A Study to Evaluate the Relationship of Lenalidomide With Tumor Flare Reaction and High Tumor Burden in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Last updated: March 3, 2025
Sponsor: Celgene
Overall Status: Completed

Phase

N/A

Condition

Lymphoma

Treatment

Lenalidomide

Clinical Study ID

NCT03647124
CC-5013-MCL-005
U1111-1213-1816
EUPAS23366
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Received at least one dose of lenalidomide commencing after 08 July 2016 for the treatment of relapsed refractory mantle cell lymphoma.

Informed consent of the patient or an authorized third person or authority, if required by law, given prior to data collection.

Patient must be ≥18 years of age at the time of signing the informed consent form.

Exclusion

Exclusion Criteria:

  1. Patients will be excluded if they were participating in an interventional clinicaltrial during the treatment period under observation in this Post AuthorizationSafety Study.

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: Lenalidomide
Phase:
Study Start date:
March 13, 2019
Estimated Completion Date:
January 10, 2024

Study Description

This is a European multinational, retrospective, non-interventional study of participants with relapsed or refractory mantle cell lymphoma (R/R MCL). Potential sites will be identified where R/R MCL participants have been treated with lenalidomide. Site inclusion will be limited to countries where lenalidomide is reimbursed for this indication.

Connect with a study center

  • LKH Graz Medizinische Universitätsklinik

    Graz, 8036
    Austria

    Site Not Available

  • Local Institution - 105

    Graz, 73013
    Austria

    Site Not Available

  • LKH Hochsteiermark, Standort Leoben

    Leoben, 8700
    Austria

    Site Not Available

  • Local Institution - 104

    Leoben, 8700
    Austria

    Site Not Available

  • Local Institution - 102

    Salzburg, 5020
    Austria

    Site Not Available

  • Salzburger Landeskliniken - Universitaetsklinikum Salzburg

    Salzburger, 5020
    Austria

    Site Not Available

  • AKH Wien, Universitaetsklinik fuer Innere Medizin III

    Wien, 1090
    Austria

    Site Not Available

  • Local Institution - 101

    Wien, 1090
    Austria

    Site Not Available

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, 2700
    Austria

    Site Not Available

  • Local Institution - 103

    Wiener Neustadt, 2700
    Austria

    Site Not Available

  • CHRU de Brest - Hopital Morvan

    Brest, 29200
    France

    Site Not Available

  • CHU de Caen, institut d'hematologie de basse Nomandie

    Caen Cedex 9, 14033
    France

    Site Not Available

  • Centre Hospitalier de Versailles André Mignot

    Le Chesnay, 78157
    France

    Site Not Available

  • Local Institution - 303

    Le Chesnay Cedex, 78157
    France

    Site Not Available

  • Clinique Victor Hugo

    Le Mans, 72015
    France

    Site Not Available

  • Institution: Hopital Prive du Confluent

    Nantes, 4402
    France

    Site Not Available

  • Local Institution - 308

    Nantes, 4402
    France

    Site Not Available

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)

    Paris, 75013
    France

    Site Not Available

  • Centre Hospitalier de Saint-Quentin

    Saint Quentin Picardie, 2321
    France

    Site Not Available

  • Local Institution - 305

    Toulouse CEDEX 9, 31059
    France

    Site Not Available

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse Cedex 9, 31000
    France

    Site Not Available

  • Gesundheitszentrum St. Marien Gmbh

    Amberg, 92224
    Germany

    Site Not Available

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739
    Germany

    Site Not Available

  • Berufsausuebungsgemeinschaft Kiehl/Stein

    Frankfurt/ Oder Brandenburg, 15236
    Germany

    Site Not Available

  • Klinikum Garmisch-Partenkirchen Gmbh - Zentrum Fuer Innere Medizin

    Garmisch-Partenkirchen Bavaria, 82467
    Germany

    Site Not Available

  • Praxis fuer Haematolgie, Onkologie und Palliativmedizin

    Leipzig, 04289
    Germany

    Site Not Available

  • Local Institution - 256

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Local Institution - 0617

    Patras, Achaïa 26500
    Greece

    Site Not Available

  • General University Hospital of Alexandroupolis

    Alexandrouppoli, 68100
    Greece

    Site Not Available

  • General Anti-Cancer Hospital "Agios Savvas"

    Athens, 11522
    Greece

    Site Not Available

  • General University Hospital of Athens "LAIKO", Athens

    Athens, 11527
    Greece

    Site Not Available

  • Local Institution - 501

    Athens, 11525
    Greece

    Site Not Available

  • Local Institution - 502

    Athens, GR 115-27
    Greece

    Site Not Available

  • Private hospital "Iatriko Psychikou", Athens

    Athens, 11525
    Greece

    Site Not Available

  • Local Institution - 506

    Athens Goudi, 11527
    Greece

    Site Not Available

  • General University Hospital "Attikon"

    Chaidari, 12462
    Greece

    Site Not Available

  • Metaxa Cancer Hospital, Athens

    Piraeous, 18537
    Greece

    Site Not Available

  • Local Institution - 511

    Rio, Patras, 265 04
    Greece

    Site Not Available

  • Theageneio General Hospital, Thessaloniki

    Thessaloniki, 54007
    Greece

    Site Not Available

  • Local Institution - 601

    Busto Arsizio, 21052
    Italy

    Site Not Available

  • Ospedale di Busto Arsizio - ASST Valle Olona

    Busto Arsizio, 21052
    Italy

    Site Not Available

  • Local Institution - 607

    Genova, 16132
    Italy

    Site Not Available

  • Ospedale Policlinico San Martino - IRCCS

    Genova, 16132
    Italy

    Site Not Available

  • Azienda Ospedaliera Niguarda Ca' Granda

    Milano, 20162
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico

    Milano, 20122
    Italy

    Site Not Available

  • Istituto Clinico Humanitas IRCCS

    Milano, 20089
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia

    Milano, 20141
    Italy

    Site Not Available

  • Local Institution - 603

    Milano, 20162
    Italy

    Site Not Available

  • Local Institution - 614

    Milano, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia

    Padova, 35128
    Italy

    Site Not Available

  • Local Institution - 613

    Padova, 35128
    Italy

    Site Not Available

  • Local Institution - 617

    Padova, 35043
    Italy

    Site Not Available

  • Azienda Ospedaliero - Universiaria di Parma

    Parma, 43126
    Italy

    Site Not Available

  • Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Local Institution - 609

    Pavia, 27100
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126
    Italy

    Site Not Available

  • Local Institution - 610

    Pisa, 56100
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova - AUSL Reggio Emilia

    Reggio Emilia, 42122
    Italy

    Site Not Available

  • Local Institution - 602

    Reggio Emilia, 42122
    Italy

    Site Not Available

  • Infermi Hospital

    Rimini, 47923
    Italy

    Site Not Available

  • Local Institution - 605

    Rimini, 47923
    Italy

    Site Not Available

  • Policlinico Umberto I , Universita La Sapienza

    Roma, 161
    Italy

    Site Not Available

  • Local Institution - 611

    Rome, 00161
    Italy

    Site Not Available

  • Local Institution - 608

    Siena, 53100
    Italy

    Site Not Available

  • Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

    Siena, 53100
    Italy

    Site Not Available

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Site Not Available

  • Local Institution - 616

    Torino, 10126
    Italy

    Site Not Available

  • Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza

    Torino, 10126
    Italy

    Site Not Available

  • Ospedale Dell'Angelo Di Mestre

    Venezia, 30174
    Italy

    Site Not Available

  • Local Institution - 606

    Venezia - Mestre, 30174
    Italy

    Site Not Available

  • HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg

    Den Haag, 2545 AA
    Netherlands

    Site Not Available

  • Local Institution - 401

    Den Haag, 2545 CH
    Netherlands

    Site Not Available

  • Local Institution - 204

    Alava, 01009
    Spain

    Site Not Available

  • Hospital universitario de Alava

    Alava País Vasco, 1009
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Local Institution - 207

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Regional Universitario Carlos Haya

    Malaga, 29730
    Spain

    Site Not Available

  • Local Institution - 201

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital de Orense

    Ourense, 32005
    Spain

    Site Not Available

  • Local Institution - 206

    Ourense, 32005
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona Navarra, 31008
    Spain

    Site Not Available

  • Hospital Clínico Universiatrio de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Local Institution - 202

    Salamanca, 37003
    Spain

    Site Not Available

  • Local Institution - 209

    Santa Cruz De Tenerife, 38010
    Spain

    Site Not Available

  • Local Institution - 205

    Sevilla, 41014
    Spain

    Site Not Available

  • Nuestra Senora de Valme

    Sevilla, 41014
    Spain

    Site Not Available

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