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

October 19, 2022 updated by: Celgene

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 73013
        • Recruiting
        • Local Institution - 105
      • Graz, Austria, 8036
        • Not yet recruiting
        • LKH Graz Medizinische Universitätsklinik
      • Leoben, Austria, 8700
        • Not yet recruiting
        • LKH Hochsteiermark, Standort Leoben
      • Leoben, Austria, 8700
        • Recruiting
        • Local Institution - 104
      • Salzburg, Austria, 5020
        • Recruiting
        • Local Institution - 102
      • Salzburger, Austria, 5020
        • Recruiting
        • Salzburger Landeskliniken - Universitaetsklinikum Salzburg
      • Wien, Austria, 1090
        • Recruiting
        • AKH Wien, Universitaetsklinik fuer Innere Medizin III
      • Wien, Austria, 1090
        • Recruiting
        • Local Institution - 101
      • Wiener Neustadt, Austria, 2700
        • Recruiting
        • Landesklinikum Wiener Neustadt
      • Wiener Neustadt, Austria, 2700
        • Recruiting
        • Local Institution - 103
  • France
      • Brest, France, 29200
        • Withdrawn
        • CHRU de Brest - Hôpital Morvan
      • Caen Cedex 9, France, 14033
        • Withdrawn
        • CHU de Caen, institut d'hematologie de basse Nomandie
      • Le Chesnay, France, 78157
        • Not yet recruiting
        • Centre Hospitalier de Versailles André Mignot
      • Le Chesnay Cedex, France, 78157
        • Recruiting
        • Local Institution - 303
      • Le Mans, France, 72015
        • Withdrawn
        • Clinique Victor Hugo
      • Nantes, France, 4402
        • Recruiting
        • Institution: Hopital Prive du Confluent
      • Nantes, France, 4402
        • Recruiting
        • Local Institution - 308
      • Paris, France, 75013
        • Not yet recruiting
        • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)
      • Saint Quentin Picardie, France, 2321
        • Recruiting
        • Centre Hospitalier de Saint-Quentin
      • Toulouse CEDEX 9, France, 31059
        • Recruiting
        • Local Institution - 305
      • Toulouse Cedex 9, France, 31000
        • Not yet recruiting
        • Institut Universitaire du Cancer Toulouse - Oncopole
  • Germany
      • Amberg, Germany, 92224
        • Withdrawn
        • Gesundheitszentrum St. Marien GmbH
      • Aschaffenburg, Germany, 63739
        • Withdrawn
        • Studienzentrum Aschaffenburg
      • Frankfurt/ Oder Brandenburg, Germany, 15236
        • Recruiting
        • Berufsausuebungsgemeinschaft Kiehl/Stein
      • Garmisch-Partenkirchen Bavaria, Germany, 82467
        • Withdrawn
        • Klinikum Garmisch-Partenkirchen Gmbh - Zentrum Fuer Innere Medizin
      • Leipzig, Germany, 04289
        • Recruiting
        • Praxis fuer Haematolgie, Onkologie und Palliativmedizin
      • Wuerzburg, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg
      • Wuerzburg, Germany, 97080
        • Completed
        • Local Institution - 256
  • Greece
      • Alexandrouppoli, Greece, 68100
        • Not yet recruiting
        • General University Hospital of Alexandroupolis
      • Athens, Greece, 11522
        • Not yet recruiting
        • General Anti-Cancer Hospital "Agios Savvas"
      • Athens, Greece, 11525
        • Recruiting
        • Local Institution - 501
      • Athens, Greece, 11525
        • Recruiting
        • Private hospital "Iatriko Psychikou", Athens
      • Athens, Greece, 11527
        • Recruiting
        • General University Hospital of Athens "LAIKO", Athens
      • Athens, Greece, GR 115-27
        • Recruiting
        • Local Institution - 502
      • Athens Goudi, Greece, 11527
        • Recruiting
        • Local Institution - 506
      • Chaidari, Greece, 12462
        • Not yet recruiting
        • General University Hospital "Attikon"
      • Piraeous, Greece, 18537
        • Recruiting
        • Metaxa Cancer Hospital, Athens
      • Rio, Patras, Greece, 265 04
        • Recruiting
        • Local Institution - 511
      • Thessaloniki, Greece, 54007
        • Not yet recruiting
        • Theageneio General Hospital, Thessaloniki
    • Achaïa
      • Patras, Achaïa, Greece, 26500
        • Withdrawn
        • Local Institution - 0617
  • Italy
      • Busto Arsizio, Italy, 21052
        • Recruiting
        • Local Institution - 601
      • Busto Arsizio, Italy, 21052
        • Recruiting
        • Ospedale di Busto Arsizio - ASST Valle Olona
      • Genova, Italy, 16132
        • Recruiting
        • Local Institution - 607
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino - IRCCS
      • Milano, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
      • Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas IRCCS
      • Milano, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico
      • Milano, Italy, 20122
        • Recruiting
        • Local Institution - 614
      • Milano, Italy, 20162
        • Recruiting
        • Azienda Ospedaliera Niguarda Ca' Granda
      • Milano, Italy, 20162
        • Recruiting
        • Local Institution - 603
      • Padova, Italy, 35043
        • Not yet recruiting
        • Local Institution - 617
        • Contact:
          • Site 617
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
      • Padova, Italy, 35128
        • Recruiting
        • Local Institution - 613
      • Parma, Italy, 43126
        • Not yet recruiting
        • Azienda Ospedaliero - Universiaria di Parma
      • Pavia, Italy, 27100
        • Recruiting
        • Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo
      • Pavia, Italy, 27100
        • Recruiting
        • Local Institution - 609
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Pisa, Italy, 56100
        • Recruiting
        • Local Institution - 610
      • Reggio Emilia, Italy, 42122
        • Recruiting
        • Arcispedale Santa Maria Nuova - AUSL Reggio Emilia
      • Reggio Emilia, Italy, 42122
        • Recruiting
        • Local Institution - 602
      • Rimini, Italy, 47923
        • Recruiting
        • Infermi Hospital
      • Rimini, Italy, 47923
        • Recruiting
        • Local Institution - 605
      • Roma, Italy, 161
        • Recruiting
        • Policlinico Umberto I , Universita La Sapienza
      • Rome, Italy, 00161
        • Recruiting
        • Local Institution - 611
      • Siena, Italy, 53100
        • Recruiting
        • Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
      • Siena, Italy, 53100
        • Recruiting
        • Local Institution - 608
      • Torino, Italy, 10126
        • Recruiting
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
      • Torino, Italy, 10126
        • Recruiting
        • Local Institution - 616
      • Torino, Italy, 10126
        • Recruiting
        • Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza
      • Venezia, Italy, 30174
        • Recruiting
        • Ospedale Dell'Angelo Di Mestre
      • Venezia - Mestre, Italy, 30174
        • Recruiting
        • Local Institution - 606
  • Netherlands
      • Den Haag, Netherlands, 2545 AA
        • Recruiting
        • HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg
      • Den Haag, Netherlands, 2545 CH
        • Recruiting
        • Local Institution - 401
  • Spain
      • Alava, Spain, 01009
        • Recruiting
        • Local Institution - 204
      • Alava País Vasco, Spain, 1009
        • Recruiting
        • Hospital Universitario de Alava
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28041
        • Recruiting
        • Local Institution - 207
      • Malaga, Spain, 29010
        • Recruiting
        • Local Institution - 201
      • Malaga, Spain, 29730
        • Recruiting
        • Hospital Regional Universitario Carlos Haya
      • Ourense, Spain, 32005
        • Recruiting
        • Hospital de Orense
      • Ourense, Spain, 32005
        • Recruiting
        • Local Institution - 206
      • Pamplona Navarra, Spain, 31008
        • Withdrawn
        • Complejo Hospitalario de Navarra
      • Salamanca, Spain, 37003
        • Recruiting
        • Local Institution - 202
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Clínico Universiatrio de Salamanca
      • Santa Cruz De Tenerife, Spain, 38010
        • Not yet recruiting
        • Local Institution - 209
        • Contact:
          • Site 209
      • Sevilla, Spain, 41014
        • Recruiting
        • Local Institution - 205
      • Sevilla, Spain, 41014
        • Recruiting
        • Nuestra Senora de Valme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe
Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid
  • L04AX04

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting.
Time Frame: 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.
Approximately 8.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Approximately 8.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 13, 2019

Primary Completion (ANTICIPATED)

December 31, 2026

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (ACTUAL)

August 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-MCL-005
  • U1111-1213-1816 (REGISTRY: WHO)
  • EUPAS23366 (REGISTRY: EU PAS Register)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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