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 Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT) (NCT01518153), a randomized phase 2 study. The primary outcome is Success Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01518153 |
| Phase | Phase 2 |
| Condition | Leukemia, Lymphoma, Myeloma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | 2 |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with leukemia, lymphoma, myeloma, or myeloproliferative diseases who underwent reduced-intensity allogeneic stem cell transplantation. The study summary also describes patients with MDS and Hodgkin disease. Sixteen participants were treated and evaluable for treatment response.
Intervention
The intervention of interest was a planned donor lymphocyte infusion of CD3+ T-cells after transplantation. The registry describes a low-dose group and a high-dose group, with the planned infusion between Day +56 and +64. Both groups also received the transplant regimen described in the arm records.
Comparator
The low-dose donor T-cell group was the comparator for the high-dose donor T-cell group. The registry identifies the study as randomized, with a parallel design and no masking. Seven participants met the criteria to receive planned DLI; nine did not meet those criteria. The registry does not fully explain how those eligibility and analysis details relate to each posted arm count.
Primary question
The primary question was whether the planned dose groups differed in the chance of meeting the study’s day-100 success definition: being alive and engrafted, without grade 3 or 4 GvHD or relapse. The posted arm results are counts, with 1 of 3 participants in the low-dose group and 3 of 4 in the high-dose group meeting the reported success outcome. No statistical comparison is posted.
3. Trial Design
This was a phase 2, randomized, parallel-group study with no masking. Its official title describes a study of planned donor lymphocyte infusion after reduced-intensity allogeneic stem cell transplantation. The registry lists M.D. Anderson Cancer Center as sponsor. Enrollment was 16, and the record’s status is terminated. The study began in 2012-02, with primary completion in 2014-08.
The study compared planned low-dose and high-dose donor T-cell infusions after the transplant. Both arm descriptions include fludarabine, melphalan, alemtuzumab, and a reduced-intensity stem cell transplant. The low-dose arm description specifies 3 * 106 CD3+ cells/kg and the high-dose description specifies 1 * 107 CD3+ cells/kg, with the planned infusion between Day +56 and +64. The posted arm records contain outcome counts for 3 participants in the low-dose group and 4 in the high-dose group.
The registry states that 16 participants were treated and evaluable for treatment response. Of these, 7 met the criteria to receive planned DLI, while 9 did not meet the criteria to receive randomized planned DLI. The record does not provide enough detail to establish how these groups were handled in the analysis, beyond the reported arm results. A protocol-level account of allocation concealment, stratification, or the process used to determine eligibility for DLI is not reported in the registry record.
Overall survival is listed as a secondary outcome, but no analysis of that outcome is posted. The registry lists two outcome measures and zero analyses. It does not report a sample-size justification, a detailed statistical analysis plan, or an explanation of why the trial was terminated.
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: Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned Donor Lymphocyte Infusion (DLI). 9 participants did not meet the criteria to receive randomized planned DLI.
Stem Cell Transplant
| Stage | Stem Cell Infusion | Low Dose Donor T-Cells | High Dose Donor T-Cells |
|---|---|---|---|
| STARTED | 16 | 0 | 0 |
| COMPLETED | 7 | 0 | 0 |
| NOT COMPLETED | 9 | 0 | 0 |
Reasons for not completing this period:
| Reason | Stem Cell Infusion | Low Dose Donor T-Cells | High Dose Donor T-Cells |
|---|---|---|---|
| Active graft-vs-host disease (GvHD) | 5 | 0 | 0 |
| Death | 2 | 0 | 0 |
| Secondary graft failure | 1 | 0 | 0 |
| Adverse Event | 1 | 0 | 0 |
Donor Lymphocyte Infusion
| Stage | Stem Cell Infusion | Low Dose Donor T-Cells | High Dose Donor T-Cells |
|---|---|---|---|
| STARTED | 0 | 3 | 4 |
| COMPLETED | 0 | 1 | 3 |
| NOT COMPLETED | 0 | 2 | 1 |
Reasons for not completing this period:
| Reason | Stem Cell Infusion | Low Dose Donor T-Cells | High Dose Donor T-Cells |
|---|---|---|---|
| Death | 0 | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI. 9 participants did not meet the criteria to receive randomized planned DLI.
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 | Stem Cell Transplant + Donor Lymphocyte Infusion |
|---|---|---|
| Participants analysed | 16 | |
| Age, Continuous | years | 58 (35 to 65) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 11 |
| Region of Enrollment: United States | participants | 16 |
6. Primary Endpoint
The registry lists the primary outcome as Success Rate, measured over 100 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is called Success Rate and is recorded as a number of participants. Success is defined as being alive and engrafted at day 100 after allogeneic stem cell transplantation followed by donor lymphocyte infusion, without grade 3 or 4 GvHD or relapse. The endpoint therefore combines several conditions into a single binary outcome: a participant either meets the full definition or does not.
A composite endpoint can be used when researchers want one measure to capture several aspects of a clinical course. In this case, the definition includes survival, engraftment, severe GvHD, and relapse. A participant’s status on any of those components affects whether the combined success criterion is met. The registry does not report separate primary-endpoint results for each component, so the posted counts cannot show which component determined an individual participant’s outcome.
The timeframe is 100 days. The record says 16 participants were treated and evaluable for treatment response, while the arm results report 1 of 3 participants meeting the endpoint in the low-dose group and 3 of 4 in the high-dose group. It does not report a confidence interval or a statistical test for the difference between groups. The relationship between the full evaluable group and the smaller arm-level counts is not explained in detail.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports 1 of 3 participants meeting the day-100 success definition in the low-dose group and 3 of 4 in the high-dose group. Those are small arm counts, and the record posts no statistical analysis comparing them. The counts describe the observed outcomes in the participants represented in those arm records; they do not by themselves establish whether the groups differ beyond chance variation.
The study’s planned comparison is clinically and statistically distinct from simply asking how many participants in each arm met the endpoint. A randomized comparison would ordinarily estimate the difference between assigned groups and express uncertainty around that estimate. The registry gives neither a comparative effect estimate nor a confidence interval or p-value. It also reports zero analyses. As a result, the precision of any between-group difference cannot be assessed from the posted results, and no inferential conclusion about dose can be drawn from the counts alone.
The registry reports 16 participants treated and evaluable for response, but only 7 met the criteria to receive planned DLI. The two arm records contain counts for 3 and 4 participants. Nine participants did not meet the criteria to receive randomized planned DLI. The record does not fully clarify the relationship between those eligibility groups, the 16 evaluable participants, and the arm-level outcome counts. This makes it important not to treat the posted arm figures as a complete account of all participants’ outcome paths.
The endpoint itself is composite. Meeting the definition requires being alive and engrafted and having no grade 3 or 4 GvHD or relapse at day 100. The registry does not report the separate status of participants for each of these components. Thus, even for the participants with posted arm results, the counts do not identify which aspects of the composite contributed to success or failure.
Overall survival is listed as a secondary outcome, but no result is posted for it. The record also supplies adverse-event counts, which describe safety reporting groups rather than provide a statistical comparison of the primary endpoint. The serious adverse-event groups include Stem Cell Infusion, Low Dose Donor T-Cells, and High Dose Donor T-Cells; the registry does not establish a causal interpretation of those events in the figures alone.
The record’s terminated status is relevant context, but the reason for termination is not reported in the registry record. It is therefore not possible to determine from the posted information whether termination affected enrollment, follow-up, or planned analyses. The most defensible reading is descriptive: the registry reports the specified counts, while leaving uncertainty, comparative inference, and the disposition of participants outside the arm-level results unresolved.
9. Statistical Methods Explained
The primary outcome is binary: each participant either met the day-100 success definition or did not. For a binary endpoint, a basic descriptive summary gives the number meeting the criterion alongside the number in the group. The registry reports 1 of 3 for the low-dose group and 3 of 4 for the high-dose group. These counts are the observed data posted for the two arms. They are not, on their own, a formal estimate of a treatment effect.
What would a group comparison address?
A comparative analysis would estimate how outcomes differ between the assigned dose groups, with uncertainty reflecting the amount of information in the data. Randomization is intended to support a fair comparison by assigning participants to groups through a chance process. But a randomized design does not remove the need to report how participants were analyzed, how missing outcomes were handled, or what estimate and uncertainty were obtained. Those details are not reported in the registry record.
A confidence interval is a statistical range that describes uncertainty around an estimated effect under the assumptions of the analysis. With small numbers of participants, estimates for a binary endpoint can be imprecise, and a confidence interval can make that uncertainty visible. No confidence interval is posted for these arm results. A p-value, if reported, would address how compatible the data are with a specified no-difference model; it would not measure the size or clinical importance of an effect. No p-value or other comparative test is posted.
Why are the posted counts not enough for inference?
The arm counts are limited, and the registry does not report a comparative estimate. It is therefore not appropriate to infer a reliable dose difference from the apparent separation in counts. The record also reports 16 participants evaluable for response, while the arm results cover 3 participants in one group and 4 in the other. Seven participants met the criteria to receive planned DLI, and nine did not. How those participant groups connect to the analysis population is not fully specified. That uncertainty about the analysis denominator affects interpretation of the arm-level summaries.
The registry identifies the study as randomized and parallel, but does not report the detailed statistical analysis plan, allocation procedures, or an analysis population such as intention-to-treat or per-protocol. These concepts matter because an intention-to-treat analysis generally retains participants in their randomized groups, while a per-protocol analysis may focus on participants who met specified study requirements. The record does not state which approach was used for the posted primary outcome.
How should planning calculations be understood?
Planning calculations estimate the sample size that might be needed under stated assumptions. They are not results observed in the trial and are not evidence that a study had a particular probability of detecting an effect. The planning description associated with the posted material uses a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect framed as a stated fraction of the observed effect. Any sample-size figures based on that approach are planning illustrations, not the trial’s own design justification or observed power. The registry does not report the trial’s original sample-size justification.
In general, over-dispersion means that observed variation is greater than a model expects. It matters for outcomes analyzed with models that assume a particular level of variation, because standard errors and uncertainty estimates may then be too small if the extra variation is ignored. The primary endpoint is posted as participant counts for a binary outcome, and the registry does not report an over-dispersion analysis or model-based comparison. There is no basis for assigning a particular model or variance correction to the sponsor’s analysis.
What does the absence of an analysis mean?
The registry reports zero analyses and indicates that values are missing or not estimable for a two-arm comparison of the binary endpoint. That means no recalculated comparative estimate should be substituted for a sponsor analysis. No sponsor comparison is posted in the record, so there is no sponsor estimate to interpret alongside a recalculation. The arm counts remain useful as descriptive results, but they cannot supply the missing details about uncertainty or the statistical test.
General statistical practice distinguishes estimates from decisions: a point estimate describes the observed contrast, while its uncertainty and the analysis assumptions determine how strongly it supports an inference. Here, the registry provides outcome counts but not the comparison, interval, or testing results needed for that fuller interpretation. The conclusions should stay within the descriptive information actually posted.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Low Dose Donor T-Cells | 3 | 1 | 33.3% | 0.8% to 90.6% | 6.1% to 79.2% | 6.8% to 80.6% |
| High Dose Donor T-Cells | 4 | 3 | 75.0% | 19.4% to 99.4% | 30.1% to 95.4% | 28.4% to 94.7% |
R code and output
arm <- c("Low Dose Donor T-Cells", "High Dose Donor T-Cells")
n <- c(3, 4)
events <- c(1, 3)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Low Dose Donor T-Cells 3 1 33.3 0.8 90.6 6.1 79.2 6.8 80.6
ARM High Dose Donor T-Cells 4 3 75.0 19.4 99.4 30.1 95.4 28.4 94.711. Multiplicity, Missing Data and Analysis Populations
The registry lists Overall Survival as a secondary outcome and reports two outcome measures in total. It does not post an analysis for the primary outcome or the secondary outcome. A multiplicity plan is not reported in the registry record. Multiplicity refers to the interpretive issue that can arise when several outcomes or comparisons are tested: the more tests performed, the greater the chance of obtaining an apparently notable result by chance. Without a stated analysis plan, it is not possible to determine whether or how the study addressed that issue.
Missing-data methods are not reported in the registry record. The record does not describe whether any endpoint information was missing, how missing values were handled, or whether any sensitivity analysis was performed. The full analysis population is also not specified. Sixteen participants were treated and evaluable for treatment response; 7 met criteria to receive planned DLI and 9 did not. The arm results report outcomes for 3 participants in the low-dose group and 4 in the high-dose group. The relationship among these counts and the analysis population is not fully described.
The registry does not state whether participants were analyzed according to randomized assignment, according to DLI received, or under another rule. That distinction can matter when some participants do not meet criteria for the planned intervention. No imputation procedure, censoring rule for the primary endpoint, or sensitivity analysis is reported. Accordingly, the potential effect of missing information or analysis-population choices cannot be assessed from the registry record.
12. 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 |
|---|---|---|---|
| Stem Cell Infusion | 9 | 9 | 100.0% |
| Low Dose Donor T-Cells | 2 | 3 | 66.7% |
| High Dose Donor T-Cells | 4 | 4 | 100.0% |
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 |
|---|---|
| Stem Cell Infusion | 9 of 9 |
| Low Dose Donor T-Cells | 3 of 3 |
| High Dose Donor T-Cells | 4 of 4 |
Most frequent serious adverse event terms
| Event term | Organ system | Stem Cell Infusion | Low Dose Donor T-Cells | High Dose Donor T-Cells |
|---|---|---|---|---|
| Death | General disorders | 5 of 9 | 2 of 3 | 1 of 4 |
| Liver GvHD | Hepatobiliary disorders | 0 of 9 | 1 of 3 | 3 of 4 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 3 of 9 | 0 of 3 | 0 of 4 |
| Secondary Graft Failure | Immune system disorders | 1 of 9 | 0 of 3 | 1 of 4 |
| Neutropenic Fevers | General disorders | 1 of 9 | 0 of 3 | 1 of 4 |
| Respiratory Syncytial Virus Upper Respiratory Illness | Respiratory, thoracic and mediastinal disorders | 1 of 9 | 1 of 3 | 0 of 4 |
| Idiopathic Thrombocytopenic Purpura | Blood and lymphatic system disorders | 1 of 9 | 0 of 3 | 0 of 4 |
| Enterococcus Faecium Stool Infection | Gastrointestinal disorders | 1 of 9 | 0 of 3 | 0 of 4 |
| Parvovirus | Infections and infestations | 1 of 9 | 0 of 3 | 0 of 4 |
| Disseminated Cytomegalovirus Infections | Infections and infestations | 1 of 9 | 0 of 3 | 0 of 4 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Stem Cell Infusion | Low Dose Donor T-Cells | High Dose Donor T-Cells |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 9 of 9 | 3 of 3 | 4 of 4 |
| Skin GvHD | Skin and subcutaneous tissue disorders | 5 of 9 | 2 of 3 | 3 of 4 |
| Cytomegalovirus Reactivation | Infections and infestations | 3 of 9 | 3 of 3 | 3 of 4 |
| Diarrhea | Gastrointestinal disorders | 4 of 9 | 1 of 3 | 2 of 4 |
| Fluid Overload | Metabolism and nutrition disorders | 6 of 9 | 0 of 3 | 0 of 4 |
| Mucositis | Gastrointestinal disorders | 4 of 9 | 1 of 3 | 1 of 4 |
| Elevated Alanine Aminotransferase | Metabolism and nutrition disorders | 2 of 9 | 2 of 3 | 2 of 4 |
| Elevated Bilirubin | Metabolism and nutrition disorders | 4 of 9 | 0 of 3 | 1 of 4 |
| Gastrointestinal GvHD | Gastrointestinal disorders | 2 of 9 | 0 of 3 | 2 of 4 |
| Upper Gastrointestinal GvHD | Gastrointestinal disorders | 1 of 9 | 0 of 3 | 3 of 4 |
Serious events with the highest arm-level rate: liver gvhd (75.0%), death (66.7%), pneumonia (33.3%), respiratory syncytial virus upper respiratory illness (33.3%), secondary graft failure (25.0%).
The registry reports serious adverse events for three groups: Stem Cell Infusion, Low Dose Donor T-Cells, and High Dose Donor T-Cells. The serious-event figures are 9 affected among 9 at risk for Stem Cell Infusion, 2 among 3 for Low Dose Donor T-Cells, and 4 among 4 for High Dose Donor T-Cells. Other adverse events are reported as 9 among 9, 3 among 3, and 4 among 4, respectively. These are counts of participants with events in the registry’s listed groups; they are not a comparison adjusted for follow-up or participant characteristics.
The registry also lists serious-event terms and percentages: Liver GvHD, 75.0%; Death, 66.7%; Pneumonia, 33.3%; Respiratory Syncytial Virus Upper Respiratory Illness, 33.3%; Secondary Graft Failure, 25.0%; and Deep Vein Thrombosis, 25.0%. The denominator and counting details for these term percentages are not reported in the registry record. The listed Death term should not be read as an overall mortality estimate or as an outcome comparison.
These figures do not establish whether an event was caused by a study intervention. The registry does not provide a comparative safety analysis, and the counts should be read as descriptive adverse-event reporting.
13. What the Result Does, and Does Not, Mean
The posted results establish that the registry recorded day-100 success counts for participants in the low-dose and high-dose donor T-cell groups. The count was 1 of 3 in the low-dose group and 3 of 4 in the high-dose group. The endpoint was a composite requiring participants to be alive and engrafted, without grade 3 or 4 GvHD or relapse at day 100. These results describe the participants represented in those arm records.
The counts do not establish that one dose is superior, that either dose changes the chance of success, or that the difference between groups is statistically reliable. No comparative estimate, confidence interval, or p-value is reported. The arm counts are small, and the relationship between them and the 16 participants described as evaluable for response is not fully explained. The fact that the study was randomized does not fill in the missing analysis details.
The registry also does not show which component of the composite endpoint accounted for each result. It does not report a primary-outcome analysis by component, nor does it post results for Overall Survival, the listed secondary outcome. The serious and other adverse-event counts provide descriptive safety reporting but do not establish a causal link to an intervention or a comparative safety effect.
The record’s terminated status is part of the study context. The reason for termination and its consequences for planned enrollment, follow-up, or analyses are not reported in the registry record. Consequently, the results should be understood as limited descriptive evidence rather than a completed inferential comparison of the two planned doses. Broader claims about efficacy, safety, or the expected course of disease are not supported by the posted results.
14. Why This Trial Matters Statistically
This trial illustrates the difference between reporting outcome counts and reporting a statistical comparison. For a randomized study, readers generally need both the observed outcomes and an estimate of the contrast between groups, together with an indication of its uncertainty. The registry provides arm-level counts for the primary binary endpoint, but no comparative estimate, confidence interval, or test. That distinction is especially important when the posted arm counts are small.
The study also makes the analysis population central to interpretation. Sixteen participants were treated and evaluable for response, but only 7 met the criteria to receive planned DLI, and the arm outcome counts cover 3 participants in one group and 4 in the other. A clear account of how participants moved from enrollment through eligibility and analysis would help readers understand which question the posted counts address. That detail is not reported in the registry record.
The endpoint’s composite definition shows another statistical issue: a single success count can combine distinct clinical events. Without component-specific results, the overall count does not reveal how survival, engraftment, GvHD, and relapse contributed. The secondary outcome of Overall Survival is listed but has no posted analysis.
Finally, the record demonstrates why safety counts and treatment comparisons should be kept separate. Adverse-event groups and terms are reported descriptively, but those figures alone do not provide causal or comparative evidence. Taken together, the record is useful for identifying the study question, endpoint, and reported counts, while also showing the importance of transparent analysis populations, uncertainty estimates, and outcome-level reporting.
15. 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.
Several limitations of interpretation arise from the registry record. Although the study is identified as randomized, the record does not report the allocation procedure, concealment, or detailed statistical analysis plan. It does not specify whether the primary analysis followed randomized assignment or used another analysis population. These details are important when some participants did not meet criteria to receive planned DLI.
The population counts do not align transparently across the record: 16 participants were treated and evaluable for response, 7 met the criteria to receive planned DLI, 9 did not, and the arm results include 3 participants in the low-dose group and 4 in the high-dose group. The record does not explain fully how these figures relate to each other. No information is reported about missing outcome data, imputation, or sensitivity analyses.
The primary endpoint is composite, and component-specific outcome counts are not reported. The registry posts no comparative effect estimate, confidence interval, or p-value for the primary endpoint, and no result for the listed secondary outcome of Overall Survival. It also does not report the reason for termination, the trial’s sample-size justification, interim analyses, or a multiplicity plan.
Safety information is descriptive. The registry does not report a comparative safety analysis or establish that the reported events were caused by the interventions. The denominators and counting details for the listed serious-event term percentages are not reported in the registry record. These gaps limit how much can be concluded from the posted results.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT) — NCT01518153.
- Registry record last updated 2016-03-17; status last verified 2016-02.
- Results first posted 2016-03-17.
- 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.
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19. Record Summary
NCT01518153 is a phase 2 randomized, parallel-group study of planned donor lymphocyte infusion after reduced-intensity allogeneic stem cell transplantation. The registry identifies M.D. Anderson Cancer Center as sponsor, lists enrollment of 16, and records the study status as terminated. The primary outcome is day-100 success, defined by survival and engraftment without grade 3 or 4 GvHD or relapse.
The posted primary outcome counts are 1 of 3 participants in the low-dose group and 3 of 4 in the high-dose group. The record states that 16 participants were evaluable for response, 7 met criteria to receive planned DLI, and 9 did not. It reports no statistical analyses, and the relationship among these counts is not fully explained. Overall Survival is listed as a secondary outcome but has no posted result. The reason for termination, detailed analysis plan, and missing-data methods are not reported in the registry record.