Phase 2 Trial of Lenalidomide (Revlimid)-Dexamethasone + Rituximab in Recurrent Small B-Cell Non-Hodgkin Lymphomas (NHL) Resistant to Rituximab

NCT00783367 Phase 2 COMPLETED Results posted

Pre-clinical data and recently published clinical data suggest a synergistic effect between lenalidomide and dexamethasone. We hypothesize that a combination of lenalidomide-dexamethasone can overcome rituximab resistance. To determine the response rate to lenalidomide and dexamethasone plus rituximab therapy in subjects with recurrent small B-cell non-Hodgkin lymphoma who have had lymphoma progression within 6 months of being treated with rituximab alone or with a rituximab-containing regimen, we propose initial treatment with both drugs for two 28-day treatment cycles (Part I). After response assessment following two cycles of lenalidomide-dexamethasone, patients will enter Part II of the study. In Part II, patients will receive lenalidomide-dexamethasone and rituximab to evaluate the potential reversal of rituximab resistance as measured by response to rituximab and progression-free survival following rituximab.

Details

Lead sponsor	Abramson Cancer Center at Penn Medicine
Phase	Phase 2
Status	COMPLETED
Enrolment	50
Start date	2008-07
Completion	2020-11-23

Conditions

• Follicular Lymphoma
• Marginal Zone B-Cell Lymphoma
• MALT Lymphoma
• Lymphoma of Mucosa-Associated Lymphoid Tissue
• Lymphoma, Small Lymphocytic
• Waldenstrom Macroglobulinemia
• Mantle-Cell Lymphoma

Interventions

• Lenalidomide
• Dexamethasone
• Rituximab

Primary outcomes

• Response Rate to Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphoma With Rituximab Resistance — 3 months
  Response rate is defined as a complete response or partial response using anatomic criteria of the International Workshop Response Critieria (Cheson, 1999).

Countries

United States