Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01855750
Registration number
NCT01855750
Ethics application status
Date submitted
14/05/2013
Date registered
16/05/2013
Date last updated
13/04/2020
Titles & IDs
Public title
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
Query!
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
Query!
Secondary ID [1]
0
0
PCI-32765DBL3001
Query!
Secondary ID [2]
0
0
CR102118
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ibrutinib
Treatment: Drugs - Placebo
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone (or equivalent)
Placebo comparator: Treatment Arm A: placebo + R-CHOP - Treatment Arm A = placebo + R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone)
Experimental: Treatment Arm B: ibrutinib + R-CHOP - Treatment Arm B = ibrutinib + R-CHOP
Treatment: Drugs: Ibrutinib
560 mg capsules administered by mouth once daily (21-day cycles)
Treatment: Drugs: Placebo
4 matched capsules administered by mouth once daily (21-day cycles)
Treatment: Drugs: Rituximab
375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Treatment: Drugs: Cyclophosphamide
750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Treatment: Drugs: Doxorubicin
50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Treatment: Drugs: Vincristine
1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Treatment: Drugs: Prednisone (or equivalent)
100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population
Query!
Assessment method [1]
0
0
EFS: duration from randomization date to disease progression(PD) date, relapse from complete response(CR) assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either positron emission tomography(PET)-positive/ biopsy-proven residual disease upon completion of \>=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in sum of product of diameters(SPD) of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.
Query!
Timepoint [1]
0
0
Up to 5.5 years
Query!
Primary outcome [2]
0
0
Event-Free Survival (EFS) - Activated B-Cell (ABC) Population
Query!
Assessment method [2]
0
0
EFS: duration from randomization date to PD date, relapse from CR assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either PET-positive/ biopsy-proven residual disease upon completion of \>=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.
Query!
Timepoint [2]
0
0
Up to approximately 4.5 years
Query!
Secondary outcome [1]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [1]
0
0
PFS was defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD): any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 centimeter (cm) in any axis, 50% increase in SPD of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.
Query!
Timepoint [1]
0
0
Up to approximately 4.5 years
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Achieved Complete Response (CR)
Query!
Assessment method [2]
0
0
Percentage of participants with measurable disease who achieved CR were reported. CR: disappearance of all evidence of disease. CR Criteria: Complete disappearance of all disease-related symptoms; all lymph nodes and nodal masses regressed to normal size (less than or equal to \[\<=\]1.5 cm in greatest transverse diameter \[GTD\] for nodes greater than \[\>\]1.5 cm before therapy). Previous nodes of 1.1 to 1.5 cm in long axis and greater than (\>)1.0 cm in short axis before treatment decreased to \<=1.0 cm in short axis after treatment. Disappearance of all splenic and hepatic nodules and other extranodal disease; a negative positron emission tomography (PET) scan. A posttreatment residual mass of any size but PET-negative; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.
Query!
Timepoint [2]
0
0
Up to approximately 4.5 years
Query!
Secondary outcome [3]
0
0
Overall Survival
Query!
Assessment method [3]
0
0
Overall survival was defined as the duration from the date of randomization to the date of the participant's death. Median Overall Survival was estimated by using the Kaplan-Meier method.
Query!
Timepoint [3]
0
0
Up to 5.5 years
Query!
Secondary outcome [4]
0
0
Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Query!
Assessment method [4]
0
0
Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.
Query!
Timepoint [4]
0
0
Up to approximately 4.5 years
Query!
Eligibility
Key inclusion criteria
* No prior treatment for diffuse B-cell lymphoma (DLBCL)
* Histologically-confirmed non-germinal center B-cell subtype DLBCL
* Stage II (not candidates for local x-ray therapy), III, or IV disease by the Ann Arbor Classification
* At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
* Revised International Prognostic Index score of >=1
* Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2
* Hematology and biochemical laboratory values within protocol-defined parameters prior to random assignment and at baseline
* Left ventricular ejection fraction within institutional normal limits, as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan
* Agrees to protocol-defined use of effective contraception (for women, these restrictions apply for 12 months after the last dose of rituximab or 1 month after the last dose of study drug, whichever is later; for men, these restrictions apply for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later)
* Men must agree to not donate sperm during and after the study for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later
* Women of childbearing potential must have a negative serum or urine pregnancy test at screening
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Major surgery within 4 weeks of random assignment
* Known central nervous system or primary mediastinal lymphoma
* Prior history of indolent lymphoma
* Diagnosed or treated for malignancy other than DLBCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease
* History of stroke or intracranial hemorrhage within 6 months prior to random assignment
* Requires anticoagulation with warfarin or equivalent vitamin K antagonists
* Requires treatment with strong CYP3A inhibitors
* Prior anthracycline use >=150 mg/m2
* Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
* Known history of human immunodeficiency virus or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics
* Women who are pregnant or breastfeeding
* Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/09/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
5/04/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
838
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Concord
Query!
Recruitment hospital [3]
0
0
- Darlinghurst
Query!
Recruitment hospital [4]
0
0
- Hobart
Query!
Recruitment hospital [5]
0
0
- Melbourne
Query!
Recruitment hospital [6]
0
0
- Nedlands
Query!
Recruitment hospital [7]
0
0
- Perth
Query!
Recruitment hospital [8]
0
0
- Randwick
Query!
Recruitment hospital [9]
0
0
- South Brisbane
Query!
Recruitment hospital [10]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
- Adelaide
Query!
Recruitment postcode(s) [2]
0
0
- Concord
Query!
Recruitment postcode(s) [3]
0
0
- Darlinghurst
Query!
Recruitment postcode(s) [4]
0
0
- Hobart
Query!
Recruitment postcode(s) [5]
0
0
- Melbourne
Query!
Recruitment postcode(s) [6]
0
0
- Nedlands
Query!
Recruitment postcode(s) [7]
0
0
- Perth
Query!
Recruitment postcode(s) [8]
0
0
- Randwick
Query!
Recruitment postcode(s) [9]
0
0
- South Brisbane
Query!
Recruitment postcode(s) [10]
0
0
- Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nebraska
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oregon
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Vermont
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Washington
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Buenos Aires
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Ciudad Autonoma de Buenos Aires
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Ciudad de Buenos Aires
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Antwerpen
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Brugge
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Brussel
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Gent
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Haine-saint-paul, LA Louviere
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Kortrijk
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Leuven
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Porto Alegre
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Rio de Janeiro
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Sao Paulo
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
São Paulo
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Alberta
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
British Columbia
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Nova Scotia
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Ontario
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Quebec
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Beijing
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Changchun
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Chengdu
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Guangzhou
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Hangzhou
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Harbin
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Jinan
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Nanjing
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Shanghai
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Tianjin
Query!
Country [55]
0
0
Czechia
Query!
State/province [55]
0
0
Brno
Query!
Country [56]
0
0
Czechia
Query!
State/province [56]
0
0
Hradec Kralove
Query!
Country [57]
0
0
Czechia
Query!
State/province [57]
0
0
Ostrava
Query!
Country [58]
0
0
Czechia
Query!
State/province [58]
0
0
Praha 10
Query!
Country [59]
0
0
Czechia
Query!
State/province [59]
0
0
Praha 2
Query!
Country [60]
0
0
Denmark
Query!
State/province [60]
0
0
Aarhus N.
Query!
Country [61]
0
0
Denmark
Query!
State/province [61]
0
0
Copenhagen
Query!
Country [62]
0
0
Denmark
Query!
State/province [62]
0
0
Roskilde
Query!
Country [63]
0
0
Denmark
Query!
State/province [63]
0
0
Vejle
Query!
Country [64]
0
0
Finland
Query!
State/province [64]
0
0
Helsinki
Query!
Country [65]
0
0
Finland
Query!
State/province [65]
0
0
Jyväskylä
Query!
Country [66]
0
0
Finland
Query!
State/province [66]
0
0
Oulu
Query!
Country [67]
0
0
Finland
Query!
State/province [67]
0
0
Turku
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Grenoble Cedex 9
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Limoges
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Paris
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Pessac
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Pierre Benite
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Rouen
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Tours
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Villejuif
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Augsburg
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Bamberg
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Berlin
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Dresden
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Essen
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Frankfurt
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Jena
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Muenchen
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Münster
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Villingen-Schwenningen
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Budapest N/a
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Debrecen
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Gyula
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Szombathely
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Veszprém
Query!
Country [91]
0
0
Israel
Query!
State/province [91]
0
0
Beer-Sheva
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Hadera
Query!
Country [93]
0
0
Israel
Query!
State/province [93]
0
0
Haifa
Query!
Country [94]
0
0
Israel
Query!
State/province [94]
0
0
Petah Tikva
Query!
Country [95]
0
0
Israel
Query!
State/province [95]
0
0
Ramat-Gan
Query!
Country [96]
0
0
Israel
Query!
State/province [96]
0
0
Tel Aviv
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Fukuoka
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Hiroshima
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Isehara
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Kobe
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Kumamoto
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Kyoto
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Nagano
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Nagoya
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Narita
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Osaka-Sayama
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Osaka
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Sapporo
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Sendai
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Suita
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Tachikawa
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Tokyo
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Tsukuba
Query!
Country [114]
0
0
Korea, Republic of
Query!
State/province [114]
0
0
Busan
Query!
Country [115]
0
0
Korea, Republic of
Query!
State/province [115]
0
0
Goyang-Si
Query!
Country [116]
0
0
Korea, Republic of
Query!
State/province [116]
0
0
Seoul
Query!
Country [117]
0
0
Mexico
Query!
State/province [117]
0
0
Mexico
Query!
Country [118]
0
0
Mexico
Query!
State/province [118]
0
0
Monterrey
Query!
Country [119]
0
0
Mexico
Query!
State/province [119]
0
0
San Luis Potosi
Query!
Country [120]
0
0
Netherlands
Query!
State/province [120]
0
0
Amsterdam Zuidoost
Query!
Country [121]
0
0
Netherlands
Query!
State/province [121]
0
0
Arnhem
Query!
Country [122]
0
0
Netherlands
Query!
State/province [122]
0
0
Dordrecht
Query!
Country [123]
0
0
Netherlands
Query!
State/province [123]
0
0
Groningen
Query!
Country [124]
0
0
Netherlands
Query!
State/province [124]
0
0
Leiden
Query!
Country [125]
0
0
Netherlands
Query!
State/province [125]
0
0
Nieuwegein
Query!
Country [126]
0
0
Netherlands
Query!
State/province [126]
0
0
Rotterdam
Query!
Country [127]
0
0
Norway
Query!
State/province [127]
0
0
Oslo
Query!
Country [128]
0
0
Norway
Query!
State/province [128]
0
0
Tromso
Query!
Country [129]
0
0
Poland
Query!
State/province [129]
0
0
Brzozow
Query!
Country [130]
0
0
Poland
Query!
State/province [130]
0
0
Chorzów
Query!
Country [131]
0
0
Poland
Query!
State/province [131]
0
0
Krakow
Query!
Country [132]
0
0
Poland
Query!
State/province [132]
0
0
Lodz
Query!
Country [133]
0
0
Poland
Query!
State/province [133]
0
0
Olsztyn
Query!
Country [134]
0
0
Poland
Query!
State/province [134]
0
0
Poznan
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Warszawa
Query!
Country [136]
0
0
Poland
Query!
State/province [136]
0
0
Wroclaw
Query!
Country [137]
0
0
Russian Federation
Query!
State/province [137]
0
0
Ekaterinburg
Query!
Country [138]
0
0
Russian Federation
Query!
State/province [138]
0
0
Moscow
Query!
Country [139]
0
0
Russian Federation
Query!
State/province [139]
0
0
Nizhny Novgorod
Query!
Country [140]
0
0
Russian Federation
Query!
State/province [140]
0
0
Rostov-Na-Donu
Query!
Country [141]
0
0
Russian Federation
Query!
State/province [141]
0
0
Saint-Petersburg,
Query!
Country [142]
0
0
Russian Federation
Query!
State/province [142]
0
0
Sochi
Query!
Country [143]
0
0
Russian Federation
Query!
State/province [143]
0
0
St. Petersburg
Query!
Country [144]
0
0
Russian Federation
Query!
State/province [144]
0
0
Volgograd
Query!
Country [145]
0
0
Spain
Query!
State/province [145]
0
0
Barcelona
Query!
Country [146]
0
0
Spain
Query!
State/province [146]
0
0
Madrid
Query!
Country [147]
0
0
Spain
Query!
State/province [147]
0
0
Salamanca
Query!
Country [148]
0
0
Spain
Query!
State/province [148]
0
0
Sevilla
Query!
Country [149]
0
0
Sweden
Query!
State/province [149]
0
0
Linköping
Query!
Country [150]
0
0
Sweden
Query!
State/province [150]
0
0
Luleå
Query!
Country [151]
0
0
Sweden
Query!
State/province [151]
0
0
Lund
Query!
Country [152]
0
0
Sweden
Query!
State/province [152]
0
0
Uppsala
Query!
Country [153]
0
0
Taiwan
Query!
State/province [153]
0
0
Taichung
Query!
Country [154]
0
0
Taiwan
Query!
State/province [154]
0
0
Tainan
Query!
Country [155]
0
0
Taiwan
Query!
State/province [155]
0
0
Taoyuan County
Query!
Country [156]
0
0
Turkey
Query!
State/province [156]
0
0
Adana
Query!
Country [157]
0
0
Turkey
Query!
State/province [157]
0
0
Ankara
Query!
Country [158]
0
0
Turkey
Query!
State/province [158]
0
0
Istanbul
Query!
Country [159]
0
0
Turkey
Query!
State/province [159]
0
0
Izmir
Query!
Country [160]
0
0
Turkey
Query!
State/province [160]
0
0
Kayseri
Query!
Country [161]
0
0
Turkey
Query!
State/province [161]
0
0
Samsun
Query!
Country [162]
0
0
Ukraine
Query!
State/province [162]
0
0
Cherkassy
Query!
Country [163]
0
0
Ukraine
Query!
State/province [163]
0
0
Khmelnitskiy
Query!
Country [164]
0
0
Ukraine
Query!
State/province [164]
0
0
Kiev
Query!
Country [165]
0
0
Ukraine
Query!
State/province [165]
0
0
Lviv
Query!
Country [166]
0
0
Ukraine
Query!
State/province [166]
0
0
Makiivka
Query!
Country [167]
0
0
United Kingdom
Query!
State/province [167]
0
0
Glasgow
Query!
Country [168]
0
0
United Kingdom
Query!
State/province [168]
0
0
Liverpool
Query!
Country [169]
0
0
United Kingdom
Query!
State/province [169]
0
0
London
Query!
Country [170]
0
0
United Kingdom
Query!
State/province [170]
0
0
Maidstone
Query!
Country [171]
0
0
United Kingdom
Query!
State/province [171]
0
0
Manchester
Query!
Country [172]
0
0
United Kingdom
Query!
State/province [172]
0
0
Nottingham
Query!
Country [173]
0
0
United Kingdom
Query!
State/province [173]
0
0
Oxford
Query!
Country [174]
0
0
United Kingdom
Query!
State/province [174]
0
0
Romford
Query!
Country [175]
0
0
United Kingdom
Query!
State/province [175]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Pharmacyclics LLC.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01855750
Query!
Trial related presentations / publications
Wilson WH, Wright GW, Huang DW, Hodkinson B, Balasubramanian S, Fan Y, Vermeulen J, Shreeve M, Staudt LM. Effect of ibrutinib with R-CHOP chemotherapy in genetic subtypes of DLBCL. Cancer Cell. 2021 Dec 13;39(12):1643-1653.e3. doi: 10.1016/j.ccell.2021.10.006. Epub 2021 Nov 4. Younes A, Sehn LH, Johnson P, Zinzani PL, Hong X, Zhu J, Patti C, Belada D, Samoilova O, Suh C, Leppa S, Rai S, Turgut M, Jurczak W, Cheung MC, Gurion R, Yeh SP, Lopez-Hernandez A, Duhrsen U, Thieblemont C, Chiattone CS, Balasubramanian S, Carey J, Liu G, Shreeve SM, Sun S, Zhuang SH, Vermeulen J, Staudt LM, Wilson W; PHOENIX investigators. Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non-Germinal Center B-Cell Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2019 May 20;37(15):1285-1295. doi: 10.1200/JCO.18.02403. Epub 2019 Mar 22.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/50/NCT01855750/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/50/NCT01855750/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01855750
Download to PDF