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
- Registration Number
- NCT03647124
- Lead Sponsor
- Celgene
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe Lenalidomide -
- Primary Outcome Measures
Name Time Method To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting. Approximately 8.5 years 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.
- Secondary Outcome Measures
Name Time Method 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 Approximately 8.5 years 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.
Trial Locations
- Locations (79)
Local Institution - 614
🇮🇹Milano, Italy
Local Institution - 101
🇦🇹Wien, Austria
Local Institution - 303
🇫🇷Le Chesnay Cedex, France
Centre Hospitalier de Versailles André Mignot
🇫🇷Le Chesnay, France
Institution: Hopital Prive du Confluent
🇫🇷Nantes, France
Local Institution - 308
🇫🇷Nantes, France
Local Institution - 202
🇪🇸Salamanca, Spain
Hospital ClÃnico Universiatrio de Salamanca
🇪🇸Salamanca, Spain
Ospedale Policlinico San Martino - IRCCS
🇮🇹Genova, Italy
Istituto Clinico Humanitas IRCCS
🇮🇹Milano, Italy
Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico
🇮🇹Milano, Italy
Local Institution - 105
🇦🇹Graz, Austria
LKH Graz Medizinische Universitätsklinik
🇦🇹Graz, Austria
LKH Hochsteiermark, Standort Leoben
🇦🇹Leoben, Austria
Centre Hospitalier de Saint-Quentin
🇫🇷Saint Quentin Picardie, France
Local Institution - 256
🇩🇪Wuerzburg, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
General University Hospital of Alexandroupolis
🇬🇷Alexandrouppoli, Greece
Local Institution - 506
🇬🇷Athens Goudi, Greece
General Anti-Cancer Hospital "Agios Savvas"
🇬🇷Athens, Greece
Local Institution - 501
🇬🇷Athens, Greece
Private hospital "Iatriko Psychikou", Athens
🇬🇷Athens, Greece
General University Hospital of Athens "LAIKO", Athens
🇬🇷Athens, Greece
Local Institution - 502
🇬🇷Athens, Greece
General University Hospital "Attikon"
🇬🇷Chaidari, Greece
Metaxa Cancer Hospital, Athens
🇬🇷Piraeous, Greece
Local Institution - 511
🇬🇷Rio, Patras, Greece
Theageneio General Hospital, Thessaloniki
🇬🇷Thessaloniki, Greece
Local Institution - 607
🇮🇹Genova, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Azienda Ospedaliera Niguarda Ca' Granda
🇮🇹Milano, Italy
Local Institution - 603
🇮🇹Milano, Italy
Local Institution - 617
🇮🇹Padova, Italy
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
🇮🇹Padova, Italy
Local Institution - 613
🇮🇹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
Local Institution - 610
🇮🇹Pisa, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
AKH Wien, Universitaetsklinik fuer Innere Medizin III
🇦🇹Wien, Austria
Local Institution - 104
🇦🇹Leoben, Austria
Salzburger Landeskliniken - Universitaetsklinikum Salzburg
🇦🇹Salzburger, Austria
Local Institution - 102
🇦🇹Salzburg, Austria
Landesklinikum Wiener Neustadt
🇦🇹Wiener Neustadt, Austria
Local Institution - 103
🇦🇹Wiener Neustadt, Austria
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)
🇫🇷Paris, France
Institut Universitaire du Cancer Toulouse - Oncopole
🇫🇷Toulouse Cedex 9, France
Local Institution - 305
🇫🇷Toulouse CEDEX 9, France
Berufsausuebungsgemeinschaft Kiehl/Stein
🇩🇪Frankfurt/ Oder Brandenburg, Germany
Praxis fuer Haematolgie, Onkologie und Palliativmedizin
🇩🇪Leipzig, Germany
Local Institution - 601
🇮🇹Busto Arsizio, Italy
Ospedale di Busto Arsizio - ASST Valle Olona
🇮🇹Busto Arsizio, 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
Local Institution - 606
🇮🇹Venezia - Mestre, Italy
Ospedale Dell'Angelo Di Mestre
🇮🇹Venezia, Italy
HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg
🇳🇱Den Haag, Netherlands
Local Institution - 401
🇳🇱Den Haag, Netherlands
Hospital universitario de Alava
🇪🇸Alava PaÃs Vasco, Spain
Local Institution - 204
🇪🇸Alava, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Local Institution - 207
🇪🇸Madrid, Spain
Local Institution - 201
🇪🇸Malaga, Spain
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
Hospital de Orense
🇪🇸Ourense, Spain
Local Institution - 206
🇪🇸Ourense, Spain
Local Institution - 209
🇪🇸Santa Cruz De Tenerife, Spain
Local Institution - 205
🇪🇸Sevilla, Spain
Nuestra Senora de Valme
🇪🇸Sevilla, Spain