A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: Ibrutinib; Rituximab; Ifosfamide; Carboplatin; Etoposide; Vincristine; Idarubicin; Dexamethasone
Intervention description: Participants will receive Ibrutinib (dose 240 mg/m^2 /329 mg/m^2 per day) during part 1 and part 2.; 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.; 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.; 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.; 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.; 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.; 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.; 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.
Intervention MeSH terms: Dexamethasone; Rituximab; Carboplatin; Etoposide; Vincristine; Ifosfamide; Idarubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Lymphoma, Non-Hodgkin; Ibrutinib; JNJ-54179060

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with 1 to less than (<) 18 years of age (Part 1 only), or 1 to 30 years
             of age, inclusive, if initial diagnosis of mature B-cell non-Hodgkin lymphoma (NHL)
             occurred at <18 years of age (Part 2 only)

          -  Participants must be in first recurrence and have received only one prior line of
             therapy or have disease that is primarily refractory to conventional therapy

          -  Participants must have at least 1 of the following: 1 site of measurable disease
             greater than (>) 1 centimeter (cm) in the longest diameter and >1 cm in the shortest
             diameter by radiological imaging; bone marrow involvement; cerebrospinal fluid with
             blasts present

          -  Participants with lansky-Karnofsky score of greater than or equal to (>=) 50

          -  Adolescent women/young women of childbearing potential must have a negative highly
             sensitive serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test
             at Screening before enrollment/randomization. Adolescent/young women who are pregnant
             or breastfeeding are ineligible for this study

        Exclusion Criteria:

          -  Participants with ongoing anticoagulation treatment with warfarin or equivalent
             vitamin K antagonists (example phenprocoumon), or ongoing treatment with agents known
             to be strong CYP3A4/5 inhibitors, or has taken any disallowed therapies as noted in
             Section 8.2, Prohibited Medications, before the planned first dose of study drug

          -  Participants with inherited or acquired bleeding disorders

          -  Participants with clinically significant arrhythmias, complex congenital heart
             disease, or left ventricular ejection fraction (LVEF) <50 percent (%) or shortening
             fraction (SF) <=28%

          -  Participants with known history of human immunodeficiency virus (HIV) or active
             Hepatitis B or C virus

          -  Participants with any condition that could interfere with the absorption or metabolism
             of ibrutinib including malabsorption syndrome, disease significantly affecting
             gastrointestinal function, or resection of the stomach or small bowel

          -  Participants with known allergies, hypersensitivity, or intolerance to ibrutinib or
             its excipients (refer to Investigator's Brochure)

          -  A diagnosis of post-transplant lymphoproliferative disease (PTLD)

          -  Participants who are within 6 months of an allogeneic bone marrow transplant

          -  Participants who have had prior exposure to ibrutinib