Trial intelligence / Profile preview

Genotype-guided Pola-RCHP-X in DLBCL

NCT06441097Phase 2

Key facts

Status: Not yet recruiting
Start: Dec 2024
Primary completion: Dec 2027
Sponsor: Ruijin Hospital
Modality: Small Molecules

Drugs: acalabrutinib tablet (Variant 1)lenalidomidedecitabine
Conditions: diffuse large B-cell lymphoma (DLBCL)

Overview

Phase 2, randomised, open-label trial of acalabrutinib tablet (Variant 1), lenalidomide and decitabine in diffuse large B-cell lymphoma (DLBCL) (2 arms), sponsored by Ruijin Hospital. Primary endpoint: Progression-free survival (by IRC) up to 24 months. Planned start Dec 2024; status: not yet recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Pola-RCHP-X
Pola-RCHP + Genotype-guided agent (Acalabrutinib, Lenalidomide, or Decitabine)
Pola-RCHP
Standard Pola-RCHP

Who it enrols

Patients with previously untreated CD20+ DLBCL, IPI 2-5, ECOG 0-2. Must have suboptimal response (ctDNA decrease < 3.0 LFC) after 1 cycle of Pola-RCHP to be randomized.

Endpoints

Primary

Progression-free survival (by IRC)up to 24 months

Secondary

Progression-free survival (by investigator)up to 24 months
Event-free survivalup to 24 months
Complete response rate6-8 weeks after last dose
Objective response rate6-8 weeks after last dose
Overall survivalup to 2 years
Treatment-Related Adverse Eventsup to 3 years

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