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

NCT ID: NCT03647124

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-13

Study Completion Date

2024-01-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma, Mantle-Cell

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe

Lenalidomide

Intervention Type DRUG

Specified dose on specified days

Interventions

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Lenalidomide

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Revlimid L04AX04

Eligibility Criteria

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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 Criteria

1\) Patients will be excluded if they were participating in an interventional clinical trial during the treatment period under observation in this Post Authorization Safety Study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Institution: Hopital Prive du Confluent

Nantes, , France

Site Status

Local Institution - 308

Nantes, , France

Site Status

Local Institution - 105

Graz, , Austria

Site Status

LKH Graz Medizinische Universitätsklinik

Graz, , Austria

Site Status

LKH Hochsteiermark, Standort Leoben

Leoben, , Austria

Site Status

Local Institution - 104

Leoben, , Austria

Site Status

Local Institution - 102

Salzburg, , Austria

Site Status

Salzburger Landeskliniken - Universitaetsklinikum Salzburg

Salzburger, , Austria

Site Status

AKH Wien, Universitaetsklinik fuer Innere Medizin III

Vienna, , Austria

Site Status

Local Institution - 101

Vienna, , Austria

Site Status

Landesklinikum Wiener Neustadt

Wiener Neustadt, , Austria

Site Status

Local Institution - 103

Wiener Neustadt, , Austria

Site Status

Centre Hospitalier de Versailles André Mignot

Le Chesnay, , France

Site Status

Local Institution - 303

Le Chesnay, , France

Site Status

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

Paris, , France

Site Status

Centre Hospitalier de Saint-Quentin

Saint Quentin Picardie, , France

Site Status

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, , France

Site Status

Local Institution - 305

Toulouse, , France

Site Status

Berufsausuebungsgemeinschaft Kiehl/Stein

Frankfurt/ Oder Brandenburg, , Germany

Site Status

Praxis fuer Haematolgie, Onkologie und Palliativmedizin

Leipzig, , Germany

Site Status

Local Institution - 256

Würzburg, , Germany

Site Status

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status

General University Hospital of Alexandroupolis

Alexandrouppoli, , Greece

Site Status

General Anti-Cancer Hospital "Agios Savvas"

Athens, , Greece

Site Status

Local Institution - 501

Athens, , Greece

Site Status

Private hospital "Iatriko Psychikou", Athens

Athens, , Greece

Site Status

General University Hospital of Athens "LAIKO", Athens

Athens, , Greece

Site Status

Local Institution - 502

Athens, , Greece

Site Status

Local Institution - 506

Athens Goudi, , Greece

Site Status

General University Hospital "Attikon"

Chaïdári, , Greece

Site Status

Metaxa Cancer Hospital, Athens

Piraeous, , Greece

Site Status

Local Institution - 511

Rio, Patras, , Greece

Site Status

Theageneio General Hospital, Thessaloniki

Thessaloniki, , Greece

Site Status

Local Institution - 601

Busto Arsizio, , Italy

Site Status

Ospedale di Busto Arsizio - ASST Valle Olona

Busto Arsizio, , Italy

Site Status

Local Institution - 607

Genova, , Italy

Site Status

Ospedale Policlinico San Martino - IRCCS

Genova, , Italy

Site Status

Istituto Clinico Humanitas IRCCS

Milan, , Italy

Site Status

Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico

Milan, , Italy

Site Status

Local Institution - 614

Milan, , Italy

Site Status

Istituto Europeo di Oncologia

Milan, , Italy

Site Status

Azienda Ospedaliera Niguarda Ca' Granda

Milan, , Italy

Site Status

Local Institution - 603

Milan, , Italy

Site Status

Local Institution - 617

Padua, , Italy

Site Status

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

Padua, , Italy

Site Status

Local Institution - 613

Padua, , Italy

Site Status

Azienda Ospedaliero - Universiaria di Parma

Parma, , Italy

Site Status

Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

Pavia, , Italy

Site Status

Local Institution - 609

Pavia, , Italy

Site Status

Local Institution - 610

Pisa, , Italy

Site Status

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status

Arcispedale Santa Maria Nuova - AUSL Reggio Emilia

Reggio Emilia, , Italy

Site Status

Local Institution - 602

Reggio Emilia, , Italy

Site Status

Infermi Hospital

Rimini, , Italy

Site Status

Local Institution - 605

Rimini, , Italy

Site Status

Policlinico Umberto I , Universita La Sapienza

Roma, , Italy

Site Status

Local Institution - 611

Rome, , Italy

Site Status

Local Institution - 608

Siena, , Italy

Site Status

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

Siena, , Italy

Site Status

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, , Italy

Site Status

Local Institution - 616

Torino, , Italy

Site Status

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

Torino, , Italy

Site Status

Ospedale Dell'Angelo Di Mestre

Venezia, , Italy

Site Status

Local Institution - 606

Venezia - Mestre, , Italy

Site Status

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

The Hague, , Netherlands

Site Status

Local Institution - 401

The Hague, , Netherlands

Site Status

Local Institution - 204

Alava, , Spain

Site Status

Hospital universitario de Alava

Alava País Vasco, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Local Institution - 207

Madrid, , Spain

Site Status

Local Institution - 201

Málaga, , Spain

Site Status

Hospital Regional Universitario Carlos Haya

Málaga, , Spain

Site Status

Hospital de Orense

Ourense, , Spain

Site Status

Local Institution - 206

Ourense, , Spain

Site Status

Local Institution - 202

Salamanca, , Spain

Site Status

Hospital Clínico Universiatrio de Salamanca

Salamanca, , Spain

Site Status

Local Institution - 209

Santa Cruz de Tenerife, , Spain

Site Status

Local Institution - 205

Seville, , Spain

Site Status

Nuestra Senora de Valme

Seville, , Spain

Site Status

Countries

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Austria France Germany Greece Italy Netherlands Spain

Other Identifiers

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U1111-1213-1816

Identifier Type: REGISTRY

Identifier Source: secondary_id

EUPAS23366

Identifier Type: REGISTRY

Identifier Source: secondary_id

CC-5013-MCL-005

Identifier Type: -

Identifier Source: org_study_id

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