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Not Recruiting
Trial ID: NCT02703272
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
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
drug: Ibrutinib
drug: Rituximab
drug: Ifosfamide
drug: Carboplatin
drug: Etoposide
drug: Vincristine
drug: Idarubicin
drug: Dexamethasone
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Christina Baggott
650-497-7659