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Mantle Cell LymphomaPhase 3RENEWNCT01021423

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).

A Phase 3 study testing Lenalidomide in people with Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, run by Celgene at 92 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma
What is being tested?
Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
92 sitesin 12 countries
Study dates
1 Apr 2010to 1 Mar 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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)

Trial locations and contacts

92 sites in 12 countries.

92 sites in 12 countries

France19 sites

  • CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique

    Amiens, 80054

  • CHU Hôpital Hotel Dieu

    Angers, 49000

  • CHU ESTAING, Service d'Hématologie

    Clermont-Ferrand, 63003

  • Hôpital Henri Mondor Unité Hémopathies Lymphoides

    Créteil, 94010

  • CHD Les Oudairies, Service d'Oncologie Hématologie

    La Roche-sur-Yon, 85000

  • Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie

    La Tronche, 38700

  • CHRU - Hôpital Claude Huriez

    Lille, 59037

  • CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale

    Montpellier, 34295

  • CHRU - Hotel Dieu

    Nantes, 44093

  • Hôpital Saint-Louis

    Paris, 75475

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

    Pessac, 33604

  • Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie

    Pierre-Bénite, 69495

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

    Poitiers, 86000

  • CHU de Reims, Hôpital Robert Debré, Hématologie Clinique

    Reims, 51092

  • Hôpital Pontchaillou Hématologie Clinique

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Hôpital Purpan CHU de Toulouse

    Toulouse, 31059

  • Hôpital Bretonneau - CHU Tours

    Tours, 37044

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

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy16 sites

  • Az. Osp. SS.Antonio e Biagio SC Ematologia

    Alessandria, 15121

  • Ospedale Regionale di Bolzano - Divisione di Ematologia

    Bolzano, 39100

  • Hematology Dept, Azienda Ospedaliero Universitaria Careggi

    Florence, 50139

  • Azienda Ospedaliera Universitaria "San Martino"

    Genova, 16132

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

    Messina, 98158

  • A,O Ospedale Niguarda Ca Granda Dept Hematology

    Milan, 20162

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

    Milan, 20132

  • Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia

    Naples, 80131

  • Università del Piemonte Orientale "Amedeo Avogadro"

    Novara, 28100

  • Policlinico San Matteo - Dip. Di Ematologia

    Pavia, 27100

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

    Reggio Calabria, 89100

  • Università Cattolica del Sacro Cuore Policlinico A. Gemelli

    Roma, 00168

  • IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia

    S.Giovanni Rotondo (FG), 71013

  • Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)

    Torino, 10126

  • Ospedale Cardinale G. Panico - Ematologia e Immunoematologia

    Tricase, 73039

  • Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria

    Udine, 33100

Other trials in Italy

United States13 sites

  • University of Virginia Health Systems

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Providence Cancer Center

    Indianapolis, Indiana, 97213

  • Arena Oncology Associates

    Lake Success, New York, 11042

  • Nebraska Hematology-Oncology, PC

    Lincoln, Nebraska, 68506

  • Weill Cornell Medical College/New York Presbyterian Hospital

    New York, New York, 10021

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Sharp Healthcare Oncology Associates of San Diego

    San Diego, California, 92123

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

Russia8 sites

  • Republican Clinical Oncological Dispensary

    Kazan', 420029

  • Russian Oncological Research Centre

    Moscow, 115478

  • Perm Regional Clinical Hospital

    Perm, 614600

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

    Saint Petersburg, 191024

  • State Educational Institution of High Professional Education

    Saint Petersburg, 197022

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

    Saint Petersburg, 197341

  • State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1

    Volgograd, 400138

  • Sverdlovsk Regional Clinical Hospital - Volgogradskaya

    Yekaterinburg, 620102

Other trials in Russia

United Kingdom8 sites

  • Kent and Canterbury Hospital

    Canterbury, Kent, CT1 3NG

  • Torbay Hospital

    County of Devon, TQ2 7AA

  • Royal Devon & Exeter Hospital

    Exeter, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 OXL

  • Barts & The London NHS Trust Medical Oncology

    London, EC1M 6BQ

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Salisbury NHS Foundation Trust, Haematology

    Salisbury, SP2 8BJ

  • St Helens Hospital, Lilac Lower Ground

    St Helens, WA9 3DA

Other trials in United Kingdom

Germany7 sites

  • Universitätsklinikum Essen Zentrum für Innere Medizin

    Essen, 45122

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

    Freiburg im Breisgau, 79106

  • UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie

    Göttingen, 37099

  • Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation

    Hamburg, 20099

  • Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe

    Karlsruhe, 76135

  • Klinikum der Universität München - Großhadern, Medizinische Klinik III

    München, 81377

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Spain7 sites

  • Hospital Universitario Vall d´Hebrón Hematology Department

    Barcelona, 08035

  • Hospital de Madrid Norte- Sanchinarro

    Madrid

  • Hospital Costa del Sol, Oncology

    Marbella (Málaga), 29600

  • C. H. de Orense

    Ourense

  • Clinica Universitaria de Navarra, Hematology

    Pamplona, 31008

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Marques de Valdecilla

    Santander, 39008

Other trials in Spain

Czechia5 sites

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

    Hradec Králové, 500 05

  • Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika

    Olomouc, 77520

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague, 10034

  • Vseobecna Fakultni Nemocnice

    Prague, 12808

  • Clinic of Oncology Faculty Hospital Motol

    Prague

Other trials in Czechia

Poland3 sites

  • Małopolskie Centrum Medyczne

    Krakow, 30-510

  • Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

    Lodz, 93510

  • Dolnoslaskie Centrum Transplantacji Komórkowych

    Wroclaw, 53439

Other trials in Poland

Portugal3 sites

  • Serviço de Hematologia

    Coimbra, 300-075

  • Instituto Português de Oncologia (IPO) de Lisboa

    Lisbon, 1099-023

  • Instituto Português de Oncologia (IPO) do Porto

    Porto, 4200-072

Other trials in Portugal

Israel2 sites

  • Soroka Medical Center The Institute of Hematology

    Beersheba, 84101

  • Davidoff Cancer Center The Institute of Hematology

    Petah Tikva, 49100

Other trials in Israel

Puerto Rico1 site

  • Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Lenalidomide, Placebo
Keywords
Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, CC-5013, Revlimid, Lenalidomide
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid

    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.

  • PlaceboOther

    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.

Study groups in NCT01021423
Study groupRoleWhat they receive
LenalidomideExperimentalLenalidomide - 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.
Receives: Drug: Lenalidomide
PlaceboExperimentalPlacebo (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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 7 years

Secondary outcomes (5)

  1. Overall Survival

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

    Study terminated prematurely. Analysis not conducted.

    Measured: up to 7 years

  2. 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.

    Measured: up to 9 months

  3. 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.

    Measured: up to 7 years

  4. 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.

    Measured: up to 2 years

  5. 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.

    Measured: up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2009 (estimated)
  2. Study start1 Apr 2010
  3. Primary completion1 Mar 2011
  4. Study completion1 Mar 2011

Why it stopped: Terminated by sponsor due to new unpublished data that rendered the current design of the study no longer clinically relevant. There were no safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01021423
Sponsor's protocol ID
CC-5013-MCL-003
Acronym
RENEW
Status last verified
Nov 2019
First submitted
25 Nov 2009
Last updated
19 Nov 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23834234

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide in people with Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, run by Celgene at 92 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in France, Italy, United States, Russia, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: up to 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01021423, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.

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