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).

Non-Hodgkin's Lymphoma Clinical Trial

— RENEW  

Official title:

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01021423
• Other study ID #: CC-5013-MCL-003
• Status: Terminated
• Phase: Phase 3
• Start date: April 1, 2010
• Est. completion date: March 1, 2011

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant.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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 1, 2011
• Est. primary completion date: March 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Mantle Cell Lymphoma
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Lenalidomide
15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.

Other:
• Placebo
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Israel,  Italy,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir.; Study terminated prematurely. Analysis not conducted.	up to 7 years
Secondary	Overall Survival	Overall survival was defined as the time from randomization to death from any cause.; Study terminated prematurely. Analysis not conducted.	up to 7 years
Secondary	Participants With Treatment Emergent Adverse Events (TEAEs)	Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.; The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.	up to 9 months
Secondary	Time to Progression	Time to progression was defined as the time from the date of randomization until the first date of documented disease progression.; Study terminated prematurely. Analysis not conducted.	up to 7 years
Secondary	Time to Treatment Failure	Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.	up to 2 years
Secondary	Participants With a Tumor Response	Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).; Study terminated prematurely. Analysis not conducted.	up to 7 years