Comparison · NCT02425904-deaths
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine vs LCH-related Disorders + Clofarabine: deaths from any cause
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. Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine vs LCH-related Disorders + Clofarabine: deaths from any cause. Trial comparisons, record NCT02425904-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02425904-deaths
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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 | 0 | 0.161 | wilson | |
| Risk in group 2 | 0.75 | 0.301 | 0.954 | wilson | |
| Risk difference, group 1 minus group 2 | -0.75 | -0.954 | -0.273 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer death from any cause on Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine than on LCH-related Disorders + Clofarabine | 1.33 | 1.05 | 3.67 | from the risk difference interval |
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 | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.~Clofarabine: second-generation purine nucleoside analog | 0 | 20 | EG000 |
| Group 2 | LCH-related Disorders + Clofarabine | Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.~Clofarabine: second-generation purine nucleoside analog | 3 | 4 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Source ClinicalTrials.gov
Trial
- Title
- Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders
- NCT number
- NCT02425904
- Phases
- PHASE2
- Conditions
- Langerhans Cell Histiocytosis
- Interventions
- Clofarabine
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2022-02-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02425904?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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