Trial intelligence / Profile preview

PET-Adapted Treatment in Low Risk DLBCL

NCT01285765Phase 3

Key facts

Status: Completed
Start: Dec 2010
Primary completion: May 2020
Countries: 2
Sponsor: LYSARC
Modality: Monoclonal Antibodies, Targeted Liposomes, Orthosteric Ligands

Drugs: rituximabcyclophosphamidepegylated liposomal doxorubicinvincristine sulfate liposome injectionprednisone
Conditions: diffuse large B-cell lymphoma (DLBCL)

Overview

Phase 3, randomised, open-label trial of rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine sulfate liposome injection and prednisone in diffuse large B-cell lymphoma (DLBCL) (2 arms), sponsored by LYSARC. Primary endpoint: Progression Free Survival at 3 years. Started Dec 2010; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Early-PET-result-adapted treatment
R-CHOP duration adapted based on PET-2 result (4 or 6 cycles)
Standard treatment
6 cycles of R-CHOP

Who it enrols

Patients aged 18-80 with previously untreated, CD20+ DLBCL, Ann Arbor Stage I or II, aaIPI=0, and no major organ dysfunction or active infection.

Endpoints

Primary

Progression Free Survival3 years

Secondary

Delta Standardized Uptake Value3 weeks post C4
Overall Survival3 years
Event Free Survival3 years
Response Duration3 years
Disease Free Survival3 years
Overall Response Rate3 weeks post last cycle
Rate of good responders according to results at PET after C23 weeks post C2

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