Clinical trial NCT03647124: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Mantle-Cell
Keywords: Mantle Cell Lymphoma
MCL
Revlimid
Non-Interventional
PASS
CC-5013
Relapsed
Refractory
TFR
Tumor Flare Reaction
High Tumor Burden
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of a retrospective cohort of participants with refractory mantle cell lymphoma (R/R-MCL) who have commenced treatment with lenalidomide after 08 July 2016 (date marketing authorization was granted). Three datasets will be described for the study population and will form the basis of subsequent analyses: Population dataset, Treatment dataset, Outcomes dataset

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting.
timeFrame: Approximately 8.5 years
Secondary outcomes:
measure: 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
timeFrame: Approximately 8.5 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Local Institution - 105
city: Graz
country: Austria
facility: LKH Graz Medizinische Universitätsklinik
city: Leoben
country: Austria
facility: LKH Hochsteiermark, Standort Leoben
city: Leoben
country: Austria
facility: Local Institution - 104
city: Salzburger
country: Austria
facility: Salzburger Landeskliniken - Universitaetsklinikum Salzburg
city: Salzburg
country: Austria
facility: Local Institution - 102
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Wiener Neustadt
country: Austria
facility: Local Institution - 103
city: Wien
country: Austria
facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III
city: Wien
country: Austria
facility: Local Institution - 101
city: Le Chesnay Cedex
country: France
facility: Local Institution - 303
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles André Mignot
city: Nantes
country: France
facility: Institution: Hopital Prive du Confluent
city: Nantes
country: France
facility: Local Institution - 308
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)
city: Saint Quentin Picardie
country: France
facility: Centre Hospitalier de Saint-Quentin
city: Toulouse Cedex 9
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
city: Toulouse CEDEX 9
country: France
facility: Local Institution - 305
city: Frankfurt/ Oder Brandenburg
country: Germany
facility: Berufsausuebungsgemeinschaft Kiehl/Stein
city: Leipzig
country: Germany
facility: Praxis fuer Haematolgie, Onkologie und Palliativmedizin
city: Wuerzburg
country: Germany
facility: Local Institution - 256
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Alexandrouppoli
country: Greece
facility: General University Hospital of Alexandroupolis
city: Athens Goudi
country: Greece
facility: Local Institution - 506
city: Athens
country: Greece
facility: General Anti-Cancer Hospital "Agios Savvas"
city: Athens
country: Greece
facility: Local Institution - 501
city: Athens
country: Greece
facility: Private hospital "Iatriko Psychikou", Athens
city: Athens
country: Greece
facility: General University Hospital of Athens "LAIKO", Athens
city: Athens
country: Greece
facility: Local Institution - 502
city: Chaidari
country: Greece
facility: General University Hospital "Attikon"
city: Piraeous
country: Greece
facility: Metaxa Cancer Hospital, Athens
city: Rio, Patras
country: Greece
facility: Local Institution - 511
city: Thessaloniki
country: Greece
facility: Theageneio General Hospital, Thessaloniki
city: Busto Arsizio
country: Italy
facility: Local Institution - 601
city: Busto Arsizio
country: Italy
facility: Ospedale di Busto Arsizio - ASST Valle Olona
city: Genova
country: Italy
facility: Local Institution - 607
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino - IRCCS
city: Milano
country: Italy
facility: Istituto Clinico Humanitas IRCCS
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico
city: Milano
country: Italy
facility: Local Institution - 614
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Azienda Ospedaliera Niguarda Ca' Granda
city: Milano
country: Italy
facility: Local Institution - 603
city: Padova
country: Italy
facility: Local Institution - 617
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
city: Padova
country: Italy
facility: Local Institution - 613
city: Parma
country: Italy
facility: Azienda Ospedaliero - Universiaria di Parma
city: Pavia
country: Italy
facility: Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo
city: Pavia
country: Italy
facility: Local Institution - 609
city: Pisa
country: Italy
facility: Local Institution - 610
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - AUSL Reggio Emilia
city: Reggio Emilia
country: Italy
facility: Local Institution - 602
city: Rimini
country: Italy
facility: Infermi Hospital
city: Rimini
country: Italy
facility: Local Institution - 605
city: Roma
country: Italy
facility: Policlinico Umberto I , Universita La Sapienza
city: Rome
country: Italy
facility: Local Institution - 611
city: Siena
country: Italy
facility: Local Institution - 608
city: Siena
country: Italy
facility: Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino
city: Torino
country: Italy
facility: Local Institution - 616
city: Torino
country: Italy
facility: Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza
city: Venezia - Mestre
country: Italy
facility: Local Institution - 606
city: Venezia
country: Italy
facility: Ospedale Dell'Angelo Di Mestre
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg
city: Den Haag
country: Netherlands
facility: Local Institution - 401
city: Alava País Vasco
country: Spain
facility: Hospital universitario de Alava
city: Alava
country: Spain
facility: Local Institution - 204
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Local Institution - 207
city: Malaga
country: Spain
facility: Local Institution - 201
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Ourense
country: Spain
facility: Hospital de Orense
city: Ourense
country: Spain
facility: Local Institution - 206
city: Salamanca
country: Spain
facility: Local Institution - 202
city: Salamanca
country: Spain
facility: Hospital Clínico Universiatrio de Salamanca
city: Santa Cruz De Tenerife
country: Spain
facility: Local Institution - 209
city: Sevilla
country: Spain
facility: Local Institution - 205
city: Sevilla
country: Spain
facility: Nuestra Senora de Valme
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: