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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511641-18-00

Acronym

FIL_RI-CHOP

Enrollment

Registered

2024-12-02

Start date

2019-08-01

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma ABC

Brief summary

Progression-free survival (PFS) of the high/high-intermediate risk patients from date of enrolment

Detailed description

Event Free Survival (EFS) and Overall survival (OS), Rate of complete response (CRR) and of overall response (ORR), Duration of response (DOR), Rate of complete response (CRR) before and after maintenance, Rate of conversion in CR with Ibrutinib maintenance for patients in PR after the induction with RI-CHOP21, Toxicity: all grade of toxicity and severe, life- threatening, fatal (grade 3, 4 and 5) and/or serious adverse events will be defined according to “Common Terminology Criteria for Adverse Events” (CTCAE)

Interventions

DRUGDOXORUBICIN

DRUGVINCRISTINE

DRUGPREDNISONE

DRUGRITUXIMAB

DRUGIBRUTINIB

DRUGCYCLOPHOSPHAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) of the high/high-intermediate risk patients from date of enrolment	—

Secondary

Measure	Time frame
Event Free Survival (EFS) and Overall survival (OS), Rate of complete response (CRR) and of overall response (ORR), Duration of response (DOR), Rate of complete response (CRR) before and after maintenance, Rate of conversion in CR with Ibrutinib maintenance for patients in PR after the induction with RI-CHOP21, Toxicity: all grade of toxicity and severe, life- threatening, fatal (grade 3, 4 and 5) and/or serious adverse events will be defined according to “Common Terminology Criteria for Adverse Events” (CTCAE)	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026