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.
- Conditions
- B-AL)Burkitt leukemia (ieBurkitt-like lymphoma (BLL)DLBCLRelapsed/refractory BL10025320
- Registration Number
- NL-OMON50711
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
- 1 to <18 years of age enrollment will begin with children in the 2 older age
groups (6-11, 12-17 years) to assess pharmacokinetics and safety data before
allowing enrollment of children in the youngest age group (1-5 years) (Part 1
only), or 1 to 30 years of age, inclusive, if initial diagnosis of mature
B-cell NHL occurred at <18 years of age (Part 2 only)
- Relapsed/refractory BL, Burkitt-like lymphoma (BLL), Burkitt leukemia (ie,
B-AL) with FAB3 morphology or presence of surface immunoglobulin by flow
cytometry, DLBCL, DLBCL not otherwise specified (NOS), or other pediatric
mature B-cell NHL
- Must be in first recurrence and have received only one prior line of therapy
or have disease that is primarily refractory to conventional therapy
- Must have at least 1 of the following:
a) 1 site of measurable disease >1 cm in the longest diameter and >1 cm in the
shortest diameter by radiological imaging
b) bone marrow involvement
c) cerebrospinal fluid with blasts present
- Lansky-Karnofsky score of *50
- Adequate organ function
- Must have recovered from the acute toxic effects of prior chemotherapy,
immunotherapy, or radiotherapy, in the opinion of the investigator, prior to
entering this study.
- signed, written, informed consent or assent as applicaple.
- 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.
- Must be willing and able to adhere to the prohibitions and restrictions
specified in this protocol
- Ongoing anticoagulation treatment with warfarin or equivalent vitamin K
antagonists (eg, phenprocoumon), or ongoing treatment with agents known to be
strong CYP3A4/5 inhibitors, or has taken any disallowed therapies, Prohibited
Medications, before the planned first dose of study drug
- Inherited or acquired bleeding disorders
- Clinically significant arrhythmias, complex congenital heart disease, or left
ventricular ejection fraction (LVEF) <50% or shortening fraction (SF) *28%
- Known history of human immunodeficiency virus (HIV) or active Hepatitis B or
C virus
- 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
- Known allergies, hypersensitivity, or intolerance to ibrutinib or its
excipients (refer to Investigator's Brochure)
- Known allergy, hypersensitivity, or intolerance to any of the backbone CIT
- Received an investigational drug (including investigational vaccines) or used
an invasive investigational medical device within 30 days before the planned
first dose of study drug, or is - currently being treated in an investigational
study
- Pregnant, or breastfeeding, or planning to become pregnant while enrolled in
this study or within 3 months after the last dose of study drug
- Plans to father a child while enrolled in this study or within 3 months after
the last dose of study drug
- Any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the subject (eg, compromise the
well-being) or that could prevent, limit, or confound the protocol-specified
assessments
- Had major surgery, (eg, requiring general anesthesia) within 4 weeks before
enrollment/randomization, or has not fully recovered from surgery, or has
surgery planned during the time the subject is expected to participate in the
study or within 4 weeks after the last dose of study drug administration.
Lumbar puncture, bone marrow aspiration/biopsy, or placement of central venous
access device are not considered major procedures.
- A diagnosis of post-transplant lymphoproliferative disease (PTLD)
-Patients who are within 6 months of an allogeneic bone marrow transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Run-in Part (Part 1):<br /><br><br /><br>* Exposure (area under the plasma concentration-time curve [AUC])<br /><br>* Apparent (oral) plasma clearance (CL/F), apparent (oral) volume of<br /><br>distribution (Vd/F), and derived measures of exposure such as maximum observed<br /><br>plasma concentration (Cmax)<br /><br>* Relationship between pharmacokinetic parameters and age or measure of body<br /><br>size<br /><br><br /><br><br /><br>Randomized Part (Part 2):<br /><br><br /><br>* Difference in EFS between the 2 treatment groups (an event is defined as the<br /><br>time from randomization to death, disease progression, or lack of CR or PR<br /><br>after 3 cycles of treatment based on blinded independent event review)</p><br>
- Secondary Outcome Measures
Name Time Method