Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
This trial is active, not recruiting.
|Condition||diffuse large b-cell lymphoma|
|Treatments||lenalidomide, gemcitabine, oxaliplatin, rituximab, etoposide|
|Phase||phase 2/phase 3|
|Start date||September 2010|
|End date||July 2013|
|Trial size||111 participants|
|Trial identifier||NCT01197560, CC-5013-DLC-001|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Burbank, CA||Providence St Joseph Medical Center/Cancer Center||no longer recruiting|
|Orlando, FL||MD Anderson Cancer Center Orlando||no longer recruiting|
|Atlanta, GA||Emory University||no longer recruiting|
|Chicago, IL||Northwestern University||no longer recruiting|
|Chicago, IL||Rush University Medical Center||no longer recruiting|
|Bethesda, MD||Center for Cancer and Blood Disorders||no longer recruiting|
|Ann Arbor, MI||University of Michigan, Comprehensive Cancer Center||no longer recruiting|
|Hattiesburg, MS||Hattiesburg Clinic||no longer recruiting|
|St. Louis, MO||Washington University Siteman Cancer Center||no longer recruiting|
|Buffalo, NY||Roswell Park Cancer Institute||no longer recruiting|
|Sioux Falls, SD||Avera Cancer Institute||no longer recruiting|
|Nashville, TN||Vanderbilt-Ingram Cancer Center||no longer recruiting|
|Houston, TX||MD Anderson Houston||no longer recruiting|
|Adelaide, Australia||Royal Adelaide Hospital||no longer recruiting|
|Herston, Australia||Royal Brisbaine and Womens Hospital||no longer recruiting|
|Woolloongabba, Australia||Princess Alexandra Hospital||no longer recruiting|
|Innsbruck, Austria||Innsbruck University Hospital||no longer recruiting|
|Salzburg, Austria||Universitätsklinikum Salzburg||no longer recruiting|
|Vienna, Austria||Medical University of Vienna||no longer recruiting|
|Hradec Kralove 5, Czech Republic||University Hospital Hradec Kralove||no longer recruiting|
|Praha, Czech Republic||Charles University||no longer recruiting|
|Brest Cedex 2, France||ICH CHU Brest- C.H.U. MORAVAN||no longer recruiting|
|Grenoble, France||CHU de Grenoble-Hopital Albert Michallon||no longer recruiting|
|La Roche Sur Yon, France||Chd -Vendee||no longer recruiting|
|Lyon, France||Centre Hospitalier Lyon Sud||no longer recruiting|
|Marsielle, France||Institute Paoli-Calmette||no longer recruiting|
|Nantes Cedex 1, France||Hotel Dieu||no longer recruiting|
|Perpignan, France||Hôpital Saint Jean||no longer recruiting|
|Pessac, France||CHRU-Hopital du Haut -Leveque||no longer recruiting|
|Rennes, France||CHU de Rennes Hopital de Pontchaillou||no longer recruiting|
|Toulouse, France||University Hospital OF Toulouse Purpan||no longer recruiting|
|Vandoeuvre-les Nancy cedex, France||Hopital de Brabois Adultes||no longer recruiting|
|Bologna, Italy||Istituto di Ematologica Istituto di Ematologica " L.e. A. Seragnoli' Azienda Ospedaliera Universitaria Policlinico||no longer recruiting|
|Firenze, Italy||Azienda Ospedaliera Universitaria Careggi||no longer recruiting|
|Genova, Italy||Clinica Ematologica, A.O.U. San Martino di Genova||no longer recruiting|
|Miano, Italy||IEO istituto Europeo di Oncologia||no longer recruiting|
|Napoli, Italy||Universita Federico II di Napoli Nuovo Policlinico||no longer recruiting|
|Pavia, Italy||Fondazione IRCCS Policlinico San Matteo||no longer recruiting|
|Rionero in Vulture (PZ), Italy||Irccs/Crob||no longer recruiting|
|Roma, Italy||Policlinico Tor Vergata (Universta Tor Vergata)||no longer recruiting|
|Terni, Italy||Azienda Ospedaliera di Perugai Ospedale S. Maria della Miseri||no longer recruiting|
|Barcelona, Spain||Hospital Universitari Vll D' Hebron||no longer recruiting|
|Cordoba, Spain||Hospital Universitario Reina Sofia||no longer recruiting|
|Marbella, Spain||Hospital Costa Del Sol||no longer recruiting|
|Ourense, Spain||CH de Orense||no longer recruiting|
|Pamplona, Spain||Complejo Hospitalario de Navarra||no longer recruiting|
|Salamanca, Spain||Hosptial Clinico Universitario de Salamanca||no longer recruiting|
|Umea, Sweden||Onkologiska kliniken||no longer recruiting|
|Uppsala, Sweden||Akademiska Sjukhuset||no longer recruiting|
|Bournemouth, United Kingdom||Royal Bournemouth Hospital Haematology||no longer recruiting|
|Exeter, United Kingdom||Royal Devon and Exeter Hospital Haematology Department||no longer recruiting|
|Leeds, United Kingdom||St. James Institute of Oncology||no longer recruiting|
|London, United Kingdom||Royal Mardsen Hospital - Fulham (Satellite Site)||no longer recruiting|
|Manchester, United Kingdom||The Christie Foundation Trust, I'st Floor, Haemotology Oncology Outpatients, Lymphoma Team||no longer recruiting|
|Plymouth, United Kingdom||Derrford Hospital||no longer recruiting|
|Southhampton, United Kingdom||Southhampton University Hospital NHS Trust||no longer recruiting|
|Sutton, United Kingdom||Royal Mardsen NHS Foundation Trust||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Stage 1: Percentage of Participants With an Overall Response Rate (ORR) According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999.
time frame: From Sept 2010 to the data cut-off of 4 July 2013; when all participants had reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment). Median follow-up time was 6.7 and 4.7 months in each arm respectively
Stage 2: Progression-free Survival for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Stage 2: Complete Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Stage 2: Duration of Overall Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
time frame: Approximately 3.5 years
Stage 2: Overall Survival (OS) for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Stage 2: Duration of Complete Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Patients With a Duration of Response Lasting ≥ 16 Weeks
Stage 2: Time to Progression for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Stage 2: Health Related Quality of Life for Diffuse Large B-Cell Lymphoma (DLBCL) Patients
Male or female participants at least 18 years old.
- Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).
- Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant.
- Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- Diagnosis of lymphoma histologies other than DLBCL.
- History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more.
- Eligible for autologous stem cell transplant.
- Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV)
- Neuropathy grade 4.
|Official title||A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma|
|Description||This research study is for patients who have been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called lymphocytes. DLBCL is just one type of lymphoma. Within DLBCL there are two different subtypes called Germinal Center B-cell (GCB) and non-GCB which can be determined by cell surface marker tests or by gene expression tests. Scientists can look at cells and genes in the laboratory and see that the two kinds are different, but they don't know yet what the difference means. To patients and doctors these two kinds seem the same. Right now doctors don't usually do tests to find out which kind a patient has because the treatment is the same for both. This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate patients by subtype and then test whether patients taking lenalidomide or any one of four other drugs have a better response. It is possible that lenalidomide will work better than one of the other drugs in zero, one, or both subtypes. Stage 2 will further test only the subtype(s) from Stage 1 that showed a good response to lenalidomide. The main purpose of Stage 2 is to test how long patients are disease free on lenalidomide compared to one of the four other drugs. On 29 January 2013 the enrolment goal for the Stage 1 portion of the study was met and enrollment was stopped. The final analysis for Stage 1 was performed as of the 04 Jul 2013 data cutoff date. According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Additionally, a suitable assay for the selection of participants for the Stage 2 study was not available. Therefore, on 6 January 2014, Celgene decided to not open Stage 2.|
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