Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

Phase 2

Active, not recruiting

• Conditions: DLBCL
• Interventions: Drug: Ibrutinib

• 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.

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-06
• Study Start: 2019-07-02
• Primary Completion: 2024-07-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-16
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

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

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