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 Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia (NCT00001575), a na phase 1, phase 2 study. The primary outcome is Maximum Tolerated Dose (MTD) of 90Y-HAT.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00001575 |
| Phase | Phase 1, Phase 2 |
| Condition | Hodgkin's Disease, Lymphoma, Non-Hodgkin |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 87 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned adults with Hodgkin's disease, non-Hodgkin's lymphoma, or lymphoid leukemia whose cancer cells had proteins that react with anti-Tac. The primary endpoint description says that the MTD population was the Phase I portion and that only Hodgkin's participants were analyzed for that endpoint, identified as 28 participants.
Intervention
The intervention was yttrium-90-labeled humanized anti-Tac, also called 90 Y-HAT. The arm description lists 10 mCi for participants whose previous therapy included a bone marrow transplant or 15 mCi otherwise, followed by calcium trisodium injection, also called Ca-DTPA. Ca-DTPA was administered intravenously on Days 1-3 to clear the radioactive agent from the body.
Comparator
There was no concurrent comparison group: the registry classifies the study as single group, with allocation listed as NA. The record therefore does not describe a randomized or like-for-like control comparison.
Primary question
The primary endpoint was the maximum tolerated dose of 90Y-HAT. The registry defines MTD using dose-limiting toxicities in the first cycle of therapy. It does not report a numerical MTD result, so the endpoint definition alone does not establish which dose level met the rule.
The registry summary says the study would examine safety and effectiveness as well as determine the maximum tolerated dose. These are different aims: dose finding focuses on tolerability under a specified rule, while evaluating effectiveness would require outcome results that are not reported in the record. The posted primary endpoint is MTD, not a comparative estimate of treatment effect. Because the design has a single group, its structure does not support a randomized comparison against another treatment or control group.
3. Trial Design
This was a completed, single-group Phase I/Phase II study sponsored by the National Cancer Institute (NCI). The registry lists enrollment of 87, allocation as NA, and masking as none. The study start is recorded as 1997-04 and primary completion as 2013-11. The conditions listed are Hodgkin's Disease and Lymphoma, Non-Hodgkin; the brief summary also names lymphoid leukemia among the cancers considered.
The study intervention was Y-90 Humanized Anti-Tac, a biological intervention. Calcium-DTPA is listed as a drug and is described in the arm information as following the radioactive antibody. The arm description gives 10 mCi for participants with a previous bone marrow transplant or 15 mCi otherwise. It states that Ca-DTPA was given intravenously on Days 1-3 to clear the radioactive agent from the body. The registry also describes possible repeated treatment: participants could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks. The record does not reconcile that treatment wording with the dose alternatives in the arm description.
The primary endpoint was defined for the Phase I portion, and its population description says only Hodgkin's participants were analyzed for that endpoint, identified as 28. That is distinct from the overall enrollment of 87: these figures describe different registry fields and populations. The reason for the endpoint population restriction is not reported in the registry record.
The registry describes the MTD rule, but does not report the dose-level results needed to identify the observed MTD. Details such as the full dose-escalation sequence, the allocation of participants across dose levels, and any changes to the design are not reported in the registry record. No randomized treatment contrast is described.
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: All ph I pts who received an initial bone marrow transplantation received an initial dose of 10mCi followed by 15mCi. At the discretion of the PI on the basis of persistent reduced hematopoietic values, a subsequent dose may have been reduced from 15mCi to 10mCi or 5mCi. All ph II pts received at least one dose of 10mCi and/or 15mCi, or 20mCi.
Overall Study
| Stage | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) |
|---|---|
| STARTED | 87 |
| Treated | 65 |
| COMPLETED | 42 |
| NOT COMPLETED | 45 |
Reasons for not completing this period:
| Reason | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) |
|---|---|
| Screening failures-Ph I portion | 22 |
| Withdrawn/deaths | 23 |
Analysis population for the primary outcome, as defined in the registry: Phase I portion-maximum tolerated dose. Only the Hodgkin's participants was analyzed (i.e., 28).
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 | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) |
|---|---|---|
| Participants analysed | 87 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 70 |
| Age, Categorical: >=65 years | Participants | 17 |
| Age, Continuous | years | 36 (SD 16) |
| Sex: Female, Male: Female | Participants | 34 |
| Sex: Female, Male: Male | Participants | 53 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 81 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 15 |
| Race (NIH/OMB): White | Participants | 66 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 5 |
| Region of Enrollment: United States | participants | 87 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose (MTD) of 90Y-HAT, measured over Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mci |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is maximum tolerated dose (MTD) of 90Y-HAT, with the endpoint unit listed as mci. Rather than being a direct measure of tumor response, MTD is a dose-finding endpoint: it identifies a dose level according to a prespecified tolerability rule. In this record, the rule is based on dose-limiting toxicity (DLT) during the first cycle of therapy.
The registry defines the Phase I MTD as the dose level below a dose at which 2 out of 2-6 patients develop DLT, if any. It further says there can be no more than 1 out of 6 patients with DLT at the MTD. A participant with grade IV toxicity of any type, excluding grade IV neutropenia, or grade III non-hematologic toxicity could not continue at the same dose level and was considered to have had a DLT. The MTD assessment uses only results from the first cycle.
General statistical context: a dose-finding endpoint is useful because it turns early tolerability observations into a rule for selecting a dose level for further study. Its interpretation depends on the toxicity definitions, observation window, and dose-escalation procedure. The record gives toxicity criteria and says the first cycle is used, but a numerical MTD result and dose-level toxicity counts are not reported in the registry record. Consequently, the endpoint definition can be explained, but the selected dose cannot be established from the posted primary outcome information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes the study's objective and endpoint but does not post a numerical primary outcome for MTD. There is no reported dose level identified as the MTD, no dose-specific DLT count, and no estimate of uncertainty around an MTD result. These omissions mean the primary endpoint cannot be interpreted quantitatively from the registry record. A definition of an endpoint is not itself an observed result.
The record lists a total enrollment of 87, while the primary endpoint population description specifies the Phase I portion and only Hodgkin's participants, identified as 28. Those numbers should not be treated as interchangeable. The registry does not explain in the endpoint description how the 28 participants were distributed across dose levels or how many contributed evaluable first-cycle toxicity information. That information is not reported in the registry record.
Safety information is posted separately. The adverse-event entry lists 64 participants at risk for serious adverse events and 8 affected, and 64 at risk for other adverse events and 49 affected. The record also lists selected serious adverse-event terms and their percentages. These figures describe reported safety categories; they do not supply the missing primary MTD result, nor do they establish a causal comparison because there is no control group. The record does not report deaths in the adverse-event entry.
General statistical context: single-group observations can describe outcomes among participants who received an intervention, but without a concurrent control they cannot isolate how much of an observed outcome is attributable to the intervention rather than other influences. In dose finding, the interpretation also relies on the pattern of toxicities across the tested dose levels. A summary count across the study cannot replace those dose-specific data.
No primary-endpoint confidence interval, hypothesis test, or sponsor analysis result is reported in the registry record. The record lists no analyses. This does not establish that no analysis was performed; it means that an analysis result is not available in the posted registry information. Any planning illustration based on an observed effect is a design calculation, not observed power, and cannot fill the gap in the primary endpoint results.
Accordingly, the defensible statistical reading is limited: the registry defines an MTD decision rule and reports some safety counts, but it does not report the numerical outcome needed to say what MTD was reached or how precisely it was estimated. The single-group design also does not support a randomized treatment-effect comparison.
9. Statistical Methods Explained
The registry identifies a single-group Phase I/Phase II study and gives MTD as the primary endpoint. The analysis description is limited: the MTD definition specifies a toxicity rule and says to use only the first cycle, but a detailed statistical analysis plan is not reported in the registry record. The record lists no analyses. The following explanation distinguishes that stated endpoint rule from general statistical concepts.
How the MTD rule works
The stated rule defines a dose level in relation to DLT observed among participants treated at that level. The registry says the MTD is the dose level below a dose at which 2 out of 2-6 patients develop DLT, if any, and that no more than 1 out of 6 patients may have DLT at the MTD. It specifies which toxicities count: grade IV toxicity of any type except grade IV neutropenia, or grade III non-hematologic toxicity. It also says that a participant meeting those criteria could not continue at the same dose and had a DLT. Only first-cycle results are used for the MTD assessment.
General statistical context: this kind of rule uses observed toxicity to guide dose selection. It is not the same as estimating a treatment effect against a control group. How confidently a dose can be characterized depends on the number of participants observed at each dose, the toxicity pattern, the length of follow-up for the defined window, and the escalation algorithm. The posted record does not provide dose-level counts or identify the dose ultimately selected, so no quantitative dose-finding estimate can be reconstructed from the endpoint description alone.
What a confidence interval would convey
General statistical context: a confidence interval expresses uncertainty around an estimate under the assumptions of the method used. For a dose-finding endpoint, an interval or other uncertainty summary could help show how much information supports the selected dose or estimated toxicity probability. The registry record does not report a confidence interval for MTD or a related dose-specific uncertainty measure. No interval should be inferred from the stated rule or from the overall adverse-event counts.
Why the study structure matters
The registry classifies the design as single group, with allocation NA and masking none. There is therefore no concurrent randomized comparator in the record. General statistical context: random allocation is used to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. A single-group study cannot obtain that protection through randomization. It can describe events in the treated group, but a difference attributable to treatment cannot be isolated without an appropriate comparison and suitable analysis.
The phase labels are Phase I and Phase II, but the primary endpoint is explicitly an MTD endpoint for the Phase I portion. The registry does not report separate inferential results for a Phase II effectiveness outcome. A brief summary states that safety and effectiveness were to be examined, but the primary outcome information does not include an effectiveness estimate. The record also does not report a separate response endpoint result in the information describing the primary endpoint.
Interpreting the posted safety counts
The serious adverse-event entry gives an at-risk count of 64 and an affected count of 8. For other adverse events, it gives 64 at risk and 49 affected. These are counts, not comparative risk estimates. General statistical context: a count is easier to interpret when the event definition, observation period, and population at risk are clear. A rate or percentage would require a specified denominator and calculation; no additional summary should be inferred beyond the values explicitly posted. The listed serious-event terms are selected terms with percentages, not a full account of all toxicity patterns by dose.
The adverse-event information does not provide a dose-by-dose breakdown or connect events to the first-cycle DLT rule. Thus, the safety counts cannot be substituted for the MTD analysis. Nor should they be read as evidence of a comparative treatment risk: there is no control group in this design, and no adjusted or unadjusted comparison is reported.
Analysis plan and multiplicity
General statistical context: multiplicity arises when several outcomes, time points, or comparisons are tested, because repeated testing can increase the chance of a false-positive finding if results are interpreted without accounting for that testing. The registry lists 3 outcome measures and one secondary outcome title, but a multiplicity strategy is not reported in the registry record. It is also not reported whether any interim analyses were planned or conducted, or how missing observations were handled. The description of the MTD rule does not answer those questions.
The record does not report a sample-size justification, detailed statistical model, analysis population rules beyond the stated MTD population, or inferential results. General statistical context: a sample-size calculation is a planning exercise based on assumptions, while observed power calculated after a study is not a substitute for an estimate and its uncertainty. Any planning illustration should therefore be read as hypothetical planning information, not as evidence that the study had a particular probability of detecting an effect. Since a numerical primary endpoint result is not reported, the principal statistical conclusion remains that the registry states a decision rule but not its outcome.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures and identifies Number of Participants With Adverse Events as a secondary outcome. It does not report a multiplicity strategy for interpreting multiple outcomes or analyses. It is also not reported in the registry record whether interim analyses were planned or conducted. The MTD description states that the assessment uses first-cycle results; that is an endpoint rule, not a report of interim monitoring.
Missing-data methods are not reported in the registry record. The record does not say how participants without complete first-cycle toxicity information were handled, how incomplete adverse-event follow-up was treated, or whether any outcome data were excluded. The endpoint population description identifies the Phase I portion and says only Hodgkin's participants were analyzed, identified as 28, but does not explain the flow from enrollment to that endpoint population.
Analysis-population details are similarly limited. The registry reports enrollment of 87 and an MTD population description referring to 28 Hodgkin's participants, while safety counts list 64 at risk. The record does not explain the relationship among these populations. They should not be assumed to represent the same participants or analysis set. The reason for any differences is not reported in the registry record.
General statistical context: multiplicity, missingness, and population definitions affect how estimates and tests should be interpreted. Multiple testing can make isolated findings less reliable without an appropriate plan; missing outcome data can affect estimates if the pattern of missingness relates to participant characteristics or outcomes; and different analysis populations can answer different questions. In the absence of registry entries, no particular method or assumption can be attributed to this study.
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 |
|---|---|---|---|
| Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 8 | 64 | 12.5% |
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 |
|---|---|
| Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 49 of 64 |
Most frequent serious adverse event terms
| Event term | Organ system | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) |
|---|---|---|
| Secondary Malignancy-Other (Specify,____) excludes metastasis from initial primary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 of 64 |
| BLOOD/BONE MARROW:: Bone marrow cellularity | Blood and lymphatic system disorders | 1 of 64 |
| CARDIOVASCULAR (GENERAL):: Hypotension | Cardiac disorders | 1 of 64 |
| HEPATIC:: Liver dysfunction/failure (clinical) | Hepatobiliary disorders | 1 of 64 |
| Multi-organ failure | General disorders | 1 of 64 |
| PULMONARY:: Pulmonary-Other (Specify, respiratory failure) | Respiratory, thoracic and mediastinal disorders | 1 of 64 |
| PAIN:: Abdominal pain or cramping | Gastrointestinal disorders | 1 of 64 |
| PAIN:: Pain-Other (Specify, tooth pain) | General disorders | 1 of 64 |
| PULMONARY:: Hypoxia | Respiratory, thoracic and mediastinal disorders | 1 of 64 |
| PULMONARY:: Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | 1 of 64 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) |
|---|---|---|
| BLOOD/BONE MARROW:: Lymphopenia | Blood and lymphatic system disorders | 37 of 64 |
| BLOOD/BONE MARROW:: Platelets | Blood and lymphatic system disorders | 37 of 64 |
| METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, low zinc) | Metabolism and nutrition disorders | 34 of 64 |
| BLOOD/BONE MARROW:: Hemoglobin | Blood and lymphatic system disorders | 33 of 64 |
| BLOOD/BONE MARROW:: Leukocytes (total WBC) | Blood and lymphatic system disorders | 32 of 64 |
| HEPATIC:: Hypoalbuminemia | Hepatobiliary disorders | 31 of 64 |
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | General disorders | 18 of 64 |
| METABOLIC/LABORATORY:: Hypomagnesemia | Metabolism and nutrition disorders | 18 of 64 |
| HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | 16 of 64 |
| HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | 16 of 64 |
Serious events with the highest arm-level rate: secondary malignancy-other (specify,____) excludes metastasis from initial primary (4.7%), blood/bone marrow:: bone marrow cellularity (1.6%), cardiovascular (general):: hypotension (1.6%), hepatic:: liver dysfunction/failure (clinical) (1.6%), multi-organ failure (1.6%).
The registry reports 8 participants affected by serious adverse events among 64 at risk. It reports 49 participants affected by other adverse events among 64 at risk. These are separate categories in the record and should be read as posted, not combined. The adverse-event entry does not report deaths.
The selected serious adverse-event terms include Secondary Malignancy-Other (Specify,____) excludes metastasis from initial primary at 4.7%; BLOOD/BONE MARROW:: Bone marrow cellularity at 1.6%; CARDIOVASCULAR (GENERAL):: Hypotension at 1.6%; HEPATIC:: Liver dysfunction/failure (clinical) at 1.6%; Multi-organ failure at 1.6%; and PULMONARY:: Pulmonary-Other (Specify, respiratory failure) at 1.6%. These are terms and percentages listed in the registry, not a complete dose-specific toxicity analysis. The record does not explain the denominator used for each listed percentage.
General statistical context: adverse-event counts describe how many participants were recorded in a category, while percentages describe proportions under a particular denominator. Neither alone establishes that the intervention caused an event. A control group and clear event definitions and observation windows are important for comparative interpretation. Here, the study is single group and the posted serious-event counts are not broken down by dose or linked to the first-cycle DLT rule. They therefore should not be treated as the MTD result or as a comparative risk estimate.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a single-group Phase I/Phase II study of 90Y-HAT, with an MTD endpoint for the Phase I portion. It describes a rule based on first-cycle dose-limiting toxicities and gives the toxicity criteria used by that rule. It also reports selected safety counts and serious adverse-event terms. These details provide information about the study's aims, design, endpoint definition, and reported safety categories.
They do not establish the numerical MTD. No dose level selected under the rule, dose-specific DLT counts, or uncertainty estimate is reported in the registry record. The record's stated intention to examine effectiveness does not substitute for an effectiveness outcome. A numerical estimate of tumor response or comparative benefit is not reported in the primary endpoint information.
The single-group structure means the posted safety observations are descriptive rather than a randomized comparison. Without a control group, the registry data cannot isolate whether an event pattern differs from what would have occurred under another treatment or no study intervention. Nor can a single-group record establish a causal treatment effect from a count alone.
General statistical context: an endpoint definition describes what investigators intend to measure and how a decision may be made; an endpoint result reports what was observed. These are not interchangeable. Likewise, safety monitoring counts, a dose-selection outcome, and effectiveness estimates answer distinct questions. The registry includes a definition for MTD and some safety information, but it does not provide enough primary outcome detail to determine the dose selected or the precision of that determination.
The responsible interpretation is therefore bounded. The record documents an intended dose-finding study and reports certain adverse-event summaries. It does not provide a quantitative primary endpoint result or a randomized comparison. No conclusion about comparative effectiveness, comparative safety, or the selected MTD can be drawn from the posted primary outcome information alone.
13. Why This Trial Matters Statistically
This trial is statistically notable for the distinction between an endpoint rule and an endpoint result. The record defines MTD using dose-limiting toxicities observed in the first cycle and provides thresholds and toxicity criteria. Yet the numerical dose level selected under that rule is not reported in the registry record. Statistical interpretation depends on both parts: a clear rule supports understanding what investigators intended to decide, while the outcome data are needed to know what decision followed.
The study also illustrates why populations and denominators need explicit descriptions. Overall enrollment is 87, the MTD population description refers to 28 Hodgkin's participants, and the safety entry lists 64 at risk. Those figures belong to different record fields, and their relationship is not explained. A reader cannot assume that they refer to identical analysis populations or infer why they differ.
The single-group design is another important feature. It can describe outcomes among participants in the study, but it does not create a randomized control contrast. The serious and other adverse-event counts are therefore descriptive, and the registry does not provide dose-specific safety results that would connect directly to the MTD rule.
General statistical context: early dose-finding studies and comparative trials serve different statistical purposes. Dose finding organizes toxicity observations around a dose-selection decision, while comparative trials estimate differences between groups. The record's Phase I/Phase II labels do not remove that distinction. Here, the primary endpoint is dose finding, and comparative effectiveness results are not reported in the registry record. Recognizing these boundaries prevents an endpoint definition or a safety count from being mistaken for a treatment-effect estimate.
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 main limitation for statistical interpretation is that the registry defines the MTD endpoint but does not report its numerical result. Dose-level enrollment and DLT counts, the selected dose, and an uncertainty measure are not reported in the registry record. Without those details, the dose-finding outcome cannot be evaluated quantitatively.
The record describes the MTD population as the Phase I portion and says only Hodgkin's participants were analyzed, identified as 28. It separately reports overall enrollment of 87 and safety counts based on 64 at risk. The relationship among these populations is not reported. The reason that the endpoint population is restricted to Hodgkin's participants is not reported in the registry record.
The design is single group, with allocation listed as NA and masking as none. There is no concurrent control comparison in the record. Consequently, the posted safety counts cannot support a randomized comparative safety estimate, and an effect relative to another treatment is not reported. Although the registry summary says safety and effectiveness would be examined, an effectiveness estimate is not reported in the primary endpoint information.
Other methodological details are not reported in the registry record, including a sample-size justification, a detailed statistical analysis plan, interim-analysis plans, handling of missing data, multiplicity procedures, and the relationship between adverse-event summaries and the first-cycle DLT assessment. The treatment description also includes dose wording that is not reconciled within the registry information. These limitations restrict conclusions to the stated design, endpoint definition, and posted safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia — NCT00001575.
- Registry record last updated 2015-12-07; status last verified 2015-10.
- Results first posted 2015-12-07.
- 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
NCT00001575 is a completed Phase I/Phase II, single-group study sponsored by the National Cancer Institute (NCI). The registry lists enrollment of 87, no masking, and no allocation. The record gives a start of 1997-04 and primary completion of 2013-11. The conditions include Hodgkin's Disease and Lymphoma, Non-Hodgkin, and the study summary also mentions lymphoid leukemia.
The intervention was Y-90 Humanized Anti-Tac, followed by calcium-DTPA as described in the treatment information. The primary endpoint was MTD of 90Y-HAT, defined using first-cycle dose-limiting toxicity. The MTD population description refers to the Phase I portion and only Hodgkin's participants, identified as 28.
The adverse-event entry reports 8 participants with serious adverse events among 64 at risk and 49 with other adverse events among 64 at risk. A numerical MTD result, a comparative treatment analysis, and a detailed statistical analysis plan are not reported in the registry record.