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)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03647124 |
|
Recruitment Status :
Recruiting
First Posted : August 27, 2018
Last Update Posted : September 17, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Actual Study Start Date : | October 2, 2018 |
| Estimated Primary Completion Date : | December 31, 2026 |
| Estimated Study Completion Date : | December 31, 2026 |
| 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 |
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
Inclusion Criteria:
- 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.
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.
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
| Contact: Associate Director Clinical Trial Disclosure | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
Show 43 study locations
| Study Director: | Philippe Arnaud, MD | Celgene |
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT03647124 |
| 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: | 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 |
|
Mantle Cell Lymphoma MCL Revlimid Non-Interventional PASS CC-5013 |
Relapsed Refractory TFR Tumor Flare Reaction High Tumor Burden |
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
Lenalidomide Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |