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Trial record 6 of 308 for:    IBRUTINIB

Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

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ClinicalTrials.gov Identifier: NCT03731234
Recruitment Status : Not yet recruiting
First Posted : November 6, 2018
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Janssen-Cilag S.p.A.
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:

This is a prospective, multicenter, single arm, phase II trial in patients with ≥ 18 and <80 years with poor-prognosis (IPI ≥ 2) and newly diagnosed ABC-DLBCL.

Aim of the study is to assess the efficacy and the safety of R-CHOP in combination with ibrutinib for 6 cycles followed by ibrutinib maintenance for 18 months in ABC-DLBCL patients achieving at least a PR after the induction phase


Condition or disease Intervention/treatment Phase
DLBCL Drug: Ibrutinib Phase 2

Detailed Description:

Step 1 - Screening phase If central review will confirm and define the diagnosis of ABC-DLBCL according the COO, eligible patients will have to sign an additional informed consent prior to receive the study subsequent treatment.

Step 2 - study treatment phases Induction phase: 5 courses of R-CHOP every 21 days combined with ibrutinib (560 mg/day, continuously).

Maintenance phase: patients achieving a CR or a PR after 5 courses of RI-CHOP21 will enter the maintenance phase with ibrutinib (560 mg/day, continuously) for 18 months.

Radiotherapy could be delivered as consolidation treatment at the end of R-chemotherapy, according to Institution local clinical practice, in patients with focal PET positive residual disease and to bone extranodal lesions or scrotum, if testicular involvement irrespective of initial tumor diameter.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Ibrutinib in combination to rituximab-CHOP followed by ibrutinib maintenance
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicenter Single Arm Study to Evaluate the Efficacy and Safety of Ibrutinib in Combination to Rituximab-CHOP Followed by Ibrutinib Maintenance in Untreated Patients With Activated-B-Cell (ABC)-DLBCL at Intermediate-high and High Risk (IPI ≥2)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ibrutinib

Arm Intervention/treatment
Experimental: Ibrutinib+R-CHOP
Screening phase for selection of Activated-B-Cell (ABC)-DLBCL Induction phase: R-CHOP21 x 5 cycles in combination with ibrutinib Maintenance phase: maintenance with Ibrutinib for 18 months for patients responding to the induction phase (CR or PR)
Drug: Ibrutinib
Ibrutinib in combination to rituximab-CHOP followed by ibrutinib maintenance
Other Name: IMBRUVICA (commercial name)




Primary Outcome Measures :
  1. Progression-free survival (PFS) (1st time point of assessment) [ Time Frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (24 months) ]
    PFS of the high/high-intermediate risk patients from date of enrolment

  2. Progression-free survival (PFS) (2nd time point of assessment) [ Time Frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (36 months) ]
    PFS of the high/high-intermediate risk patients from date of enrolment

  3. Progression-free survival (PFS) (3dr time point of assessment) [ Time Frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (48 months) ]
    PFS of the high/high-intermediate risk patients from date of enrolment


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Time between the date of enrolment and the date of death from any cause (24, 36 and 48 months). ]
    Overall Survival

  2. Complete response and Overall Response (CR+PR) rate at the end of induction [ Time Frame: End of induction (EOI) (4 months) ]
    Complete response and Overall Response

  3. Duration of response (DOR) [ Time Frame: From the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression or death from other causes will be censored at their last assessment date (24 months from response date) ]
    Duration of response

  4. Complete remission (CRR) after ibrutinib maintenance [ Time Frame: End of treatment (EOT) (up to 24 months) ]
    Complete remission after ibrutinib maintenance

  5. Event Free Survival (EFS) [ Time Frame: From the date of enrolment to the date of disease progression, relapse from CR, initiation of subsequent systemic anti-lymphoma therapy after the least 6 cycles of RI-CHOP (each cycle is 21 days), or death whichever occurs first (24, 36 and 48 months) ]
    Event Free Survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Histologically confirmed DLBCL not otherwise specified (NOS)
  • ABC type defined by Lymph2Cx on the NanoString platform. Note: A formalin fixed paraffin embedded lymph node or tumor biopsy specimen must be submitted to Central Pathology for review during the Screening Period. The specimen must have been acquired by a surgical incision or excision biopsy or from a core needle biopsy
  • Previously untreated disease
  • Age ≥ 18 and < 65 years
  • IPI score ≥ 2
  • Ann Arbor stage II-IV disease
  • Measurable disease ≥ 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions
  • Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤2 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥40 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN; International normalized ratio (INR) < 1.5 × the ULN in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) < 1.5 × the ULN in the absence of a lupus anticoagulant
  • Patients with occult or prior hepatitis B infection (defined as HBsAg negative, anti-HBs positive and /or anti-HBc positive) may be included if hepatitis B virus (HBV) DNA is undetectable. These patients must be willing to undergo bi-monthly DNA testing and they should receive prophylaxis with Lamivudine
  • No active hepatitis C virus (HCV) infection
  • Known availability of biopsy material
  • No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma)
  • Absence of active infections
  • No peripheral neuropathy or active neurological non-neoplastic disease of CNS
  • No major surgical intervention prior 3 months to enrolment if not due to lymphoma and/or no other disease life-threatening that can compromise chemotherapy treatment
  • Patient with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study.
  • Patients with any other malignancy that has been treated with surgery alone with curative intent and the malignancy has been in remission without treatment for at least 5 years prior to enrolment.
  • Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [Beta-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
  • Life expectancy > 6 months

EXCLUSION CRITERIA

  • DLBCL including High grade B-cell Lymphomas, both with double hit and NOS according to the 2017 Revised WHO Classification of Tumour of Haematopoietic and Lymphoid Tissues
  • GCB-DLBCL after centralized COO profiling
  • Any other histologies than DLBCL: composite or transformed disease, patients with follicular lymphoma IIIB and large B-cell lymphoma with IRF4 rearrangement.
  • Primary mediastinal lymphoma (PMBL)
  • Known central nervous system lymphoma
  • Primary testicular lymphoma
  • Any prior lymphoma therapy
  • Contraindication to any drug in the chemotherapy regimen
  • Left ventricular ejection fraction (LVEF) < 50%
  • Neuropathy ≥ grade 2
  • Seropositive for or active viral infection with HBV
  • HBsAg positive
  • HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable viral DNA
  • Known seropositive active HCV
  • Human immunodeficiency virus (HIV) infection
  • Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma): creatinine ≥ 2 times the ULN (unless creatinine clearance normal, or calculated creatinine clearance < 40 mL/min (using the Cockcroft-Gault formula); AST or ALT ≥3 × the ULN; total bilirubin >1.5 × the ULN: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN; INR > 1.5 × the ULN in the absence of therapeutic anticoagulation; PTT or aPTT > 1.5 × the ULN in the absence of a lupus anticoagulant"
  • History of stroke or intracranial hemorrhage within the past 6 months.
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong CYP3A inhibitors
  • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
  • 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.
  • Any uncontrolled active systemic infection requiring intravenous (IV) antibiotics
  • Major surgical intervention prior 4 weeks to enrollment if not due to lymphoma and/or other disease life-threatening that can compromise chemotherapy treatment
  • Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
  • If female, the patient is pregnant or breast-feeding

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731234


Contacts
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Contact: Maurizio Martelli, Prof 00390649974779 martelli@bce.uniroma1.it

Locations
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Italy
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia Not yet recruiting
Alessandria, Italy, 15121
Contact: Manuela Zanni, Dott.ssa         
Contact       manuela.zanni@ospedale.al.it   
Principal Investigator: Manuela Zanni, Dott.ssa         
Università Politecnica delle Marche- Clinica di Ematologia Not yet recruiting
Ancona, Italy, 60121
Contact: Guido Gini, Dott.         
Contact       guido.gini@ospedaliriuniti.marche.it   
Principal Investigator: Guido Gini, Dott.         
Centro Riferimento Oncologico- S.O.C. Oncologia Medica A Not yet recruiting
Aviano, Italy, 33081
Contact: Michele Spina, Dott.         
Contact       mspina@cro.it   
Principal Investigator: Michele Spina, Dott.         
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia Not yet recruiting
Bari, Italy, 70121
Contact: Attilio Guarini, Dott.         
Contact       attilioguarini@oncologico.bari.it   
Principal Investigator: Attilio Guarini, Dott.         
Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli" Not yet recruiting
Bologna, Italy, 40121
Contact: Pier Luigi Zinzani, Prof.         
Contact       pierluigi.zinzani@unibo.it   
Principal Investigator: Pier Luigi Zinzani, Prof.         
Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O. Not yet recruiting
Bolzano, Italy, 39100
Contact: Micheal Mian, Dott.         
Contact       micheal.mian@asbz.it   
Principal Investigator: Michael Mian, Dott.         
ASST Spedali Civili di Brescia - Ematologia Not yet recruiting
Brescia, Italy, 25123
Contact: Alessandra Tucci, Dott.ssa         
Contact       alessandra.tucci@asst-spedalicivili.it   
Principal Investigator: Alessandra Tucci, Dott.ssa         
Ospedale Businco - SC Ematologia e CTMO Not yet recruiting
Cagliari, Italy, 09121
Contact: Maria Giuseppina Cabras, Dott.ssa         
Contact       cabras.giuseppina@tiscali.it   
Principal Investigator: Maria Giuseppina Cabras, Dott.ssa         
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia Not yet recruiting
Catania, Italy, 95123
Contact: Ugo Consoli, Dott.         
Contact       ugo.consoli@tin.it   
Principal Investigator: Ugo Consoli, Dott.         
Azienda Ospedaliera di Cosenza - UOC Ematologia Not yet recruiting
Cosenza, Italy, 87100
Contact: Massimo Gentile, Dott.         
Contact       massimogentile@virgilio.it   
Principal Investigator: Massimo Gentile, Dott.         
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia Not yet recruiting
Firenze, Italy, 50141
Contact: Benedetta Puccini, Dott.ssa         
Contact       benedettapuccini@virgilio.it   
Principal Investigator: Benedetta Puccini, Dott.ssa         
Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia - Ematologia Not yet recruiting
Genova, Italy
Contact: Chiara Ghiggi, MD         
Contact       chiara.ghiggi@hsanmartino.it   
Principal Investigator: Chiara Ghiggi, MD         
Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia Not yet recruiting
Messina, Italy, 98158
Contact: Donato Mannina, Dott.         
Contact       donamanni@gmail.com   
Principal Investigator: Donato Mannina, Dott.         
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia Not yet recruiting
Milano, Italy, 20132
Contact: Andres Ferreri, Dott.         
Contact       andres.ferreri@hsr.it   
Principal Investigator: Andres Ferreri, Dott.         
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia Not yet recruiting
Milano, Italy, 20133
Contact: Paolo Corradini, Prof.         
Contact       paolo.corradini@unimi.it   
Principal Investigator: Paolo Corradini, Prof.         
IEO Istitito Europeo di Oncologia - Divisione Ematoncologia Not yet recruiting
Milano, Italy, 20141
Contact: Corrado Tarella, Prof.         
Contact       corrado.tarella@ieo.it   
Principal Investigator: Corrado Tarella, Prof.         
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia Not yet recruiting
Milano, Italy, 20162
Contact: Chiara Rusconi, Dott.ssa         
Contact       chiara.rusconi@ospedaleniguarda.it   
Principal Investigator: Chiara Rusconi, Dott.ssa         
Azienda Ospedaliero-Universitaria Policlinico di Modena - Ematologia Not yet recruiting
Modena, Italy, 41123
Contact: Giovanna Leonardi, Dott.ssa         
Contact       leonardi.giovanna@policlinico.mo.it   
Principal Investigator: Giovanna Leonardi, Dott.ssa         
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica Not yet recruiting
Napoli, Italy, 80131
Contact: Antonio Pinto, Dott.         
Contact       apinto.int.napoli@tin.it   
Principal Investigator: Antonio Pinto, Dott.         
AOU Maggiore della Carità di Novara - SCDU Ematologia Not yet recruiting
Novara, Italy, 28100
Contact: Gianluca Gaidano, Prof.         
Contact       gaidano@med.uniupo.it   
Principal Investigator: Gianluca Gaidano, Prof.         
AOU di Padova - Ematologia Not yet recruiting
Padova, Italy, 35121
Contact: Francesco Piazza, Dott.         
Contact       francesco.piazza@unipd.it   
Principal Investigator: Francesco Piazza, Dott.         
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia Not yet recruiting
Pavia, Italy, 27100
Contact: Luca Arcaini, Dott.         
Contact       luca.arcaini@unipv.it   
Principal Investigator: Luca Arcaini, Dott.         
Ospedale S. Maria della Misericordia - Ematologia Not yet recruiting
Perugia, Italy, 06129
Contact: Leonardo Flenghi, Dott.         
Contact       flenghi@yahoo.it   
Principal Investigator: Leonardo Flenghi, Dott.         
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi Not yet recruiting
Pescara, Italy, 65124
Contact: Francesco Angrilli, Dott.         
Contact       f.angrilli54@gmail.com   
Principal Investigator: Francesco Angrilli, Dott.         
Ospedale Guglielmo da Saliceto - U.O.Ematologia Not yet recruiting
Piacenza, Italy, 29121
Contact: Annalisa Arcari, Dott.ssa         
Contact       a.arcari@ausl.pc.it   
Principal Investigator: Annalisa Arcari, Dott.ssa         
AOU Pisana - U.O. Ematologia Not yet recruiting
Pisa, Italy, 56126
Contact: Mario Petrini, Prof.         
Contact       mario.petrini@med.unipi.it   
Principal Investigator: Mario Petrini, Prof.         
A.O.R. "San Carlo" - U.O. Ematologia Not yet recruiting
Potenza, Italy, 85100
Contact: Michele Cimminiello, Dott.         
Contact       miki-doc@virgilio.it   
Principal Investigator: Michele Cimminiello, Dott.         
Ospedale delle Croci - Ematologia Not yet recruiting
Ravenna, Italy
Contact: Monica Tani, MD         
Contact       monica.tani@auslromagna.it   
Principal Investigator: Monica Tani, MD         
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia - Not yet recruiting
Reggio Emilia, Italy, 42123
Contact: Francesco Merli, Dott.         
Contact       merli.francesco@ausl.re.it   
Principal Investigator: Francesco Merli, Dott.         
Ospedale degli Infermi di Rimini - U.O. di Ematologia Not yet recruiting
Rimini, Italy, 47923
Contact: Anna Lia Molinari, Dott.ssa         
Contact       annalia.molinari@auslromagna.it   
Principal Investigator: Anna Lia Molinari, Dott.ssa         
AO Sant'Andrea - Ematologia Not yet recruiting
Roma, Italy, 00183
Contact: Agostino Tafuri, Dott.         
Contact       agostino.tafuri@ospedalesantandrea.it   
Principal Investigator: Agostino Tafuri, Dott.         
Dipartimento di Medicina Traslazionale e di Precisione, Università 'La Sapienza' Not yet recruiting
Roma, Italy
Contact: Maurizio Martelli, Prof         
Contact       martelli@bce.uniroma1.it   
Principal Investigator: Maurizio Martelli, Prof         
Ospedale S. Camillo - Ematologia Not yet recruiting
Roma, Italy
Contact: Roberta Battistina, MD         
Contact       rbattistini@scamilloforlanini.rm.it   
Principal Investigator: Roberta Battistini, MD         
Università Cattolica S. Cuore - Ematologia Not yet recruiting
Roma, Italy
Contact: Stefan Hohaus, Prof         
Contact       stefan.hohaus@Unicatt.it   
Principal Investigator: Stefan Hohaus, MD         
Istituto Clinico Humanitas - U.O. Ematologia Not yet recruiting
Rozzano, Italy, 20089
Contact: Monica Balzarotti, Dott.ssa         
Contact       monica.balzarotti@carcercenter.humanitas.it   
Principal Investigator: Monica Balzarotti, Dott.ssa         
Casa Sollievo della Sofferenza - UO Ematologia Not yet recruiting
San Giovanni Rotondo, Italy
Contact: Nicola Cascavilla, MD         
Contact       n.cascavilla@operapadrepio.it   
Principal Investigator: Nicola Cascavilla, MD         
A.O. S. Maria di Terni - S.C. Oncoematologia Not yet recruiting
Terni, Italy
Contact: Anna Marina Liberati, Prof         
Contact       marina.liberati@unipg.it   
Principal Investigator: Anna Marina Liberati         
A.O.U. Citta della Salute e della Scienza di Torino - Centro Ematologia Universitaria Not yet recruiting
Torino, Italy, 10126
Contact: Federica Cavallo, Dott.ssa         
Contact       f.cavallo@unito.it   
Principal Investigator: Federica Cavallo, Dott.ssa         
A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia Not yet recruiting
Torino, Italy, 10126
Contact: Annalisa Chiappella, Dott.ssa         
Contact       achiappella@cittadellasalute.to.it   
Principal Investigator: Annalisa Chiappella, Dott.ssa         
A.O. C. Panico - U.O.C Ematologia e Trapianto Not yet recruiting
Tricase, Italy, 73039
Contact: Vincenzo Pavone, Dott.         
Contact       salentoematologia@piafondazionepanico.it   
Principal Investigator: Vincenzo Pavone, Dott.         
Azienda Sanitaria Universitaria Integrata Trieste (ASUITS) SC Ematologia Not yet recruiting
Trieste, Italy
Contact: Francesco Zaja, Prof         
Contact       francesco.zaja@asuits.sanita.fvg.it   
Principal Investigator: Francesco Zaja, Prof         
Ospedale Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine)-SOC Clinica Ematologica Not yet recruiting
Udine, Italy, 33100
Contact: Jacopo Olivieri, Dott.         
Contact       jacopo.olivieri@hotmail.it   
Principal Investigator: Jacopo Olivieri, Dott.         
Ospedale di Circolo U.O.C Ematologia Not yet recruiting
Varese, Italy
Contact: Michele Merli, MD         
Contact       michelepavia@hotmail.com   
Principal Investigator: Michele Merli, MD         
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia Not yet recruiting
Vicenza, Italy, 36100
Contact: Carlo Visco, Dott.         
Contact       carlovisco@hotmail.com   
Principal Investigator: Carlo Visco, Dott.         
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Janssen-Cilag S.p.A.
Investigators
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Principal Investigator: Maurizio Martelli, Prof. Dipartimento di Medicina Traslazionale e di Precisione, Università 'La Sapienza'

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Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT03731234     History of Changes
Other Study ID Numbers: FIL_RI-CHOP
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondazione Italiana Linfomi ONLUS:
DLBCL
Activated-B-Cell DLBCL
Ibrutinib
Phase II