NCT00783367

Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Type	Name	Description
DRUG	Lenalidomide	Lenalidomide: 10mg capsules, orally, once daily for each 28 day cycle for the duration of the study
DRUG	Dexamethasone	Dexamethasone: 8mg tablets, orally, once weekly on days 3, 10, 17, 24 of each 28 day cycle for the duration of the study;
DRUG	Rituximab	Rituximab: 375mg/m2 IV (in the vein), once weekly on days 1, 8, 15, 22 during month 3 of therapy

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-11-14
• Completion: 2020-11-23
• First posted: 2008-10-31
• Last updated: 2023-03-30
• Results posted: 2021-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study