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NCT02703272 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
A Phase 3 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
NCT02703272: Clinical Trial Phase 3 study, sponsored by Janssen Research & Development.
NCT02703272 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 72 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02703272, a Phase 3 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
Study Summary
The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival \[EFS\]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).
Primary Outcome
AUC is defined as area under the plasma concentration-time curve. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 milligrams per meter square \[mg/m\^2\], 329 mg/m\^2 and 440 mg/m\^2) and age group (1-5, 6-11, 12-17 and \>18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age.
Interventions
- DRUG Carboplatin
- DRUG Rituximab
- DRUG Etoposide
- DRUG Ifosfamide
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2016-07-01 |
| Est. Completion | 2021-06-11 |
| Phase | Phase 3 |
Why NCT02703272 stopped before completion
NCT02703272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT02703272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02703272 about?
NCT02703272 is a clinical study titled "A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma". The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival \[EFS\]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituxi...
What is the current status of trial NCT02703272?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2016-07-01. Estimated completion is 2021-06-11.
What interventions are being tested in trial NCT02703272?
The interventions under investigation include: Carboplatin (DRUG), Rituximab (DRUG), Etoposide (DRUG), Ifosfamide (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02703272?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02703272's enrollment target sits among peer trials
72 1780th of 2000 higher than 217 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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