Comparison · NCT03805932-107835b2
Moxetumomab - Dose Escalation 30 mcg/kg vs Moxetumomab - Dose Expansion 40 mcg/kg: Number of Participants Whose Cancer Shrinks or Disappears After Treatment
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Moxetumomab - Dose Escalation 30 mcg/kg vs Moxetumomab - Dose Expansion 40 mcg/kg: Number of Participants Whose Cancer Shrinks or Disappears After Treatment. Trial comparisons, record NCT03805932-107835b2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03805932-107835b2
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk in group 2 | 0.733 | 0.48 | 0.891 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0667 | -0.552 | 0.305 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.909 | 0.386 | 2.14 | log | |
| Odds ratio, group 1 over group 2 | 0.727 | 0.0509 | 10.4 | log | |
| Number needed to treat, for one fewer participant with the outcome on Moxetumomab - Dose Escalation 30 mcg/kg than on Moxetumomab - Dose Expansion 40 mcg/kg | 15 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Moxetumomab - Dose Escalation 30 mcg/kg | Participants with Relapsed/Refractory Hairy Cell Leukemia (HCL) or Hairy Cell Leukemia (HCLv)~Arm 1 Moxetumomab Pasudotox-tdfk + Rituximab~Dose escalation treatment with moxetumomab -pasudotox-tdfk and rituximab Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle.~Rituximab will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1. | 2 | 3 | OG000 |
| Group 2 | Moxetumomab - Dose Expansion 40 mcg/kg | Dose expansion; treatment with moxetumomab -pasudotox-tdfk and Ruxience~Arm 1 and Arm 2 Moxetumomab Pasudotox-tdfk + Ruxience~Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle.~Ruxience will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Ruxience is given on day -2, on subsequent cycles, Ruxience is given on day 1 (Delta) | 11 | 15 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Whose Cancer Shrinks or Disappears After Treatment
- Description
Number of participants whose cancer shrinks or disappears after treatment defined as minimal residual disease. MRD is no hairy cell leukemia (HCL) in the blood and bone marrow aspirate flow determined by immunohistochemistry (IHC) and flow cytometry of blood and bone marrow aspirate.
- Time frame
- 28-42 days after day 1 of the last treatment.
- Population
Source ClinicalTrials.gov
Trial
- Title
- Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia
- NCT number
- NCT03805932
- Phases
- PHASE1
- Conditions
- Hairy Cell Leukemia
- Interventions
- Moxetumomab Pasudotox-tdfk, Rituximab, Ruxience, Dexamethasone, Acetaminophen, Diphenhydramine, Famotidine, Aspirin
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-11-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03805932?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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