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). (RENEW)

November 6, 2019 updated by: Celgene

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

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This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant.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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie
      • Olomouc, Czechia, 77520
        • Fakultni nemocnice Olomouc, Hemato-onkologicka klinika
      • Prague 5, Czechia
        • Clinic of Oncology Faculty Hospital Motol
      • Praha 10, Czechia, 10034
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha 2, Czechia, 12808
        • Vseobecna Fakultní Nemocnice
  • France
      • Amiens Cedex, France, 80054
        • CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique
      • Angers, France, 49000
        • CHU Hôpital Hôtel Dieu
      • Clermont Ferrand Cedex 1, France, 63003
        • CHU ESTAING, Service d'Hématologie
      • Créteil, France, 94010
        • Hôpital Henri Mondor Unité Hémopathies Lymphoides
      • La Roche sur Yon, France, 85000
        • CHD Les Oudairies, Service d'Oncologie Hématologie
      • La Tronche, France, 38700
        • Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
      • Lille Cedex, France, 59037
        • CHRU - Hôpital Claude Huriez
      • Montpellier cedex 5, France, 34295
        • CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale
      • Nantes Cedex 1, France, 44093
        • CHRU - Hôtel Dieu
      • Paris Cedex 10, France, 75475
        • Hopital Saint-Louis
      • Pessac, France, 33604
        • CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie
      • Pierre Bénite Cedex, France, 69495
        • Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
      • Poitiers, France, 86000
        • CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire
      • Reims Cedex, France, 51092
        • CHU de Reims, Hôpital Robert Debré, Hématologie Clinique
      • Rennes Cedex, France, 35033
        • Hôpital Pontchaillou Hématologie Clinique
      • Rouen Cedex 1, France, 76038
        • Centre Henri Becquerel
      • Toulouse cedex 9, France, 31059
        • Hôpital Purpan CHU de Toulouse
      • Tours, France, 37044
        • Hôpital Bretonneau - CHU Tours
      • Vandoeuvre Les Nancy, France, 54511
        • CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne
  • Germany
      • Essen, Germany, 45122
        • Universitätsklinikum Essen Zentrum für Innere Medizin
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie
      • Göttingen, Germany, 37099
        • UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation
      • Karlsruhe, Germany, 76135
        • Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe
      • München, Germany, 81377
        • Klinikum der Universität München - Großhadern, Medizinische Klinik III
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka Medical Center The Institute of Hematology
      • Petah Tiqwa, Israel, 49100
        • Davidoff Cancer Center The Institute of Hematology
  • Italy
      • Alessandria, Italy, 15121
        • Az. Osp. SS.Antonio e Biagio SC Ematologia
      • Bolzano, Italy, 39100
        • Ospedale Regionale di Bolzano - Divisione di Ematologia
      • Florence, Italy, 50139
        • Hematology Dept, Azienda Ospedaliero Universitaria Careggi
      • Genova, Italy, 16132
        • Azienda Ospedaliera Universitaria "San Martino"
      • Messina, Italy, 98158
        • Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia
      • Milan, Italy, 20162
        • A,O Ospedale Niguarda Ca Granda Dept Hematology
      • Milano, Italy, 20132
        • Fondazione San Raffaele del Monte Tabor I.R.C.C.S.
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia
      • Novara, Italy, 28100
        • Universita del Piemonte Orientale "Amedeo Avogadro"
      • Pavia, Italy, 27100
        • Policlinico San Matteo - Dip. Di Ematologia
      • Reggio Calabria, Italy, 89100
        • Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia
      • Roma, Italy, 00168
        • Università Cattolica del Sacro Cuore Policlinico A. Gemelli
      • S.Giovanni Rotondo (FG), Italy, 71013
        • IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia
      • Torino, Italy, 10126
        • Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)
      • Tricase, Italy, 73039
        • Ospedale Cardinale G. Panico - Ematologia e Immunoematologia
      • Udine, Italy, 33100
        • Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria
  • Poland
      • Krakow, Poland, 30-510
        • Małopolskie Centrum Medyczne
      • Lodz, Poland, 93510
        • Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
      • Wroclaw, Poland, 53439
        • Dolnoslaskie Centrum Transplantacji Komorkowych
  • Portugal
      • Coimbra, Portugal, 300-075
        • Serviço de Hematologia
      • Lisboa, Portugal, 1099-023
        • Instituto Português de Oncologia (IPO) de Lisboa
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia (IPO) do Porto
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Centro De Cancer, Hospital Espanol Auxilio De Puerto Rico
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
        • Sverdlovsk Regional Clinical Hospital - Volgogradskaya
      • Kazan, Russian Federation, 420029
        • Republican Clinical Oncological Dispensary
      • Moscow, Russian Federation, 115478
        • Russian Oncological Research Centre
      • Perm, Russian Federation, 614600
        • Perm Regional Clinical Hospital
      • St. Petersburg, Russian Federation, 191024
        • Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency
      • St. Petersburg, Russian Federation, 197022
        • State Educational Institution of High Professional Education
      • St. Petersburg, Russian Federation, 197341
        • Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies
      • Volgograd, Russian Federation, 400138
        • State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d´Hebrón Hematology Department
      • Madrid, Spain
        • Hospital de Madrid Norte- Sanchinarro
      • Marbella (Málaga), Spain, 29600
        • Hospital Costa del Sol, Oncology
      • Ourense, Spain
        • C. H. de Orense
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra, Hematology
      • Salamanca, Spain, 37007
        • Hospital Clínico Universitario de Salamanca
      • Santander, Spain, 39008
        • Hospital Marques de Valdecilla
  • United Kingdom
      • Canterbury, Kent, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • County Of Devon, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital
      • Glasgow, United Kingdom, G12 OXL
        • Beatson West Of Scotland Cancer Centre
      • London, United Kingdom, EC1M 6BQ
        • Barts & The London NHS Trust Medical Oncology
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Salisbury, United Kingdom, SP2 8BJ
        • Salisbury NHS Foundation Trust, Haematology
      • St. Helens, United Kingdom, WA9 3DA
        • St Helens Hospital, Lilac Lower Ground
  • United States
    • California
      • San Diego, California, United States, 92123
        • Sharp Healthcare Oncology Associates of San Diego
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 97213
        • Providence Cancer Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Hematology-Oncology, PC
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Lake Success, New York, United States, 11042
        • Arena Oncology Associates
      • New York, New York, United States, 10021
        • Weill Cornell Medical College/New York Presbyterian Hospital
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenalidomide
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
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 Names:
  • Revlimid
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: up to 7 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: up to 7 years

Overall survival was defined as the time from randomization to death from any cause.

Study terminated prematurely. Analysis not conducted.
up to 7 years
Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: up to 9 months

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
Time to Progression
Time Frame: up to 7 years

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
Time to Treatment Failure
Time Frame: up to 2 years
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
Participants With a Tumor Response
Time Frame: up to 7 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Principal Investigator: Martin Dreyling, Prof. Dr, Medizinische Klinik III der Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

November 30, 2009

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-MCL-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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