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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Ibrutinib in combination to rituximab-CHOP followed by ibrutinib maintenance
Progression-free survival (PFS) (1st time point of assessment)
PFS of the high/high-intermediate risk patients from date of enrolment
Time frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (24 months)
Progression-free survival (PFS) (2nd time point of assessment)
PFS of the high/high-intermediate risk patients from date of enrolment
Time frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (36 months)
Progression-free survival (PFS) (3dr time point of assessment)
PFS of the high/high-intermediate risk patients from date of enrolment
Time frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (48 months)
Overall Survival (OS)
Overall Survival
Time frame: Time between the date of enrolment and the date of death from any cause (24, 36 and 48 months).
Complete response and Overall Response (CR+PR) rate at the end of induction
Complete response and Overall Response
Time frame: End of induction (EOI) (4 months)
Duration of response (DOR)
Duration of response
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)
Complete remission (CRR) after ibrutinib maintenance
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Florence, Italy
...and 29 more locations
Complete remission after ibrutinib maintenance
Time frame: End of treatment (EOT) (up to 24 months)
Event Free Survival (EFS)
Event Free Survival
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)