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Comparison · NCT04624633-deaths

Cohort 1 - Relapsed Disease vs Cohort 2 - Treatment Naive: 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

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ConductScience Library. Cohort 1 - Relapsed Disease vs Cohort 2 - Treatment Naive: deaths from any cause. Trial comparisons, record NCT04624633-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04624633-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1250.02240.471wilson
Risk in group 2000.155wilson
Risk difference, group 1 minus group 20.125-0.06060.471newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harm, for one more death from any cause on Cohort 1 - Relapsed Disease than on Cohort 2 - Treatment Naive8from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Cohort 1 - Relapsed Disease
Participants with relapsed disease~* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,~* Ublituximab beginning C7D1~* Assessment of treatment response~* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
18EG000
Group 2Cohort 2 - Treatment Naive
Participants with previously untreated disease~* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,~* Ublituximab beginning C7D1~* Assessment of treatment response~* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
021EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.

Source ClinicalTrials.gov

Trial

Title
Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL
NCT number
NCT04624633
Phases
PHASE2
Conditions
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
Interventions
Acalabrutinib, Umbralisib, Ublituximab
Lead sponsor
Jennifer R. Brown, MD, PhD
Results first posted
2025-02-27

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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