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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT00783367
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2008
Status verified
Mar 2023
Primary completion
Nov 14, 2012
Completion
Nov 23, 2020

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenalidomide plus rituximab with dexamethasone
    Lenalidomide-low dose dexamethasone plus rituximab

Primary Outcome Measure

Response Rate to Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphoma With Rituximab Resistance [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania; Abramson Cancer Center; Lymphoma ProgramPhiladelphiaPennsylvania19104-

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By research site
University of Pennsylvania; Abramson Cancer Center; Lymphoma Program· Philadelphia, PA

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