Clinical Trials

Date: 2017-12-21

Type of information: Results

phase: 3

Announcement: results

Company: Celgene (USA - NJ) Lysarc (France)

Product: Revlimid® (lenalidomide) and rituximab

Action mechanism:

immunomodulating agent/monoclonal antibody. Lenalidomide is an immunomodulating agent. This means that it affects the activity of the immune system. The drug is expected to work in a number of different ways in mantle cell lymphoma: it blocks the production of cytokines which help the tumour cells survive, prevents the growth of blood vessels within tumours and also stimulates some of the specialised cells of the immune system to attack the cancerous cells. It also increases production of a protein that blocks an enzyme involved in the control of cell division, to help slow down the growth and spread of the cancer.
Rituximab binds to the CD20 antigen on the surface of normal and malignant B-cells and then recruits the body’s natural defenses to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

Disease: previously untreated follicular lymphoma

Therapeutic area: Cancer - Oncology

Country: Australia, Belgium, Canada, France, Germany, Italy, Portugal, Spain

Trial details:

The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment. (NCT01650701)

Latest news:

• On December 21, 2017, Celgene and the Lymphoma Study Association (LYSA) announced that the Lymphoma Academic Research Organisation (LYSARC) reported results from the phase III, randomized, open-label, international clinical study RELEVANCE. This investigational study evaluated Revlimid® (lenalidomide) plus rituximab (R2) followed by R2 maintenance compared to the standard of care with rituximab plus chemotherapy (R-CHOP, R-bendamustine or R-CVP) followed by rituximab maintenance in patients with previously untreated follicular lymphoma.
The R2 treatment arm did not achieve superiority in the co-primary endpoints of complete response or unconfirmed complete response (CR/CRu) at 120 weeks and progression-free survival (PFS) during the pre-planned analysis (final analysis of CR/CRu and interim analysis of PFS). Neither arm was superior for either of the co-primary endpoints. The safety findings were consistent with the known profiles of the regimens investigated. Additional analyses are ongoing and planned.