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

Protocol: 
AAAR3866
Phase: 
III

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

The purpose of this study is to see whether B-cell Non-Hodgkin Lymphoma
responds to ibrutinib treatment when taken with either RICE chemotherapy or
RVICI chemotherapy and the effects (good and bad) of the treatment. The safety
of ibrutinib will also be studied.

Are you Eligible? (Inclusion Criteria)

1. 1 to <18 years of age (Part 1 only), or 1 to 30 years of age, inclusive,
if initial
diagnosis of mature B-cell NHL occurred at <18 years of age (Part 2 only)
2. Criterion modified per amendment 1
2.1 Relapsed/refractory BL, Burkitt-like lymphoma (BLL), Burkitt leukemia
(ie, B-AL) with FAB3 morphology or presence of surface immunoglobulin by
flow
cytometry, DLBCL, DLBCL not otherwise specified (NOS), or other pediatric
mature B-cell NHL
3. Must be in first or later recurrence or have disease that is primarily
refractory to
conventional therapy
4. Must have at least 1 of the following:
a) 1 site of measurable disease >1 cm in the longest diameter by
radiological
imaging
b) bone marrow involvement
c) cerebrospinal fluid with blasts present
5. Lansky-Karnofsky score of ≥50

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States