Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02703272
Status:
TERMINATED
Last Update Posted:
2022-12-02
First Post:
2016-03-03
Brief Title:
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Randomized Open-label Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IDMC recommended that enrolment be stoped as the EFS hazard ratio and associated p-value crossed the futility boundary specified in protocol July 2020
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This is a Phase 3 randomized study medication assigned to participants by chance open-label identity of study drug will be known to participant and study staff controlled study which consists of two parts Part 1 and Part 2 The Part 1 is a pharmacokinetic run-in part which will be conducted before starting the randomized part Part 2 of the study and Part 2 is a randomized and open-label study Part 1 and Part 2 of the study will be conducted in 3 phases a Pretreatment Screening Phase Up to 14 days before administration of study drug a Treatment Phase and a Posttreatment Phase The Treatment Phase will extend from enrollment in Part 1 or randomization in Part 2 until 1 of the following 1 completion of 3 cycles of therapy 2 transplantation if clinically indicated or 3 progressive disease PD whichever comes first The Posttreatment Phase will continue until death loss to follow up consent withdrawal or study end whichever occurs first The end of study is defined as when approximately 60 event-free survival EFS events have occurred in Part 2 death disease progression or lack of complete response CR or partial response PR after 3 cycles of treatment based on blinded independent event review or the sponsor terminates the study whichever comes first Participants in Part 1 will be 1 to less than 18 years old Participants in Part 2 will be 1 to 30 years old Participants will be primarily evaluated for pharmacokinetics in part 1 and efficacy EFS of ibrutinib in combination with RICE or RVICI background therapy compared to RICE or RVICI background therapy alone in part 2 Participants safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 54179060LYM3003 | OTHER | None | None |
| 2016-000259-28 | EUDRACT_NUMBER | Janssen Research Development LLC | None |