This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Phase II Study Of Imtox-25 In Adults With Refractory/Relapsed Cd25 Positive Adult T Cell Leukemia/Lymphoma (NCT01378871), a na phase 2 study. The primary outcome is Overall Response of Imtox-25.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01378871 |
| Phase | Phase 2 |
| Condition | Adult T Cell Leukemia, Adult T Cell Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Amit Verma |
| Results posted | Yes |
2. Clinical Question
Population
Adults with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) whose disease was immunophenotypically confirmed and whose blasts met the protocol’s CD25 expression criterion: at least 50% expressing CD25 at relapse.
Intervention
IMTOX-25, described as intravenous treatment over 4 hours every other day for 4 doses, with hospital admission required. The study description also says repeat courses could be given every two weeks if specified safety and antibody-level conditions were met.
Comparator
There was no concurrent comparator group. The design is recorded as single-group, with allocation not applicable and no masking. The study therefore does not provide a randomized, like-for-like comparison against another treatment or control.
Primary question
The stated primary question was whether IMTOX-25 showed anti-tumor activity, assessed by overall response within 28 days. The registry record says the outcome was not collected and/or aggregated and therefore was not analyzed for the one participant.
The protocol description set out a phase II evaluation in people with relapsed or refractory CD25-positive ATL. Its planned treatment and response framework aimed to determine whether responses occurred after IMTOX-25. In the registry record, however, enrollment is 1 and the primary outcome has no analyzed result. Consequently, the clinical question is documented, but the posted record does not answer it with an estimate of response.
3. Trial Design
This was a phase II, single-group study of IMTOX-25 in adults with refractory or relapsed CD25-positive ATL. The record lists no allocation and no masking. A single-group design gives participants the intervention without a concurrent comparison arm; it can describe outcomes among treated participants, but it cannot establish a randomized contrast with another treatment.
The treatment description specifies intravenous administration over 4 hours every other day for 4 doses, with hospital admission. The brief study description says repeat courses could be given every two weeks if participants did not experience a dose-limiting toxicity and did not have a HAMA/HARA level greater than 1 μg/ml. The detailed protocol definitions and implementation are not reported in the registry record.
The planned enrollment strategy called for a minimum of 10 patients. The brief summary describes an early stopping rule: if no response was observed among the initial 9 patients, the study would stop and be declared negative; if at least one response was observed, accrual would continue to 17 evaluable patients, with a total study size of 19 to account for 10% being unevaluable. These are protocol plans, not the achieved enrollment. The registry records enrollment of 1 and status as terminated. The reason for termination is not reported in the registry record.
The registry lists overall response as the primary outcome, with a timeframe of 28 days, and toxicity and affect of treatment as secondary outcomes. The primary outcome was not analyzed for the participant. Details of the statistical analysis plan, including how response would be assessed and how the planned stopping rule would be implemented in the analysis, 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 | Anitbody Therapy |
|---|---|
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Data was not collected and/or aggregated and therefore not analyzed for the 1 patient on this study.
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.
Population: Only 1 patient was enrolled prior to study termination.
| Characteristic | Unit | Anitbody Therapy |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 |
| 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 | 1 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Response of Imtox-25, measured over 28 days.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled overall response of IMTOX-25. Its stated purpose is to determine anti-tumor activity in relapsed or refractory ATL patients within a phase II study, and its timeframe is 28 days. The outcome is therefore intended to classify or summarize whether a response occurred over that assessment period. The registry record does not specify response criteria, response categories, or whether confirmation was required; those details are not reported in the registry record.
General: Overall response is commonly used in oncology studies to describe tumor activity using prespecified response definitions. A clear endpoint definition matters because the classification depends on how disease is measured, which changes count as response, and when assessments take place. The registry entry gives the endpoint name and timeframe but not these operational details, so its exact measurement procedure cannot be evaluated from this record.
For this study, the key limitation is that the outcome was not collected and/or aggregated and therefore was not analyzed for the one participant. No response count, response proportion, or uncertainty estimate is reported. The endpoint’s intended role can be described, but there is no posted primary-outcome result to interpret as evidence of observed response or nonresponse.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry records one participant enrolled in a study designed as a single-group phase II evaluation. It also records that overall response, the primary outcome with a 28-day timeframe, was not collected and/or aggregated and therefore was not analyzed for that participant. There is consequently no analyzed primary endpoint result in the record. The absence of an analyzed result is not the same as a finding of no response: the record does not report whether a response occurred.
The protocol’s planned enrollment and stopping rule describe how the study was intended to proceed, not what was observed. The plan called for a minimum of 10 patients, with a decision after the initial 9 based on whether any response was observed. If at least one response occurred, accrual was to continue to 17 evaluable patients, with a total study size of 19 to account for 10% unevaluable. Actual enrollment is 1, and the study status is terminated. The registry does not explain why it terminated, and the posted information does not establish whether the stopping rule was applied.
No effect estimate, confidence interval, or hypothesis-test result for overall response is reported. General: an estimate describes the observed result, while a confidence interval communicates uncertainty around that estimate under the statistical method used. Without an analyzed endpoint result, neither the magnitude of response nor its precision can be assessed. No statistical analysis is listed, and the record reports zero analyses.
The design has no concurrent comparator, so even a reported response in a larger single group would not be a randomized comparison. Here, the lack of a primary outcome analysis is an additional and more immediate limitation: the record does not support a conclusion about the frequency of response in the enrolled participant, let alone about a treatment effect relative to another option.
The safety record lists one participant at risk for serious adverse events and one with a serious adverse event; death is listed as the serious event, and one death is recorded. These entries describe the posted safety counts, not a causal assessment. The record does not report the cause or timing of death or whether investigators attributed it to treatment. The figures therefore should not be interpreted as establishing treatment causation.
Overall, the registry documents a planned phase II question and a terminated study with very limited enrollment, but it does not provide an analyzed response outcome. The posted data cannot quantify anti-tumor activity, compare treatment strategies, or establish the reason for termination.
9. Statistical Methods Explained
General: A trial design determines what comparisons the data can support. This study is recorded as single-group, with allocation not applicable and masking absent. Participants were intended to receive IMTOX-25; there was no concurrent control group. A single-group study can describe outcomes among participants who receive the intervention, but it cannot provide the same treatment contrast as a randomized comparison. In this record, even a descriptive primary outcome is unavailable because overall response was not analyzed.
What can a single-group result show?
General: A single-group response estimate, when reported, is a description of the observed response frequency in the studied participants. It does not by itself separate treatment effects from other explanations, such as the course of the disease, participant selection, or differences in assessment. A concurrent comparator and a prespecified comparison can address some of these questions, depending on design and conduct. No such comparison is reported, and the primary response result is absent.
What does the response endpoint require?
General: An endpoint needs a prespecified definition, assessment schedule, and analysis rule. For an overall-response endpoint, the definition generally explains which response categories count, how disease status is measured, and whether an apparent response must be confirmed. The registry identifies overall response and a 28-day timeframe, but the response criteria and assessment details are not reported in the registry record. Without those details, readers cannot assess endpoint reproducibility or determine precisely how a response classification would have been made.
What does a confidence interval communicate?
General: A confidence interval is a range calculated from observed data using a statistical method. It communicates the precision of an estimate under that method; it is not a guarantee that the true value lies within the particular interval. Interval width is affected by the amount of information and the variability of the measured outcome. Since no primary response estimate is reported, there is no response confidence interval to interpret. The registry also lists zero analyses.
What role would a hypothesis test have?
General: A hypothesis test evaluates how compatible observed data are with a specified statistical null model, under stated assumptions. A p-value is not the probability that a treatment works, nor is it a measure of clinical importance. Interpretation requires an outcome estimate, a prespecified test, and the relevant analysis assumptions. No p-value or primary-outcome test is reported for this study, and the statistical plan is not reported in the registry record.
How should the planning illustration be understood?
The described planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect defined as a stated fraction of the observed effect. For time-to-event tables, the planning quantity is total events; for other outcomes, it is participants per arm. These assumptions describe a planning calculation, not the design recorded for this study, which is single-group. Any sample-size figures are planning illustrations, never observed power. The record does not provide an analyzed response effect to interpret alongside that illustration, and the study’s own sample-size justification is not reported in the registry record.
General: Over-dispersion matters when variability is greater than a statistical model assumes. If a model ignores that extra variability, uncertainty can be understated and inference can be too optimistic. This general issue cannot be assessed for this study because the primary endpoint has no analyzed result and the analysis model is not reported in the registry record. More broadly, statistical methods should be matched to the endpoint, design, and amount of observed information; those details are not available for a primary response analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, overall response within 28 days, and a secondary outcome described as toxicity and affect of treatment. It reports zero analyses. No multiplicity procedure, testing hierarchy, or plan for interpreting multiple endpoints is reported in the registry record. General: multiplicity arises when several statistical questions are tested or several outcomes are examined; without a prespecified approach, the chance of a false-positive finding across a set of tests can be difficult to interpret. There are no reported primary outcome tests in this record, so no multiplicity-adjusted or unadjusted result can be assessed.
The registry says the primary outcome was not collected and/or aggregated and therefore was not analyzed for the one participant. This does not identify whether the outcome was never measured, whether records were unavailable, or whether aggregation was not possible; the reason is not reported in the registry record. No imputation method or sensitivity analysis is reported. General: missing outcome data can affect both the number of participants contributing to an analysis and the conclusions, particularly when missingness is related to outcome status. Here, there is no analyzed response outcome on which to evaluate such effects.
The protocol plan refers to evaluable patients and accounts for participants considered unevaluable in its intended total study size. The criteria for evaluability and the analysis population definitions are not reported in the registry record. No intention-to-treat, per-protocol, or other analysis population is identified. The registry’s enrollment of 1 should therefore not be treated as evidence that the planned analysis populations or missing-data procedures were implemented.
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 |
|---|---|---|---|
| Anitbody Therapy | 1 | 1 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Anitbody Therapy | 1 of 1 |
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 |
|---|---|
| Anitbody Therapy | 0 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Anitbody Therapy |
|---|---|---|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 1 |
Serious events with the highest arm-level rate: death (100.0%).
The safety record lists 1 participant at risk for serious adverse events and 1 participant affected by a serious adverse event. Death is listed as the serious event, and the record lists 1 death. The top serious-event term is Death, with 100.0%. These are counts and a percentage within a record containing one participant; they are not a comparative risk estimate.
The same record lists 1 participant at risk for other adverse events and 0 affected. These entries should be read as reported safety counts, not as proof that no other symptoms or events occurred outside the recorded categories or reporting process. The registry does not provide event timing, cause of death, event-level detail, or an investigator assessment of relationship to IMTOX-25. Such information is not reported in the registry record.
General: An adverse event occurring during a study does not by itself establish that the intervention caused it. Causal interpretation requires clinical assessment and context, and comparative safety assessment generally needs an appropriate comparator and adequate information. This single-group record, with enrollment of 1, does not support a stable estimate of event frequency or a comparison of safety between treatments. The serious-event entry should be described as recorded, without assigning causality.
12. What the Result Does, and Does Not, Mean
The study set out to examine overall response to IMTOX-25 in adults with relapsed or refractory CD25-positive ATL. The registry record documents a phase II, single-group design, a planned response assessment within 28 days, enrollment of 1, and terminated status. It also states that the primary outcome was not collected and/or aggregated and therefore was not analyzed for that participant. These registry entries describe the study record but do not establish whether the participant experienced a response.
The planned enrollment and early stopping framework should not be confused with observed evidence. The protocol described a minimum of 10 patients, a decision after the initial 9, and potential continuation to 17 evaluable patients with a total planned size of 19. Those targets were not the actual enrollment. The registry does not say why the study terminated or whether the planned stopping decision was reached.
No response estimate or uncertainty interval is reported, so the magnitude and precision of anti-tumor activity cannot be evaluated. There is also no concurrent comparator. The record therefore does not provide evidence from a randomized comparison, and it cannot quantify a relative effect against another treatment or control.
The safety entries report one serious adverse event and one death among one participant. They do not establish that IMTOX-25 caused the death. Cause, timing, and attribution are not reported. With this limited record, the listed counts should not be extended into broader estimates of safety or risk.
In practical statistical terms, the registry preserves the intended clinical question and some planned design features, but the outcome information needed to answer the primary question is absent. The result is not a positive or negative response finding; it is an unanalyzed primary outcome in a terminated study with one enrolled participant.
13. Why This Trial Matters Statistically
This record is statistically informative in part because it distinguishes a planned trial from an analyzed result. The protocol described a phase II response question, an early stopping framework, and planned enrollment targets. The registry separately reports enrollment of 1, terminated status, and no analyzed primary response outcome. Keeping those elements distinct prevents a planned threshold or target from being mistaken for an observed finding.
The record also illustrates how the design constrains interpretation. A single-group study can be intended to describe response, but it does not create a randomized comparison with another treatment. Here the primary outcome was not analyzed, so even the basic descriptive response question remains unanswered in the posted record. Neither the treatment effect nor its precision can be estimated from the response endpoint information recorded.
The safety information illustrates a related principle: event counts need context. One serious adverse event and one death are listed, but the record does not report timing, cause, or treatment attribution. A count should not be converted into a causal conclusion, particularly when there is no concurrent comparator and enrollment is 1.
Finally, the protocol’s staged enrollment plan and the statistical planning assumptions are not substitutes for observed data. Planning calculations address hypothetical study requirements under stated assumptions; they do not show that the trial had a particular probability of detecting an effect or that an effect was observed. Distinguishing planning from inference is especially important when the actual record contains no analyzed primary outcome.
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 principal limitation is the lack of an analyzed primary endpoint. The registry states that overall response was not collected and/or aggregated and therefore was not analyzed for the one participant. As a result, no response estimate or precision measure is available. The reason the outcome was not analyzed is not reported in the registry record.
Enrollment was 1, compared with a planned minimum of 10 and a protocol description that allowed continuation to 17 evaluable patients, with a total study size of 19. The study is recorded as terminated, but the reason for termination and whether its planned stopping rule was applied are not reported in the registry record. These limitations prevent evaluation of the intended accrual and response decision process.
The design was single-group, with no allocation and no masking. There was no concurrent control for a comparative treatment effect. In addition, response criteria and assessment procedures are not reported in the registry record, limiting assessment of how the primary outcome was defined and measured.
The statistical analysis plan, sample-size justification, analysis populations, missing-data procedures, and multiplicity approach are not reported in the registry record. The safety information is also sparse: one serious adverse event and one death are listed, without timing, cause, or attribution. Together, these gaps limit both efficacy interpretation and safety assessment. The available record does not explain why the trial ended or support conclusions about treatment effect.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase II Study Of Imtox-25 In Adults With Refractory/Relapsed Cd25 Positive Adult T Cell Leukemia/Lymphoma — NCT01378871.
- Registry record last updated 2023-06-09; status last verified 2023-05.
- Results first posted 2023-06-09.
- 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
This is a phase II, single-group study of IMTOX-25 in adults with relapsed or refractory CD25-positive ATL. The intervention description specifies intravenous treatment over 4 hours every other day for 4 doses, with hospital admission. The primary outcome was overall response within 28 days; toxicity and affect of treatment were listed as secondary outcomes.
The registry records enrollment of 1 and status as terminated. It says the primary outcome was not collected and/or aggregated and therefore was not analyzed for that participant. No response estimate or statistical analysis is reported. The safety record lists one serious adverse event, death, and one death overall, without reported cause or treatment attribution. The reason for termination is not reported in the registry record.