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Trial record 19 of 855 for:    LENALIDOMIDE AND Angiogenesis

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 : Recruiting
First Posted : August 27, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date August 23, 2018
First Posted Date August 27, 2018
Last Update Posted Date September 12, 2019
Actual Study Start Date October 2, 2018
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03647124 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 23, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Lymphoma, Mantle-Cell
Intervention Drug: Lenalidomide
Lenalidomide
Study Groups/Cohorts
  • 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
    Intervention: Drug: 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
    Intervention: Drug: Lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 23, 2018)
560
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2026
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries Austria,   France,   Germany,   Greece,   Netherlands,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03647124
Other Study ID Numbers CC-5013-MCL-005
U1111-1213-1816 ( Registry Identifier: WHO )
EUPAS23366 ( Registry Identifier: EU PAS Register )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Celgene
Study Sponsor Celgene
Collaborators Not Provided
Investigators
Study Director: Philippe Arnaud, MD Celgene
PRS Account Celgene
Verification Date September 2019