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Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Primary Purpose

Follicular Lymphoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ibrutinib
placebo to match ibrutinib
rituximab
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
  • Measurable disease
  • Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities.
  • Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
  • Adequate hematologic function within protocol-defined parameters.
  • Adequate hepatic and renal function within protocol-defined parameters.
  • ECOG performance status score of 0-2.

Exclusion Criteria:

  • Transformed lymphoma
  • Prior treatment for follicular lymphoma
  • Central nervous system lymphoma or leptomeningeal disease
  • Currently active, clinically significant cardiovascular disease

Sites / Locations

  • Southern Cancer Center
  • City of Hope
  • Sansum Clinic
  • UCLA Hematology/Oncology
  • Helen F. Graham Cancer Center and Research Institute
  • SCRI Florida Cancer Specialists South
  • Florida Cancer Affiliates
  • SCRI Florida Cancer Specialists North
  • Rush University Medical Center
  • Norton Cancer Institute
  • Goldschmidt Cancer Center
  • Southeast Nebraska Cancer Center
  • OHSU Knight Cancer Institute Beaverton Clinic
  • Greenville Health System
  • SCRI Tennessee Oncology Chattanooga
  • SCRI Tennessee Oncology Nashville
  • Texas Oncology (Medical City)
  • Texas Oncology-Dallas Presbyterian Hospital
  • SCRI The Center For Cancer and Blood Disorders
  • MD Anderson Cancer Center
  • Texas Oncology (Tyler)
  • Oncology and Hematology Associates of Southwest Virginia (Blacksburg)
  • Swedish Cancer Institute
  • Medical Oncology Associates
  • W VA University Mary Babb Randolph Cancer Center
  • The Canberra Hospital
  • Mater Misericordiae Health Services
  • Royal Hobart Hospital
  • Monash Medical Centre Clayton Campus
  • Andrew Love Cancer Center
  • Universitätsklinikum Innsbruck
  • Uniklinikum Salzburg
  • Cliniques Universitaires Saint-Luc
  • ZNA Stuivenberg
  • AZ Sint-Jan Brugge Oostende AV
  • UZ Gent
  • CHU de Liège
  • AZ Nikolaas
  • Gasthuis Zusters Antwerpen
  • Moncton Hospital
  • CIUSSS-de-l'Est-de-l'Île-de-Montréal
  • CHUM Notre Dame Hospital
  • Fakultni nemocnice Hradec Kralove
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice v Motole
  • Fakultni nemocnice Kralovske Vinohrady
  • Centre Hospitalier de Valence
  • CHRU de Poitiers La Miletrie
  • CHU de Limoges Hôpital Dupuytren
  • Centre Hospitalier de Perigueux
  • CHU Bordeaux
  • Hôpital Civil
  • University General Hospital of Patras
  • Laiko General Hospital of Athens
  • University General Hospital of Larissa
  • Somogy Megyei Kaposi Mór Oktató Kórház
  • Országos Onkológiai Intézet
  • Debreceni Egyetem Klinikai Kozpont
  • Petz Aladár Megyei Oktató Kórház
  • Pécsi Tudományegyetem
  • Barzilai Medical Center
  • Bnei Zion Medical Center
  • Lady Davis Carmel Medical Center
  • Rabin Medical Center Beilinson Campus
  • Assuta Medical Center
  • Assaf Harofe Medical Center
  • Ospedale Infermi di Rimini
  • Ospedale Policlinico San Martino
  • Istituto Europeo Di Oncologia
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Azienda ospedaliera Universiataria Senese
  • Centro Di Riferimento Oncologico
  • Azienda Sanitaria Ospedaliera S. Croce e Carle
  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
  • San Raffaele Scientific Institute
  • Azienda Ospedaliero Universitaria di Parma
  • Farmacia Polo Ematologico Policlinico Umberto I
  • Policlinico Universitario Campus Biomedico di Roma
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Gelre Ziekenhuizen
  • Maasstad Ziekenhuis
  • Leids Universitair Medisch Centrum
  • ETZ-Elisabeth
  • Centrum Onkologii Ziemi Lubelskiej
  • Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
  • Szpitale Pomorskie Sp. z o. o.
  • Malopolskie Centrum Medyczne
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • Unidade Local de Saúde de Matosinhos SA
  • Centro Hospitalar de São João, E.P.E.
  • Centro Hospitalar do Porto - Hospital de Santo António
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
  • Regional Clinical Hospital
  • Russian Oncology Research Center n a N N Blokhin
  • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
  • City Hospital #31
  • North-West Federal Medical Research Center n.a. V.A. Almazov
  • Hospital de Cabueñes
  • Hospital Universitario Virgen de Valme
  • Hospital del Mar
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Vall dHebron
  • ICO L'Hospitalet
  • Hospital Universitario HM Sanchinarro - CIOCC
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario La Paz
  • Hospital Arnau de Vilanova
  • Hospital Clinico Universitario de Valladolid
  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung Medical University Hospital
  • Chi Mei Medical Center, Liouying
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Gazi Universitesi Tip Fakultesi Hastanesi
  • Ege Universitesi Tip Fakultesi Hastanesi
  • Mersin Universitesi Tip Fakultesi Hastanesi
  • Erciyes Universitesi Tip Fakultesi Hastanesi
  • Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
  • Namik Kemal Universitesi Tip Fakultesi Hastanesi
  • Royal Cornwall Hospital - Hospital Treliske
  • Norfolk and Norwich University Hospital
  • Addenbrooke's Hospital
  • Leeds Teaching Hospitals NHS Trust
  • Barts and The London NHS Trust
  • Derriford Hospital
  • Royal Berkshire Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

(Arm A) ibrutinib + rituximab

(Arm B) placebo + rituximab

Arm Description

Participants will receive 560mg of ibrutinib and rituximab 375mg/m^2 weekly x4 with maintenance.

Participants will receive placebo and rituximab 375mg/m^2 weekly x4 with maintenance.

Outcomes

Primary Outcome Measures

Number of Participants with Progression-Free Survival (PFS)
PFS, is assessed by the investigator, will be analyzed in the intent to treat (ITT) population, comparing the 2 treatment arms (Arm A and Arm B).

Secondary Outcome Measures

Overall Response Rate (ORR)
ORR of the two treatment arms will be compared using the Cochran-Mantel-Haenszel (CMH) chi-square test, stratified by the randomization stratification factors, under the hierarchical procedure.
Overall Survival
Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause.
Infusion-Related Reaction Rate
Infusion-related reaction rate Arm A vs. Arm B.
Duration of Response (DOR) as Assessed by Investigator
DOR is defined as the time from the date of the participant's documented disease progression or death due to the disease, whichever occurs first.
Number of Participants with Adverse Events (AE)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Full Information

First Posted
October 26, 2016
Last Updated
April 28, 2023
Sponsor
Pharmacyclics LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT02947347
Brief Title
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 25, 2026 (Anticipated)
Study Completion Date
June 25, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(Arm A) ibrutinib + rituximab
Arm Type
Experimental
Arm Description
Participants will receive 560mg of ibrutinib and rituximab 375mg/m^2 weekly x4 with maintenance.
Arm Title
(Arm B) placebo + rituximab
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo and rituximab 375mg/m^2 weekly x4 with maintenance.
Intervention Type
Drug
Intervention Name(s)
ibrutinib
Other Intervention Name(s)
Imbruvica
Intervention Description
ibrutinib 560mg administered orally
Intervention Type
Drug
Intervention Name(s)
placebo to match ibrutinib
Intervention Description
placebo capsules to match ibrutinib administered orally
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
rituximab 375mg/m^2 IV
Primary Outcome Measure Information:
Title
Number of Participants with Progression-Free Survival (PFS)
Description
PFS, is assessed by the investigator, will be analyzed in the intent to treat (ITT) population, comparing the 2 treatment arms (Arm A and Arm B).
Time Frame
2-5 years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR of the two treatment arms will be compared using the Cochran-Mantel-Haenszel (CMH) chi-square test, stratified by the randomization stratification factors, under the hierarchical procedure.
Time Frame
2-5 years
Title
Overall Survival
Description
Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause.
Time Frame
2-5 years
Title
Infusion-Related Reaction Rate
Description
Infusion-related reaction rate Arm A vs. Arm B.
Time Frame
2-5 years
Title
Duration of Response (DOR) as Assessed by Investigator
Description
DOR is defined as the time from the date of the participant's documented disease progression or death due to the disease, whichever occurs first.
Time Frame
2-5 years
Title
Number of Participants with Adverse Events (AE)
Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame
2-5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease. Measurable disease Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities. Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria. Adequate hematologic function within protocol-defined parameters. Adequate hepatic and renal function within protocol-defined parameters. ECOG performance status score of 0-2. Exclusion Criteria: Transformed lymphoma Prior treatment for follicular lymphoma. Central nervous system lymphoma or leptomeningeal disease. Currently active, clinically significant cardiovascular disease.
Facility Information:
Facility Name
Southern Cancer Center
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
Country
United States
Facility Name
UCLA Hematology/Oncology
City
Santa Monica
State/Province
California
Country
United States
Facility Name
Helen F. Graham Cancer Center and Research Institute
City
Newark
State/Province
Delaware
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Florida Cancer Affiliates
City
Ocala
State/Province
Florida
Country
United States
Facility Name
SCRI Florida Cancer Specialists North
City
Saint Petersburg
State/Province
Florida
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Goldschmidt Cancer Center
City
Jefferson City
State/Province
Missouri
Country
United States
Facility Name
Southeast Nebraska Cancer Center
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
OHSU Knight Cancer Institute Beaverton Clinic
City
Beaverton
State/Province
Oregon
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
SCRI Tennessee Oncology Nashville
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Oncology (Medical City)
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Texas Oncology-Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
Country
United States
Facility Name
SCRI The Center For Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
Texas Oncology (Tyler)
City
Tyler
State/Province
Texas
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia (Blacksburg)
City
Blacksburg
State/Province
Virginia
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Medical Oncology Associates
City
Spokane
State/Province
Washington
Country
United States
Facility Name
W VA University Mary Babb Randolph Cancer Center
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Mater Misericordiae Health Services
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Monash Medical Centre Clayton Campus
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Andrew Love Cancer Center
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Universitätsklinikum Innsbruck
City
Innsbruck
State/Province
Tirol
Country
Austria
Facility Name
Uniklinikum Salzburg
City
Salzburg
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
State/Province
Brussels
Country
Belgium
Facility Name
ZNA Stuivenberg
City
Antwerpen
Country
Belgium
Facility Name
AZ Sint-Jan Brugge Oostende AV
City
Bruges
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
CHU de Liège
City
Liège
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint-Niklaas
Country
Belgium
Facility Name
Gasthuis Zusters Antwerpen
City
Wilrijk
Country
Belgium
Facility Name
Moncton Hospital
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
CIUSSS-de-l'Est-de-l'Île-de-Montréal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CHUM Notre Dame Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
Country
Czechia
Facility Name
Centre Hospitalier de Valence
City
Valence
State/Province
Drôme
Country
France
Facility Name
CHRU de Poitiers La Miletrie
City
Poitiers
State/Province
Vienne
Country
France
Facility Name
CHU de Limoges Hôpital Dupuytren
City
Limoges
Country
France
Facility Name
Centre Hospitalier de Perigueux
City
Perigueux
ZIP/Postal Code
24019
Country
France
Facility Name
CHU Bordeaux
City
Pessac
Country
France
Facility Name
Hôpital Civil
City
Strasbourg
Country
France
Facility Name
University General Hospital of Patras
City
Patras
State/Province
Achaïa
Country
Greece
Facility Name
Laiko General Hospital of Athens
City
Athens
State/Province
Attiki
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
Country
Greece
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Gyor
Country
Hungary
Facility Name
Pécsi Tudományegyetem
City
Pecs
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Bnei Zion Medical Center
City
Haifa
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Rabin Medical Center Beilinson Campus
City
Petah Tikva
Country
Israel
Facility Name
Assuta Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Assaf Harofe Medical Center
City
Zerifin
Country
Israel
Facility Name
Ospedale Infermi di Rimini
City
Rimini
State/Province
Emilia-Romagna
Country
Italy
Facility Name
Ospedale Policlinico San Martino
City
Genova
State/Province
Liguria
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milan
State/Province
Lombardia
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
Country
Italy
Facility Name
Azienda ospedaliera Universiataria Senese
City
Siena
State/Province
Toscana
Country
Italy
Facility Name
Centro Di Riferimento Oncologico
City
Aviano
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera S. Croce e Carle
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
City
Milano
Country
Italy
Facility Name
San Raffaele Scientific Institute
City
Milan
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
Country
Italy
Facility Name
Farmacia Polo Ematologico Policlinico Umberto I
City
Roma
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico di Roma
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
Country
Italy
Facility Name
Gelre Ziekenhuizen
City
Apeldoorn
State/Province
Gelderland
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
State/Province
Zuid-Holland
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
Country
Netherlands
Facility Name
ETZ-Elisabeth
City
Tilburg
Country
Netherlands
Facility Name
Centrum Onkologii Ziemi Lubelskiej
City
Lublin
State/Province
Lubelskie
Country
Poland
Facility Name
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
City
Gdansk
State/Province
Pomorskie
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o. o.
City
Gdynia
State/Province
Pomorskie
Country
Poland
Facility Name
Malopolskie Centrum Medyczne
City
Krakow
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
City
Wroclaw
Country
Poland
Facility Name
Unidade Local de Saúde de Matosinhos SA
City
Matosinhos
Country
Portugal
Facility Name
Centro Hospitalar de São João, E.P.E.
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António
City
Porto
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
City
Porto
Country
Portugal
Facility Name
Regional Clinical Hospital
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Russian Oncology Research Center n a N N Blokhin
City
Moscow
Country
Russian Federation
Facility Name
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
City Hospital #31
City
Saint Petersburg
Country
Russian Federation
Facility Name
North-West Federal Medical Research Center n.a. V.A. Almazov
City
Saint Petersburg
Country
Russian Federation
Facility Name
Hospital de Cabueñes
City
Gijón
State/Province
Asturias
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme
City
Seville
State/Province
Sevilla
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Barcelona
Country
Spain
Facility Name
Hospital Vall dHebron
City
Barcelona
Country
Spain
Facility Name
ICO L'Hospitalet
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro - CIOCC
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
Country
Spain
Facility Name
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Chi Mei Medical Center, Liouying
City
Liuying
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Gazi Universitesi Tip Fakultesi Hastanesi
City
Ankara
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi
City
Bornova
Country
Turkey
Facility Name
Mersin Universitesi Tip Fakultesi Hastanesi
City
Gaziantep
Country
Turkey
Facility Name
Erciyes Universitesi Tip Fakultesi Hastanesi
City
Kayseri
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
City
Kocaeli
Country
Turkey
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
City
Samsun
Country
Turkey
Facility Name
Namik Kemal Universitesi Tip Fakultesi Hastanesi
City
Tekirdağ
Country
Turkey
Facility Name
Royal Cornwall Hospital - Hospital Treliske
City
Tururo
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
Norfolk
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Facility Name
Barts and The London NHS Trust
City
London
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
Royal Berkshire Hospital NHS Foundation Trust
City
Reading
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

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