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

Phase 1

• Conditions: Mature B-Cell Neoplasm; MedDRA version: 19.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000259-28-IT
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-19
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

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 or later recurrence 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 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 82
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified