Education and Training
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
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).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Ibrutinib
- drug: Rituximab
- drug: Ifosfamide
- drug: Carboplatin
- drug: Etoposide
- drug: Vincristine
- drug: Idarubicin
- drug: Dexamethasone
Eligibility
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
Ages Eligible for Study
1 Year - 30 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Christina Baggott
650-497-7659
Not Recruiting