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 Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment (NCT04541017), a randomized phase 1, phase 2 study. The primary outcome is Recommended Phase 2 Dose (RP2D) of Magrolimab When Given in Combination With Mogamulizumab (Phase Ib).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04541017 |
| Phase | Phase 1, Phase 2 |
| Condition | Mycosis Fungoides, Recurrent Mycosis Fungoides, Recurrent Mycosis Fungoides and Sezary Syndrome |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
People with previously treated, relapsed or refractory mycosis fungoides or Sezary syndrome, types of T-cell lymphoma. The eligibility description includes stage IB-IV disease.
Intervention
Magrolimab in combination with mogamulizumab. The combination arm received magrolimab and mogamulizumab by intravenous infusion on schedules that varied across treatment cycles.
Comparator
Mogamulizumab alone was the planned Phase II comparator. The posted results list no participants in that arm, so they do not support a comparative estimate.
Primary question
The Phase Ib primary question was what recommended Phase 2 dose of magrolimab to use with mogamulizumab. The primary endpoint was a dose value, not a direct comparison of tumor response or survival between arms.
The registry describes a phase 1b/2 study in people whose T-cell lymphoma had returned after treatment or had not responded to treatment. Its stated clinical aim included identifying a dose and assessing possible benefits and side effects of the combination. The Phase Ib primary endpoint focused specifically on the recommended Phase 2 dose of magrolimab with mogamulizumab.
The design also included a Phase II arm receiving mogamulizumab alone, and the listed secondary outcomes include response, progression-free survival, duration of response, and time to next treatment. Those outcomes could address questions about disease control and the duration of observed outcomes if results were available. The registry record does not report numerical results for those secondary outcomes, and it lists no participants in the mogamulizumab-only arm. Therefore, the posted results do not answer whether the combination differs from mogamulizumab alone on those outcomes.
3. Trial Design
The registry classifies this as a randomized, unmasked, crossover phase 1b/2 study. It lists an enrollment of 8 and a terminated status. The Phase Ib portion was planned to enroll 6-18 patients, but the record states that the study was closed following a full clinical hold issued by the FDA for magrolimab and the sponsor’s decision to discontinue further development of the drug.
The combination arm received magrolimab weekly during cycles 1-2 and every other week during cycles 3-12. Mogamulizumab was given weekly during cycle 1 and every other week during cycles 2-12. Treatment cycles were 28 days, for up to 12 cycles, subject to disease progression or unacceptable toxicity. The mogamulizumab-only arm had the same listed mogamulizumab schedule. The arm results list 6 participants in the combination arm and 0 in the mogamulizumab-only arm. The registry record does not explain the relationship between the overall enrollment and the arm counts.
Although the design is labeled randomized and crossover, details about the randomization procedure, crossover sequence, timing, and rules for moving between treatments are not reported in the registry record. The description for the combination arm mentions treatment in Phase Ib and Phase II; the mogamulizumab-only arm is described for Phase II. It is not possible to determine from the posted results how the planned comparative design operated in practice. The primary endpoint was a dose recommendation in Phase Ib, while response and time-to-event outcomes were listed as secondary outcomes.
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: Eight patients were enrolled in the Phase Ib portion of the study. However, due to early study termination, two patients did not initiate treatment. As a result, six patients were included in the final analysis.
Overall Study
| Stage | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | Arm II (Mogamulizumab), Phase II |
|---|---|---|
| STARTED | 6 | 0 |
| COMPLETED | 6 | 0 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug.
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.
Population: The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug.
| Characteristic | Unit | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | Arm II (Mogamulizumab), Phase II | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 0 | 6 | |
| Age, Continuous | years | 50 (28 to 68) | — | 50 (28 to 68) |
| Sex: Female, Male: Female | Participants | 4 | — | 4 |
| Sex: Female, Male: Male | Participants | 2 | — | 2 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | — | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 | — | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | — | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | — | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | — | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | — | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | — | 1 |
| Race (NIH/OMB): White | Participants | 3 | — | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 | — | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | — | 1 |
| Region of Enrollment: United States | participants | 6 | — | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Recommended Phase 2 Dose (RP2D) of Magrolimab When Given in Combination With Mogamulizumab (Phase Ib), measured over Up to 4 weeks from the first infusion of magrolimab (priming infusion).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg/kg |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the recommended Phase 2 dose of magrolimab when given with mogamulizumab, measured in mg/kg. The registry defines its timeframe as up to 4 weeks from the first magrolimab infusion, described as the priming infusion. The posted result is 30 mg/kg, with 6 participants listed for the combination arm.
A recommended Phase 2 dose is used to select a dose for further study. In general, dose-finding work seeks a dose that can be carried forward while considering both the intended treatment exposure and tolerability. The registry says this Phase Ib portion was designed to determine the dose, but its detailed selection criteria and the statistical procedure used to reach the recommendation are not reported in the registry record. The posted result therefore identifies the reported dose recommendation, but does not show the underlying dose-level observations, uncertainty around the choice, or the criteria applied.
This endpoint is not a measure of how long participants lived, how often tumors responded, or whether the combination outperformed mogamulizumab alone. Those clinical outcomes were listed separately among the secondary outcomes. Their numerical results are not reported in the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary result is a recommended magrolimab dose of 30 mg/kg in combination with mogamulizumab. The result is reported for the combination arm, which lists 6 participants. No confidence interval, range, or other measure of uncertainty is reported for the dose recommendation. The record also does not describe the dose-level findings or decision rules that led to it, so the strength and precision of the dose-selection evidence cannot be assessed from the registry record alone.
The trial was intended to include a Phase II comparison with mogamulizumab alone, but the arm results list 0 participants in that group. The registry’s analysis information states that values are missing or not estimable for a two-arm comparison for this count-other endpoint. There are no posted analyses. Thus, the posted results do not give a comparative estimate for response, progression-free survival, duration of response, time to next treatment, or any other outcome between the arms.
Six secondary outcomes are listed: overall response rate in Phase Ib, overall response rate at 4 months and at 12 months in Phase II, progression-free survival, duration of response, and time to next treatment. Listing an outcome does not mean that a result was reported. The registry record does not provide numerical findings for these outcomes, their uncertainty, or the populations included in their analyses.
The record gives important context for the trial’s status: it was terminated after a full clinical hold for magrolimab and the sponsor’s decision to discontinue further development of the drug. This context explains the recorded closure, but it does not establish what the efficacy or safety results would have been under a completed comparative study.
In general, a point estimate is most informative when accompanied by a description of its uncertainty and the data and analysis that produced it. Here, the dose recommendation is posted, but the detailed evidence behind that decision is not. The results support describing what the registry reports; they do not support a conclusion about comparative treatment effects.
9. Statistical Methods Explained
What does a dose recommendation represent?
General statistical context: Early-phase dose-finding studies evaluate dose levels to inform which dose should be carried into later research. The endpoint in this trial was the recommended Phase 2 dose of magrolimab with mogamulizumab. The registry reports 30 mg/kg but does not report the dose-escalation or dose-selection method, the observations at each dose, or a measure of uncertainty. It is therefore possible to describe the recorded recommendation, but not to reconstruct how the decision was reached.
What does randomization contribute?
General statistical context: Randomization assigns participants to treatment groups using a chance-based process. When implemented as planned, it can reduce systematic differences between groups at the start of a study. The registry labels this study randomized, but does not report the sequence-generation method, allocation concealment, or other operational details. More importantly for interpretation of the posted results, the mogamulizumab-only arm lists 0 participants. The record therefore does not provide a populated comparator group for estimating a treatment contrast.
What does the unmasked label mean?
General statistical context: In an unmasked study, treatment assignment is not concealed from participants or study personnel in the way it would be in a masked design. Knowledge of treatment can affect care, reporting, or assessment, depending on the outcome and safeguards used. The registry identifies the study as having no masking, but does not report outcome-assessment procedures or safeguards against assessment bias. No claim about the effect of masking on this trial’s results can be made from the record.
How should the crossover label be understood?
General statistical context: A crossover design can involve participants receiving different treatments in sequence, allowing comparisons that account for stable differences between participants. Such designs also require attention to treatment period, sequence, and possible carryover effects. Although the registry labels the model crossover, it does not report the planned sequence, transition rules, timing, or how period and carryover effects would be handled. The arm descriptions and posted participant counts are not enough to reconstruct the actual crossover experience or its analysis.
What do the listed outcome types imply?
General statistical context: Response rates describe the proportion of participants meeting a response definition. Time-to-event outcomes, such as progression-free survival and time to next treatment, describe the timing of an event while accounting for follow-up and censoring. Duration of response concerns the time responses persist. These outcomes need clear definitions, assessment schedules, and analysis populations to be interpreted. The registry lists these secondary outcomes, but their numerical results and detailed analysis methods are not reported in the posted results.
How do estimates and confidence intervals help?
General statistical context: An estimate gives a summary of the observed data, while a confidence interval conveys how uncertain that estimate is under the specified statistical model. For a treatment comparison, the estimate and interval help readers assess both the direction and precision of the contrast. The posted dose result has no reported confidence interval, and no comparative treatment estimate is reported. A p-value would address a particular statistical test, but it cannot replace an estimate and its uncertainty. No p-values or analysis results are posted for the listed secondary outcomes.
What can a planning calculation tell readers?
General statistical context: A sample-size calculation is a planning illustration based on assumptions; it is not evidence that a study had a particular probability of detecting an effect after the results are known. The record describes planning illustrations based on a fraction of an observed effect, with equal allocation and a normal approximation for non-time-to-event outcomes, and a total-event approach for time-to-event outcomes. The calculations are not the trial’s own design justification. The record does not report a sample-size justification for the trial, and no posted two-arm effect estimate is available to interpret as a comparative result. Planning assumptions should therefore not be mistaken for observed findings.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six secondary outcomes alongside the primary dose endpoint. When a study assesses several outcomes or time points, the chance of at least one apparently notable result can increase if each is tested separately without accounting for multiplicity. General statistical context: Multiplicity procedures can help control that risk, but the appropriate approach depends on the study questions and analysis plan. The registry record does not report whether any multiplicity adjustment was planned or used, nor does it report a statistical analysis plan for these outcomes.
The posted results list no analyses, and numerical results for the secondary outcomes are not reported. This means readers cannot assess whether outcome definitions, analysis choices, or multiplicity handling affected any estimates.
Missing-data methods and analysis populations are also not reported in the registry record. The record does not describe how participants who stopped treatment, lacked outcome assessments, or were otherwise unavailable for analysis would be handled. It does not identify an intention-to-treat, per-protocol, safety, or other analysis population for the efficacy outcomes. These are distinct choices that can affect interpretation, particularly in a small, terminated study.
The arm listing reports 6 participants in the combination group and 0 in the mogamulizumab-only group, while the overall enrollment field lists 8. The registry record does not explain this difference. The posted data also state that values are missing or not estimable for a two-arm comparison. Consequently, the results do not support an inferential comparison between the planned groups, and no missing-data or population assumptions should be filled in by inference.
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 |
|---|---|---|---|
| Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 3 | 6 | 50.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 0 of 6 |
| Arm II (Mogamulizumab), Phase II | 0 of 0 |
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 |
|---|---|
| Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 6 of 6 |
| Arm II (Mogamulizumab), Phase II | 0 of 0 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | Arm II (Mogamulizumab), Phase II |
|---|---|---|---|
| Fever | General disorders | 1 of 6 | 0 of 0 |
| Skin infection | Infections and infestations | 1 of 6 | 0 of 0 |
| Upper respiratory infection | Infections and infestations | 1 of 6 | 0 of 0 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | Arm II (Mogamulizumab), Phase II |
|---|---|---|---|
| Urinary tract infection | Infections and infestations | 3 of 6 | 0 of 0 |
| Lymphocyte count decreased | Investigations | 3 of 6 | 0 of 0 |
| Headache | Nervous system disorders | 3 of 6 | 0 of 0 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 3 of 6 | 0 of 0 |
| Anemia | Blood and lymphatic system disorders | 2 of 6 | 0 of 0 |
| Mucositis oral | Gastrointestinal disorders | 2 of 6 | 0 of 0 |
| Nausea | Gastrointestinal disorders | 2 of 6 | 0 of 0 |
| Fatigue | General disorders | 2 of 6 | 0 of 0 |
| Pain | General disorders | 2 of 6 | 0 of 0 |
| Upper respiratory infection | Infections and infestations | 2 of 6 | 0 of 0 |
Serious events with the highest arm-level rate: fever (16.7%), skin infection (16.7%), upper respiratory infection (16.7%).
The safety results list 6 participants at risk in the combination arm. Serious adverse events affected 3 participants in that group, and other adverse events affected 6. The listed number of deaths is 0. In the mogamulizumab-only arm, the record lists 0 participants at risk and no events; that arm therefore does not provide an informative safety comparison.
The serious adverse event terms listed most often are fever, skin infection, and upper respiratory infection, each reported as 16.7%. These are registry-listed terms; the record does not provide further detail about event severity, timing, recurrence, or possible overlap among terms. The percentages should not be treated as evidence of a causal relationship to treatment based on this information alone.
General statistical context: Safety counts describe events observed and recorded in the study population. They do not by themselves establish whether treatment caused an event, and small groups can provide limited precision for uncommon events. The registry record does not report comparative safety analyses or uncertainty intervals. These figures should therefore be read as descriptive results for the listed group, not as a reliable comparison between treatments.
12. What the Result Does, and Does Not, Mean
The primary result establishes what dose the registry records as the recommended Phase 2 dose: 30 mg/kg of magrolimab with mogamulizumab. It does not show how consistently that dose was tolerated across dose levels, because the registry does not report the underlying dose-finding data or decision criteria. Nor does it provide a precision estimate for the recommendation.
The trial also listed clinical outcomes that could describe response and time to disease-related events. Their presence in the outcome list is not equivalent to a reported finding. The record has no numerical results for those outcomes and no analyses. Since the mogamulizumab-only arm lists 0 participants, the posted results cannot establish a comparative effect of adding magrolimab.
General statistical context: A treatment comparison requires data from the groups being compared and an analysis that accounts for the study design and outcome. If those elements are not available, a difference in treatment effect cannot be estimated from the posted results. A dose recommendation and a comparative efficacy conclusion answer different questions; the former does not answer the latter.
The terminated status and the recorded reason for closure are relevant context, but they do not turn the missing comparative results into evidence for or against either treatment. The posted safety counts are descriptive and do not establish causation. Overall, the registry record documents a dose recommendation and limited safety counts in the combination arm, while leaving the planned comparative outcomes unreported or not estimable.
13. Why This Trial Matters Statistically
This trial illustrates why a study’s planned question and its posted results must be distinguished. The Phase Ib primary endpoint concerned dose selection, while the Phase II component included a mogamulizumab-only comparator and several clinical outcomes. The posted result addresses the dose recommendation, but the comparator arm has no listed participants and the registry reports no analyses. The study label alone does not guarantee that a comparative estimate can be produced.
It also shows how trial status affects the evidence available for interpretation. The registry reports that the study was terminated following a full clinical hold for magrolimab and the sponsor’s decision to discontinue further development. That context is important for understanding why the planned study did not yield posted comparative results, while remaining separate from conclusions about treatment effects.
General statistical context: Transparent reporting of participant flow, endpoint definitions, analysis populations, statistical methods, and uncertainty allows readers to distinguish a numerical result from a fully interpretable estimate. When these details are absent, conclusions should remain close to what the record actually reports. Here, the dose recommendation is documented, but the clinical outcomes that might have supported a comparative assessment are not numerically available.
The record is therefore useful as an example of the limits of registry results: a study can have a stated randomized design and planned comparator yet still lack an estimable comparison in its posted results. Careful separation of design, observed data, and interpretation prevents a dose-finding result from being mistaken for evidence about comparative efficacy.
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 principal limitation is that the planned mogamulizumab-only arm lists 0 participants, and the registry states that a two-arm comparison is not estimable. Although the study is labeled randomized and crossover, the record does not provide enough information to determine how those design features were implemented or whether crossover comparisons were possible in practice.
The primary endpoint is reported as a dose value, but the dose-selection method, dose-level observations, and uncertainty around the recommendation are not reported in the registry record. The six listed secondary outcomes have no numerical results or analyses. The record does not provide detailed endpoint definitions, assessment procedures, analysis populations, missing-data methods, or multiplicity procedures.
The registry lists overall enrollment as 8, while the arm results list 6 participants in the combination arm and 0 in the mogamulizumab-only arm. The record does not explain the relationship between these figures. This limits interpretation of the participant accounting and prevents assumptions about which participants contributed to particular outcomes.
Safety information is descriptive and limited to the posted group counts and adverse event terms. There is no populated comparator group for a safety contrast, and the record does not provide additional detail about the events. Finally, the terminated status and stated reason for closure mean that the posted results do not include the comparative outcomes envisioned for Phase II. These limitations constrain what can be concluded from the registry record, without indicating what unreported results might have been.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment — NCT04541017.
- Registry record last updated 2025-10-16; status last verified 2025-09.
- Results first posted 2025-10-16.
- 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 National Cancer Institute sponsored this phase 1b/2 trial of magrolimab plus mogamulizumab in relapsed or refractory T-cell lymphoma, including mycosis fungoides and Sezary syndrome. The registry lists a randomized, unmasked, crossover design and an enrollment of 8. The trial began on 2021-04-06, had a primary completion date of 2024-10-24, and is recorded as terminated.
The primary endpoint was the recommended Phase 2 dose of magrolimab with mogamulizumab. The posted result is 30 mg/kg, with 6 participants listed in the combination arm. The mogamulizumab-only arm lists 0 participants, and the registry reports no analyses or estimable two-arm comparison. Six secondary outcomes are listed without numerical results. The record states that the study closed following a full clinical hold for magrolimab and the sponsor’s decision to discontinue further development.