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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.

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

Clinicaltrials.gov identifier NCT03647124

Recruitment Status Recruiting

First Posted August 27, 2018

Last update posted September 17, 2020

Study Description

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:Lymphoma, Mantle-Cell
  • Intervention/Treatment: Drug: Lenalidomide
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: December 2026
  • Estimated Study Completion Date: December 2026
Groups and Cohorts
Groups/Cohorts 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
Outcome Measures
  • 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.
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts

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

Locations
Show 43 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Philippe Arnaud, MD Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03647124 History of Changes
  • Other Study ID Numbers: CC-5013-MCL-005, U1111-1213-1816, EUPAS23366
  • First Posted: August 27, 2018 Key Record Dates
  • Last Update Posted: September 17, 2020
  • Last Verified: September 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: CC-5013
    Non-Interventional
    Relapsed
    Refractory
    TFR
    PASS
    Revlimid
    Tumor Flare Reaction
    High Tumor Burden
    Mantle Cell Lymphoma
    MCL
  • Additional relevant MeSH terms: Lymphoma, Mantle-Cell Lymphoma