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

PHASE3TerminatedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 1, 2016

Primary Completion Date

June 11, 2021

Study Completion Date

June 11, 2021

Conditions
Lymphoma, Non-Hodgkin
Interventions
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.

Trial Locations (76)

Unknown

Los Angeles

Orange

Palo Alto

Aurora

Washington D.C.

Atlanta

Baltimore

Boston

New York

Valhalla

Charlotte

Cincinnati

Columbus

Philadelphia

Dallas

Salt Lake City

Milwaukee

Brussels

Leuven

Barretos

Curitiba

São Paulo

Plovdiv

Sofia

Halifax

Toronto

Brno

Prague

Bordeaux

Lille

Lyon

Marseille

Nantes

Toulouse

Vandœuvre-lès-Nancy

Villejuif

Berlin

Freiburg im Breisgau

Kiel

München

Münster

Budapest

Debrecen

Rotterdam

Utrecht

Krakow

Warsaw

Wroclaw

Bucharest

Cluj-Napoca

Oradea

Timișoara

Moscow

Saint Petersburg

Yekaterinburg

Seoul

Barcelona

Esplugues de Llobregat

Madrid

Valencia

Gothenburg

Kaohsiung City

Taipei

Taoyuan District

Ankara

Izmir

Kiev

Birmingham

Cambridge

Leeds

Liverpool

London

Manchester

Newcastle

Sheffield

Surrey

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY