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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
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
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