Non Hodgkin Lymphoma Clinical Trial

A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).

Summary

A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).

This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically-proven mantle cell non-Hodgkin's lymphoma,
One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide)
Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma)
ECOG performance status score of ≤ 2
Willing to follow pregnancy precaution

Exclusion Criteria:

Patients who have received more than 1 line of induction chemotherapy;
Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible;
Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy;
Any of the following laboratory abnormalities:
Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5*10^9/L)
Platelet count < 60,000/mm^3 (60*10^9/L)
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) > 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
Serum bilirubin > 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma
Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of < 30 mL /min
Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma
Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis
Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

9

Study ID:

NCT01021423

Recruitment Status:

Terminated

Sponsor:

Celgene

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 89 Locations for this study

See Locations Near You

Sharp Healthcare Oncology Associates of San Diego
San Diego California, 92123, United States
Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Providence Cancer Center
Indianapolis Indiana, 97213, United States
Nebraska Hematology-Oncology, PC
Lincoln Nebraska, 68506, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Arena Oncology Associates
Lake Success New York, 11042, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York New York, 10021, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
University of Virginia Health Systems
Charlottesville Virginia, 22908, United States
Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie
Hradec Králové , 500 0, Czechia
Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika
Olomouc , 77520, Czechia
Clinic of Oncology Faculty Hospital Motol
Prague 5 , , Czechia
Fakultni Nemocnice Kralovske Vinohrady
Praha 10 , 10034, Czechia
Vseobecna Fakultni Nemocnice
Praha 2 , 12808, Czechia
CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique
Amiens Cedex , 80054, France
CHU Hôpital Hotel Dieu
Angers , 49000, France
CHU ESTAING, Service d'Hématologie
Clermont Ferrand Cedex 1 , 63003, France
Hôpital Henri Mondor Unité Hémopathies Lymphoides
Créteil , 94010, France
CHD Les Oudairies, Service d'Oncologie Hématologie
La Roche sur Yon , 85000, France
Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
La Tronche , 38700, France
CHRU - Hôpital Claude Huriez
Lille Cedex , 59037, France
CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale
Montpellier cedex 5 , 34295, France
CHRU - Hotel Dieu
Nantes Cedex 1 , 44093, France
Hôpital Saint-Louis
Paris Cedex 10 , 75475, France
CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie
Pessac , 33604, France
Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
Pierre Bénite Cedex , 69495, France
CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire
Poitiers , 86000, France
CHU de Reims, Hôpital Robert Debré, Hématologie Clinique
Reims Cedex , 51092, France
Hôpital Pontchaillou Hématologie Clinique
Rennes Cedex , 35033, France
Centre Henri Becquerel
Rouen Cedex 1 , 76038, France
Hôpital Purpan CHU de Toulouse
Toulouse cedex 9 , 31059, France
Hôpital Bretonneau - CHU Tours
Tours , 37044, France
CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne
Vandoeuvre Les Nancy , 54511, France
Universitätsklinikum Essen Zentrum für Innere Medizin
Essen , 45122, Germany
Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie
Freiburg , 79106, Germany
UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie
Göttingen , 37099, Germany
Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation
Hamburg , 20099, Germany
Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe
Karlsruhe , 76135, Germany
Klinikum der Universität München - Großhadern, Medizinische Klinik III
München , 81377, Germany
Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
Soroka Medical Center The Institute of Hematology
Beer Sheva , 84101, Israel
Davidoff Cancer Center The Institute of Hematology
Petah Tiqwa , 49100, Israel
Az. Osp. SS.Antonio e Biagio SC Ematologia
Alessandria , 15121, Italy
Ospedale Regionale di Bolzano - Divisione di Ematologia
Bolzano , 39100, Italy
Hematology Dept, Azienda Ospedaliero Universitaria Careggi
Florence , 50139, Italy
Azienda Ospedaliera Universitaria "San Martino"
Genova , 16132, Italy
Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia
Messina , 98158, Italy
Fondazione San Raffaele del Monte Tabor I.R.C.C.S.
Milano , 20132, Italy
A,O Ospedale Niguarda Ca Granda Dept Hematology
Milan , 20162, Italy
Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia
Napoli , 80131, Italy
Università del Piemonte Orientale "Amedeo Avogadro"
Novara , 28100, Italy
Policlinico San Matteo - Dip. Di Ematologia
Pavia , 27100, Italy
Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia
Reggio Calabria , 89100, Italy
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Roma , 00168, Italy
IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia
S.Giovanni Rotondo (FG) , 71013, Italy
Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)
Torino , 10126, Italy
Ospedale Cardinale G. Panico - Ematologia e Immunoematologia
Tricase , 73039, Italy
Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria
Udine , 33100, Italy
Małopolskie Centrum Medyczne
Krakow , 30-51, Poland
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
Lodz , 93510, Poland
Dolnoslaskie Centrum Transplantacji Komórkowych
Wroclaw , 53439, Poland
Serviço de Hematologia
Coimbra , 300-0, Portugal
Instituto Português de Oncologia (IPO) de Lisboa
Lisboa , 1099-, Portugal
Instituto Português de Oncologia (IPO) do Porto
Porto , 4200-, Portugal
Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico
San Juan , 00918, Puerto Rico
Sverdlovsk Regional Clinical Hospital - Volgogradskaya
Ekaterinburg , 62010, Russian Federation
Republican Clinical Oncological Dispensary
Kazan , 42002, Russian Federation
Russian Oncological Research Centre
Moscow , 11547, Russian Federation
Perm Regional Clinical Hospital
Perm , 61460, Russian Federation
Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency
St. Petersburg , 19102, Russian Federation
State Educational Institution of High Professional Education
St. Petersburg , 19702, Russian Federation
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies
St. Petersburg , 19734, Russian Federation
State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1
Volgograd , 40013, Russian Federation
Hospital Universitario Vall d´Hebrón Hematology Department
Barcelona , 08035, Spain
Hospital de Madrid Norte- Sanchinarro
Madrid , , Spain
Hospital Costa del Sol, Oncology
Marbella (Málaga) , 29600, Spain
C. H. de Orense
Ourense , , Spain
Clinica Universitaria de Navarra, Hematology
Pamplona , 31008, Spain
Hospital Clínico Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Marques de Valdecilla
Santander , 39008, Spain
Kent and Canterbury Hospital
Canterbury, Kent , CT1 3, United Kingdom
Torbay Hospital
County Of Devon , TQ2 7, United Kingdom
Royal Devon & Exeter Hospital
Exeter , EX2 5, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow , G12 O, United Kingdom
Barts & The London NHS Trust Medical Oncology
London , EC1M , United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Salisbury NHS Foundation Trust, Haematology
Salisbury , SP2 8, United Kingdom
St Helens Hospital, Lilac Lower Ground
St. Helens , WA9 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

9

Study ID:

NCT01021423

Recruitment Status:

Terminated

Sponsor:


Celgene

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider