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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

September 2, 2010

Primary Completion Date

July 4, 2013

Study Completion Date

April 5, 2018

Conditions
Diffuse Large B-cell Lymphoma
Interventions
DRUG

Lenalidomide

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).

DRUG

Gemcitabine

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

DRUG

Oxaliplatin

Suggested starting dose and regimen for Oxaliplatin is 100 mg/m\^2 IV day 1 for 21 days for 6 Cycles

DRUG

Rituximab

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)

DRUG

Etoposide

"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"

Trial Locations (57)

4029

Royal Brisbaine and Womens Hospital, Herston

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

5005

University Hospital Hradec Kralove, Hradec Králové

6156

Azienda Ospedaliera di Perugai Ospedale S. Maria della Miseri, Terni

8035

Hospital Universitari Vll D' Hebron, Barcelona

12808

Charles University, Prague

13009

Institute Paoli-Calmette, Marsielle

14004

Hospital Universitario Reina Sofia, Córdoba

14263

Roswell Park Cancer Institute, Buffalo

16132

Clinica Ematologica, A.O.U. San Martino di Genova, Genova

20817

Center for Cancer and Blood Disorders, Bethesda

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

29600

Hospital Costa Del Sol, Marbella

29609

ICH CHU Brest- C.H.U. MORAVAN, Brest

30322

Emory University, Atlanta

31008

Complejo Hospitalario de Navarra, Pamplona

31059

University Hospital OF Toulouse Purpan, Toulouse

32005

CH de Orense, Ourense

32806

MD Anderson Cancer Center Orlando, Orlando

33604

CHRU-Hopital du Haut -Leveque, Pessac

35033

CHU de Rennes Hopital de Pontchaillou, Rennes

37007

Hosptial Clinico Universitario de Salamanca, Salamanca

37232

Vanderbilt-Ingram Cancer Center, Nashville

38043

CHU de Grenoble-Hopital Albert Michallon, Grenoble

39402

Hattiesburg Clinic, Hattiesburg

40138

"Istituto di Ematologica Istituto di Ematologica L.e. A. Seragnoli' Azienda Ospedaliera Universitaria Policlinico", Bologna

44903

Hotel Dieu, Nantes

48105

University of Michigan, Comprehensive Cancer Center, Ann Arbor

50141

Azienda Ospedaliera Universitaria Careggi, Florence

54511

Hopital de Brabois Adultes, Vandœuvre-lès-Nancy

57105

Avera Cancer Institute, Sioux Falls

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

63110

Washington University Siteman Cancer Center, St Louis

66046

Hôpital Saint Jean, Perpignan

69495

Centre Hospitalier Lyon Sud, Lyon

75185

Akademiska Sjukhuset, Uppsala

77030

MD Anderson Houston, Houston

80131

Universita Federico II di Napoli Nuovo Policlinico, Napoli

85205

Chd -Vendee, La Roche-sur-Yon

85208

Irccs/Crob, Rionero in Vulture (PZ)

90185

Onkologiska kliniken, Umeå

91505

Providence St Joseph Medical Center/Cancer Center, Burbank

201401

IEO istituto Europeo di Oncologia, Miano

A6020

Innsbruck University Hospital, Innsbruck

A-5020

Universitätsklinikum Salzburg, Salzburg

A-1090

Medical University of Vienna, Vienna

00133

Policlinico Tor Vergata (Universta Tor Vergata), Roma

BH7 7DW

Royal Bournemouth Hospital Haematology, Bournemouth

EX2 5DW

Royal Devon and Exeter Hospital Haematology Department, Exeter

LS9 7TF

St. James Institute of Oncology, Leeds

SW3 6U

Royal Mardsen Hospital - Fulham (Satellite Site), London

M20 4BX

The Christie Foundation Trust, I'st Floor, Haemotology Oncology Outpatients, Lymphoma Team, Manchester

PL6 8DH

Derrford Hospital, Plymouth

SO16 6YD

Southhampton University Hospital NHS Trust, Southhampton

SM2 SPT

Royal Mardsen NHS Foundation Trust, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY