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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 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 72 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02703272
The ClinicalTrials.gov registry entry for NCT02703272 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT02703272 reports 0 study locations.
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.
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