A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Parti... | Recruiting
A Safety and Efficacy Study of Ibru... | Recruiting
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

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Medical Conditions
  • Lymphoma, Non-Hodgkin
Primary Contact Details
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Recruitment Status
Recruiting
Trial source and source ID number
NCT02703272
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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).
Research Details
  • This is a Phase 3, randomized (study medication assigned to participants by chance), open-label (identity of study drug will be known to participant and study staff), controlled study which consists of two parts: Part 1 and Part 2. The Part 1 is a pharmacokinetic run-in part, which will be conducted before starting the randomized part (Part 2) of the study and Part 2 is a randomized and open-label study. Part 1 and Part 2 of the study will be conducted in 3 phases: a Pretreatment (Screening) Phase (Up to 14 days before administration of study drug), a Treatment Phase, and a Posttreatment Phase. The Treatment Phase will extend from enrollment (in Part 1) or randomization (in Part 2) until 1 of the following: 1) completion of 3 cycles of therapy, 2) transplantation, if clinically indicated, or 3) progressive disease (PD), whichever comes first. The Posttreatment Phase will continue until death, loss to follow up, consent withdrawal, or study end, whichever occurs first. The end of study is defined as when approximately 60 event-free survival (EFS) events have occurred in Part 2 (death, disease progression, or lack of complete response [CR] or partial response [PR] after 3 cycles of treatment based on blinded independent event review), or the sponsor terminates the study, whichever comes first. Participants in Part 1 will be 1 to less than (<) 18 years old. Participants in Part 2 will be 1 to 30 years old. Participants will be primarily evaluated for pharmacokinetics in part 1 and efficacy (EFS) of ibrutinib in combination with RICE or RVICI background therapy compared to RICE or RVICI background therapy alone in part 2. Participants' safety will be monitored throughout the study.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Ibrutinib, Drug : Rituximab, Drug : Ifosfamide, Drug : Carboplatin, Drug : Etoposide, Drug : Vincristine, Drug : Idarubicin, Drug : Dexamethasone

Study Arm Groups : Part 1: Ibrutinib, Part 2: Ibrutinib, Part 1: Ibrutinib, Part 2: Ibrutinib, Part 1: Ibrutinib, Part 2: Ibrutinib, Part 1: Ibrutinib, Part 2: Ibrutinib, Part 1: Ibrutinib, Part 2: Ibrutinib, Part 1: Ibrutinib, Part 2: Ibrutinib, Part 1: Ibrutinib, Part 2: Ibrutinib, Part 1: Ibrutinib, Part 2: Ibrutinib

Intervention Type
See Interventions above
Primary Outcome Measures
    Part 1: Area Under The Plasma Concentration-Time Curve (AUC) of Ibrutinib; Predose, at 1, 2, 4, and 6 hours postdose on Day 1, and Day 7 or 8 of cycle 1; predose, 1, 2, 4, and 6 hours postdose on Day 1 of Cycle 2 or Cycle 3 (each cycle of 28 days); Part 1: Apparent (oral) Plasma Clearance (CL/F) of Ibrutinib; Predose, at 1, 2, 4, and 6 hours postdose on Day 1, and Day 7 or 8 of Cycle 1; predose, 1, 2, 4, and 6 hours postdose on Day 1 of Cycle 2 or Cycle 3 (each cycle of 28 days); Part 1: Apparent (oral) Volume of Distribution (Vd/F) of Ibrutinib; Predose, at 1, 2, 4, and 6 hours postdose on Day 1, and Day 7 or 8 of cycle 1; predose, 1, 2, 4, and 6 hours postdose on Day 1 of Cycle 2 or Cycle 3 (each cycle of 28 days); Part 1: Maximum Observed Plasma Concentration (Cmax); Predose, at 1, 2, 4, and 6 hours postdose on Day 1, and Day 7 or 8 of cycle 1; predose, 1, 2, 4, and 6 hours postdose on Day 1 of Cycle 2 or Cycle 3 (each cycle of 28 days); Part 1: Relationship Between Pharmacokinetic Parameters and Age or Measure of Body Size; up to three 28-day cycles; Part 2: Event-free Survival [EFS]) of Ibrutinib; Randomization to death, disease progression, or lack of CR or PR after 3 cycles of treatment (approximately 4.2 years)
Secondary Outcome Measures
    Part 1: Number of Participants with Adverse Events; Throughout the study duration (approximately up to 4.2 years); Part 1: Percentage of Participants Who Achieve Complete Response (CR) and Partial Response (PR); Approximately up to 4.2 years; Part 1: Disease-specific Biomarkers Assessment; Cycle 1: Days 1, and 7 or 8, Cycle 2: Day 1, and Cycle 3: Day 1 (each cycle of 28 days) and End of treatment visit (30 days after last dose); Part 1: Bruton's tyrosine kinase (BTK) Percent Occupancy; Predose and 4 hours postdose on Day 1, Day 7 or 8 of Cycle 1, predose on Cycle 2 Day 1 or Cycle 3 Day 1 (each cycle of 28 days), and the End-of-Treatment visit (30 days after last dose); Part 1: Visual analog Scale Score for Palatability; Cycle 1 Day 1 and Cycle 3 Day 1 (each cycle of 28 days); Part 2: Number of Participants with Adverse Events; Throughout the study duration (approximately up to 4.2 years); Part 2: Percentage of Participants Who Achieve Complete Response (CR) and Partial Response (PR); Approximately up to 4.2 years; Part 2: Tumor Volume Reduction; Day 14; Part 2: Percentage of Participants who Proceed to Stem Cell Transplantation; Cycle 2 (Day 28); Part 2: Time to Response; Up to 4.2 years; Part 2: Duration of Response; Up to 4.2 years; Part 2: Percentage of Participants with Long-term Survival; 2, 3 years; Part 2: Overall Survival; Randomization to the date of death (maximum up to 4.2 years); Part 2: Disease-specific Biomarkers Assessment; Cycle 1: Days 1 and 14, Cycle 2: Day 1, Cycle 3: Day 1 (each cycle of 28 days) and End of treatment visit (30 days after last dose); Part 2: Bruton's tyrosine kinase (BTK) Percent Occupancy; Predose and 4 hours postdose on Cycle 1 Day 1, predose and 4 hours post dose on Cycle 1 Day 14 or Cycle 2 Day 1, predose on Cycle 3 Day 1 (each cycle of 28 days), and End-of-Treatment visit (30 days after last dose); Part 2: Visual analog Scale Score for Palatability; Cycle 1 Day 1 and Cycle 3 Day 1 (each cycle of 28 days); Part 2: Area under the plasma concentration-time curve (AUC); Predose, 1, 2, and 4 hours postdose, either on Cycle 1 Day 14 or Cycle 2 Day 1 (each cycle of 28 days)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
1 Year - 30 Years
Who Can Participate
Patients
Number of Participants
96
Participant Inclusion Criteria
    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 or later 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Oxford Road
Manchester
M13 9WL
GSK Investigational Site
Cambridge
CB2 0QQ
London
WC1N 3JH
Birmingham
B4 6NH
Leeds
West Yorkshire
LS1 3EX
Sutton
SM2 5PT
Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
GB006
Sheffield
S10 2TH
Alder Hey Children's Hospital, Alder Hey Children's Hospital NHS Foundation Trust
Liverpool
L14 5AB
University College of London Hospitals
London
NW1 5PT
Trial Contact(s)
Primary Trial Contact
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Romania, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CR108134
Sponsor(s)
Janssen Research & Development, LLC
Key Dates

Recruitment Start Date

Jul 2016

Recruitment End Date

Jun 2021

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

03 Mar 2016

Date updated in source

05 Apr 2018