Comparison · NCT02425904-6b5a4ed7
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine vs LCH-related Disorders + Clofarabine: Number of Participants With at Least One Grade 3 or Higher Treatment-Related Toxicity
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: Number of Participants With at Least One Grade 3 or Higher Treatment-Related Toxicity. Trial comparisons, record NCT02425904-6b5a4ed7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02425904-6b5a4ed7
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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 | 0.75 | 0.531 | 0.888 | wilson | |
| Risk in group 2 | 1 | 0.51 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.25 | -0.469 | 0.259 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.75 | 0.582 | 0.966 | log | |
| 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 participant with the outcome on Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine than on LCH-related Disorders + Clofarabine | 4 | 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 | 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. | 15 | 20 | OG000 |
| 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. | 4 | 4 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With at Least One Grade 3 or Higher Treatment-Related Toxicity
- Description
All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4.0 as reported on case report forms were counted. Number of Participants with at least one Grade 3 or Higher Treatment-Related Toxicity defined as number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
- Time frame
Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. LCH treatment duration is median 5.8 with range 2.1-7 months; LCH-related treatment duration is 5.5 (1.7-5.6).
- Population
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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