report results of that comparison. Historical comparisons are not equivalent to a randomized, concurrent control.
Primary question
The primary endpoint is best response under the iwCLL2008 criteria, recorded as a count of participants. The assessment window ranges from 8 weeks from initiation of treatment to 2 months post-treatment. The registry record gives descriptions of response categories, including complete response, complete response with incomplete marrow recovery, and partial response, but does not report how many participants reached each category or the overall best-response result. The posted record therefore identifies what was intended to be assessed, but does not answer the primary efficacy question numerically.
3. Trial Design
This is a phase II, open-label, single-group trial sponsored by Northwestern University. The registry lists the trial start as 2011-06, primary completion as 2015-08-17, and status as active, not recruiting. Enrollment is 53. The design has no randomized allocation and no concurrent control group; masking is listed as NONE. Consequently, the treatment group’s outcomes can be described, but the design does not by itself provide a randomized estimate of how outcomes differ from another treatment or from no treatment.
The treatment arm is described as monoclonal antibody therapy. Participants receive alemtuzumab subcutaneously three times a week in weeks 1-18, with ofatumumab intravenously over 4-6 hours on day 1 of weeks 3, 5, 7, 9, 11, 13, 15, and 17. The registry also lists biopsy as an intervention, without further detail in the treatment schedule. The trial’s stated focus is side effects and how well the combination works in previously untreated symptomatic CLL.
The primary endpoint is best response according to iwCLL2008 criteria. The stated assessment window runs from 8 weeks after treatment initiation to 2 months post-treatment. Secondary outcomes include survival rates, treatment toxicity measured by adverse events experienced while on treatment, correlation of disease characteristics with disease outcomes, and a comparison of efficacy with a historical control study of alemtuzumab-rituximab. The record names these outcomes but does not provide results for them in the information available.
A historical-control comparison, if conducted, would not turn this single-group study into a randomized comparison. Differences in participant selection, follow-up, assessment, or care between studies can affect such comparisons. The registry record does not provide details of a statistical plan, a sample-size justification, interim analyses, or the methods for any historical comparison. Those design details 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.
Trial Entry (Registration)
| Stage | Alemtuzumab + Ofatumumab |
|---|---|
| STARTED | 53 |
| Received Dose of Study Drug | 52 |
| COMPLETED | 52 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Alemtuzumab + Ofatumumab |
|---|---|
| Patient did not meet Protocol criteria for trial entry | 1 |
Week 9 Bone Marrow Response Assessment
| Stage | Alemtuzumab + Ofatumumab |
|---|---|
| STARTED | 52 |
| COMPLETED | 51 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Alemtuzumab + Ofatumumab |
|---|---|
| Complete Remission in Week 8 | 1 |
Continued Treatment After 9 Weeks
| Stage | Alemtuzumab + Ofatumumab |
|---|---|
| STARTED | 51 |
| COMPLETED | 44 |
| NOT COMPLETED | 7 |
Reasons for not completing this period:
| Reason | Alemtuzumab + Ofatumumab |
|---|---|
| Complete Remission in Week 9 | 7 |
Continued Treatment After 12 Weeks
| Stage | Alemtuzumab + Ofatumumab |
|---|---|
| STARTED | 44 |
| COMPLETED | 41 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Alemtuzumab + Ofatumumab |
|---|---|
| Complete Remission in Week 12 | 2 |
| Progressive Disease at Week 11 | 1 |
Analysis population for the primary outcome, as defined in the registry: Criteria from Outcome Measure Description cont. MRD=Bone marrow with less than one CLL cell per 10,000 leukocytes. To qualify as a PD: at least two of the criteria of in Group A, plus one of the criteria in Group B, must be met. Group A: An increase ≥ 50% of: lymphadenopathy, hepatomegaly, or splenomegaly. An increase ≥ 50% over baseline in blood lymphocytes. Group B: Platelet count decrease of ≥ 50% from baseline secondary to CLL, Hemoglobin decrease of \> 2g/dl from baseline secondary to CLL.
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 | Alemtuzumab + Ofatumumab |
|---|---|---|
| Participants analysed | 52 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 28 |
| Age, Categorical: >=65 years | Participants | 24 |
| Sex: Female, Male: Female | Participants | 23 |
| Sex: Female, Male: Male | Participants | 29 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 51 |
| 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 | 50 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: Sweden | participants | 20 |
| Region of Enrollment: United States | participants | 32 |
6. Primary Endpoint
The registry lists the primary outcome as Best Response as Defined by the iwCLL2008 (International Workshop on Chronic Lymphocytic Leukemia 2008), measured over Range of responses between 8 weeks from initiation of treatment to 2 months post-treatment..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants according to their best response under the iwCLL2008 (International Workshop on Chronic Lymphocytic Leukemia 2008) criteria. Response categories are intended to capture changes in disease findings and blood counts. The description defines complete response (CR) using the absence of clonal lymphocytes in peripheral blood, significant lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms, along with specified blood-count and bone-marrow criteria. It also describes CRi as meeting CR criteria while having anemia, thrombocytopenia, or neutropenia related to drug toxicity. Partial response (PR) is described through criteria involving reductions in disease measures and blood-count changes.
Using a defined response framework helps make clinical assessments more consistent than relying on an unspecified impression of improvement. In general, a categorical endpoint can communicate how many participants meet each response definition, while retaining the clinical meaning encoded in the criteria. It does not, by itself, show how long a response lasts or how outcomes compare with another treatment.
The assessment window is stated as a range of responses between 8 weeks from initiation of treatment and 2 months post-treatment. The registry record reports the endpoint definition but not the number of participants with CR, CRi, PR, progressive disease, or another response, nor a total response estimate. Some of the criteria in the registry description are incomplete; the remaining full criteria are not reported in the registry record. As a result, the intended measure can be described, but the primary outcome cannot be quantified from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the trial’s design and endpoint, but the primary response outcome is not numerically reported. Although best response under iwCLL2008 criteria is named as the primary measure and the record describes several response definitions, it gives no participant counts by response category and no overall best-response estimate. There is also no reported confidence interval, p-value, or other inferential result for this endpoint. The posted information therefore does not support a numerical conclusion about the response distribution in this trial.
The trial enrolled 53 participants and used one treatment group. That enrollment figure describes the study size; it is not a response result. Without the number of participants assessed, the response counts, and information about how missing assessments were handled, the reader cannot determine the observed response proportion or its precision. Those details are not reported in the registry record.
The secondary outcomes include survival rates, toxicity, associations between disease characteristics and outcomes, and efficacy compared with a historical control study. Naming an outcome does not establish that an analysis was completed or what it found. The record does not report numerical results for these secondary outcomes or the historical comparison. No analyses are listed in the record’s analysis count. The historical-control objective, even if assessed, would require cautious interpretation because it is not a randomized concurrent comparison.
The safety information is separate from the missing efficacy result. In the adverse-event summary, 52 participants are listed as at risk for serious adverse events, with 20 affected; 52 are listed as at risk for other adverse events, with 52 affected. The record lists 6 deaths. It also lists serious-event terms and percentages, including febrile neutropenia at 9.6% and fever at 7.7%. These figures describe reported safety events in the trial group; they do not establish causation or provide a comparison with another treatment group. The record does not give enough detail to infer why the deaths occurred.
In general, a confidence interval expresses the uncertainty around an estimate: a wider interval indicates less precision, while a narrower interval indicates greater precision under the method used. No confidence interval for the primary response result is reported, so its statistical precision cannot be evaluated. The central interpretation is therefore limited: the registry identifies the study question, design, and some safety summaries, but does not report the primary response findings needed to judge the endpoint result.
9. Statistical Methods Explained
The design determines what statistical questions the data can address. This trial is listed as a phase II, single-group study with allocation NA and masking NONE. There is one treatment group, not a randomized comparison between groups. The data can describe outcomes observed among participants receiving the combination, but a within-trial treatment contrast is not available. In general, a concurrent randomized control helps distinguish treatment-associated differences from differences due to participant characteristics, changes over time, or other aspects of care. A single-group study cannot make that distinction as securely.
What a participant count can tell us
The primary endpoint is a count of participants classified by best response under iwCLL2008 criteria. A count is a descriptive summary: it tells how many participants fall into a defined category. To interpret a count as a proportion, the relevant denominator must also be clear, including how many participants were eligible for assessment and how participants with missing assessments were treated. The record reports enrollment of 53, but does not provide the primary response counts or the assessed population denominator. A response proportion and its uncertainty therefore cannot be reconstructed from the record.
Response categories also depend on their definitions. The registry description includes criteria for CR, CRi, and PR, and part of a progressive-disease definition. Some text is incomplete, and the complete remaining criteria are not reported in the registry record. In general, an endpoint based on a structured clinical definition is interpretable only when the criteria and the assessment process are sufficiently clear. The registry record does not provide additional information about adjudication, assessor training, or procedures for resolving ambiguous classifications.
Precision and uncertainty
In general, an estimate from a study is subject to sampling variability: a different set of participants could produce a different estimate, even under similar study conditions. A confidence interval gives a range of values compatible with the observed data under the stated statistical method. It communicates precision, not the probability that a particular treatment effect is true. The registry record does not report a confidence interval for best response, nor a p-value or model-based estimate. It is therefore not possible to assess the statistical precision of the primary endpoint from the posted information.
Statistical significance and clinical meaning are distinct ideas. In general, a p-value addresses how compatible data are with a specified statistical null model; it does not measure the size or importance of an effect. An effect estimate and its uncertainty are needed to assess magnitude and precision. No inferential result for the primary endpoint is reported, and the single-group design does not supply a randomized between-group effect estimate. The registry record also does not state a hypothesis test or analysis model for the endpoint.
Historical comparisons and planning illustrations
One secondary outcome names comparison with a historical control study of alemtuzumab-rituximab. In general, such a comparison uses results from a separate study rather than participants randomized alongside the current treatment group. Study populations, eligibility rules, follow-up, event definitions, and measurement practices may differ. Statistical adjustment can address only measured factors included in a suitable analysis; it cannot guarantee that all differences between studies have been removed. The registry record does not report the methods or results of this historical comparison, so no comparative estimate can be evaluated.
A separate planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect stated as a fraction of the observed effect. This is a hypothetical planning framework, not the design used in this single-group trial. Such participant-count illustrations are not observed power and do not show the probability that the trial detected an effect. They describe assumptions for planning a hypothetical study. The registry record does not report the trial’s own sample-size justification, so the planning illustration should not be treated as evidence of the rationale for enrolling 53 participants.
Over-dispersion and model choice
In general, over-dispersion occurs when count data vary more than a chosen statistical model expects. If a model assumes less variability than the data contain, standard errors can be too small and intervals or tests can appear more certain than warranted. The appropriate model depends on the endpoint structure, sampling process, and analysis objective. The primary outcome is described as a participant count, but no statistical model or dispersion assessment is reported. It would not be appropriate to infer that a particular model was used or that over-dispersion was present.
Time and outcome interpretation
The primary response assessment window ranges from 8 weeks from initiation of treatment to 2 months post-treatment. A response assessed over a defined interval is not the same as a time-to-event outcome. Survival rates are listed as a secondary outcome, but no survival estimates, follow-up duration, censoring approach, or survival-analysis method are reported. In general, time-to-event methods account for both the timing of events and incomplete follow-up; interpretation depends on how follow-up and censoring are defined. Those details are not reported in the registry record.
Overall, the methods information is sufficient to identify the broad design and endpoint, but not to reproduce or independently assess the primary analysis. The analysis plan, endpoint-specific denominators, missing-data methods, statistical model, and inferential results are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry names a primary endpoint and several secondary outcomes: survival rates, treatment toxicity measured by adverse events experienced while on treatment, associations between disease characteristics and outcomes, and efficacy compared with a historical control study. Testing or estimating several outcomes can raise multiplicity concerns. In general, when many statistical hypotheses are examined, the chance of at least one apparently notable result can increase unless the analysis plan accounts for the number and structure of tests. The record does not describe any multiplicity adjustment, hierarchy among secondary endpoints, or prespecified approach to interpreting multiple results.
The analysis count is 0. This means the registry record does not list analyses in the available record; it does not establish what analyses may or may not have been conducted outside the registry. No primary endpoint results, p-values, confidence intervals, or analysis-specific effect estimates are reported. The statistical analysis plan is not reported in the registry record.
Missing-data handling is also not reported. The record does not state how many participants had an evaluable best-response assessment, how missing response assessments were classified, whether participants who stopped treatment were included in the endpoint analysis, or how incomplete follow-up was handled for survival outcomes. In general, missingness can affect estimates when the probability of missing data is related to participant characteristics or outcomes. Without a stated approach and the relevant participant counts, the possible impact cannot be evaluated.
Analysis-population definitions are not reported in the registry record. The response endpoint description refers to an analysis population description, but the complete details are not available in the record. Consequently, it is unclear which participants were included in each endpoint analysis. Interim analyses and stopping rules are not reported in the registry record. No assumptions about these methods should be inferred from the trial’s phase or enrollment.
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 |
|---|---|---|---|
| Alemtuzumab + Ofatumumab | 20 | 52 | 38.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Alemtuzumab + Ofatumumab | 6 of 52 |
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 |
|---|---|
| Alemtuzumab + Ofatumumab | 52 of 52 |
Most frequent serious adverse event terms
| Event term | Organ system | Alemtuzumab + Ofatumumab |
|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 5 of 52 |
| Fever | General disorders | 4 of 52 |
| Fever | General disorders | 3 of 52 |
| Infection | Infections and infestations | 1 of 52 |
| Abnormal Platelets | Blood and lymphatic system disorders | 1 of 52 |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 52 |
| CMV infection | Infections and infestations | 1 of 52 |
| MRSA Bacteremia | Infections and infestations | 1 of 52 |
| Neutropenic fever | Blood and lymphatic system disorders | 1 of 52 |
| Diffuse Large B-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 52 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Alemtuzumab + Ofatumumab |
|---|---|---|
| Injection site reaction | General disorders | 47 of 52 |
| Abnormal Hemoglobin count | Investigations | 44 of 52 |
| Abnormal neutrophil count | Investigations | 44 of 52 |
| Abnormal platelet count | Investigations | 43 of 52 |
| Fever | General disorders | 35 of 52 |
| White blood cell decreased | Investigations | 35 of 52 |
| Fatigue | General disorders | 34 of 52 |
| Infusion related reaction | General disorders | 29 of 52 |
| Hyperglycemia | Metabolism and nutrition disorders | 25 of 52 |
| Aspartate aminotransferase increased | Investigations | 24 of 52 |
Serious events with the highest arm-level rate: febrile neutropenia (9.6%), fever (7.7%), infection (1.9%), abnormal platelets (1.9%), prostate cancer (1.9%).
The registry safety summary lists one group, Alemtuzumab + Ofatumumab. It reports 52 participants at risk for serious adverse events and 20 participants affected. For other adverse events, it reports 52 at risk and 52 affected. These are event-summary counts; the record does not provide a randomized comparison group. The listed number of deaths is 6. The registry information does not state that these deaths were caused by treatment, nor does it provide enough detail to determine their causes.
The listed serious adverse-event terms include febrile neutropenia at 9.6%, fever at 7.7%, infection at 1.9%, abnormal platelets at 1.9%, prostate cancer at 1.9%, and CMV infection at 1.9%. These percentages should be read as the registry’s reported values for the listed terms, not as comparative estimates of risk. The record does not provide further detail about event timing, severity grading, recurrence, or whether a participant could contribute to more than one term.
In general, an adverse event is an occurrence reported during a study and is not automatically evidence that the treatment caused it. A serious adverse event is a seriousness classification, not a measure of how likely an event is to occur under a treatment. Without a concurrent comparator and fuller event-level information, the figures describe the reported safety experience but cannot establish a causal treatment effect or support a direct safety comparison.
12. What the Result Does, and Does Not, Mean
The record shows that a phase II, single-group trial was conducted to study alemtuzumab plus ofatumumab in previously untreated symptomatic CLL. It identifies a best-response endpoint based on iwCLL2008 criteria, an assessment window, and safety summaries. These details establish the broad question and some of the information collected. They do not supply the primary response results: the number of participants in each response category and the overall best-response finding are not reported in the registry record.
That distinction matters. A trial can specify a clinically defined endpoint without reporting the estimate needed to interpret what happened. Enrollment of 53 does not reveal how many participants responded, how many had an evaluable assessment, or how uncertain any estimate would be. The posted safety counts and terms are separate from the missing efficacy result and cannot fill that gap.
The single-group design also limits what can be inferred. Outcomes observed in the treatment group cannot, by themselves, show what would have happened to comparable participants under a different treatment or under another care strategy. The secondary outcome naming a historical-control comparison does not remove this limitation, and its results and methods are not reported. A historical comparison is not equivalent to random assignment with a concurrent control.
In general, statistical interpretation requires both an estimate and information about its uncertainty, along with attention to the study design and analysis choices. No primary endpoint estimate, confidence interval, or inferential result is reported. The record therefore does not establish the magnitude or precision of the response outcome. Nor does it support a conclusion that the combination does or does not work. The defensible reading is narrower: the registry describes the trial’s intended response assessment and reports selected safety summaries, while leaving the primary response result and several key analysis details unreported.
13. Why This Trial Matters Statistically
This trial illustrates why design and reporting must be read together. The registry describes a phase II investigation and a clearly named response framework, but the study is single group, with no randomized concurrent comparator. That design can document outcomes observed in the treated group, while leaving open how those outcomes compare with an alternative. The distinction is important whenever a trial’s stated objective includes treatment efficacy.
The case also shows that an endpoint definition is not a result. iwCLL2008 criteria specify what counts as response, but the registry record does not give the participant counts needed to assess the endpoint. Without those counts, a reader cannot evaluate the response distribution or its precision. The missing inferential results also prevent assessment of whether the observed data were compatible with a range of possible effects.
Safety summaries require similar care. Counts and listed adverse-event terms are useful descriptions of what the record reports, but they are not comparative estimates and do not establish causation. A number of deaths is not, by itself, evidence about cause. Interpretation depends on context such as follow-up, attribution, event definitions, and a suitable comparison; those details are not all reported in the registry record.
Finally, the named secondary outcomes and planning assumptions do not substitute for a reported analysis. Multiplicity, missing-data handling, analysis populations, and the statistical plan affect how findings should be understood, yet these methods are not reported in the registry record. The trial is therefore a useful example of the difference between a protocol-level question, a descriptive safety record, and a fully interpretable statistical result. Transparent reporting of estimates, uncertainty, denominators, and analysis methods is essential for readers to assess evidence.
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 primary limitation for statistical interpretation is that the registry record does not report the primary best-response result. No response-category counts, response estimate, confidence interval, or p-value are available. The number enrolled is given, but the evaluable denominator and handling of missing response assessments are not. This prevents assessment of the endpoint’s magnitude and precision.
The single-group design has no randomized concurrent comparator. It can describe outcomes in the treatment group but cannot isolate a treatment contrast from other possible explanations for those outcomes. Although efficacy comparison with a historical control study is listed as a secondary outcome, the comparison methods and results are not reported. Historical controls may differ in eligibility, follow-up, assessment, and other factors; the registry record does not describe how such differences would be addressed.
Several other design and analysis details are absent. Masking is listed as NONE, but the record does not describe procedures for response assessment or outcome adjudication. The full response criteria are not completely present in the registry description. Analysis-population definitions, missing-data methods, the statistical analysis plan, multiplicity handling, sample-size justification, and interim analyses are not reported in the registry record. The absence of these details makes it difficult to evaluate analysis choices or reproduce an endpoint analysis.
The safety summary is also limited as a basis for comparison. It reports affected counts, listed event terms, percentages, and deaths, but does not provide event-level context sufficient to assess causation or compare safety with another group. These limitations concern what can be concluded from the registry record; they do not establish that unreported procedures or analyses were absent from the conduct of the trial.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia — NCT01361711.
- Registry record last updated 2025-05-23; status last verified 2025-05.
- Results first posted 2021-01-22.
- 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
NCT01361711 is a phase II, open-label, single-group trial sponsored by Northwestern University. It studies alemtuzumab plus ofatumumab in previously untreated symptomatic CLL. Enrollment is 53; the listed status is active, not recruiting. The primary endpoint is best response under iwCLL2008 criteria, assessed from 8 weeks after treatment initiation to 2 months post-treatment.
The treatment description schedules alemtuzumab subcutaneously three times a week in weeks 1-18 and ofatumumab intravenously on specified days in weeks 3, 5, 7, 9, 11, 13, 15, and 17. There is no randomized concurrent comparator. The primary response counts and inferential results are not reported in the registry record. The safety summary lists 52 at risk and 20 affected for serious adverse events, 52 at risk and 52 affected for other adverse events, and 6 deaths. These figures describe the posted safety information and do not establish causation or a comparative treatment effect.