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COMPLETED
NCT01556035
PHASE2

Lenalidomide in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma Leg-type : Multicentre Prospective Phase II Single Arm Trial of the French Study Group of Cutaneous Lymphoma

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

In spite of high initial response rate after a first line treatment by R-polychemotherapy, cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the patients with PCBCL-LT. Thereafter there is no consensus concerning patients care: radiotherapy has only a palliative effect, advanced age often limits using more aggressive chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties. Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells lymphomas, especially of nongerminal cells phenotype. By analogy with these results, lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a manageable toxicity even in advanced age patients. If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.

Official title: A Multicentre Prospective Phase II Single Arm Trial Evaluating the Benefit of Therapy With Lenalidomide (Revlimid®) in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type) After First Line Treatment by Chemotherapy Plus Rituximab for the French Study Group of Cutaneous Lymphoma (GFELC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2012-07

Completion Date

2015-08

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

DRUG

Lenalidomide

Patient orally treated with lenalidomide 25 mg daily for 21 days with 7 days rest of a 28 days cycle.Treatment maintained for 12 months unless progression

Locations (24)

CHU Amiens, Hôpital Sud

Amiens, France

CHU Besançon, Hôpital Saint-Jacques

Besançon, France

AP-HP Hôpital Avicenne

Bobigny, France

AP-HP Hôpital Ambroise Paré

Boulogne-Billancourt, France

CHU de Clermont-Ferrand, Estaing

Clermont-Ferrand, France

AP-HP Hôpital Henri Mondor

Créteil, France

CHU de Dijon, Le Bocage

Dijon, France

CHU de Grenoble

Grenoble, France

CHU de Lille Hôpital Claude Huriez

Lille, France

Centre Léon Bérard

Lyon, France

AP-HM Hôpital Nord

Marseille, France

CHRU de Montpellier Hôpital Saint-Eloi

Montpellier, France

CHU de Nantes, Hôtel Dieu

Nantes, France

CHU de Nice Groupe hospitalier l'Archet

Nice, France

AP-HP- Hôpital Saint Louis

Paris, France

AP-HP Groupe hospitalier Cochin

Paris, France

AP-HP Groupe hospitalier Bichat - Claude Bernard

Paris, France

AP-HP Hôpital Tenon

Paris, France

CHU de Bordeaux Hôpital du Haut Lévèque

Pessac, France

CHU Lyon Sud

Pierre-Bénite, France

CHU de Reims, Hôpital Robert Debré

Reims, France

CHU de Rouen, Hôpital Charles Nicolle

Rouen, France

CHU de Toulouse Hôpital Larrey

Toulouse, France

CHU de Tours- Hôpital Trousseau

Tours, France