Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Part of paid clinical trials in Burbank, California.

Sponsor
Celgene
Study ID
NCT01197560
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Lenalidomide — DRUG
    Lenalidomide 25 mg orally for 21/28 days until Diffuse Large B-Cell Lymphoma (DLBCL) progressive disease. For patients with Creatinine Clearance ≥ 30 mL/min but \< 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).
  • Gemcitabine — DRUG
    Suggested starting doses and regimens for Gemcitabine is 1,250 mg/m\^2 intravenous (IV) administration on days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m\^2 IV days 1 and 15 every 28 days for 6 Cycles
  • Oxaliplatin — DRUG
    Suggested starting dose and regimen for Oxaliplatin is 100 mg/m\^2 IV day 1 for 21 days for 6 Cycles
  • Rituximab — DRUG
    Suggested starting dose for Rituximab is 375 mg/m\^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
  • Etoposide — DRUG
    Suggested starting doses for Etoposide are: 100 mg/m\^2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m\^2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m\^2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m\^2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m\^2 oral days 1-10 every 28 days for 6 Cycles

Study Details

The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.

Key Dates

Start date
Sep 2, 2010
Status verified
Nov 2019
Primary completion
Jul 4, 2013
Completion
Apr 5, 2018

Study Design

Enrollment
111 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lenalidomide
    Lenalidomide 25 mg capsules by mouth on days 1-21 of each 28 day cycle. For patients with Creatinine Clearance ≥ 30 mL/min but \< 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).
  • Active Comparator: Investigators Choice
    One of the following: Gemcitabine, Oxaliplatin, Rituximab, or Etoposide

Primary Outcome Measure

Stage 1: Percentage of Participants With an Overall Response According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 and Evaluated by the Independent Response Adjudication Committee (IRAC) [ Time Frame: From the date of randomization to the data cut-off of 4 July 2013; when all patients reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment); the median study duration was 27.0 and 19.7 weeks, respectively. ]

Locations (13)

FacilityCityStateZIPSite coordinators
Providence St Joseph Medical Center/Cancer CenterBurbankCalifornia91505-
MD Anderson Cancer Center OrlandoOrlandoFlorida32806-
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
University of Michigan, Comprehensive Cancer CenterAnn ArborMichigan48105-
Hattiesburg ClinicHattiesburgMississippi39402-
Washington University Siteman Cancer CenterSt LouisMissouri63110-
Roswell Park Cancer InstituteBuffaloNew York14263-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
MD Anderson HoustonHoustonTexas77030-

Find similar trials in Burbank, CA

By research site
Providence St Joseph Medical Center/Cancer Center· Burbank, CAMD Anderson Cancer Center Orlando· Orlando, FLEmory University· Atlanta, GANorthwestern University· Chicago, ILRush University Medical Center· Chicago, ILCenter for Cancer and Blood Disorders· Bethesda, MD

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