NCT01582776

Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Relapsed/Refractory Follicular and Aggressive B-cell Lymphoma

Completed Phase 1, PHASE2 Last updated 17 March 2023

What this trial tests

Phase 1, PHASE2 trial testing Lenalidomide and GA101 in Follicular Lymphoma Patients (Phase IB) in 317 participants. Completed in 20 May 2022.

Timeline

3 October 2012

Primary endpoint
11 July 2018

20 May 2022

Quick facts

Lead sponsor	The Lymphoma Academic Research Organisation
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	317
Start date	3 October 2012
Primary completion	11 July 2018
Estimated completion	20 May 2022
Sites	25 locations across Belgium, France

Drugs / interventions tested

• Lenalidomide and GA101 — full drug profile →

Conditions studied

• Follicular Lymphoma Patients (Phase IB) — all drugs for Follicular Lymphoma Patients (Phase IB) →
• Follicular and Agressive (DLBCL&MCL) B-cell Lymphoma Patients (Phase II) — all drugs for Follicular and Agressive (DLBCL&MCL) B-cell Lymphoma Patients (Phase II) →

Sponsor

The Lymphoma Academic Research Organisation — full company profile →

Who can join

18 and older, any sex, with Follicular Lymphoma Patients (Phase IB) or Follicular and Agressive (DLBCL&MCL) B-cell Lymphoma Patients (Phase II). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to determine first the appropriate dose of lenalidomide to administer in combination with fixed doses of obinutuzumab in relapsed/refractory follicular lymphoma patients.

In a second step, this study aims to determine the efficacy of this combination in 3 separate populations: relapsed/refractory aggressive lymphoma (diffuse large B-cell lymphoma and mantle cell lymphoma: cohort 1), relapsed/refractory follicular lymphoma (cohort 2) and previously untreated follicular lymphoma (cohorts 3 and 4).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanisms of Action of Lenalidomide in B-Cell Non-Hodgkin Lymphoma.
   Gribben JG, Fowler N, Morschhauser F. · · 2015 · cited 231× · PMID 26195701 · DOI 10.1200/jco.2014.59.5363
2. A Review of Obinutuzumab (GA101), a Novel Type II Anti-CD20 Monoclonal Antibody, for the Treatment of Patients with B-Cell Malignancies.
   Tobinai K, Klein C, Oya N, Fingerle-Rowson G. · · 2017 · cited 128× · PMID 28004361 · DOI 10.1007/s12325-016-0451-1
3. Obinutuzumab combined with lenalidomide for relapsed or refractory follicular B-cell lymphoma (GALEN): a multicentre, single-arm, phase 2 study.
   Morschhauser F, Le Gouill S, Feugier P, Bailly S, et al · · 2019 · cited 69× · PMID 31296423 · DOI 10.1016/s2352-3026(19)30089-4
4. Trial Watch: Lenalidomide-based immunochemotherapy.
   Semeraro M, Vacchelli E, Eggermont A, Galon J, et al · · 2013 · cited 46× · PMID 24482747 · DOI 10.4161/onci.26494
5. Emerging therapies in mantle cell lymphoma.
   Hanel W, Epperla N. · · 2020 · cited 33× · PMID 32552760 · DOI 10.1186/s13045-020-00914-1
6. NK cell activation and recovery of NK cell subsets in lymphoma patients after obinutuzumab and lenalidomide treatment.
   Vo DN, Alexia C, Allende-Vega N, Morschhauser F, et al · · 2018 · cited 27× · PMID 29632722 · DOI 10.1080/2162402x.2017.1409322
7. An open-label phase 1b study of obinutuzumab plus lenalidomide in relapsed/refractory follicular B-cell lymphoma.
   Morschhauser F, Salles G, Le Gouill S, Tilly H, et al · · 2018 · cited 24× · PMID 30068505 · DOI 10.1182/blood-2018-05-853499
8. Obinutuzumab in the treatment of B-cell malignancies: a comprehensive review.
   Davies A, Kater AP, Sharman JP, Stilgenbauer S, et al · · 2022 · cited 23× · PMID 35856239 · DOI 10.2217/fon-2022-0112