Comparison · NCT00924170-6ce3a804
Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC vs All Other Patients: Number of Participants With Dose Limiting Toxicity (DLT)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC vs All Other Patients: Number of Participants With Dose Limiting Toxicity (DLT). Trial comparisons, record NCT00924170-6ce3a804. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00924170-6ce3a804
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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 | 0.278 | wilson | |
| Risk in group 2 | 0 | 0 | 0.324 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.324 | 0.278 | 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 | from the risk difference interval | the two groups' risks are equal |
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 | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | Leukemic patients receiving LMB-2 and at least 25+250 mg/m\^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14. | 0 | 10 | OG000 |
| Group 2 | All Other Patients | Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m\^2 of fludarabine cyclophosphamide (FC). | 0 | 8 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Dose Limiting Toxicity (DLT)
- Description
DLT is a grade II-IV LMB-2 or fludarabine and cyclophosphamide (FC)-related toxicity, except vascular leak syndrome, alopecia, grade II-III allergic reaction with asymptomatic bronchospasm or urticarial is considered DLT. Grade III aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and fever are not considered DLT. Grade IV creatine phosphokinase associated with any other DLT or not resolving to \<grade II within 2 weeks is considered DLT. Hematologic toxicity is not considered DLT unless it fails to resolve to \<grade 2 or baseline by day 18 after cycle 1 or after day 25 after cycles 2-7. DLT from hepatotoxicity, creatine phosphokinase, and vascular leak syndrome is assumed from LMB-2, and hematologic toxicity from fludarabine and cyclophosphamide. Grade III proteinuria lasting \<2 weeks after the last dose of LMB-2 is not considered DLT, and needs to resolve to grade 0-2 prior to retreatment.
- Time frame
- 30 days after last dose of LMB2
- Population
Source ClinicalTrials.gov
Trial
- Title
- Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia
- NCT number
- NCT00924170
- Phases
- PHASE1, PHASE2
- Conditions
- Adult T-Cell Leukemia (ATL)
- Interventions
- LMB-2, Fludarabine, Cyclophosphamide
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2017-09-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00924170?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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