A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509358-72-00

Acronym

D8227C00001

Enrollment

221

Registered

2024-05-20

Start date

2020-11-23

Completion date

Unknown

Last updated

2025-12-15

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

Brief summary

Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B

Detailed description

Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B, Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification for NHL, Overall survival in Arm A compared to Arm B

Interventions

DRUGCYCLOPHOSPHAMIDE

DRUGDOXORUBICIN

DRUGPlacebo

DRUG100mg hard capsules; Identical to IMP apart from the active substance

DRUGPREDNISONE

DRUGRITUXIMAB

DRUGVINCRISTINE

DRUGCalquence 100 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B	—

Secondary

Measure	Time frame
Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B, Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification for NHL, Overall survival in Arm A compared to Arm B	—

Countries

Austria, Belgium, Czechia, France, Germany, Italy, Poland, Portugal, Spain

Outcome results

None listed

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