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: 20.0Level: 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-GB
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-09
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 96

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)
NOTE: Must have pathology report for the original NHL diagnosis or from the time of relapse (if available). If these pathology reports are not available, the pathology results of a fresh biopsy will be required for enrollment into the study.
- Participants must be in first recurrence or 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
- ICF must be signed by legally authorized representative or by the subject if at legal age of consent indicating understanding of the purpose of, and procedures required for, the study and willingness to participate in the study. Assent is also required of children capable of understanding the nature of the study per country-specific or site-specific standards as described in Section 16.2.3, Informed Consent and Assent Form.
- 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
- Adolescents/young women of childbearing potential must be practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agree to remain on a highly effective method throughout the study and for at least 3 months after the last dose of ibrutinib and 1 year after the last dose of the background CIT whichever is later.
Are the trial subjects under 18? yes
Number of subjects for this age range: 96
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

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)
- Participants who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within at least 3 months after the last dose of ibrutinib or 1 year after the last dose of the background CIT, whichever is later
- A diagnosis of post-transplant lymphoproliferative disease (PTLD)
- Patients who are within 6 months of an allogeneic bone marrow transplant
- Subjects who have had prior exposure to ibrutinib

Study & Design

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