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).

NCT01021423 | Terminated Phase 3 Results DMC

• 1 other identifier: CC-5013-MCL-003
• Study Type: interventional
• Target: 9
• Locations: 12 countries
• Sites: 92

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 This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant.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

Conditions

Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma

Keywords

Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma; CC-5013; Revlimid; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Survival

  up to 7 years

• Participants With Treatment Emergent Adverse Events (TEAEs)

  up to 9 months

• Time to Progression

  up to 7 years

• Time to Treatment Failure

  up to 2 years

• Participants With a Tumor Response

  up to 7 years

Study Arms (2)

Lenalidomide

EXPERIMENTAL

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.

Drug: Lenalidomide

Placebo

EXPERIMENTAL

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.

Other: Placebo

Interventions

Lenalidomide DRUG

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.

Also known as: Revlimid

Lenalidomide

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Celgene: lead

Study Sites (92)

Sharp Healthcare Oncology Associates of San Diego

San Diego, California, 92123, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Providence Cancer Center

Indianapolis, Indiana, 97213, United States

Location

Nebraska Hematology-Oncology, PC

Lincoln, Nebraska, 68506, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Arena Oncology Associates

Lake Success, New York, 11042, United States

Location

Weill Cornell Medical College/New York Presbyterian Hospital

New York, New York, 10021, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

University of Virginia Health Systems

Charlottesville, Virginia, 22908, United States

Location

Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie

Hradec Králové, 500 05, Czechia

Location

Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika

Olomouc, 77520, Czechia

Location

Fakultni Nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

Location

Vseobecna Fakultni Nemocnice

Prague, 12808, Czechia

Location

Clinic of Oncology Faculty Hospital Motol

Prague, Czechia

Location

CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique

Amiens, 80054, France

Location

CHU Hôpital Hotel Dieu

Angers, 49000, France

Location

CHU ESTAING, Service d'Hématologie

Clermont-Ferrand, 63003, France

Location

Hôpital Henri Mondor Unité Hémopathies Lymphoides

Créteil, 94010, France

Location

CHD Les Oudairies, Service d'Oncologie Hématologie

La Roche-sur-Yon, 85000, France

Location

Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie

La Tronche, 38700, France

Location

CHRU - Hôpital Claude Huriez

Lille, 59037, France

Location

CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale

Montpellier, 34295, France

Location

CHRU - Hotel Dieu

Nantes, 44093, France

Location

Hôpital Saint-Louis

Paris, 75475, France

Location

CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie

Pierre-Bénite, 69495, France

Location

CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire

Poitiers, 86000, France

Location

CHU de Reims, Hôpital Robert Debré, Hématologie Clinique

Reims, 51092, France

Location

Hôpital Pontchaillou Hématologie Clinique

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Hôpital Purpan CHU de Toulouse

Toulouse, 31059, France

Location

Hôpital Bretonneau - CHU Tours

Tours, 37044, France

Location

CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne

Vandœuvre-lès-Nancy, 54511, France

Location

Universitätsklinikum Essen Zentrum für Innere Medizin

Essen, 45122, Germany

Location

Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie

Freiburg im Breisgau, 79106, Germany

Location

UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie

Göttingen, 37099, Germany

Location

Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation

Hamburg, 20099, Germany

Location

Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe

Karlsruhe, 76135, Germany

Location

Klinikum der Universität München - Großhadern, Medizinische Klinik III

München, 81377, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

Soroka Medical Center The Institute of Hematology

Beersheba, 84101, Israel

Location

Davidoff Cancer Center The Institute of Hematology

Petah Tikva, 49100, Israel

Location

Az. Osp. SS.Antonio e Biagio SC Ematologia

Alessandria, 15121, Italy

Location

Ospedale Regionale di Bolzano - Divisione di Ematologia

Bolzano, 39100, Italy

Location

Hematology Dept, Azienda Ospedaliero Universitaria Careggi

Florence, 50139, Italy

Location

Azienda Ospedaliera Universitaria "San Martino"

Genova, 16132, Italy

Location

Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia

Messina, 98158, Italy

Location

A,O Ospedale Niguarda Ca Granda Dept Hematology

Milan, 20162, Italy

Location

Fondazione San Raffaele del Monte Tabor I.R.C.C.S.

Milan, 20132, Italy

Location

Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia

Napoli, 80131, Italy

Location

Università del Piemonte Orientale "Amedeo Avogadro"

Novara, 28100, Italy

Location

Policlinico San Matteo - Dip. Di Ematologia

Pavia, 27100, Italy

Location

Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia

Reggio Calabria, 89100, Italy

Location

Università Cattolica del Sacro Cuore Policlinico A. Gemelli

Roma, 00168, Italy

Location

IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia

S.Giovanni Rotondo (FG), 71013, Italy

Location

Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)

Torino, 10126, Italy

Location

Ospedale Cardinale G. Panico - Ematologia e Immunoematologia

Tricase, 73039, Italy

Location

Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria

Udine, 33100, Italy

Location

Małopolskie Centrum Medyczne

Krakow, 30-510, Poland

Location

Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

Lodz, 93510, Poland

Location

Dolnoslaskie Centrum Transplantacji Komórkowych

Wroclaw, 53439, Poland

Location

Serviço de Hematologia

Coimbra, 300-075, Portugal

Location

Instituto Português de Oncologia (IPO) de Lisboa

Lisbon, 1099-023, Portugal

Location

Instituto Português de Oncologia (IPO) do Porto

Porto, 4200-072, Portugal

Location

Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico

San Juan, 00918, Puerto Rico

Location

Republican Clinical Oncological Dispensary

Kazan', 420029, Russia

Location

Russian Oncological Research Centre

Moscow, 115478, Russia

Location

Perm Regional Clinical Hospital

Perm, 614600, Russia

Location

Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency

Saint Petersburg, 191024, Russia

Location

State Educational Institution of High Professional Education

Saint Petersburg, 197022, Russia

Location

Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies

Saint Petersburg, 197341, Russia

Location

State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1

Volgograd, 400138, Russia

Location

Sverdlovsk Regional Clinical Hospital - Volgogradskaya

Yekaterinburg, 620102, Russia

Location

Hospital Universitario Vall d´Hebrón Hematology Department

Barcelona, 08035, Spain

Location

Hospital de Madrid Norte- Sanchinarro

Madrid, Spain

Location

Hospital Costa del Sol, Oncology

Marbella (Málaga), 29600, Spain

Location

C. H. de Orense

Ourense, Spain

Location

Clinica Universitaria de Navarra, Hematology

Pamplona, 31008, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Marques de Valdecilla

Santander, 39008, Spain

Location

Kent and Canterbury Hospital

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Torbay Hospital

County of Devon, TQ2 7AA, United Kingdom

Location

Royal Devon & Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 OXL, United Kingdom

Location

Barts & The London NHS Trust Medical Oncology

London, EC1M 6BQ, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Salisbury NHS Foundation Trust, Haematology

Salisbury, SP2 8BJ, United Kingdom

Location

St Helens Hospital, Lilac Lower Ground

St Helens, WA9 3DA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23834234 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Lymphoma, Non-Hodgkin

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Study terminated early. Most analyses were not performed.

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• Martin Dreyling, Prof. Dr

  Medizinische Klinik III der Universität München

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: April 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 19, 2019
• Results First Posted: December 2, 2011

Record last verified: 2019-11

Locations

PL (3); RU (8); US (13); IL (2); PT (3); CZ (5); FR (19); GB (8); ES (7); DE (7); PR (1); IT (16)