NCT02703272

A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	Ibrutinib	Participants will receive Ibrutinib (dose 240 mg/m\^2 /329 mg/m\^2 per day) during part 1 and part 2.
DRUG	Rituximab	Participants will receive a cumulative dose of rituximab 750 mg/m\^2 as a part of RICE/RVICI regimen in part 1 and part 2 per cycle.
DRUG	Ifosfamide	Participants will receive a cumulative dose of Ifosfamide 9 g/m\^2 and 10 g/m\^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.
DRUG	Carboplatin	Participants will receive a cumulative dose of carboplatin 635 mg/m\^2 and 800 mg/m\^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.
DRUG	Etoposide	Participants will receive a cumulative dose of etoposide 300 mg/m\^2 in part 1 and part 2 as a part of RICE regimen per cycle.
DRUG	Vincristine	Participants will receive a cumulative dose of vincristine 1.6 mg/m\^2 in part 1 and part 2 as a part of RVICI regimen per cycle.
DRUG	Idarubicin	Participants will receive a cumulative dose of idarubicin 20 mg/m\^2 in part 1 and part 2 as a part of RVICI regimen per cycle.
DRUG	Dexamethasone	Participants will receive a cumulative dose of dexamethasone 100 mg/m\^2 in part 1 and part 2 as a part of RICE/RVICI regimen per cycle.

Timeline

• Start date: 2016-07-01
• Primary completion: 2021-06-11
• Completion: 2021-06-11
• First posted: 2016-03-09
• Last updated: 2022-12-02
• Results posted: 2022-12-02

Locations

76 sites across 20 countries: United States, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Hungary, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom