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 Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant (NCT02869633), a na phase 2 study. The primary outcome is Progression Free Survival Probability at 12-month Post HCT.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02869633 |
| Phase | Phase 2 |
| Condition | Blastoid Variant Mantle Cell Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Follicular Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 23 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Vanderbilt-Ingram Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The primary endpoint concerns Cohort A: patients with chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) who received ibrutinib beginning between day 60 and day 90 after allogeneic hematopoietic cell transplant (HCT). The trial also includes a Cohort B of patients with follicular lymphoma (FL) or Hodgkin lymphoma (HL). The registry lists 23 participants overall.
Intervention
The treatment is ibrutinib by mouth once daily, starting between 60 and 90 days after donor stem cell transplant. The treatment description says participants continued until 1 year after transplant unless disease progression or unacceptable toxicity occurred. Laboratory biomarker analysis is also listed as an intervention.
Comparator
This is a single-group trial, with no randomized comparator. Allocation is listed as not applicable, and masking is listed as none. The design therefore does not provide a like-for-like control group against which to estimate a treatment contrast. Cohort B is a separate disease group, not a control for Cohort A.
Primary question
The primary question is the probability of being alive without progression or relapse at 12 months after HCT among treated Cohort A participants. The registry defines progression-free survival from the transplant date and specifies that the event includes progression, relapse of the disease for which transplant was undertaken, or death from a non-relapse cause. The numerical estimate is not reported in the registry record.
3. Trial Design
This completed phase II study evaluates ibrutinib after allogeneic hematopoietic cell transplant for lymphoma described as refractory or relapsed. The registry lists Vanderbilt-Ingram Cancer Center as sponsor, an enrollment of 23, a start date of 2016-11, and primary completion on 2021-11-18. The listed status is completed.
The design is single group and unmasked, with allocation recorded as not applicable. Participants received ibrutinib rather than being assigned between treatment and control groups. Thus the design describes outcomes during treatment but does not, by itself, estimate how outcomes would have differed under an alternative treatment or no ibrutinib. The registry explicitly notes that its arms are not a like-for-like control comparison.
The treatment description places ibrutinib initiation between 60 and 90 days after donor stem cell transplant. Treatment was to continue until 1 year after transplant in the absence of disease progression or unacceptable toxicity. The record does not report how closely treatment timing or duration was achieved for each participant, or how many participants stopped treatment early.
The primary endpoint is restricted to Cohort A, which includes CLL and MCL. Cohort B is described as FL/HL and is represented separately in the serious adverse event information. The condition list also names recurrent and refractory forms of CLL, FL, HL, and MCL, as well as blastoid variant MCL. The registry does not report the count of participants for each diagnosis in the information summarized for this trial.
Five outcome measures are listed, including the primary outcome and secondary measures concerning minimal residual disease, T-cell repertoire, B-cell subsets and signaling, and T-cell subsets and signaling. The registry describes biomarker assessments but does not report numerical results for them in the record summarized for these outcomes. No detailed statistical analysis results are listed.
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 | Cohort A - Chronic Lymphocytic Leukemia (CLL) Mantle Cell Lymphoma (MCL) | Cohort B - Follicular Lymphoma (FL) /Hodgkin Lymphoma (HL) Lymphoma (HL) Cohort |
|---|---|---|
| STARTED | 16 | 7 |
| COMPLETED | 3 | 2 |
| NOT COMPLETED | 13 | 5 |
Reasons for not completing this period:
| Reason | Cohort A - Chronic Lymphocytic Leukemia (CLL) Mantle Cell Lymphoma (MCL) | Cohort B - Follicular Lymphoma (FL) /Hodgkin Lymphoma (HL) Lymphoma (HL) Cohort |
|---|---|---|
| Death | 2 | 1 |
| Patient refused follow-up | 1 | 0 |
| Provider discretion | 1 | 0 |
| Investigator decision | 1 | 0 |
| Lost to Follow-up | 0 | 1 |
| Not eligible | 6 | 1 |
| Protocol-defined follow-up period completed | 2 | 1 |
| Withdrawal by Subject | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Cohort A - CLL/MCL patients treated with ibrutinib starting between day 60 and day 90 after allogeneic HCT
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 | Cohort A - CLL/MC | Cohort B - FL/HL Cohort | Total |
|---|---|---|---|---|
| Participants analysed | 16 | 7 | 23 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 15 | 7 | 22 |
| Age, Categorical: >=65 years | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Female | Participants | 3 | 2 | 5 |
| Sex: Female, Male: Male | Participants | 13 | 5 | 18 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 14 | 5 | 19 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 2 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 12 | 6 | 18 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Region of Enrollment: United States | participants | 16 | 7 | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Progression Free Survival Probability at 12-month Post HCT, measured over Time to progression, or relapse of the underlying disease for which transplant was undertaken, or death from any non-relapse causes, assessed 12 months post HCT..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | probability |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the probability of progression-free survival at 12 months after HCT in Cohort A, the CLL/MCL group treated with ibrutinib. The registry defines progression-free survival from the date of stem cell transplant. An event is progression or relapse of the underlying disease for which transplant was undertaken, or death from a non-relapse cause. This endpoint combines disease control and survival into one time-to-event outcome.
A 12-month probability expresses the estimated share of the defined population expected to remain free of the specified events through that time point. The registry says this probability ranges from 0 to 1, with a higher value representing a larger estimated probability of remaining progression-free. The numerical probability and its 95% confidence interval are not reported in the registry record, so the endpoint's observed magnitude and precision cannot be assessed from the posted information.
The registry specifies the Kaplan-Meier method for estimating the probability. In general, time-to-event methods are useful when participants can have different lengths of follow-up, because they use event timing and account for periods during which participants are known to remain event-free. The method relies on information about when events occur and when follow-up ends without a recorded event. Trial-specific details about follow-up completeness, censoring, or endpoint adjudication are not reported in the registry record.
This endpoint answers a narrowly defined question about the CLL/MCL cohort after transplant. It is not a direct comparison with another therapy, and it does not summarize every outcome relevant to participants. The listed biomarker outcomes and serious adverse event information address other aspects of the study, but do not replace the primary time-to-event measure.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study design, the treatment schedule, and the definition of the primary endpoint, but does not report a numerical 12-month progression-free survival estimate or its 95% confidence interval. Consequently, the posted record does not establish the estimated probability for Cohort A, nor how statistically precise that estimate was. A result should not be inferred from the study's completion status or enrollment alone.
The primary analysis is meant to describe outcomes for CLL/MCL participants treated with ibrutinib after allogeneic HCT. Because the study is single group, the endpoint would be an estimate within the treated cohort rather than a treatment effect measured against a concurrent control group. Natural variation in prognosis, transplant-related factors, and other differences cannot be separated from treatment effects using a within-group estimate alone. The registry record does not provide an adjusted comparative analysis.
The 95% confidence interval is important alongside the point estimate. In general, a confidence interval describes uncertainty around an estimated quantity under the method's assumptions. A narrower interval indicates greater precision than a wider interval, but it does not correct limitations in the study design or guarantee that the estimate applies to other populations. Here, neither the interval nor the point estimate is reported in the registry record, so that precision cannot be evaluated.
The enrollment of 23 applies to the overall trial. The primary endpoint population is specifically Cohort A; the record identifies 16 participants at risk in that cohort for the serious adverse event information. These counts serve different purposes, and the overall enrollment should not be treated as the number contributing to every outcome. The record does not give a primary endpoint analysis population count or explain exclusions from that analysis.
Serious adverse event information is reported separately for Cohort A and Cohort B. The listed counts describe participants at risk and participants affected, while the listed terms and percentages provide additional safety information. Those observations are descriptive; without further information about event timing, severity details, attribution, or a comparator, they do not establish whether ibrutinib caused an event or how risks compare with another treatment.
The record lists secondary outcomes focused on disease and immune biomarkers, but gives no numerical outcome results in the information. It also lists zero analyses. This means there are no analysis results available in the registry record for interpretation; it does not establish that no analyses were conducted outside the registry. Any conclusion about the trial's clinical effect, comparative benefit, or balance of benefits and harms would go beyond the results reported.
9. Statistical Methods Explained
The registry describes the planned primary analysis as an estimate of 12-month progression-free survival using the Kaplan-Meier method, with a 95% confidence interval. The endpoint begins at the date of stem cell transplant, and the stated primary population is Cohort A, consisting of CLL/MCL participants treated with ibrutinib. The registry record does not report the resulting estimate, interval, or further details of the analysis.
What does a time-to-event estimate represent?
In general, time-to-event analysis considers both whether an event occurred and how long participants remained under observation before an event or the end of follow-up. For this trial, the event definition combines progression, relapse of the disease for which transplant was undertaken, and death from a non-relapse cause. The endpoint therefore treats those specified outcomes as events in the progression-free survival measure. It should not be interpreted as a measure of any one event type in isolation.
Kaplan-Meier estimation is a general method for describing the probability of remaining event-free over time. It updates the estimate as events occur, using the participants still under observation at each event time. Participants whose event status is not observed through the endpoint time may contribute information up to the time their follow-up ends. In general, this is called censoring. The registry record does not report the number censored, reasons for censoring, loss to follow-up, or how censoring was handled in the actual analysis.
How should the confidence interval be read?
A confidence interval communicates sampling uncertainty around an estimate. The registry specifies a 95% confidence interval for the 12-month probability. In general, the interval is not a range containing a known fixed percentage of individual participant outcomes; it is an uncertainty summary for the estimated population quantity under the statistical method. The interval's width conveys precision, while the estimated probability conveys the central result. Neither quantity is reported in the registry record, so the result's direction, magnitude, and precision cannot be assessed.
A confidence interval also does not address every source of uncertainty. It does not by itself remove bias from selection, differences in care, incomplete outcome assessment, or the lack of a comparison group. It reflects uncertainty under the analysis framework and data available. Because the study is single group, even a precise estimate would remain an estimate of outcomes in the treated cohort rather than a randomized contrast between treatment strategies.
What does the single-group structure imply?
In general, random allocation to treatment groups can support a more direct comparison by balancing factors that influence outcomes, on average. This trial has no randomized comparison; its allocation is listed as not applicable and its model as single group. Cohort B is a different lymphoma group, not a control arm for Cohort A. Comparisons between the cohorts would therefore mix differences in diagnosis and cohort membership with any other differences, and the registry does not define such a comparison as the primary analysis.
The treatment schedule is also tied to transplant timing: ibrutinib begins between 60 and 90 days after HCT and is intended to continue until 1 year after transplant unless progression or unacceptable toxicity occurs. This schedule describes the intervention but does not reveal the amount of treatment actually received. Treatment adherence, interruptions, discontinuations, and reasons for stopping are not reported in the registry record.
What can planning calculations tell readers?
In general, sample-size calculations explore how many participants might be needed to detect a chosen effect under specified assumptions. Such calculations are planning illustrations, not observed power and not evidence that an effect occurred. The stated planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. For time-to-event calculations, the stated quantity is the total number of events; for other calculations, it is participants per arm. These assumptions do not describe this single-group design as a randomized two-arm comparison.
The registry record does not report the observed effect needed to interpret those hypothetical calculations, nor does it report a trial-specific sample-size justification. No numeric planning results are reported in the information available for this trial. Such calculations therefore should not be read as evidence that the study had adequate power, or as a substitute for the missing endpoint estimate and confidence interval.
What analysis details remain unclear?
The registry identifies the Kaplan-Meier method for the primary endpoint, but detailed statistical procedures are not reported in the registry record. This includes any rules for censoring, handling missing outcome information, analysis population definitions beyond the stated Cohort A population, subgroup analyses, or adjustments for multiple outcomes. The record lists five outcome measures and zero analyses, but does not provide results for the primary or secondary outcomes. Without these details and results, readers can describe the intended endpoint and design, but cannot reproduce or independently assess the outcome analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures: progression-free survival at 12 months after HCT, minimal residual disease assessed by sequencing, T-cell repertoire assessed by IMMUNOSEQ, and B-cell and T-cell subsets and signaling assessed by mass cytometry. These outcomes address different questions, and the primary endpoint is specifically the 12-month progression-free survival probability in Cohort A. The numerical results for the listed outcomes are not reported in the registry record.
When a study evaluates multiple outcomes or multiple comparisons, the chance of at least one apparently notable result can change. In general, prespecified testing strategies or multiplicity adjustments can help define how results should be interpreted across several tests. The registry record does not report a multiplicity strategy, any hierarchy among secondary outcomes, or whether analyses were prespecified beyond the description of the primary endpoint. No adjustment should be assumed.
Missing-data procedures and analysis population rules are also not reported in the registry record. The entry does not state how missing outcome assessments, withdrawal, loss to follow-up, treatment discontinuation, or incomplete biomarker measurements were handled. It describes the primary population as Cohort A participants treated with ibrutinib, but does not provide a detailed count of participants included in each outcome analysis or specify a broader analysis population.
The registry lists zero analyses. This indicates that no analysis results are listed in the record; it does not establish whether analyses were conducted elsewhere. The available information is therefore insufficient to assess missingness, multiplicity, or the relationship between planned and completed 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 |
|---|---|---|---|
| Cohort A - CLL/MCL | 12 | 16 | 75.0% |
| Cohort B - FL/HL Cohort | 5 | 7 | 71.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort A - CLL/MCL | 2 of 16 |
| Cohort B - FL/HL Cohort | 1 of 7 |
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 |
|---|---|
| Cohort A - CLL/MCL | 3 of 16 |
| Cohort B - FL/HL Cohort | 2 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort A - CLL/MCL | Cohort B - FL/HL Cohort |
|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | 7 of 16 | 1 of 7 |
| Fever | General disorders | 2 of 16 | 3 of 7 |
| Sepsis | Infections and infestations | 3 of 16 | 1 of 7 |
| Diarrhea | Gastrointestinal disorders | 2 of 16 | 1 of 7 |
| Lung infection | Infections and infestations | 2 of 16 | 0 of 7 |
| Headache | Nervous system disorders | 1 of 16 | 1 of 7 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 1 of 16 | 1 of 7 |
| Vascular access complication | Injury, poisoning and procedural complications | 2 of 16 | 0 of 7 |
| Nausea | Gastrointestinal disorders | 1 of 16 | 0 of 7 |
| Flu-Like Symptoms | General disorders | 1 of 16 | 0 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort A - CLL/MCL | Cohort B - FL/HL Cohort |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 3 of 16 | 2 of 7 |
| Hypomagnesemia | Metabolism and nutrition disorders | 3 of 16 | 2 of 7 |
| Platelet count decreased | Investigations | 3 of 16 | 1 of 7 |
| Neutrophil count decreased | Investigations | 2 of 16 | 1 of 7 |
| White blood cell decreased | Investigations | 2 of 16 | 1 of 7 |
| Hyperglycemia | Metabolism and nutrition disorders | 2 of 16 | 1 of 7 |
| Vomitting | Gastrointestinal disorders | 2 of 16 | 1 of 7 |
| Alanine aminotransferase increased | Investigations | 0 of 16 | 2 of 7 |
| Pruritus | Skin and subcutaneous tissue disorders | 2 of 16 | 0 of 7 |
| Hypertension | Vascular disorders | 1 of 16 | 1 of 7 |
Serious events with the highest arm-level rate: febrile neutropenia (43.8%), fever (42.9%), sepsis (18.8%), diarrhea (14.3%), headache (14.3%).
The serious adverse event information is divided into Cohort A - CLL/MCL and Cohort B - FL/HL Cohort. For Cohort A, 16 participants were listed at risk for serious events and 12 were affected; for Cohort B, 7 were listed at risk and 5 were affected. The record also lists other adverse event counts and deaths separately: Cohort A has 16 at risk and 3 affected for the other-event measure, with 2 deaths; Cohort B has 7 at risk and 2 affected, with 1 death. These are descriptive counts and should not be combined into a treatment comparison.
The registry lists febrile neutropenia at 43.8%, fever at 42.9%, sepsis at 18.8%, diarrhea at 14.3%, headache at 14.3%, and rash maculo-papular at 14.3% among the top serious terms. The record does not provide further detail in this information about event timing, repeated events, severity grades, attribution to treatment, or the denominator associated with each term. The percentages should therefore be read as reported, without inferring additional rates or comparisons.
Because the trial has no control group, these figures do not show how the observed event experience compares with another treatment or with no ibrutinib. They also do not establish causation. The registry record does not report a detailed safety analysis or the treatment exposure duration for each participant.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed phase II, single-group study of ibrutinib after allogeneic HCT and specifies a clinically interpretable time-to-event endpoint for the CLL/MCL cohort. It also records serious adverse event counts for two lymphoma cohorts and lists biomarker outcomes. These details clarify what the study set out to examine and which populations its primary endpoint concerns.
However, the registry record does not report the numerical primary endpoint estimate or its 95% confidence interval. It therefore does not show the estimated 12-month probability of remaining free of the specified progression, relapse, or non-relapse death events, nor the precision of that estimate. The listed secondary outcome results are also not reported in the registry information, so no numerical conclusions about those biomarkers can be drawn from it.
The single-group design does not provide a randomized comparison. Even if an outcome estimate were available, an outcome observed among treated participants would not alone establish what would have happened to comparable participants without ibrutinib or under another treatment. The design also does not isolate treatment effects from other influences on post-transplant outcomes. Cohort B is a distinct disease cohort rather than a control group for Cohort A.
The serious adverse event figures describe events recorded in the listed cohorts, but do not establish that ibrutinib caused them or allow direct comparison with another treatment. The record does not report the additional details needed to evaluate event timing, attribution, or exposure-adjusted rates.
Accordingly, the registry information supports a description of the study design, endpoint definition, treatment schedule, and reported safety counts. It does not support a conclusion about the magnitude or precision of the primary result, comparative effectiveness, or causal effects. Those questions remain unresolved by the results reported in the registry record.
13. Why This Trial Matters Statistically
This trial raises a useful statistical question about how to interpret time-to-event outcomes after transplant. Its primary endpoint begins at the transplant date, while ibrutinib is scheduled to begin between 60 and 90 days afterward. The distinction between the endpoint's time origin and treatment initiation matters when defining the population and interpreting the period being measured. The registry describes these timings, but does not report further analysis details about the interval before treatment.
The study also illustrates why an endpoint estimate and its uncertainty are both important. A 12-month probability would describe the outcome level for the defined Cohort A population, while its confidence interval would indicate precision under the statistical method. Since neither is reported in the registry record, readers cannot judge the estimate itself, regardless of the recorded enrollment or completed status.
The single-group structure is central to interpretation. A within-cohort outcome can be informative as a description, but it does not directly estimate a comparative treatment effect. This matters especially in a post-transplant setting, where the endpoint includes multiple kinds of events and the study population consists of more than one lymphoma cohort. Separating Cohort A's primary question from Cohort B's descriptive safety information avoids treating a different disease group as a control.
Finally, the record lists outcomes addressing both clinical events and laboratory biomarkers. These are not interchangeable measures: the primary endpoint concerns progression, relapse, and non-relapse death, while the secondary outcomes concern residual disease or immune characteristics. A complete statistical interpretation would require the reported estimates, their uncertainty, analysis populations, and information about missing data and multiplicity. Those elements are not reported in the registry record.
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 most important limitation for interpreting results is that the registry record does not report the primary endpoint estimate or its 95% confidence interval. It also does not report numerical results for the listed secondary outcomes. As a result, the posted information does not permit an assessment of the estimated progression-free survival probability or its precision.
The study is single group and has no randomized control. This prevents a direct randomized estimate of a treatment contrast and limits causal interpretation of outcomes observed during ibrutinib treatment. The different lymphoma cohorts are not interchangeable comparison groups, and the registry explicitly does not present the arms as a like-for-like control comparison.
The overall enrollment is 23, but the record does not provide a complete account of the number contributing to each endpoint analysis. It lists 16 participants at risk for serious events in Cohort A and 7 in Cohort B; those safety counts do not establish the analysis population for the primary endpoint. The diagnosis-specific enrollment, treatment exposure, treatment discontinuations, and follow-up completeness are not reported in the registry record.
Further analytic details are not reported in the registry record, including handling of missing data and censoring, analysis population rules, multiplicity procedures, and any adjustments or subgroup analyses. The serious adverse event information lacks details about timing, attribution, repeated events, and exposure duration. These gaps constrain both reproducibility and interpretation of the descriptive safety information.
Finally, the intended treatment schedule and completed status do not establish adherence, the amount of treatment received, or the effectiveness of treatment. Without reported outcome estimates and detailed analysis information, the registry supports characterization of the study but not a complete evaluation of its results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant — NCT02869633.
- Registry record last updated 2023-10-23; status last verified 2023-10.
- Results first posted 2023-01-20.
- 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
NCT02869633 is a completed phase II, single-group study sponsored by Vanderbilt-Ingram Cancer Center. The record lists enrollment of 23 and evaluates ibrutinib after donor stem cell transplant for relapsed or refractory lymphoma. Treatment was scheduled to start between 60 and 90 days after transplant and continue until 1 year after transplant unless progression or unacceptable toxicity occurred.
The primary endpoint is 12-month progression-free survival in Cohort A, the CLL/MCL group, defined to include progression, relapse of the underlying disease, or death from a non-relapse cause. The registry specifies Kaplan-Meier estimation with a 95% confidence interval, but the numerical estimate and interval are not reported in the registry record. Secondary outcomes concern residual disease and immune biomarkers. Serious adverse event counts are listed separately for Cohort A and Cohort B. No randomized comparator is included, and zero analyses are listed.