Source: https://www.kinderkrebsinfo.de/fachinformationen/studienportal/phase_i_ii_studien__pharmastudien/ibrutinib/index_ger.html
Timestamp: 2019-09-15 15:14:05
Document Index: 399648320

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Autor: Julia Dobke, erstellt am: 12.07.2017, Zuletzt geändert: 19.09.2018
Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma
This is a 2-part, multicenter study. A safety and pharmacokinetic run-in part (Part 1) will be conducted before starting the randomized part (Part 2) of the study. Part 2 is a randomized, open-label, Phase 3 study to compare the safety and efficacy of ibrutinib in combination with CIT (RICE or RVICI) versus CIT alone in children and young adult subjects with relapsed or refractory mature B-cell NHL.
The trial is devided in 2 parts:
In part 1 it shall be confirmed, that the pharmacokinetics in pediatric subjects is consistent with that in adults
In part 2 the efficacy (event-free survival [EFS]) of ibrutinib in combination with RICE or RVICI background therapy compared to RICE or RVICI background therapy alone is assessed.
All subjects in Part 1 will receive ibrutinib in combination with CIT (investigator choice of RICE or RVICI); 6 to approximately 24 pediatric subjects (1 to <18 years) will be enrolled to allow confirmation of the dose regimen. Enrollment will begin with children in the 2 older age groups (6-11, 12-17 years) to assess
pharmacokinetic and safety data before allowing enrollment of children in the youngest age group (1-5 years). The SET will meet to decide on any changes to the starting dose for each age group, and when enrollment may begin for the youngest age group. At a minimum, the first 2 subjects in each age group will enroll into Part 1 before recruitment of children in that age group will begin in Part 2.
Subjects in Part 1 will receive ibrutinib in combination with background CIT (investigator choice of RICE or RVICI) for 3 treatment cycles.
In Part 2, approximately 72 additional subjects will be randomized in a 2:1 ratio to receive ibrutinib in combination with CIT (investigator choice of RICE or RVICI) or CIT alone; at least 40 subjects are targeted to be of age 1 to <18 years and at least 10 of the 40 subjects are targeted to be age <11 years. Subjects will be
stratified by histology (Burkitt lymphoma [BL]/Burkitt leukemia [B-AL] versus other) and by background therapy (RICE versus RVICI). Pharmacokinetic samples will be obtained during Part 2 of the study to characterize the pharmacokinetics in pediatric subjects.
Subjects in Part 2 will be randomized in a 2:1 ratio to receive either ibrutinib in combination with CIT (RICE or RVICI) or CIT alone, for 3 treatment cycles.
1 to <18 years of age (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
The participant must be in first or later recurrence or have disease that is primarily refractory to conventional therapy
The participant 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 functions (Bone marror, liver, kidneys)
The participant 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
Adolescent women/young women of childbearing potential must have a negative highly sensitive serum or urine -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.
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.
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
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 at least 3 months after the last dose of ibrutinib or 1 year after the last dose of the background CIT, whichever is later
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.
Patients who are within 6 months of an allogeneic bone marrow transplant
2016-000259-28
ClinicalTrials.gov: NCTNCT02703272
mailto:JNJ.CT@sylogent.com
http://globaltrialfinder.janssen.com/trial/CR108134-0
Charité Berlin, Universitätsklinikum Freiburg, Universitätsklinikum Kiel, Universitätsklinikum Münster, (Universitätsklinikum Gießen: noch nicht offen), Van Haunersches Kinderspital München: noch nicht offen)
Jannsen Global