Clinical trial NCT01021423: 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).
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
Keywords: Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
CC-5013
Revlimid
Lenalidomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2009-11-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant.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.


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)

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: up to 7 years
Secondary outcomes:
measure: Overall Survival
timeFrame: up to 7 years
measure: Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: up to 9 months
measure: Time to Progression
timeFrame: up to 7 years
measure: Time to Treatment Failure
timeFrame: up to 2 years
measure: Participants With a Tumor Response
timeFrame: up to 7 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Healthcare Oncology Associates of San Diego
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Providence Cancer Center
state: Indiana
city: Lincoln
country: United States
facility: Nebraska Hematology-Oncology, PC
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Lake Success
country: United States
facility: Arena Oncology Associates
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College/New York Presbyterian Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika
city: Prague 5
country: Czechia
facility: Clinic of Oncology Faculty Hospital Motol
city: Praha 10
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice
city: Amiens Cedex
country: France
facility: CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique
city: Angers
country: France
facility: CHU Hôpital Hotel Dieu
city: Clermont Ferrand Cedex 1
country: France
facility: CHU ESTAING, Service d'Hématologie
city: Créteil
country: France
facility: Hôpital Henri Mondor Unité Hémopathies Lymphoides
city: La Roche sur Yon
country: France
facility: CHD Les Oudairies, Service d'Oncologie Hématologie
city: La Tronche
country: France
facility: Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
city: Lille Cedex
country: France
facility: CHRU - Hôpital Claude Huriez
city: Montpellier cedex 5
country: France
facility: CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale
city: Nantes Cedex 1
country: France
facility: CHRU - Hotel Dieu
city: Paris Cedex 10
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie
city: Pierre Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
city: Poitiers
country: France
facility: CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire
city: Reims Cedex
country: France
facility: CHU de Reims, Hôpital Robert Debré, Hématologie Clinique
city: Rennes Cedex
country: France
facility: Hôpital Pontchaillou Hématologie Clinique
city: Rouen Cedex 1
country: France
facility: Centre Henri Becquerel
city: Toulouse cedex 9
country: France
facility: Hôpital Purpan CHU de Toulouse
city: Tours
country: France
facility: Hôpital Bretonneau - CHU Tours
city: Vandoeuvre Les Nancy
country: France
facility: CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne
city: Essen
country: Germany
facility: Universitätsklinikum Essen Zentrum für Innere Medizin
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie
city: Göttingen
country: Germany
facility: UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe
city: München
country: Germany
facility: Klinikum der Universität München - Großhadern, Medizinische Klinik III
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Beer Sheva
country: Israel
facility: Soroka Medical Center The Institute of Hematology
city: Petah Tiqwa
country: Israel
facility: Davidoff Cancer Center The Institute of Hematology
city: Alessandria
country: Italy
facility: Az. Osp. SS.Antonio e Biagio SC Ematologia
city: Bolzano
country: Italy
facility: Ospedale Regionale di Bolzano - Divisione di Ematologia
city: Florence
country: Italy
facility: Hematology Dept, Azienda Ospedaliero Universitaria Careggi
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria "San Martino"
city: Messina
country: Italy
facility: Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia
city: Milano
country: Italy
facility: Fondazione San Raffaele del Monte Tabor I.R.C.C.S.
city: Milan
country: Italy
facility: A,O Ospedale Niguarda Ca Granda Dept Hematology
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia
city: Novara
country: Italy
facility: Università del Piemonte Orientale "Amedeo Avogadro"
city: Pavia
country: Italy
facility: Policlinico San Matteo - Dip. Di Ematologia
city: Reggio Calabria
country: Italy
facility: Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore Policlinico A. Gemelli
city: S.Giovanni Rotondo (FG)
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia
city: Torino
country: Italy
facility: Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)
city: Tricase
country: Italy
facility: Ospedale Cardinale G. Panico - Ematologia e Immunoematologia
city: Udine
country: Italy
facility: Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria
city: Krakow
country: Poland
facility: Małopolskie Centrum Medyczne
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Transplantacji Komórkowych
city: Coimbra
country: Portugal
facility: Serviço de Hematologia
city: Lisboa
country: Portugal
facility: Instituto Português de Oncologia (IPO) de Lisboa
city: Porto
country: Portugal
facility: Instituto Português de Oncologia (IPO) do Porto
city: San Juan
country: Puerto Rico
facility: Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital - Volgogradskaya
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncological Dispensary
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Centre
city: Perm
country: Russian Federation
facility: Perm Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency
city: St. Petersburg
country: Russian Federation
facility: State Educational Institution of High Professional Education
city: St. Petersburg
country: Russian Federation
facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies
city: Volgograd
country: Russian Federation
facility: State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebrón Hematology Department
city: Madrid
country: Spain
facility: Hospital de Madrid Norte- Sanchinarro
city: Marbella (Málaga)
country: Spain
facility: Hospital Costa del Sol, Oncology
city: Ourense
country: Spain
facility: C. H. de Orense
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra, Hematology
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
city: Canterbury, Kent
country: United Kingdom
facility: Kent and Canterbury Hospital
city: County Of Devon
country: United Kingdom
facility: Torbay Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: Barts & The London NHS Trust Medical Oncology
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Salisbury
country: United Kingdom
facility: Salisbury NHS Foundation Trust, Haematology
city: St. Helens
country: United Kingdom
facility: St Helens Hospital, Lilac Lower Ground
Study officials:
affiliation: Medizinische Klinik III der Universität München
name: Martin Dreyling, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.