Trial intelligence / Profile preview

Obinutuzumab and Lenalidomide in B-cell Lymphoma

NCT01582776Phase 2

Key facts

Status: Completed
Start: Oct 2012
Primary completion: Jul 2018
Countries: 2
Sponsor: LYSARC
Modality: Antibody Conjugates, Monoclonal Antibodies, Engineered Antibody Formats

Drugs: obinutuzumablenalidomide
Conditions: follicular lymphoma (FL)diffuse large B-cell lymphoma (DLBCL)mantle cell lymphoma (MCL)

Overview

Phase 2, open-label, single-arm trial of obinutuzumab and lenalidomide in follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL), sponsored by LYSARC. Primary endpoints: Recommended dose of lenalidomide in combination with fixed doses of GA101 at 28 days and Overall Response Rate (CR+CRu+PR) at 24 weeks. Started Oct 2012; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Lenalidomide and GA101
Obinutuzumab and Lenalidomide combination therapy

Who it enrols

Adults with CD20+ follicular lymphoma, DLBCL, or MCL, with measurable disease, ECOG 0-2, adequate organ function, and no prior obinutuzumab or lenalidomide.

Endpoints

Primary

Recommended dose of lenalidomide in combination with fixed doses of GA10128 days
Overall Response Rate (CR+CRu+PR)24 weeks

Secondary

Overall survivalUp to 4.5 years
Event Free survivalUp to 4.5 years
Progression free survivalUp to 4.5 years
Response durationUp to 4.5 years
Response rate at the end of maintenance treatment2.5 years
Complete response rate after induction24 weeks
Complete response rate after 3 cycles12 weeks

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