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 Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment (NCT00416351), a na phase 1, phase 2 study. The primary outcome is Response Rate for Participants With Non-Hodgkin's Lymphoma.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00416351 |
| Phase | Phase 1, Phase 2 |
| Condition | Leukemia, Lymphoma, Small Intestine Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with relapsed T-cell or NK-cell lymphoma, or lymphoma that had not responded to previous treatment. The primary outcome population is described as evaluable participants with Non-Hodgkin's Lymphoma. The registry record does not report how many participants met that evaluability definition or provide further eligibility details in the record.
Intervention
Participants received clofarabine, an intravenous drug. The arm description says it was given once daily for three consecutive days, with doses starting at 4 mg/m2/day and escalating to higher dose levels. The registry lists dose groups of 4 mg/m2/Day, 8 mg/m2/Day, 13.2 mg/m2/Day, 20 mg/m2/Day, and 28 mg/m2/Day.
Comparator
There was no separate control treatment: the trial is described as single-group, with allocation listed as NA and masking listed as none. Dose groups appear in the safety results, but the record does not describe them as randomized comparison groups. Differences between those groups would not constitute a like-for-like controlled comparison.
Primary question
The primary outcome asks about response among evaluable participants with Non-Hodgkin's Lymphoma over 2 years. The registry defines the response outcome using complete remission, complete remission unconfirmed, partial remission, PET-negative partial remission, stable disease, and progressive disease. The record does not report the number of participants in these categories or a numerical response rate. Therefore, it does not permit a numerical estimate of response from the information recorded.
3. Trial Design
This completed study is identified as a Phase I/II trial of clofarabine in patients with relapsed T-cell and NK-cell lymphomas. The registry lists an enrollment of 29 and describes a single-group model. Allocation is listed as NA, and masking is listed as none. This was not a randomized controlled trial, so the different dose groups should not be read as treatment and control arms or as a like-for-like comparison.
The intervention was intravenous clofarabine. The arm description states that it was administered once daily for three consecutive days, with dosing beginning at 4 mg/m2/day and escalating to higher levels. The registry lists groups receiving 4 mg/m2/Day, 8 mg/m2/Day, 13.2 mg/m2/Day, 20 mg/m2/Day, and 28 mg/m2/Day. These entries describe dose groups; the registry record does not report enough detail to reconstruct how participants were assigned to dose levels, how escalation decisions were made, or whether any particular dose was selected as the best dose.
The listed study start date is 2006-06-27, and the primary completion date is 2021-03-01. The status is completed. The primary outcome is described for evaluable participants with Non-Hodgkin's Lymphoma and has a timeframe of 2 years. Participants evaluated for toxicity are listed as a secondary outcome.
Details of the protocol beyond these registry descriptions, including the sample-size justification, are not reported in the registry record. The registry also does not report details of interim analyses or a full statistical analysis plan. The enrollment count should not be treated as the number evaluable for the primary response outcome, because the size of that analysis population is not reported.
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 | 4 mg/m2/Day Clofarabine | 8 mg/m2/Day Clofarabine | 13.2 mg/m2/Day Clofarabine | 20 mg/m2/Day Clofarabine | 28 mg/m2/Day Clofarabine |
|---|---|---|---|---|---|
| STARTED | 1 | 3 | 4 | 17 | 4 |
| COMPLETED | 1 | 3 | 4 | 17 | 4 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
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 | 4 mg/m2/Day Clofarabine | 8 mg/m2/Day Clofarabine | 13.2 mg/m2/Day Clofarabine | 20 mg/m2/Day Clofarabine | 28 mg/m2/Day Clofarabine | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 1 | 3 | 4 | 17 | 4 | 29 | |
| Age, Continuous | years | 62 (62 to 62) | 65.3 (37 to 80) | 58 (44 to 79) | 54.1 (23 to 76) | 54.5 (35 to 71) | 59 (23 to 80) |
| Sex: Female, Male: Female | Participants | 1 | 2 | 2 | 9 | 0 | 14 |
| Sex: Female, Male: Male | Participants | 0 | 1 | 2 | 8 | 4 | 15 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 0 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 2 | 4 | 17 | 4 | 28 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 0 | 1 | 0 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 5 | 2 | 7 |
| Race (NIH/OMB): White | Participants | 0 | 3 | 3 | 10 | 2 | 18 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 1 | 1 | 0 | 2 |
| Region of Enrollment: United States | Participants | 1 | 3 | 4 | 17 | 4 | 29 |
6. Primary Endpoint
The registry lists the primary outcome as Response Rate for Participants With Non-Hodgkin's Lymphoma, measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled response rate for participants with Non-Hodgkin's Lymphoma. Its population is described as evaluable participants with Non-Hodgkin's Lymphoma, and its timeframe is 2 years. The registry defines the outcome using complete remission, complete remission unconfirmed, partial remission, PET-negative partial remission, stable disease, and progressive disease. It does not report the number of participants in any category, the total evaluable population, or a numerical response rate.
In general, a response endpoint is used to describe disease status following treatment. It can provide a structured way to report how participants' disease was classified during the stated assessment period. The listed categories include several forms of remission or partial remission, as well as stable disease and progressive disease. The registry's wording does not explain how those categories were combined to produce a single response-rate value, or whether additional assessment rules were applied. Those details are not reported in the registry record.
Without the category counts and an explicit response calculation, the endpoint definition alone does not establish how many participants had a response. It also does not quantify the precision of an estimated response rate. No numerical primary outcome result or confidence interval is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the trial as a completed Phase I/II study and reports enrollment of 29. It describes clofarabine dose groups and names response rate as the primary outcome, but it does not report a numerical response result. The endpoint description lists disease-status categories, yet gives no counts for those categories and no total number of evaluable participants. Consequently, a response proportion, its uncertainty, and the distribution of disease status cannot be interpreted from the registry record.
The distinction between enrollment and the primary outcome population matters. Enrollment is reported as 29, whereas the primary outcome is defined for evaluable participants with Non-Hodgkin's Lymphoma. The registry record does not state how many enrolled participants were evaluable or explain why any participant might not have been included. It would therefore be inappropriate to use enrollment as the denominator for a response calculation.
The dose entries are not evidence of comparative efficacy. The record describes a single-group study, with allocation listed as NA and masking as none. Its dose groups do not provide a randomized control group, and the information recorded does not establish comparability among participants at different dose levels. Any apparent difference between dose groups, if one were calculated from outcome data, would need to be interpreted cautiously and would not by itself isolate a dose effect. Here, the registry does not provide numerical response results by dose group.
The safety information reports counts of participants at risk and affected for serious events and other events, as well as death counts, across the listed dose groups. Those values describe the safety reporting recorded for the groups, but the record does not establish that reported events were caused by clofarabine. The death counts likewise do not include a cause or attribution in the information recorded. The serious-event terms are accompanied by percentages, but the registry record does not provide enough context to determine the precise method used to calculate those percentages.
No effect estimate, confidence interval, or hypothesis-test result for the primary outcome is reported in the registry record. A confidence interval, in general, describes the statistical uncertainty around an estimate; without an estimate and its interval, the precision of the response result cannot be assessed. The absence of a reported numerical result should not be read as evidence that there was no response or that there was no analysis outside the registry. It means that the posted registry information does not permit a quantitative conclusion about the primary outcome.
9. Statistical Methods Explained
What does a single-group design show?
The trial is described as a single-group study, with allocation listed as NA and masking as none. Participants received clofarabine at dose levels recorded in the registry. A single-group design can describe outcomes observed among treated participants, but it does not supply a separate control group for estimating what would have happened without the intervention. General statistical interpretation therefore distinguishes a within-study outcome description from a controlled estimate of treatment effect.
The dose-level groups should not be treated as if they were randomized arms. The registry record does not report random allocation or a control treatment. It also does not describe the procedures used to move between dose levels or the characteristics of participants at each level. Even if group results were available, differences could reflect differences in participant mix or other features, rather than dose alone. The reported study design does not support interpreting those groups as a like-for-like efficacy comparison.
What does a response rate require?
A rate needs a defined numerator and denominator. For this primary outcome, the record names evaluable participants with Non-Hodgkin's Lymphoma as the population and lists complete remission, complete remission unconfirmed, partial remission, PET-negative partial remission, stable disease, and progressive disease as the outcome categories. But it does not provide the category counts, the number evaluable, or a numerical response rate. The registry's description also does not specify which categories were combined to form the rate. The endpoint label alone is therefore insufficient to reproduce or interpret a response estimate.
In general, an estimate is more informative when accompanied by a measure of uncertainty, such as a confidence interval. A confidence interval communicates the range of values compatible with the data under the stated statistical method. It does not remove design limitations or replace a suitable comparison. Since the registry record does not report a primary response estimate or confidence interval, neither the size nor the precision of that result can be assessed from the posted information.
What can be inferred from the analysis entries?
The registry record lists 3 outcome measures and 0 analyses. These registry entries do not establish whether analyses were conducted outside the registry; they indicate that analysis results are not recorded there in the information available for this account. No primary-outcome test statistic, p-value, model estimate, or adjustment method is reported in the registry record. Statistical significance cannot be assessed from the outcome definition or enrollment count alone.
The record also does not report how participants with missing assessments were handled, whether all enrolled participants were included in any analysis population, or how the evaluable population was defined. In general, missing outcome data can affect both the denominator and the interpretation of an estimate, especially when the reasons for missingness are related to participant outcomes. Without the analysis population and missing-data approach, the potential influence of missing observations cannot be evaluated.
How should planning assumptions be read?
The record describes sample-size planning 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 stated as a fraction of the observed effect. Those are planning assumptions, not a description of the study's single-group design. The record does not report the trial's own sample-size justification or a design using equal allocation between two treatment arms.
In general, sample-size calculations depend on the effect being targeted and assumptions about variability, significance level, and allocation. A planning calculation is not observed power and does not show that a study did or did not detect an effect. The registry record does not report numeric planning outputs in the information recorded for this analysis, so no particular required sample size can be interpreted. The planning assumptions do not replace a reported outcome estimate, and they do not establish the rationale for enrolling 29 participants.
Why does over-dispersion matter?
For count outcomes, over-dispersion means that the observed variability is greater than a model assumes. In general, ignoring over-dispersion can make uncertainty estimates too small and statistical evidence appear more precise than it is. The primary outcome in this record is described as a binary response-related outcome, with counts of participants rather than a continuous measurement. The registry lists no dispersion value or analysis model for the primary endpoint, so no conclusion about use of an over-dispersion adjustment can be drawn.
Overall, the available registry descriptions identify the design, endpoint categories, and some safety counts, but they do not provide a reproducible inferential analysis of the primary outcome. The absent denominator, response counts, statistical model, and uncertainty estimate limit quantitative interpretation.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies response rate for participants with Non-Hodgkin's Lymphoma as the primary outcome and Participants Evaluated for Toxicity as a secondary outcome. It lists 3 outcome measures and 0 analyses. The registry record does not report a testing hierarchy, multiplicity adjustment, or rules for selecting which outcomes would support a primary conclusion. It also does not report whether any interim analyses were planned or performed. Those details are not reported in the registry record, so the effect of multiple outcome assessments on statistical error cannot be evaluated.
The response outcome lists several disease-status categories, but the record does not state how they were grouped to calculate a response rate. It does not report category counts, a total evaluable population, or a numerical primary outcome estimate. The enrolled population is reported as 29; the number evaluable for the primary endpoint is not reported in the registry record. The enrollment count therefore cannot be assumed to be the endpoint denominator.
The registry record does not describe how missing assessments or withdrawals were handled, whether outcome data were analyzed according to a prespecified population, or how evaluability was defined. In general, missing data can change the denominator and may affect interpretation when the reasons data are unavailable are related to outcome status. Without these details, the direction or size of any missing-data effect cannot be assessed.
No statistical analysis plan is reported in the registry record. The planning assumptions that are recorded are not evidence of the analysis actually used and do not clarify multiplicity or missing-data handling. These reporting gaps limit reproducibility and make it difficult to determine how the listed endpoint definition would translate into a final statistical 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 |
|---|---|---|---|
| 4 mg/m2/Day Clofarabine | 0 | 1 | 0.0% |
| 8 mg/m2/Day Clofarabine | 1 | 3 | 33.3% |
| 13.2 mg/m2/Day Clofarabine | 1 | 4 | 25.0% |
| 20 mg/m2/Day Clofarabine | 13 | 17 | 76.5% |
| 28 mg/m2/Day Clofarabine | 4 | 4 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 4 mg/m2/Day Clofarabine | 1 of 1 |
| 8 mg/m2/Day Clofarabine | 3 of 3 |
| 13.2 mg/m2/Day Clofarabine | 3 of 4 |
| 20 mg/m2/Day Clofarabine | 12 of 17 |
| 28 mg/m2/Day Clofarabine | 4 of 4 |
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 |
|---|---|
| 4 mg/m2/Day Clofarabine | 1 of 1 |
| 8 mg/m2/Day Clofarabine | 3 of 3 |
| 13.2 mg/m2/Day Clofarabine | 4 of 4 |
| 20 mg/m2/Day Clofarabine | 17 of 17 |
| 28 mg/m2/Day Clofarabine | 4 of 4 |
Most frequent serious adverse event terms
| Event term | Organ system | 4 mg/m2/Day Clofarabine | 8 mg/m2/Day Clofarabine | 13.2 mg/m2/Day Clofarabine | 20 mg/m2/Day Clofarabine | 28 mg/m2/Day Clofarabine |
|---|---|---|---|---|---|---|
| Infection, other | Infections and infestations | 0 of 1 | 0 of 3 | 0 of 4 | 6 of 17 | 0 of 4 |
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 1 | 1 of 3 | 1 of 4 | 1 of 17 | 1 of 4 |
| Calcium, high (hypercalcemia) | Metabolism and nutrition disorders | 0 of 1 | 0 of 3 | 1 of 4 | 1 of 17 | 0 of 4 |
| Creatinine | Investigations | 0 of 1 | 0 of 3 | 0 of 4 | 2 of 17 | 0 of 4 |
| Fever (in the absence of neutropenia) | General disorders | 0 of 1 | 0 of 3 | 0 of 4 | 2 of 17 | 0 of 4 |
| Hemoglobin | Blood and lymphatic system disorders | 0 of 1 | 0 of 3 | 0 of 4 | 2 of 17 | 0 of 4 |
| Inf unknown ANC-Cellulitis(skin) | Infections and infestations | 0 of 1 | 0 of 3 | 0 of 4 | 2 of 17 | 0 of 4 |
| Mucositis (Clin exam)- Oral cavity | Gastrointestinal disorders | 0 of 1 | 0 of 3 | 0 of 4 | 2 of 17 | 0 of 4 |
| Pain - Other (specify) | General disorders | 0 of 1 | 0 of 3 | 0 of 4 | 2 of 17 | 0 of 4 |
| Platelets | Investigations | 0 of 1 | 0 of 3 | 0 of 4 | 2 of 17 | 0 of 4 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 4 mg/m2/Day Clofarabine | 8 mg/m2/Day Clofarabine | 13.2 mg/m2/Day Clofarabine | 20 mg/m2/Day Clofarabine | 28 mg/m2/Day Clofarabine |
|---|---|---|---|---|---|---|
| Lymphopenia | Investigations | 1 of 1 | 2 of 3 | 2 of 4 | 11 of 17 | 3 of 4 |
| Leukocytes (total WBC) | Investigations | 0 of 1 | 3 of 3 | 2 of 4 | 10 of 17 | 3 of 4 |
| Platelets | Investigations | 0 of 1 | 2 of 3 | 2 of 4 | 10 of 17 | 4 of 4 |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | 0 of 1 | 3 of 3 | 2 of 4 | 9 of 17 | 3 of 4 |
| Hemoglobin | Investigations | 0 of 1 | 2 of 3 | 1 of 4 | 10 of 17 | 3 of 4 |
| Fatigue (asthenia, lethargy, malaise) | General disorders | 1 of 1 | 2 of 3 | 2 of 4 | 2 of 17 | 3 of 4 |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | 0 of 1 | 0 of 3 | 2 of 4 | 3 of 17 | 1 of 4 |
| Pleural effusion (non-malig) | Respiratory, thoracic and mediastinal disorders | 0 of 1 | 0 of 3 | 0 of 4 | 1 of 17 | 4 of 4 |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | 0 of 1 | 0 of 3 | 1 of 4 | 4 of 17 | 0 of 4 |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | 0 of 1 | 0 of 3 | 0 of 4 | 2 of 17 | 2 of 4 |
Serious events with the highest arm-level rate: infection, other (35.3%), febrile neutropenia (33.3%), calcium, high (hypercalcemia) (25.0%), hypotension (25.0%), pleural effusion (non-malig) (25.0%).
The safety record presents five clofarabine dose groups. For each group, it reports participants at risk and affected for serious events, participants at risk and affected for other events, and a death count. At 4 mg/m2/Day, the figures are 1 at risk and 0 affected for serious events, 1 at risk and 1 affected for other events, and 1 death. At 8 mg/m2/Day, the corresponding figures are 3 and 1, 3 and 3, and 3 deaths. At 13.2 mg/m2/Day, they are 4 and 1, 4 and 4, and 3 deaths.
At 20 mg/m2/Day, the record lists 17 at risk and 13 affected for serious events, 17 at risk and 17 affected for other events, and 12 deaths. At 28 mg/m2/Day, it lists 4 at risk and 4 affected for serious events, 4 at risk and 4 affected for other events, and 4 deaths. These are descriptive registry counts, not a controlled comparison. The record does not report event attribution or causes of death, so neither should be inferred from these figures.
The listed serious-event terms and percentages are Infection, other at 35.3%, Febrile neutropenia at 33.3%, Calcium, high (hypercalcemia) at 25.0%, Hypotension at 25.0%, Pleural effusion (non-malig) at 25.0%, and Rigors/chills at 25.0%. The registry record does not specify the denominator or calculation method for these term percentages. They should be read as reported safety summaries, not as estimates of comparative risk or proof of causation.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed Phase I/II, single-group clofarabine study enrolled 29 participants and included a primary response outcome for evaluable participants with Non-Hodgkin's Lymphoma. It records a 2 years timeframe and defines the outcome using several disease-status categories. These details describe what the study set out to assess, but they do not provide the numerical primary outcome result.
The record does not report a response count, a response rate, a denominator for the evaluable population, or a confidence interval. Thus, the posted information cannot show how often each disease-status category occurred or how precise a response estimate would be. It also cannot establish whether any observed response differed from what would have occurred under another treatment or no treatment, because no control group is described.
The listed dose groups and safety figures provide descriptive information about participants recorded in each group. They do not establish that the groups were comparable, and they do not support a randomized dose comparison. The registry does not report causal attribution for serious events or deaths. The safety information should therefore be read as reported counts and terms, not as proof that clofarabine caused a particular event or death.
In general, an outcome definition and a completed status are not substitutes for results. A treatment-effect conclusion needs the observed outcome data and an appropriate interpretation of their uncertainty and design context. Neither a numerical efficacy estimate nor a comparative treatment effect is reported in the registry record. This does not establish that no response occurred or that no analyses took place outside the record. It means only that the registry information is insufficient to quantify the primary result or support a controlled efficacy conclusion.
13. Why This Trial Matters Statistically
Statistically, this study illustrates the difference between an endpoint definition and an endpoint result. The registry names response rate as the primary outcome and gives a set of disease-status categories, but it does not report the category counts, the number evaluable, or a response estimate. Without those components, a reader cannot reproduce the primary statistic or assess its precision. Reporting the denominator and uncertainty alongside an estimate is important for understanding what the observed data can support.
The design also matters. This is a single-group study, not a randomized comparison, and the registry lists several dose groups without describing a control treatment. The group labels alone do not create a valid comparative design. This is a useful reminder that statistical methods cannot remove confounding or selection differences that may arise when groups are not randomized or otherwise made comparable.
The safety summaries reinforce the importance of distinguishing description from attribution. Counts of affected participants and deaths can document what is recorded in dose groups, while the absence of causal attribution means those values cannot by themselves establish that the intervention caused the events. The record also leaves the denominator and calculation method for the serious-event term percentages unclear.
Finally, the record contains limited information about analysis populations, missing data, multiplicity, and statistical methods. Those omissions constrain reproducibility as well as interpretation. The case is therefore statistically informative not because it supports a numerical efficacy conclusion, but because it shows how design and reporting details determine whether an endpoint can be evaluated quantitatively.
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 interpreting efficacy is that the registry record does not report a numerical response result. It gives neither the disease-status category counts nor the number of evaluable participants. Although enrollment is 29, the primary outcome population is separately described as evaluable participants with Non-Hodgkin's Lymphoma, and its size is not reported. A response rate cannot be reconstructed from the enrollment count alone.
The registry's endpoint description lists complete remission, complete remission unconfirmed, partial remission, PET-negative partial remission, stable disease, and progressive disease, but does not explain which categories were combined to calculate the stated response rate. It also does not report assessment procedures or the timing of assessments within the 2 years timeframe. These details are not reported in the registry record.
The study is described as single-group, with allocation listed as NA and masking as none. There is no separate control treatment in the recorded design. The dose groups are not described as randomized, and the record does not provide enough information to assess whether participants at different dose levels were comparable. Accordingly, the dose entries do not support a controlled comparison.
Other limitations include the absence of a reported statistical analysis plan, sample-size justification, interim-analysis details, missing-data rules, and a definition of the evaluable population. The safety information does not state event attribution or causes of death. The denominator and calculation method for the serious-event term percentages are not reported in the registry record. Together, these gaps limit the ability to reproduce the analysis, evaluate uncertainty, and distinguish descriptive observations from comparative or causal conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment — NCT00416351.
- Registry record last updated 2022-05-17; status last verified 2021-03.
- Results first posted 2022-05-17.
- 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 identifies a completed Phase I/II study of clofarabine in relapsed or treatment-unresponsive T-cell and NK-cell lymphoma. The study is described as single-group, with no masking and enrollment of 29. Clofarabine was administered intravenously once daily for three consecutive days, with dose escalation described from 4 mg/m2/day to higher dose levels. Listed dose groups range from 4 mg/m2/Day to 28 mg/m2/Day.
The primary outcome is response rate among evaluable participants with Non-Hodgkin's Lymphoma over 2 years. The registry lists remission, partial remission, stable disease, and progressive disease categories, but reports no numerical primary outcome result or evaluable-population size. Safety information includes serious and other event counts, death counts, and serious-event terms. A controlled comparison, statistical analysis plan, missing-data approach, and sample-size justification are not reported in the registry record.