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New drug combo shows promise for aggressive lymphoma patients

NCT ID NCT03731234

Disease control Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study tests whether adding the targeted drug ibrutinib to standard chemotherapy (R-CHOP) helps people with a hard-to-treat type of lymphoma called ABC-DLBCL. About 75 adults aged 18-65 with a poor prognosis will receive the combo for 6 cycles, then take ibrutinib alone for 18 months to keep the cancer from coming back. The main goal is to see how long patients live without their disease getting worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA * Histologically confirmed DLBCL not otherwise specified (NOS). Patients with follicular lymphoma IIIB and large B-cell lymphoma with IRF4 rearrangement can be also included. * 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. * No previous malignancies or 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 or patients with any other malignancy 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 * Written informed consent from the patient stating understanding of the purpose and procedures required by the study and willingness to take part in the study 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. * 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 other medical or psychological condition that might preclude participation in the study or impair the patient's ability to give informed consent. * 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

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma diffuse large B-cell lymphoma activated B-cell type follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DLBCL

Contacts and locations

Locations

  • A.O. C. Panico - U.O.C Ematologia e Trapianto

    Tricase, 73039, Italy

  • A.O. S. Maria di Terni - S.C. Oncoematologia

    Terni, Italy

  • A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia

    Alessandria, 15121, Italy

  • A.O.R. "San Carlo" - U.O. Ematologia

    Potenza, 85100, Italy

  • A.O.U. Citta della Salute e della Scienza di Torino - Centro Ematologia Universitaria

    Torino, 10126, Italy

  • A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia

    Torino, 10126, Italy

  • AOU Maggiore della Carità di Novara - SCDU Ematologia

    Novara, 28100, Italy

  • AOU Pisana - U.O. Ematologia

    Pisa, 56126, Italy

  • ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

    Milan, 20162, Italy

  • ASST Spedali Civili di Brescia - Ematologia

    Brescia, 25123, Italy

  • Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia

    Catania, 95123, Italy

  • Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia

    Messina, 98158, Italy

  • Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

    Avellino, 83100, Italy

  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Florence, 50141, Italy

  • Azienda Ospedaliero-Universitaria Policlinico di Modena - Ematologia

    Modena, 41123, Italy

  • Azienda Sanitaria Universitaria Integrata Trieste (ASUITS) SC Ematologia

    Trieste, Italy

  • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia -

    Reggio Emilia, 42123, Italy

  • Casa Sollievo della Sofferenza - UO Ematologia

    San Giovanni Rotondo, Italy

  • Centro Riferimento Oncologico- S.O.C. Oncologia Medica A

    Aviano, 33081, Italy

  • Dipartimento di Medicina Traslazionale e di Precisione, Università 'La Sapienza'

    Roma, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia

    Milan, 20133, Italy

  • I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

    Padova, 35128, Italy

  • IEO Istitito Europeo di Oncologia - Divisione Ematoncologia

    Milan, 20141, Italy

  • IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia

    Bari, 70121, Italy

  • IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

    Pavia, 27100, Italy

  • Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica

    Naples, 80131, Italy

  • Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia

    Milan, 20132, Italy

  • Monza - Fondazione IRCCS San Gerardo dei Tintori - Ematologia

    Monza, 20900, Italy

  • Ospedale Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine)-SOC Clinica Ematologica

    Udine, 33100, Italy

  • Ospedale Businco - SC Ematologia e CTMO

    Cagliari, 09121, Italy

  • Ospedale Guglielmo da Saliceto - U.O.Ematologia

    Piacenza, 29121, Italy

  • Ospedale Policlinico San Martino S.S.R.L- IRCCS per l'Oncologia - Ematologia

    Genova, 16132, Italy

  • Ospedale degli Infermi di Rimini - U.O. di Ematologia

    Rimini, 47923, Italy

  • Ospedale delle Croci - Ematologia

    Ravenna, Italy

  • Ospedale di Castelfranco Veneto - Oncoematologia IOV

    Castelfranco Veneto, Treviso, 31033, Italy

  • Ospedale di Circolo U.O.C Ematologia

    Varese, Italy

  • P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi

    Pescara, 65124, Italy

  • Università Cattolica S. Cuore - Ematologia

    Roma, Italy

  • Università Politecnica delle Marche- Clinica di Ematologia

    Ancona, 60121, Italy

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Other studies related to the condition(s) this trial covers.