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Non-Interventional Study in Patients With Relapsed or Refractory Mantle Cell Lymphoma (R/R MCL) to Investigate the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden (PASS MCL-005)

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ClinicalTrials.gov Identifier: NCT03647124
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

This is a European multinational, retrospective, non-interventional study of patients with R/R MCL designed to further investigate the research objectives described below

The proposed study has two cohorts:

For Cohort 1, MCL patients in the Nordic countries (Denmark and Sweden) will be identified through electronic medical records (EMRs), enabling identification of R/R MCL patients. The cohort identified through EMRs at chosen hospitals will then be linked to the national health registries. Exposure to lenalidomide will be identified through prescription registers or medical chart review.

For Cohort 2, sites will be identified in other European countries where patients have been treated with lenalidomide for R/R MCL. Identification of sites will be completed through partnership with the European Mantle Cell Lymphoma (European MCL) Registry, Additional sites will be identified by Celgene and then assessed for feasibility and invited to participate in the R/R MCL PASS.

For both cohorts, only sites where lenalidomide treatment for R/R MCL is reimbursed will be selected for the study. All data will be collected retrospectively from identified patients following the first dose of lenalidomide treatment for up to 6 months including those patients who died within this data collection period.


Condition or disease Intervention/treatment
Lymphoma, Mantle-Cell Drug: Lenalidomide

Study Type : Observational
Estimated Enrollment : 560 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort Intervention/treatment
Lenalidomide treated R/R-MCL patients in Denmark and Sweden
Retrospective data collection for Lenalidomide treated R/R-MCL patients from Nordic registries and national health databases
Drug: Lenalidomide
Lenalidomide

Lenalidomide treated R/R-MCL patients in the rest of EU
Retrospective data collection for Lenalidomide treated R/R-MCL patients from sites in the rest of European Union
Drug: Lenalidomide
Lenalidomide




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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 [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of a retrospective cohort of R/R MCL patients 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
Criteria

Inclusion Criteria:

  1. Received at least one dose of lenalidomide commencing after 08 July 2016 for the treatment of relapsed refractory mantle cell lymphoma.
  2. Informed consent of the patient or an authorized third person or authority, if required by law, given prior to data collection.
  3. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647124


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Sponsors and Collaborators
Celgene
Investigators
Study Director: Philippe Arnaud, MD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03647124     History of Changes
Other Study ID Numbers: CC-5013-MCL-005
U1111-1213-1816 ( Registry Identifier: WHO )
EUPAS23366 ( Registry Identifier: EU PAS Register )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Mantle Cell Lymphoma
MCL
Revlimid
Non-Interventional
PASS
CC-5013
Relapsed
Refractory
TFR
Tumor Flare Reaction
High Tumor Burden

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents