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 Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors (NCT03615105), a non-randomized phase 2 study. The primary outcome is the Number of Incidences of Grade 3-4 Acute GVHD.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03615105 |
| Phase | Phase 2 |
| Condition | Acute Lymphoid Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML) |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The registry lists people with Acute Lymphoid Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), Hodgkin Lymphoma, Non-Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia. Enrollment is recorded as 9. The registry does not report a more detailed description of the primary outcome population, such as eligibility at the time of outcome assessment.
Intervention
The study concerns allogeneic hematopoietic cell transplantation using α/β+ T-lymphocyte depleted grafts from HLA mismatched donors. Listed interventions include hyperfractionated total body irradiation, Thiotepa, Cyclophosphamide, Busulfan, Fludarabine, Melphalan, Clofarabine, and an HPC(A) stem cell allograft. The registry names three conditioning regimen groups, but does not provide descriptions for the arms.
Comparator
The record lists three parallel groups: Radiation, Thiotepa & Cyclophosphamide; Busulfan, Fludarabine & Melphalan; and Clofarabine, Thiotepa & Melphalan. Allocation is nonrandomized. The record explicitly cautions that the groups are not a like-for-like control comparison, so differences between them should not be read as unbiased treatment effects.
Primary question
The primary outcome is the number of participants with grade 3-4 acute GVHD over 2 years. The registry description says the intervention would be considered promising if the rate were 20% or less and unpromising if the rate were greater than 40%. The posted record contains no primary outcome result, so it does not establish whether either criterion was met.
3. Trial Design
This is a Phase 2, nonrandomized, parallel-group study with no masking reported. Memorial Sloan Kettering Cancer Center is the sponsor. The record lists enrollment as 9 and gives the study status as terminated. The recorded start date is 2018-07-25, and the primary completion date is 2024-03-06. These registry entries describe the study record, but do not explain why it was terminated or whether all planned assessments were completed.
The listed groups are Radiation, Thiotepa & Cyclophosphamide; Busulfan, Fludarabine & Melphalan; and Clofarabine, Thiotepa & Melphalan. The interventions list also includes an HPC(A) stem cell allograft. The registry does not explain how participants were assigned among the groups, give arm-specific eligibility criteria, or describe the group regimen details beyond their names. Those details are not reported in the registry record.
Nonrandom allocation means that group membership may be associated with characteristics that also relate to outcomes. Without randomization, an observed difference between groups cannot by itself be attributed to the regimen. The record itself cautions that the groups are not a like-for-like control comparison. The parallel design indicates that the groups are listed as separate study arms; it does not establish that those arms were intended or suitable as direct comparators.
The stated primary outcome is the number of participants with grade 3-4 acute GVHD, assessed over 2 years. The registry also says that the number of participants with and without SAE will be evaluated. No primary outcome analysis is posted, and the record does not report an analysis population, missing-outcome handling, or detailed statistical plan. A sample-size justification, interim-analysis plan, and explanation of termination 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 | Radiation, Thiotepa & Cyclophosphamide | Busulfan, Fludarabine & Melphalan | Clofarabine, Thiotepa & Melphalan |
|---|---|---|---|
| STARTED | 3 | 5 | 1 |
| COMPLETED | 2 | 3 | 1 |
| NOT COMPLETED | 1 | 2 | 0 |
Reasons for not completing this period:
| Reason | Radiation, Thiotepa & Cyclophosphamide | Busulfan, Fludarabine & Melphalan | Clofarabine, Thiotepa & Melphalan |
|---|---|---|---|
| Protocol Violation | 1 | 0 | 0 |
| Death | 0 | 2 | 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 | Radiation, Thiotepa & Cyclophosphamide | Busulfan, Fludarabine & Melphalan | Clofarabine, Thiotepa & Melphalan | Total |
|---|---|---|---|---|---|
| Participants analysed | 3 | 5 | 1 | 9 | |
| Age, Continuous | years | 20 (18 to 22) | 31 (13 to 63) | 23 (23 to 23) | 26 (13 to 63) |
| Sex: Female, Male: Female | Participants | 2 | 4 | 0 | 6 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 1 | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 2 | 0 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 3 | 1 | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 2 | 2 | 0 | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 2 | 0 | 3 |
| Region of Enrollment: United States | Participants | 3 | 5 | 1 | 9 |
6. Primary Endpoint
The registry lists the primary outcome as the Number of Incidences of Grade 3-4 Acute GVHD, 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 endpoint counts participants with grade 3-4 acute GVHD during the stated timeframe of 2 years. It is recorded as a participant count, rather than as a continuous measurement. In general, an event-count endpoint of this type describes how many people experienced the specified outcome; it does not by itself describe when the outcome occurred, how long it lasted, or its course after onset.
The grade range specifies which severity levels are included in the endpoint. The registry does not provide further operational detail about how GVHD was assessed, how grade was assigned, or how events within the timeframe were handled. Those definitions are not reported in the registry record. The outcome description also says that a rate of 20% or less would be considered promising and a rate greater than 40% unpromising. These are stated decision thresholds, not reported study findings.
This endpoint can be used to describe the occurrence of a defined complication following transplantation. Interpretation depends on knowing both the number of participants who experienced the outcome and the relevant number assessed. The registry record does not report primary endpoint counts or an outcome denominator by group. It therefore does not support estimating an observed rate or judging how precisely that rate was measured.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically specific primary outcome and a 2 years assessment timeframe, but it does not post results for that outcome. The count of participants with grade 3-4 acute GVHD, the corresponding denominator, and any estimate of the rate are not reported in the registry record. Consequently, the posted information cannot show whether the stated threshold of 20% or less or the threshold of greater than 40% was reached.
The distinction between a missing result and a result showing no events is important. No primary outcome analysis is listed, so the record does not establish that the event count was zero. Nor does the record establish that the outcome was not assessed. The status is terminated, but the reason for termination and the completeness of outcome follow-up are not reported.
There are adverse-event figures by group, including counts of participants affected by serious events and other events, and death counts. These are safety summaries, not the primary GVHD endpoint. They cannot be substituted for the primary outcome, and the record does not state that the deaths were caused by treatment or by any particular event. The timing, attribution, and follow-up context for these safety figures are not reported in the registry record.
The group structure also limits comparative interpretation. Allocation was nonrandomized, and the registry explicitly states that the arms are not a like-for-like control comparison. In general, nonrandomized groups may differ in prognostic characteristics or clinical circumstances; such differences can affect outcome comparisons. The record does not report adjustment methods or enough detail to assess whether potential differences were accounted for. Any descriptive contrast between arms would therefore not, on its own, establish a causal effect.
The registry specifies thresholds for classifying a rate as promising or unpromising, but no primary result is available to apply them to. The sample-size assumptions describe planning illustrations based on an observed effect, but the record does not post numerical planning estimates or an observed primary effect. These illustrations should not be mistaken for evidence about the trial's observed outcome or its statistical power.
Overall, the record documents a terminated nonrandomized study and some adverse-event counts, while leaving the primary outcome result unavailable. The information supports describing the design and the reported safety counts; it does not support a conclusion about the primary endpoint or a treatment comparison.
9. Statistical Methods Explained
The registry describes the primary outcome as a count of participants with grade 3-4 acute GVHD over 2 years. In general, this is a binary outcome summarized as a count: each participant either meets the event definition during the specified timeframe or does not. A count needs an appropriate denominator to be interpreted as a rate. Neither the primary counts nor their denominators are reported in the registry record, so no rate can be interpreted from the posted primary outcome information.
What does a confidence interval describe?
In general, a confidence interval expresses the uncertainty around an estimate under a specified statistical method and its assumptions. For an event rate, it would help show how compatible the observed data are with a range of underlying rates. A narrow interval generally indicates greater precision than a wide interval, although precision is not the same as absence of bias. The registry does not report a primary outcome estimate or confidence interval. There is therefore no interval available to interpret, and the precision of the primary outcome estimate cannot be assessed.
Why does nonrandom allocation matter?
In a randomized study, allocation by chance is intended to make groups comparable on average with respect to both measured and unmeasured characteristics. Here, allocation is listed as nonrandomized. In general, a difference between nonrandomized groups may reflect differences in who entered each group, as well as differences related to the assigned regimen. Statistical adjustment can sometimes address measured characteristics, but cannot guarantee removal of confounding, especially when important characteristics are not measured. The registry does not report an adjustment plan or an adjusted primary outcome analysis.
The registry also identifies the design as parallel and unmasked. In general, masking can limit the influence of knowledge about group assignment on care, assessment, or reporting, depending on the outcome. No masking is reported for this study. The record does not describe outcome-assessment procedures or safeguards against assessment differences. These details are therefore not available for evaluating possible measurement bias.
What can the stated thresholds tell a reader?
The endpoint description says the intervention would be considered promising if the rate were 20% or less and unpromising if the rate were greater than 40%. These thresholds describe the registry's stated interpretation criteria. They do not supply an observed rate, and they do not replace uncertainty estimates. Without an endpoint count and denominator, the thresholds cannot be applied to the study results. The record does not explain how a rate between those stated boundaries would be interpreted.
What do the sample-size assumptions mean?
The record describes planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. In general, such calculations explore how a hypothetical future design might perform under selected assumptions; they are not observed study outcomes and are not observed power. The record does not report numerical planning estimates, and it does not post an observed primary effect to which the illustrations could be anchored. A sample-size justification for this trial is not reported in the registry record.
The assumptions refer to two-arm calculations, while the trial record lists three nonrandomized groups and cautions against treating them as like-for-like controls. This difference in context matters: a planning illustration under equal allocation between two arms is not evidence that the actual study used that allocation or a direct two-arm comparison. The registry does not describe how the planning assumptions relate to the study's enrollment or group assignments.
How should safety counts be distinguished from the primary analysis?
The adverse-event record lists the number at risk and number affected for serious and other events within each group. These are descriptive safety summaries. In general, counts describe what was recorded in the study, but interpretation also depends on event definitions, observation time, and whether events are counted once per participant or repeatedly. The registry does not supply all those details for the listed terms. The safety counts do not provide the missing primary GVHD analysis.
The record lists no primary outcome analyses. That absence means there are no posted inferential results to evaluate, such as a primary between-group estimate, its uncertainty, or a test of a prespecified hypothesis. It does not establish that no analyses were conducted outside the registry record. The statistical plan, including any interim analyses and missing-data methods, is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record lists one primary outcome measure, but does not provide a statistical analysis plan describing how hypotheses or outcome comparisons were to be handled. In general, testing multiple outcomes or multiple comparisons can raise the chance of a false-positive finding if the analysis does not account for that multiplicity. The registry record does not report whether any multiplicity adjustment was planned or used. Since no primary analyses are listed, there are no posted tests or estimates whose multiplicity handling can be evaluated.
Missing data can affect an outcome estimate when participants lack an assessment or when follow-up differs. In general, an analysis should make clear how missing outcome information was handled and which participants were included. The registry does not report missingness, a primary analysis population, or a method for handling missing outcome data. The terminated status alone does not reveal whether primary assessments were incomplete or why the study ended.
The record lists enrollment as 9, but does not report the number assessed for the primary outcome or provide a group-specific primary outcome denominator. It is therefore not possible to judge the extent of missing primary outcome information or the representativeness of any analyzed group. The registry's description of evaluating participants with and without SAE does not supply a primary endpoint analysis population.
Interim analyses, stopping rules, protocol deviations, and a detailed statistical analysis plan are not reported in the registry record. No conclusions about those procedures should be inferred from the terminated status or from the absence of posted primary analyses.
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 |
|---|---|---|---|
| Radiation, Thiotepa & Cyclophosphamide | 2 | 3 | 66.7% |
| Busulfan, Fludarabine & Melphalan | 3 | 5 | 60.0% |
| Clofarabine, Thiotepa & Melphalan | 1 | 1 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Radiation, Thiotepa & Cyclophosphamide | 1 of 3 |
| Busulfan, Fludarabine & Melphalan | 2 of 5 |
| Clofarabine, Thiotepa & Melphalan | 1 of 1 |
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 |
|---|---|
| Radiation, Thiotepa & Cyclophosphamide | 3 of 3 |
| Busulfan, Fludarabine & Melphalan | 5 of 5 |
| Clofarabine, Thiotepa & Melphalan | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Radiation, Thiotepa & Cyclophosphamide | Busulfan, Fludarabine & Melphalan | Clofarabine, Thiotepa & Melphalan |
|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | 1 of 3 | 1 of 5 | 0 of 1 |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | 1 of 3 | 0 of 5 | 1 of 1 |
| Sepsis | Infections and infestations | 1 of 3 | 0 of 5 | 1 of 1 |
| Diarrhea | Gastrointestinal disorders | 0 of 3 | 2 of 5 | 0 of 1 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 2 of 5 | 0 of 1 |
| Gastrointestinal disorders, other | Gastrointestinal disorders | 1 of 3 | 0 of 5 | 0 of 1 |
| Hypotension | Vascular disorders | 1 of 3 | 0 of 5 | 0 of 1 |
| Sinus Tachycardia | Cardiac disorders | 1 of 3 | 0 of 5 | 0 of 1 |
| Delirium | Psychiatric disorders | 0 of 3 | 1 of 5 | 0 of 1 |
| Enterocolitis | Gastrointestinal disorders | 0 of 3 | 1 of 5 | 0 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Radiation, Thiotepa & Cyclophosphamide | Busulfan, Fludarabine & Melphalan | Clofarabine, Thiotepa & Melphalan |
|---|---|---|---|---|
| Lymphocyte count decreased | Investigations | 3 of 3 | 5 of 5 | 1 of 1 |
| White blood cell decreased | Investigations | 3 of 3 | 5 of 5 | 1 of 1 |
| Blood bilirubin increased | Investigations | 0 of 3 | 2 of 5 | 0 of 1 |
| Hyperkalemia | Metabolism and nutrition disorders | 0 of 3 | 1 of 5 | 1 of 1 |
| Hypermagnesemia | Metabolism and nutrition disorders | 0 of 3 | 2 of 5 | 0 of 1 |
| Hyponatremia | Metabolism and nutrition disorders | 0 of 3 | 1 of 5 | 1 of 1 |
| Alanine aminotransferase increased | Investigations | 0 of 3 | 1 of 5 | 0 of 1 |
| Hypernatremia | Metabolism and nutrition disorders | 1 of 3 | 0 of 5 | 0 of 1 |
| Lipase increased | Investigations | 0 of 3 | 1 of 5 | 0 of 1 |
| Serum amylase increased | Investigations | 0 of 3 | 1 of 5 | 0 of 1 |
Serious events with the highest arm-level rate: rash maculo-papular (100.0%), sepsis (100.0%), appendicitis (100.0%), infection and infestations, other (100.0%), diarrhea (40.0%).
The serious adverse-event record gives, by group, the number at risk and the number affected. For Radiation, Thiotepa & Cyclophosphamide, the record lists 3 at risk and 2 affected; for Busulfan, Fludarabine & Melphalan, it lists 5 at risk and 3 affected; for Clofarabine, Thiotepa & Melphalan, it lists 1 at risk and 1 affected. These are reported counts and should not be interpreted as comparative treatment effects, particularly because the groups were nonrandomized and are not described as like-for-like controls.
The record also lists other adverse-event counts: 3 at risk and 3 affected in the Radiation, Thiotepa & Cyclophosphamide group; 5 at risk and 5 affected in the Busulfan, Fludarabine & Melphalan group; and 1 at risk and 1 affected in the Clofarabine, Thiotepa & Melphalan group. Death counts are listed as 1, 2, and 1 for those groups, respectively. The registry does not report whether deaths were attributed to treatment or to a specific adverse event.
Several serious-event terms are listed with 100.0%, including Rash Maculo-Papular, Sepsis, Appendicitis, and Infection and infestations, other. Diarrhea and Respiratory Failure are listed with 40.0%. The denominator and event-count basis for these term percentages are not reported in the registry record, so they should not be read as rates across all enrolled participants. Timing, duration, severity grading, and attribution details for the terms are also not reported.
12. What the Result Does, and Does Not, Mean
The posted record can establish that the study was registered as a Phase 2, nonrandomized, parallel-group study and that its primary endpoint was the number of participants with grade 3-4 acute GVHD over 2 years. It also records a terminated status, enrollment of 9, and adverse-event summaries by group. These registry entries describe the study record; they are not evidence that a particular regimen changed the risk of GVHD or other outcomes.
The central primary outcome result is not reported in the registry record. Without a primary event count, denominator, estimate, and measure of uncertainty, the stated threshold criteria cannot be evaluated. It would be incorrect to treat the absence of a posted analysis as evidence that the endpoint did not occur or that the outcome met either stated threshold.
The adverse-event counts likewise do not establish a causal relationship. The record does not report the attribution of events or deaths, and the nonrandomized groups are not like-for-like controls. Differences in counts can reflect differences in group composition, follow-up, or other factors as well as treatment. The registry does not report enough information to distinguish among those possibilities.
In general, statistical significance and clinical importance are different questions: a statistical estimate concerns compatibility with a model and its uncertainty, while clinical interpretation also depends on context and the consequences of outcomes. No primary estimate or uncertainty interval is posted, so neither can be assessed for the endpoint. The registry's stated promising and unpromising thresholds are criteria, not results.
Accordingly, the record supports a description of the design, endpoint definition, termination status, and recorded safety figures. It does not support a conclusion that any regimen is superior, that the intervention met the stated promise criterion, or that treatment caused the reported events or deaths.
13. Why This Trial Matters Statistically
This study illustrates why a registered endpoint and an endpoint result are not interchangeable. The record names a specific outcome, grade 3-4 acute GVHD, and a 2 years timeframe, and it gives criteria for interpreting a rate. Yet no primary outcome analysis is listed. Without the event count and denominator, the outcome cannot be translated into an observed rate, and the stated criteria cannot be applied.
The nonrandomized design is also important to statistical interpretation. A study can report group-specific outcomes without those groups functioning as valid controls. The registry explicitly cautions that the three arms are not a like-for-like comparison. This makes it important to distinguish descriptive summaries from estimates of treatment effect, particularly when group assignment may be related to participant characteristics or clinical decisions.
The record also separates safety reporting from the primary endpoint. Serious-event counts, other adverse-event counts, and deaths provide information about events recorded in the groups, but do not answer the primary GVHD question. Their meaning depends on denominators, follow-up, event definitions, and attribution. Some of those details are not reported in the registry record.
Finally, the study status is terminated, while the reason for termination and the completeness of primary outcome reporting are not given. That combination highlights a practical issue in evidence interpretation: registry design information may remain available even when outcome analyses are not posted. Readers should distinguish what the record documents from what remains unknown, rather than filling gaps with assumptions about the protocol, analysis, or results.
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 the study is the absence of a posted analysis for its primary endpoint. The registry does not report the number of participants with grade 3-4 acute GVHD, the number assessed, an estimated rate, or uncertainty around an estimate. This prevents evaluation of the endpoint against the stated decision thresholds.
The nonrandomized allocation and the registry's explicit warning that the groups are not like-for-like controls limit causal comparisons. The record does not describe group assignment, baseline characteristics by arm, or statistical adjustment. It is therefore not possible to assess comparability or determine whether any differences were accounted for.
The arm descriptions are blank, and the record does not provide additional detail about the treatment regimens, eligibility by arm, outcome assessment, or follow-up beyond the primary timeframe. The enrollment is recorded as 9, but the primary outcome population and group-specific denominators are not reported. The terminated status is recorded, but its reason and its implications for follow-up are not given.
The safety summaries have their own interpretive limits. The registry does not fully explain the denominator basis for the listed serious-event term percentages or report event attribution and timing. It also does not state whether the listed death counts were related to treatment. The record lacks a detailed statistical plan, including methods for missing data, interim analyses, multiplicity, and analysis populations. These omissions restrict assessment of both the primary outcome and safety findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors — NCT03615105.
- Registry record last updated 2025-04-06; status last verified 2024-03.
- Results first posted 2025-04-06.
- 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
The registry record describes a Phase 2, nonrandomized, unmasked, parallel-group study sponsored by Memorial Sloan Kettering Cancer Center. Enrollment is listed as 9; status is terminated. The recorded study start is 2018-07-25, and primary completion is listed as 2024-03-06.
The study concerns allogeneic hematopoietic cell transplantation using α/β+ T-lymphocyte depleted grafts from HLA mismatched donors. Three regimen groups are named. The primary outcome is the number of participants with grade 3-4 acute GVHD over 2 years, but no primary outcome analysis is reported.
Adverse-event counts and deaths are listed by group. Because allocation was nonrandomized and the registry says the arms are not like-for-like controls, those counts should be read descriptively rather than as causal comparisons. The reason for termination, detailed analysis methods, and primary outcome results are not reported in the registry record.