Back to resultsA 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
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Placebo
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone (or equivalent)
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Lymphoma, B-cell lymphoma, Non-germinal center B-cell subtype, Diffuse large B-cell lymphoma, Bruton's tyrosine kinase inhibitor, PCI-32765, JNJ-54179060, Ibrutinib, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Eligibility Criteria
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
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Treatment Arm A: placebo + R-CHOP
Treatment Arm B: ibrutinib + R-CHOP
Arm Description
Treatment Arm A = placebo + R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone)
Treatment Arm B = ibrutinib + R-CHOP
Outcomes
Primary Outcome Measures
Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population
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.
Event-Free Survival (EFS) - Activated B-Cell (ABC) Population
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.
Secondary Outcome Measures
Progression-Free Survival (PFS)
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.
Percentage of Participants Who Achieved Complete Response (CR)
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.
Overall Survival
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.
Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
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.
Full Information
NCT ID
NCT01855750
First Posted
May 14, 2013
Last Updated
March 30, 2020
Sponsor
Janssen Research & Development, LLC
Collaborators
Pharmacyclics LLC.
1. Study Identification
Unique Protocol Identification Number
NCT01855750
Brief 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
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2013 (Actual)
Primary Completion Date
February 26, 2018 (Actual)
Study Completion Date
April 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Pharmacyclics LLC.
4. Oversight
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 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.
Detailed Description
This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study to compare the efficacy and safety of ibrutinib in combination with R-CHOP versus R-CHOP alone in adult patients newly diagnosed non-GCB DLBCL selected by IHC or newly diagnosed patients with ABC subtype of DLBCL identified by GEP or both populations. The study will include screening, active treatment, and posttreatment follow-up phases. The study will end when 50% of participants have died or 5 years after the last participant is randomized or the sponsor terminates the study, whichever occurs first. Approximately 800 participants will be randomly assigned in a 1:1 ratio to receive either placebo+R-CHOP (treatment arm A) or ibrutinib+R-CHOP (treatment arm B). All participants will receive R-CHOP as background therapy for 6 or 8 cycles (21 days per cycle) prespecified according to local practice. After 4 treatment cycles, an interim response assessment will be performed to evaluate disease progression for each participant. Participants with progressive disease or relapsed disease after complete response will be discontinued from treatment. Participants who discontinue R-CHOP without disease progression will continue study drug (placebo or ibrutinib) until 6 or 8 cycles are completed, disease progression, or unacceptable toxicity, whichever occurs first. After completion of study drug, participants will undergo assessment of tumor response based on the Revised Response Criteria for Malignant Lymphoma. Participants with documented residual disease upon completion of at least 6 cycles of R-CHOP therapy are considered eligible to initiate subsequent antilymphoma therapy. Serial pharmacokinetic samples will be collected before and after dosing, and safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Lymphoma, B-cell lymphoma, Non-germinal center B-cell subtype, Diffuse large B-cell lymphoma, Bruton's tyrosine kinase inhibitor, PCI-32765, JNJ-54179060, Ibrutinib, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
838 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm A: placebo + R-CHOP
Arm Type
Placebo Comparator
Arm Description
Treatment Arm A = placebo + R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone)
Arm Title
Treatment Arm B: ibrutinib + R-CHOP
Arm Type
Experimental
Arm Description
Treatment Arm B = ibrutinib + R-CHOP
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Intervention Description
560 mg capsules administered by mouth once daily (21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 matched capsules administered by mouth once daily (21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Prednisone (or equivalent)
Intervention Description
100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
Primary Outcome Measure Information:
Title
Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population
Description
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.
Time Frame
Up to 5.5 years
Title
Event-Free Survival (EFS) - Activated B-Cell (ABC) Population
Description
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.
Time Frame
Up to approximately 4.5 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Up to approximately 4.5 years
Title
Percentage of Participants Who Achieved Complete Response (CR)
Description
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.
Time Frame
Up to approximately 4.5 years
Title
Overall Survival
Description
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.
Time Frame
Up to 5.5 years
Title
Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Description
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.
Time Frame
Up to approximately 4.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Greenbrae
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Salinas
State/Province
California
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Danbury
State/Province
Connecticut
Country
United States
City
Hartford
State/Province
Connecticut
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United States
City
Washington
State/Province
District of Columbia
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United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Peoria
State/Province
Illinois
Country
United States
City
Fort Wayne
State/Province
Indiana
Country
United States
City
Goshen
State/Province
Indiana
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Topeka
State/Province
Kansas
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
New Brunswick
State/Province
New Jersey
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Fresh Meadows
State/Province
New York
Country
United States
City
Johnson City
State/Province
New York
Country
United States
City
Mineola
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
North Charleston
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Temple
State/Province
Texas
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Buenos Aires
Country
Argentina
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
City
Ciudad de Buenos Aires
Country
Argentina
City
Adelaide
Country
Australia
City
Concord
Country
Australia
City
Darlinghurst
Country
Australia
City
Hobart
Country
Australia
City
Melbourne
Country
Australia
City
Nedlands
Country
Australia
City
Perth
Country
Australia
City
Randwick
Country
Australia
City
South Brisbane
Country
Australia
City
Woolloongabba
Country
Australia
City
Antwerpen
Country
Belgium
City
Brugge
Country
Belgium
City
Brussel
Country
Belgium
City
Gent
Country
Belgium
City
Haine-saint-paul, LA Louviere
Country
Belgium
City
Kortrijk
Country
Belgium
City
Leuven
Country
Belgium
City
Porto Alegre
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Sao Paulo
Country
Brazil
City
São Paulo
Country
Brazil
City
Edmonton
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Levis
State/Province
Quebec
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Montréal
State/Province
Quebec
Country
Canada
City
Beijing
Country
China
City
Changchun
Country
China
City
Chengdu
Country
China
City
Guangzhou
Country
China
City
Hangzhou
Country
China
City
Harbin
Country
China
City
Jinan
Country
China
City
Nanjing
Country
China
City
Shanghai
Country
China
City
Tianjin
Country
China
City
Brno
Country
Czechia
City
Hradec Kralove
Country
Czechia
City
Ostrava
Country
Czechia
City
Praha 10
Country
Czechia
City
Praha 2
Country
Czechia
City
Aarhus N.
Country
Denmark
City
Copenhagen
Country
Denmark
City
Roskilde
Country
Denmark
City
Vejle
Country
Denmark
City
Helsinki
Country
Finland
City
Jyväskylä
Country
Finland
City
Oulu
Country
Finland
City
Turku
Country
Finland
City
Grenoble Cedex 9
Country
France
City
Limoges
Country
France
City
Paris
Country
France
City
Pessac
Country
France
City
Pierre Benite
Country
France
City
Rouen
Country
France
City
Tours
Country
France
City
Villejuif
Country
France
City
Augsburg
Country
Germany
City
Bamberg
Country
Germany
City
Berlin
Country
Germany
City
Dresden
Country
Germany
City
Essen
Country
Germany
City
Frankfurt
Country
Germany
City
Jena
Country
Germany
City
Muenchen
Country
Germany
City
Münster
Country
Germany
City
Villingen-Schwenningen
Country
Germany
City
Budapest N/a
Country
Hungary
City
Debrecen
Country
Hungary
City
Gyula
Country
Hungary
City
Szombathely
Country
Hungary
City
Veszprém
Country
Hungary
City
Beer-Sheva
Country
Israel
City
Hadera
Country
Israel
City
Haifa
Country
Israel
City
Petah Tikva
Country
Israel
City
Ramat-Gan
Country
Israel
City
Tel Aviv
Country
Israel
City
Fukuoka
Country
Japan
City
Hiroshima
Country
Japan
City
Isehara
Country
Japan
City
Kobe
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Nagano
Country
Japan
City
Nagoya
Country
Japan
City
Narita
Country
Japan
City
Osaka-Sayama
Country
Japan
City
Osaka
Country
Japan
City
Sapporo
Country
Japan
City
Sendai
Country
Japan
City
Suita
Country
Japan
City
Tachikawa
Country
Japan
City
Tokyo
Country
Japan
City
Tsukuba
Country
Japan
City
Busan
Country
Korea, Republic of
City
Goyang-Si
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Mexico
Country
Mexico
City
Monterrey
Country
Mexico
City
San Luis Potosi
Country
Mexico
City
Amsterdam Zuidoost
Country
Netherlands
City
Arnhem
Country
Netherlands
City
Dordrecht
Country
Netherlands
City
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12. IPD Sharing Statement
Citations:
PubMed Identifier
34739844
Citation
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.
Results Reference
derived
PubMed Identifier
30901302
Citation
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.
Results Reference
derived
Learn more about this trial
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
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