Lymphoma, Mantle-CellNCT03647124
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
An observational study of Lymphoma, Mantle-Cell, run by Celgene at 79 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Mantle-Cell
- What is being tested?
- Lenalidomide
- How many people
- 105 participants
- Where
- 79 sitesin 7 countries
- Study dates
- 13 Mar 2019to 10 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
79 sites in 7 countries.
79 sites in 7 countries
Italy31 sites
Local Institution - 601
Busto Arsizio, 21052
Ospedale di Busto Arsizio - ASST Valle Olona
Busto Arsizio, 21052
Local Institution - 607
Genova, 16132
Ospedale Policlinico San Martino - IRCCS
Genova, 16132
Istituto Clinico Humanitas IRCCS
Milan, 20089
Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico
Milan, 20122
Local Institution - 614
Milan, 20122
Istituto Europeo di Oncologia
Milan, 20141
Azienda Ospedaliera Niguarda Ca' Granda
Milan, 20162
Local Institution - 603
Milan, 20162
Local Institution - 617
Padova, 35043
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
Padova, 35128
Local Institution - 613
Padova, 35128
Azienda Ospedaliero - Universiaria di Parma
Parma, 43126
Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo
Pavia, 27100
Local Institution - 609
Pavia, 27100
Local Institution - 610
Pisa, 56100
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Arcispedale Santa Maria Nuova - AUSL Reggio Emilia
Reggio Emilia, 42122
Local Institution - 602
Reggio Emilia, 42122
Infermi Hospital
Rimini, 47923
Local Institution - 605
Rimini, 47923
Policlinico Umberto I , Universita La Sapienza
Roma, 161
Local Institution - 611
Rome, 00161
Local Institution - 608
Siena, 53100
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, 53100
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, 10126
Local Institution - 616
Torino, 10126
Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza
Torino, 10126
Ospedale Dell'Angelo Di Mestre
Venezia, 30174
Local Institution - 606
Venezia - Mestre, 30174
Spain13 sites
Local Institution - 204
Alava, 01009
Hospital universitario de Alava
Alava País Vasco, 1009
Hospital Universitario 12 de Octubre
Madrid, 28041
Local Institution - 207
Madrid, 28041
Local Institution - 201
Málaga, 29010
Hospital Regional Universitario Carlos Haya
Málaga, 29730
Hospital de Orense
Ourense, 32005
Local Institution - 206
Ourense, 32005
Local Institution - 202
Salamanca, 37003
Hospital Clínico Universiatrio de Salamanca
Salamanca, 37007
Local Institution - 209
Santa Cruz de Tenerife, 38010
Local Institution - 205
Seville, 41014
Nuestra Senora de Valme
Seville, 41014
Greece11 sites
General University Hospital of Alexandroupolis
Alexandrouppoli, 68100
General Anti-Cancer Hospital "Agios Savvas"
Athens, 11522
Local Institution - 501
Athens, 11525
Private hospital "Iatriko Psychikou", Athens
Athens, 11525
General University Hospital of Athens "LAIKO", Athens
Athens, 11527
Local Institution - 502
Athens, GR 115-27
Local Institution - 506
Athens Goudi, 11527
General University Hospital "Attikon"
Chaïdári, 12462
Metaxa Cancer Hospital, Athens
Piraeous, 18537
Local Institution - 511
Rio, Patras, 265 04
Theageneio General Hospital, Thessaloniki
Thessaloniki, 54007
Austria10 sites
Local Institution - 105
Graz, 73013
LKH Graz Medizinische Universitätsklinik
Graz, 8036
LKH Hochsteiermark, Standort Leoben
Leoben, 8700
Local Institution - 104
Leoben, 8700
Local Institution - 102
Salzburg, 5020
Salzburger Landeskliniken - Universitaetsklinikum Salzburg
Salzburger, 5020
AKH Wien, Universitaetsklinik fuer Innere Medizin III
Vienna, 1090
Local Institution - 101
Vienna, 1090
Landesklinikum Wiener Neustadt
Wiener Neustadt, 2700
Local Institution - 103
Wiener Neustadt, 2700
France8 sites
Centre Hospitalier de Versailles André Mignot
Le Chesnay, 78157
Local Institution - 303
Le Chesnay, 78157
Institution: Hopital Prive du Confluent
Nantes, 4402
Local Institution - 308
Nantes, 4402
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)
Paris, 75013
Centre Hospitalier de Saint-Quentin
Saint Quentin Picardie, 2321
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31000
Local Institution - 305
Toulouse, 31059
Germany4 sites
Berufsausuebungsgemeinschaft Kiehl/Stein
Frankfurt/ Oder Brandenburg, 15236
Praxis fuer Haematolgie, Onkologie und Palliativmedizin
Leipzig, 04289
Local Institution - 256
Würzburg, 97080
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Netherlands2 sites
HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg
The Hague, 2545 AA
Local Institution - 401
The Hague, 2545 CH
About this study
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.
Read the 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.
- Conditions
- Lymphoma, Mantle-Cell
- Being tested
- Lenalidomide
- Keywords
- Mantle Cell Lymphoma, MCL, Revlimid, Non-Interventional, PASS, CC-5013, Relapsed, Refractory, TFR, Tumor Flare Reaction, High Tumor Burden
- Medical subject headings
- Lymphoma, Mantle-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid, L04AX04
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe | Not described Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 8.5 years
Secondary outcomes (1)
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.
Measured: Approximately 8.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start13 Mar 2019
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Mantle-CellStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647124
- Sponsor's protocol ID
- CC-5013-MCL-005
- Other IDs
- U1111-1213-1816, EUPAS23366
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2018
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03647124
- Acronym / sponsor ID
- CC-5013-MCL-005
- Conditions
- Lymphoma, Mantle-Cell
- Keywords
- Mantle Cell Lymphoma, MCL, Revlimid, Non-Interventional, PASS, CC-5013, Relapsed, Refractory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe | – | Drug: Lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: Revlimid, L04AX04Specified dose on specified days | Drug | Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
79 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Mantle-Cell, run by Celgene at 79 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Italy, Spain, Greece, Austria, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Approximately 8.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.