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)

• ClinicalTrials.gov Identifier: NCT03647124
• Recruitment Status: Recruiting
• First Posted: August 27, 2018
• Last Update Posted: February 5, 2021
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Tracking Information

• First Submitted Date: August 23, 2018
• First Posted Date: August 27, 2018
• Last Update Posted Date: February 5, 2021
• 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

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

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, Italy, Netherlands, Spain

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: February 2021