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
NCT ID: NCT01855750
Last Updated: 2025-02-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
838 participants
INTERVENTIONAL
2013-09-03
2019-04-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma
NCT01974440
Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT01325701
A Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With CD20-Positive B-Cell Non Hodgkin Lymphoma
NCT01569750
A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma
NCT01779791
Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT02077166
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Arm A: placebo + R-CHOP
Treatment Arm A = placebo + R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone)
Placebo
4 matched capsules administered by mouth once daily (21-day cycles)
Rituximab
375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Cyclophosphamide
750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Doxorubicin
50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Vincristine
1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Prednisone (or equivalent)
100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
Treatment Arm B: ibrutinib + R-CHOP
Treatment Arm B = ibrutinib + R-CHOP
Ibrutinib
560 mg capsules administered by mouth once daily (21-day cycles)
Rituximab
375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Cyclophosphamide
750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Doxorubicin
50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Vincristine
1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Prednisone (or equivalent)
100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ibrutinib
560 mg capsules administered by mouth once daily (21-day cycles)
Placebo
4 matched capsules administered by mouth once daily (21-day cycles)
Rituximab
375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Cyclophosphamide
750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Doxorubicin
50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Vincristine
1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Prednisone (or equivalent)
100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pharmacyclics LLC.
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Osaka, , Japan
Tucson, Arizona, United States
Greenbrae, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Salinas, California, United States
Stanford, California, United States
Danbury, Connecticut, United States
Hartford, Connecticut, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Peoria, Illinois, United States
Fort Wayne, Indiana, United States
Goshen, Indiana, United States
Indianapolis, Indiana, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
New Brunswick, New Jersey, United States
Fresh Meadows, New York, United States
Johnson City, New York, United States
Mineola, New York, United States
New York, New York, United States
Rochester, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Hickory, North Carolina, United States
Columbus, Ohio, United States
Portland, Oregon, United States
North Charleston, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Temple, Texas, United States
Burlington, Vermont, United States
Seattle, Washington, United States
Buenos Aires, , Argentina
Ciudad de Buenos Aires, , Argentina
Adelaide, , Australia
Concord, , Australia
Darlinghurst, , Australia
Hobart, , Australia
Melbourne, , Australia
Nedlands, , Australia
Perth, , Australia
Randwick, , Australia
South Brisbane, , Australia
Woolloongabba, , Australia
Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Haine Saint Paul La Louviere, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Lévis, Quebec, Canada
Montreal, Quebec, Canada
Beijing, , China
Changchun, , China
Chengdu, , China
Guangzhou, , China
Hangzhou, , China
Harbin, , China
Jinan, , China
Nanjing, , China
Shanghai, , China
Tianjin, , China
Brno, , Czechia
Hradec Králové, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Aarhus N, , Denmark
Copenhagen, , Denmark
Roskilde, , Denmark
Vejle, , Denmark
Helsinki, , Finland
Jyväskylä, , Finland
Oulu, , Finland
Turku, , Finland
Grenoble, , France
Limoges, , France
Paris, , France
Pessac, , France
Pierre-Bénite, , France
Rouen, , France
Tours, , France
Villejuif, , France
Augsburg, , Germany
Bamberg, , Germany
Berlin, , Germany
Dresden, , Germany
Essen, , Germany
Frankfurt, , Germany
Jena, , Germany
München, , Germany
Münster, , Germany
Villingen-Schwenningen, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Szombathely, , Hungary
Veszprém, , Hungary
Beersheba, , Israel
Hadera, , Israel
Haifa, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Fukuoka, , Japan
Hiroshima, , Japan
Isehara, , Japan
Kobe, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Nagano, , Japan
Nagoya, , Japan
Narita, , Japan
Ōsaka-sayama, , Japan
Sapporo, , Japan
Sendai, , Japan
Suita, , Japan
Tachikawa, , Japan
Tokyo, , Japan
Tsukuba, , Japan
México, , Mexico
Monterrey, , Mexico
San Luis Potosí City, , Mexico
Amsterdam-Zuidoost, , Netherlands
Arnhem, , Netherlands
Dordrecht, , Netherlands
Groningen, , Netherlands
Leiden, , Netherlands
Nieuwegein, , Netherlands
Rotterdam, , Netherlands
Oslo, , Norway
Tromsø, , Norway
Brzozów, , Poland
Chorzów, , Poland
Krakow, , Poland
Lodz, , Poland
Olsztyn, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Moscow, , Russia
Nizhny Novgorod, , Russia
Rostov-on-Don, , Russia
Saint Petersburg, , Russia
Sochi, , Russia
Volgograd, , Russia
Yekaterinburg, , Russia
Busan, , South Korea
Goyang-si, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Madrid, , Spain
Salamanca, , Spain
Seville, , Spain
Linköping, , Sweden
Luleå, , Sweden
Lund, , Sweden
Uppsala, , Sweden
Taichung, , Taiwan
Tainan City, , Taiwan
Taoyuan, , Taiwan
Adana, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kayseri, , Turkey (Türkiye)
Samsun, , Turkey (Türkiye)
Cherkassy, , Ukraine
Khmelnitskiy, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Makiivka, , Ukraine
Glasgow, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Maidstone, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Oxford, , United Kingdom
Romford, , United Kingdom
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024.
Johnson PWM, Balasubramanian S, Hodkinson B, Shreeve SM, Sun S, Srinivasan S, Steele AJ, Vermeulen J, Sehn LH, Wilson WH. Clinical impact of ibrutinib plus R-CHOP in untreated DLBCL coexpressing BCL2 and MYC in the phase 3 PHOENIX trial. Blood Adv. 2023 May 23;7(10):2008-2017. doi: 10.1182/bloodadvances.2022009389.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PCI-32765DBL3001
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1139-6222
Identifier Type: OTHER
Identifier Source: secondary_id
2013-000959-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR102118
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.