Lymphoma, Mantle-Cell Clinical Trial
Official title:
A Non-interventional, Post-authorization Safety Study of Patients With Relapsed or Refractory Mantle Cell Lymphoma to Further Investigate and Characterize the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden
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.
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
Austria, France, Germany, Greece, Italy, Netherlands, Spain,
| 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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