Trial Search Results

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Janssen Research & Development, LLC

Collaborator: Pharmacyclics LLC.

Stanford Investigator(s):

Intervention(s):

  • Drug: Ibrutinib
  • Drug: Rituximab
  • Drug: Ifosfamide
  • Drug: Carboplatin
  • Drug: Etoposide
  • Drug: Vincristine
  • Drug: Idarubicin
  • Drug: Dexamethasone

Phase:

Phase 3

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 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