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Celgene, LYSARC Provide Update on Phase III 'RELEVANCE' Study of Revlimid, Rituximab Combination in Previously Untreated Patients with Follicular Lymphoma.

M2 PHARMA-December 22, 2017-Celgene, LYSARC Provide Update on Phase III 'RELEVANCE' Study of Revlimid, Rituximab Combination in Previously Untreated Patients with Follicular Lymphoma

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- Lymphoma Academic Research Organisation (LYSARC) reported results from a phase III, randomised, open-label, international clinical study (RELEVANCE), US-based Celgene Corp. (NASDAQ: CELG) and the Lymphoma Study Association said.

This investigational study evaluated Revlimid plus rituximab 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 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.

Revlimid (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma

Revlimid is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

It is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Revlimid is indicated for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

It is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia outside of controlled clinical trials.

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Publication:M2 Pharma
Article Type:Clinical report
Date:Dec 22, 2017
Words:284
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