Comparison · NCT02481297-ebc31117
Cohort 1: Refractory/Relapsed After Prior Therapy vs Cohort 2: Untreated With High-rRisk mMolecular Features: Participants With a Response
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. Cohort 1: Refractory/Relapsed After Prior Therapy vs Cohort 2: Untreated With High-rRisk mMolecular Features: Participants With a Response. Trial comparisons, record NCT02481297-ebc31117. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02481297-ebc31117
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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 | 0.793 | wilson | |
| Risk in group 2 | 0.5 | 0.188 | 0.812 | wilson | |
| Risk difference, group 1 minus group 2 | -0.5 | -0.812 | 0.353 | 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 participant with the outcome on Cohort 1: Refractory/Relapsed After Prior Therapy than on Cohort 2: Untreated With High-rRisk mMolecular Features | 2 | 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 | Cohort 1: Refractory/Relapsed After Prior Therapy | Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12. | 0 | 1 | OG000 |
| Group 2 | Cohort 2: Untreated With High-rRisk mMolecular Features | Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12. | 3 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Participants With a Response
- Description
Response is defined as complete remission (CR), complete remission with incomplete marrow recovery (CRi) or partial remission (PR) that occurs during the first 6 months of therapy. CR requires the absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts. CRi is Complete remission with incomplete bone marrow recovery. PR, defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts
- Time frame
- 6 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients
- NCT number
- NCT02481297
- Phases
- PHASE2
- Conditions
- Leukemia, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia
- Interventions
- Lirilumab, Rituximab
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2020-05-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02481297?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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