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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03647124
Other study ID # CC-5013-MCL-005
Secondary ID U1111-1213-1816E
Status Recruiting
Phase
First received
Last updated
Start date March 13, 2019
Est. completion date December 31, 2026

Study information

Verified date October 2022
Source Celgene
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 560
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lenalidomide
Specified dose on specified days

Locations

Country Name City State
Austria LKH Graz Medizinische Universitätsklinik Graz
Austria Local Institution - 105 Graz
Austria LKH Hochsteiermark, Standort Leoben Leoben
Austria Local Institution - 104 Leoben
Austria Local Institution - 102 Salzburg
Austria Salzburger Landeskliniken - Universitaetsklinikum Salzburg Salzburger
Austria AKH Wien, Universitaetsklinik fuer Innere Medizin III Wien
Austria Local Institution - 101 Wien
Austria Landesklinikum Wiener Neustadt Wiener Neustadt
Austria Local Institution - 103 Wiener Neustadt
France CHRU de Brest - Hopital Morvan Brest
France CHU de Caen, institut d'hematologie de basse Nomandie Caen Cedex 9
France Centre Hospitalier de Versailles André Mignot Le Chesnay
France Local Institution - 303 Le Chesnay Cedex
France Clinique Victor Hugo Le Mans
France Institution: Hopital Prive du Confluent Nantes
France Local Institution - 308 Nantes
France Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere) Paris
France Centre Hospitalier de Saint-Quentin Saint Quentin Picardie
France Institut Universitaire du Cancer Toulouse - Oncopole Toulouse Cedex 9
France Local Institution - 305 Toulouse CEDEX 9
Germany Gesundheitszentrum St. Marien Gmbh Amberg
Germany Studienzentrum Aschaffenburg Aschaffenburg
Germany Berufsausuebungsgemeinschaft Kiehl/Stein Frankfurt/ Oder Brandenburg
Germany Klinikum Garmisch-Partenkirchen Gmbh - Zentrum Fuer Innere Medizin Garmisch-Partenkirchen Bavaria
Germany Praxis fuer Haematolgie, Onkologie und Palliativmedizin Leipzig
Germany Local Institution - 256 Wuerzburg
Germany Universitaetsklinikum Wuerzburg Wuerzburg
Greece General University Hospital of Alexandroupolis Alexandrouppoli
Greece General Anti-Cancer Hospital "Agios Savvas" Athens
Greece General University Hospital of Athens "LAIKO", Athens Athens
Greece Local Institution - 501 Athens
Greece Local Institution - 502 Athens
Greece Private hospital "Iatriko Psychikou", Athens Athens
Greece Local Institution - 506 Athens Goudi
Greece General University Hospital "Attikon" Chaidari
Greece Local Institution - 0617 Patras Achaïa
Greece Metaxa Cancer Hospital, Athens Piraeous
Greece Local Institution - 511 Rio, Patras
Greece Theageneio General Hospital, Thessaloniki Thessaloniki
Italy Local Institution - 601 Busto Arsizio
Italy Ospedale di Busto Arsizio - ASST Valle Olona Busto Arsizio
Italy Local Institution - 607 Genova
Italy Ospedale Policlinico San Martino - IRCCS Genova
Italy Azienda Ospedaliera Niguarda Ca' Granda Milano
Italy Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico Milano
Italy Istituto Clinico Humanitas IRCCS Milano
Italy Istituto Europeo di Oncologia Milano
Italy Local Institution - 603 Milano
Italy Local Institution - 614 Milano
Italy Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia Padova
Italy Local Institution - 613 Padova
Italy Local Institution - 617 Padova
Italy Azienda Ospedaliero - Universiaria di Parma Parma
Italy Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo Pavia
Italy Local Institution - 609 Pavia
Italy Azienda Ospedaliero Universitaria Pisana Pisa
Italy Local Institution - 610 Pisa
Italy Arcispedale Santa Maria Nuova - AUSL Reggio Emilia Reggio Emilia
Italy Local Institution - 602 Reggio Emilia
Italy Infermi Hospital Rimini
Italy Local Institution - 605 Rimini
Italy Policlinico Umberto I , Universita La Sapienza Roma
Italy Local Institution - 611 Rome
Italy Local Institution - 608 Siena
Italy Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte Siena
Italy Azienda Ospedaliera Citta della Salute e della Scienza di Torino Torino
Italy Local Institution - 616 Torino
Italy Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza Torino
Italy Ospedale Dell'Angelo Di Mestre Venezia
Italy Local Institution - 606 Venezia - Mestre
Netherlands HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg Den Haag
Netherlands Local Institution - 401 Den Haag
Spain Local Institution - 204 Alava
Spain Hospital universitario de Alava Alava País Vasco
Spain Hospital Universitario 12 de Octubre Madrid
Spain Local Institution - 207 Madrid
Spain Hospital Regional Universitario Carlos Haya Malaga
Spain Local Institution - 201 Malaga
Spain Hospital de Orense Ourense
Spain Local Institution - 206 Ourense
Spain Complejo Hospitalario de Navarra Pamplona Navarra
Spain Hospital Clínico Universiatrio de Salamanca Salamanca
Spain Local Institution - 202 Salamanca
Spain Local Institution - 209 Santa Cruz De Tenerife
Spain Local Institution - 205 Sevilla
Spain Nuestra Senora de Valme Sevilla

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

Austria,  France,  Germany,  Greece,  Italy,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting. To quantify and characterize the event of TFR by tumor burden (assessed based on the last CT scan performed within a maximum of 2 months prior to initiation of administration of lenalidomide) in R/R MCL patients treated with lenalidomide in a real-world setting. Approximately 8.5 years
Secondary To quantify and characterize the proportion of early deaths by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting To quantify and characterize the proportion of early deaths (defined as deaths within 20 weeks of initial administration of lenalidomide) by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting. Approximately 8.5 years
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