Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance
- Registration Number
- NCT03731234
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- Brief Summary
This is a prospective, multicenter, single arm, phase II trial in patients with ≥ 18 and \<65 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
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ibrutinib+R-CHOP Ibrutinib 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)
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) (1st time point of assessment) 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
Progression-free survival (PFS) (2nd time point of assessment) 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
Progression-free survival (PFS) (3dr time point of assessment) 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
Name Time Method Complete response and Overall Response (CR+PR) rate at the end of induction End of induction (EOI) (4 months) Complete response and Overall Response
Overall Survival (OS) Time between the date of enrolment and the date of death from any cause (24, 36 and 48 months). Overall Survival
Complete remission (CRR) after ibrutinib maintenance End of treatment (EOT) (up to 24 months) Complete remission after ibrutinib maintenance
Duration of response (DOR) 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
Event Free Survival (EFS) 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
Trial Locations
- Locations (39)
Ospedale di Castelfranco Veneto - Oncoematologia IOV
🇮🇹Castelfranco Veneto, Treviso, Italy
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
🇮🇹Alessandria, Italy
Università Politecnica delle Marche- Clinica di Ematologia
🇮🇹Ancona, Italy
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
🇮🇹Avellino, Italy
Centro Riferimento Oncologico- S.O.C. Oncologia Medica A
🇮🇹Aviano, Italy
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
🇮🇹Bari, Italy
ASST Spedali Civili di Brescia - Ematologia
🇮🇹Brescia, Italy
Ospedale Businco - SC Ematologia e CTMO
🇮🇹Cagliari, Italy
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
🇮🇹Catania, Italy
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
🇮🇹Firenze, Italy
Ospedale Policlinico San Martino S.S.R.L- IRCCS per l'Oncologia - Ematologia
🇮🇹Genova, Italy
Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia
🇮🇹Messina, Italy
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
🇮🇹Milano, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
🇮🇹Milano, Italy
IEO Istitito Europeo di Oncologia - Divisione Ematoncologia
🇮🇹Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
🇮🇹Milano, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena - Ematologia
🇮🇹Modena, Italy
Monza - Fondazione IRCCS San Gerardo dei Tintori - Ematologia
🇮🇹Monza, Italy
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica
🇮🇹Napoli, Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia
🇮🇹Novara, Italy
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
🇮🇹Padova, Italy
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
🇮🇹Pavia, Italy
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
🇮🇹Pescara, Italy
Ospedale Guglielmo da Saliceto - U.O.Ematologia
🇮🇹Piacenza, Italy
AOU Pisana - U.O. Ematologia
🇮🇹Pisa, Italy
A.O.R. "San Carlo" - U.O. Ematologia
🇮🇹Potenza, Italy
Ospedale delle Croci - Ematologia
🇮🇹Ravenna, Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia -
🇮🇹Reggio Emilia, Italy
Ospedale degli Infermi di Rimini - U.O. di Ematologia
🇮🇹Rimini, Italy
Dipartimento di Medicina Traslazionale e di Precisione, Università 'La Sapienza'
🇮🇹Roma, Italy
Università Cattolica S. Cuore - Ematologia
🇮🇹Roma, Italy
Casa Sollievo della Sofferenza - UO Ematologia
🇮🇹San Giovanni Rotondo, Italy
A.O. S. Maria di Terni - S.C. Oncoematologia
🇮🇹Terni, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Centro Ematologia Universitaria
🇮🇹Torino, Italy
A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia
🇮🇹Torino, Italy
A.O. C. Panico - U.O.C Ematologia e Trapianto
🇮🇹Tricase, Italy
Azienda Sanitaria Universitaria Integrata Trieste (ASUITS) SC Ematologia
🇮🇹Trieste, Italy
Ospedale Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine)-SOC Clinica Ematologica
🇮🇹Udine, Italy
Ospedale di Circolo U.O.C Ematologia
🇮🇹Varese, Italy