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Trial record 2 of 6 for:    ibrutinib | Recruiting Studies | Child

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02703272
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : November 15, 2019
Sponsor:
Collaborator:
Pharmacyclics LLC.
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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).

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Ibrutinib Drug: Rituximab Drug: Ifosfamide Drug: Carboplatin Drug: Etoposide Drug: Vincristine Drug: Idarubicin Drug: Dexamethasone Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 29, 2021
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ibrutinib

Arm Intervention/treatment
Experimental: Part 1: Ibrutinib
The first 2 participants enrolled in each age group (1-5 years, 6-11 years and 12-17 years) will receive starting dose of Ibrutinib 240 milligram per square meter (mg/m^2) for the first cycle, followed by dose escalation at the start of Cycle 2 as long as all pharmacokinetic assessments are within the expected range and there are no safety concerns. For participants being treated at 240 mg/m^2 dose level during the first cycle, the maximum dose should not exceed a total of 420 mg/day. All participants will receive rituximab, ifosfamide, carboplatin, etoposide and dexamethasone (RICE) or ituximab, vincristine, ifosfamide, carboplatin, idarubicin and dexamethasone (RVICI) background therapy (investigator's choice), during treatment phase. Participants with PR or better only will receive Ibrutinib for 3 cycles or until PD, unacceptable toxicity or until initiating antilymphoma therapy or a conditioning regimen for stem cell transplantation during post-treatment phase.
Drug: Ibrutinib
Participants will receive Ibrutinib (dose 240 mg/m^2 /329 mg/m^2 per day) during part 1 and part 2.

Drug: Rituximab
Participants will receive a cumulative dose of rituximab 750 mg/m^2 as a part of RICE/RVICI regimen in part 1 and part 2 per cycle.

Drug: Ifosfamide
Participants will receive a cumulative dose of Ifosfamide 9 g/m^2 and 10 g/m^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.

Drug: Carboplatin
Participants will receive a cumulative dose of carboplatin 635 mg/m^2 and 800 mg/m^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.

Drug: Etoposide
Participants will receive a cumulative dose of etoposide 300 mg/m^2 in part 1 and part 2 as a part of RICE regimen per cycle.

Drug: Vincristine
Participants will receive a cumulative dose of vincristine 1.6 mg/m^2 in part 1 and part 2 as a part of RVICI regimen per cycle.

Drug: Idarubicin
Participants will receive a cumulative dose of idarubicin 20 mg/m^2 in part 1 and part 2 as a part of RVICI regimen per cycle.

Drug: Dexamethasone
Participants will receive a cumulative dose of dexamethasone 100 mg/m^2 in part 1 and part 2 as a part of RICE/RVICI regimen per cycle.

Experimental: Part 2: Ibrutinib
Participants will either receive ibrutinib and RICE/RVICI background therapy or RICE/RVICI background therapy alone, until 3 cycles are completed or until PD or unacceptable toxicity during the treatment phase. Participants who received ibrutinib and RICE/RVICI background therapy and with PR or better only will receive ibrutinib alone for 3 cycles during post-treatment phase.
Drug: Ibrutinib
Participants will receive Ibrutinib (dose 240 mg/m^2 /329 mg/m^2 per day) during part 1 and part 2.

Drug: Rituximab
Participants will receive a cumulative dose of rituximab 750 mg/m^2 as a part of RICE/RVICI regimen in part 1 and part 2 per cycle.

Drug: Ifosfamide
Participants will receive a cumulative dose of Ifosfamide 9 g/m^2 and 10 g/m^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.

Drug: Carboplatin
Participants will receive a cumulative dose of carboplatin 635 mg/m^2 and 800 mg/m^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.

Drug: Etoposide
Participants will receive a cumulative dose of etoposide 300 mg/m^2 in part 1 and part 2 as a part of RICE regimen per cycle.

Drug: Vincristine
Participants will receive a cumulative dose of vincristine 1.6 mg/m^2 in part 1 and part 2 as a part of RVICI regimen per cycle.

Drug: Idarubicin
Participants will receive a cumulative dose of idarubicin 20 mg/m^2 in part 1 and part 2 as a part of RVICI regimen per cycle.

Drug: Dexamethasone
Participants will receive a cumulative dose of dexamethasone 100 mg/m^2 in part 1 and part 2 as a part of RICE/RVICI regimen per cycle.




Primary Outcome Measures :
  1. Part 1: Area Under The Plasma Concentration-Time Curve (AUC) of Ibrutinib [ Time Frame: 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) ]
    AUC is the under the plasma concentration-time curve.

  2. Part 1: Apparent (oral) Plasma Clearance (CL/F) of Ibrutinib [ Time Frame: 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) ]
    CL/F is the apparent (oral) Plasma Clearance.

  3. Part 1: Apparent (oral) Volume of Distribution (Vd/F) of Ibrutinib [ Time Frame: 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) ]
    Vd/F is the apparent (oral) Volume of Distribution.

  4. Part 1: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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) ]
    Cmax is the maximum observed plasma concentration.

  5. Part 1: Relationship Between Pharmacokinetic Parameters and Age or Measure of Body Size [ Time Frame: up to three 28-day cycles ]
    The impact of age or body size on the pharmacokinetic parameters will also be investigated.

  6. Part 2: Event-free Survival [EFS]) of Ibrutinib [ Time Frame: Randomization to death, disease progression, or lack of CR or PR after 3 cycles of treatment (approximately 4.2 years) ]
    EFS is the time interval from randomization to death, disease progression, or lack of CR or PR after 3 cycles of treatment, whichever occurs first based on blinded independent event review by the Independent Review Committee (IRC).


Secondary Outcome Measures :
  1. Part 1: Number of Participants with Adverse Events [ Time Frame: Throughout the study duration (approximately up to 4.2 years) ]
  2. Part 1: Percentage of Participants Who Achieve Complete Response (CR) and Partial Response (PR) [ Time Frame: Approximately up to 4.2 years ]
    CR: computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions; Resected residual mass that is pathologically negative for disease; bone marrow (BM) and cerebrospinal fluid (CSF) morphologically free of disease with no new lesions by imaging examination. PR: 50 percent (%) decrease in sum of the products of the lesion diameters (SPD) on CT or MRI; FDG-PET may be positive (Deauville score or 4 or 5 with reduced lesional uptake compared with baseline); no new or PD; morphologic evidence of disease may be present in BM or CSF if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells.

  3. Part 1: Disease-specific Biomarkers Assessment [ Time Frame: 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) ]
    Blood samples will be taken to evaluate the levels of biomarkers such as Phospho- Bruton's tyrosine kinase (BTK), spleen tyrosine kinase (SYK), p-signal transducer, activator of transcription 3 (STAT3), Caspase-3 and B-cell receptor (BCR)/CD79B, CARD11, and MYD Mutations.

  4. Part 1: Bruton's tyrosine kinase (BTK) Percent Occupancy [ Time Frame: 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) ]
    The pharmacodynamic activity of ibrutinib in the presence of chemoimmunotherapy (CIT) (RICE or RVICI) will be assessed by determining the percentage of probe occupancy of the BTK receptor. Blood samples will be obtained for pharmacodynamic assessments (BTK occupancy).

  5. Part 1: Visual analog Scale Score for Palatability [ Time Frame: Cycle 1 Day 1 and Cycle 3 Day 1 (each cycle of 28 days) ]
    Palatability will be measured using a visual analog scale. The scale is a 5-point visual analog scale incorporating a facial hedonic scale designed to span pediatric ages and levels of participant comprehension.

  6. Part 2: Number of Participants with Adverse Events [ Time Frame: Throughout the study duration (approximately up to 4.2 years) ]
  7. Part 2: Percentage of Participants Who Achieve Complete Response (CR) and Partial Response (PR) [ Time Frame: Approximately up to 4.2 years ]
    CR: CT or MRI reveals no residual disease or new lesions; Resected residual mass that is pathologically negative for disease; BM and CSF morphologically free of disease with no new lesions by imaging examination. PR: 50% decrease in SPD on CT or MRI; FDG-PET may be positive Deauville score or 4 or 5 with reduced lesional uptake compared with baseline); no new or PD; morphologic evidence of disease may be present in BM or CSF if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells.

  8. Part 2: Tumor Volume Reduction [ Time Frame: Day 14 ]
    Tumor volume reduction will be measured by decrease in the sum of the products of the lesion diameters.

  9. Part 2: Percentage of Participants who Proceed to Stem Cell Transplantation [ Time Frame: Cycle 2 (Day 28) ]
    Percentage of participants who proceeded to stem cell transplantation will be calculated.

  10. Part 2: Time to Response [ Time Frame: Up to 4.2 years ]
    The time interval from the first dose of ibrutinib to the first documented response for those participants who respond.

  11. Part 2: Duration of Response [ Time Frame: Up to 4.2 years ]
    Duration calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of PD or death.

  12. Part 2: Percentage of Participants with Long-term Survival [ Time Frame: 2, 3 years ]
    Participants with event-free survival (EFS) at 2 and 3 years will be assessed.

  13. Part 2: Overall Survival [ Time Frame: Randomization to the date of death (maximum up to 4.2 years) ]
    Duration from the date of randomization to the date of the subject's death.

  14. Part 2: Disease-specific Biomarkers Assessment [ Time Frame: 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) ]
    Blood samples will be taken to evaluate the levels of biomarkers such as Phospho- Bruton's tyrosine kinase (BTK), spleen tyrosine kinase (SYK), p-signal transducer, activator of transcription 3 (STAT3), Caspase-3 and B-cell receptor (BCR)/CD79B, CARD11, and MYD Mutations.

  15. Part 2: Bruton's tyrosine kinase (BTK) Percent Occupancy [ Time Frame: 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) ]
    The pharmacodynamic activity of ibrutinib will be assessed by determining the percentage of probe occupancy of the BTK receptor. Blood samples will be obtained for pharmacodynamic assessments (BTK occupancy).

  16. Part 2: Visual analog Scale Score for Palatability [ Time Frame: Cycle 1 Day 1 and Cycle 3 Day 1 (each cycle of 28 days) ]
    Palatability of ibrutinib will be measured using a visual analog scale. The scale is a 5-point visual analog scale incorporating a facial hedonic scale designed to span pediatric ages and levels of participant comprehension.

  17. Part 2: Area under the plasma concentration-time curve (AUC) [ Time Frame: Predose, 1, 2, and 4 hours postdose, either on Cycle 1 Day 14 or Cycle 2 Day 1 (each cycle of 28 days) ]
    AUC is the area under the plasma concentration-time curve.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703272


Contacts
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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: JNJ.CT@sylogent.com

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Locations
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United States, California
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868
Stanford University Recruiting
Palo Alto, California, United States, 94304
UCSF Benioff Children's Hospital Withdrawn
San Francisco, California, United States
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Georgia
Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Withdrawn
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Medical School CS Mott Children's Hospital Withdrawn
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Withdrawn
Minneapolis, Minnesota, United States, 55404
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
New York Medical College Recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
Carolinas Healthcare Recruiting
Charlotte, North Carolina, United States, 28203
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Cook Childrens Medical Center Withdrawn
Fort Worth, Texas, United States, 76104
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
United States, Wisconsin
Medical College Of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226-3522
Belgium
Queen Fabiola Children'S University Hospital Huderf Recruiting
Brussel, Belgium, B-1020
UZ Leuven Recruiting
Leuven, Belgium, 3000
Brazil
Hospital de Cancer de Barretos - Fundacao Pio XII Recruiting
Barretos, Brazil, 14784-400
Erasto Gaertner Not yet recruiting
Curitiba, Brazil, 82515-010
Hospital de Clínicas de Porto Alegre Not yet recruiting
Porto Alegre, Brazil, 90035-903
Sociedade Hospital Samaritano Recruiting
São Paulo, Brazil, 01232-010
GRAACC Recruiting
São Paulo, Brazil, 04023-062
Instituto da Criança - ICRHCFMUSP Recruiting
São Paulo, Brazil, 05403-000
Bulgaria
UMHAT 'Sv. Georgi' Recruiting
Plovdiv, Bulgaria, 4002
University Hospital 'Queen Joanna' Recruiting
Sofia, Bulgaria, 1000
Canada, Nova Scotia
Iwk Health Centre Completed
Halifax, Nova Scotia, Canada, B3k6r8
Canada, Ontario
Children's Hospital of Eastern Ontario Withdrawn
Ottawa, Ontario, Canada, K1H 8L1
Hospital For Sick Children Completed
Toronto, Ontario, Canada, M5G 1X8
Czechia
Fakultní nemocnici Brno Completed
Brno, Czechia, 613 00
Fakultni nemocnice v Motole Recruiting
Praha, Czechia, 15006
France
CHU de Bordeaux, Hopital des Enfants Recruiting
Bordeaux, France, 33000
Hôpital Jeanne de Flandre Recruiting
Lille, France, 59037
Institute Of Pediatric Hematology And Oncology Recruiting
Lyon, France, 69373
Hopital La Timone Recruiting
Marseille, France, 13005
Hôpital Mère Enfant CHU Nantes Recruiting
Nantes, France, 44093
CHU Toulouse Recruiting
Toulouse, France, 31300
Hôpital D'Enfants Recruiting
Vandoeuvre les Nancy, France, 54500
Gustave Roussy Recruiting
Villejuif, France, 94805
Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum Recruiting
Berlin, Germany, 13353
Medical Center- University of Freiburg, Center for Pediatrics Recruiting
Freiburg, Germany, 79106
University Children´s Hospital, Justus-Liebig-University Withdrawn
Gießen, Germany, 35392
Universitaetsklinikum Hamburg Eppendorf Not yet recruiting
Hamburg, Germany, 20246
Universitatsklinikum Schleswig-Holstein - Kiel Recruiting
Kiel, Germany, 24105
Dr. von Haunersches Kinderspital Recruiting
München, Germany, 80337
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, H-1094
Debreceni Egyetem Klinikai Kozpont Recruiting
Debrecen, Hungary, H-4032
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Azienda Ospedaliera San Gerardo Recruiting
Monza, Italy, 20900
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Ospedale Pediatrico Bambin Gesù Recruiting
Roma, Italy, 00165
AOU Città Salute e Scienza di Torino, PO Infantile Regina Margherita Recruiting
Torino, Italy, 10126
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
The Catholic University of Korea Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Netherlands
Sophia Children's hospital Terminated
Rotterdam, Netherlands, 3015 CN
Princess Maxima Center Recruiting
Utrecht, Netherlands, 3584 EA
Poland
Uniwersytecki Szpital Dzieciecy w Krakowie Recruiting
Krakow, Poland, 30-663
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Recruiting
Warszawa, Poland, 02-091
Uniwersytecki Szpital Kliniczny Recruiting
Wroclaw, Poland, 50-556
Romania
Institut Clinic Fundeni Recruiting
Bucuresti, Romania, 22328
Spitalul Clinic de Urgenta pentru Copii M.S. Curie Completed
Bucuresti, Romania, 41451
Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca Recruiting
Cluj-Napoca, Romania, 400015
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea Recruiting
Oradea, Romania
Spitalul Clinic de Urgenta pentru Copii 'Louis Turcanu' Timisoara Recruiting
Timisoara, Romania, 300011
Russian Federation
Regional Pediatric Clinical Hospital No.1 Recruiting
Ekaterinburg, Russian Federation, 620149
Pediatric Regional Clinical Hospital for Krasnodar Region Withdrawn
Krasnodar, Russian Federation, 115478
Pediatric Oncology and Hematology Research Institute FSBSI Recruiting
Moscow, Russian Federation, 115478
FRCC of Pediatric Hematology, Oncology and Immunology n.a.D.Rogachev Recruiting
Moscow, Russian Federation, 117997
City Clinical Hospital # 40 Recruiting
Moscow, Russian Federation, 129301
Rostov Research Oncology Institute Withdrawn
Rostov-on-Don, Russian Federation, 344037
City Clinical Hospital #31 Completed
St. Petersburg, Russian Federation, 197110
Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care Withdrawn
St.Petersburg, Russian Federation, 197758
Spain
Hosp. Materno Infantil Vall D'hebron Recruiting
Barcelona, Spain, 08035
Hosp. Sant Joan de Deu Recruiting
Esplugues de Llobregat, Spain, 08950
Hosp. Infantil Univ. Niño Jesus Recruiting
Madrid, Spain, 28009
Hosp. Infantil Universitario La Paz Recruiting
Madrid, Spain, 28046
Hosp. Univ. I Politecni La Fe Recruiting
Valencia, Spain, 46026
Sweden
Queen Silvias Childrens Hospital Not yet recruiting
Gothenburg, Sweden, 416 85
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 83301
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10041
Linkou Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 33305
Turkey
Gazi University Medical Faculty Recruiting
Ankara, Turkey, 06500
Ankara University Medical Faculty Recruiting
Ankara, Turkey, 6590
Ege Universitesi Tip Fakultesi Recruiting
Izmir, Turkey, 34050
Kocaeli University Medical Faculty Withdrawn
Kocaeli, Turkey, 41380
Ukraine
Ukr.National Pediatric Hosp,Center pediatric onkohem.and BMT, BMT dept Completed
Kiev, Ukraine, 01135
State Institution National Cancer Institute Recruiting
Kiev, Ukraine, 03022
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, United Kingdom, B4 6NH
Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Leeds Children's Hospital Recruiting
Leeds, United Kingdom, LS1 3EX
Alder Hey Hospital Recruiting
Liverpool, United Kingdom, L14 5AB
University College of London Hospitals Recruiting
London, United Kingdom, NW1 5PT
Great Ormond Street Hospital Recruiting
London, United Kingdom, WC1N 3JH
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Great North Children's Hospital Recruiting
Newcastle, United Kingdom, NE1 4LP
Sheffield Children's Hospital Recruiting
Sheffield, United Kingdom, S10 2TH
Royal Marsden Hospital Recruiting
Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Janssen Research & Development, LLC
Pharmacyclics LLC.
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02703272     History of Changes
Other Study ID Numbers: CR108134
54179060LYM3003 ( Other Identifier: Janssen Research & Development, LLC )
2016-000259-28 ( EudraCT Number )
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Lymphoma, Non-Hodgkin
Ibrutinib
JNJ-54179060
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Carboplatin
Rituximab
Etoposide
Etoposide phosphate
Vincristine
Ifosfamide
Isophosphamide mustard
Idarubicin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal