A Combination of Lenalidomide and Rituximab as Front Line Therapy for the Treatment of Elderly Frail Patients Evaluated in CGA With Diffuse Large B-cells Non-Hodgkin Lymphoma. A Phase II Study of the Fondazione Italiana Linfomi (FIL)

NCT02955823 Phase 2 COMPLETED

A phase II study to evaluate the combination of Lenalidomide and Rituximab as front line therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large B-cells non-Hodgkin Lymphoma.

Details

Lead sponsor	Fondazione Italiana Linfomi - ETS
Phase	Phase 2
Status	COMPLETED
Enrolment	68
Start date	2016-09
Completion	2022-11-24

Conditions

• Diffuse Large B-cells Non-Hodgkin Lymphoma

Interventions

• Rituximab-Dexamethasone-Lenalidomide

Primary outcomes

• ORR — 48 months
  Overall response rate (ORR) is defined as the proportion of patients with complete and partial response respectively according to Cheson 2014 (Appendix K). The ORR rate will be evaluated both on assessed patients and on all treated patients, considering patients without a response assessment (due to any reason) as non-responders. Response of R2 will be calculated for the EP according to Response Criteria for non-Hodgkin lymphoma (NHL) with CT scan; Cheson 2014; patients will be categorized into Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Non Responders (NR).
• Safety: clinical relevant toxicity — 48 months
  Clinical relevant toxicity, defined as the proportion of patients experiencing a grade 3 or greater non haematological toxicity.

Countries

Italy