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Comparison · NCT02703272-1ffa16ae

Part 2: Ibrutinib+CIT (RICE or RVICI) vs Part 2: Chemoimmunotherapy: Part 2: Number of Participants Who Proceeded to Stem Cell Transplantation

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. Part 2: Ibrutinib+CIT (RICE or RVICI) vs Part 2: Chemoimmunotherapy: Part 2: Number of Participants Who Proceeded to Stem Cell Transplantation. Trial comparisons, record NCT02703272-1ffa16ae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02703272-1ffa16ae

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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 10.3710.2320.537wilson
Risk in group 20.4380.2310.668wilson
Risk difference, group 1 minus group 2-0.0661-0.3360.198newcombe hybrid score
Risk ratio, group 1 over group 20.8490.421.72log
Odds ratio, group 1 over group 20.760.2282.53log
Number needed to treat, for one fewer participant with the outcome on Part 2: Ibrutinib+CIT (RICE or RVICI) than on Part 2: Chemoimmunotherapy15.1from 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 1Part 2: Ibrutinib+CIT (RICE or RVICI)
Participants received ibrutinib based on age group and BSA in combination with CIT (investigator choice of RICE or RVICI) until 3 treatment cycles, transplantation if indicated, or until progressive disease (PD) or unacceptable toxicity. For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for central nervous system (CNS) prophylaxis in age-appropriate dosing. Participants of age groups 1-5 years and 6-11 years received ibrutinib 440 mg/m\^2, and age group 12-17 years received Ibrutinib 329 mg/m\^2 (dose selected from Part 1).
1335OG000
Group 2Part 2: Chemoimmunotherapy
Participants received CIT (investigator choice of RICE or RVICI) alone based on age group and BSA until 3 treatment cycles, transplantation if indicated, or until PD or unacceptable toxicity. For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for CNS prophylaxis in age-appropriate dosing. The RICE regimen was composed of rituximab 750 mg/m\^2, ifosfamide 9 g/m2, carboplatin 635 mg/m\^2, etoposide 300 mg/m\^2, and dexamethasone 100 mg/m\^2. The RVICI regimen was composed of rituximab 750 mg/m\^2, vincristine 1.6 mg/m\^2, idarubicin 20 mg/m\^2, carboplatin 800 mg/m\^2, ifosfamide 10 g/m\^2, and dexamethasone 100 mg/m\^2 (all doses represented as cumulative administered in 1 cycle).
716OG001

Outcome

Type
SECONDARY
Title
Part 2: Number of Participants Who Proceeded to Stem Cell Transplantation
Description
Number of participants who proceeded to stem cell transplantation were reported.
Time frame
Up to end of the study (Up to 4 year and 4 months)
Population
The ITT population consisted of all randomized participants; participants were analyzed based on randomization, regardless of study drug received.

Source ClinicalTrials.gov

Trial

Title
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
NCT number
NCT02703272
Phases
PHASE3
Conditions
Lymphoma, Non-Hodgkin
Interventions
Ibrutinib, Rituximab, Ifosfamide, Carboplatin, Etoposide, Vincristine, Idarubicin, Dexamethasone
Lead sponsor
Janssen Research & Development, LLC
Results first posted
2022-12-02

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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