Clinical trial

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

Name

CC-5013-MCL-005

Description

The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.

Trial arms

Trial start

2019-03-13

Estimated PCD

2026-12-31

Trial end

2026-12-31

Status

Recruiting

Treatment

Lenalidomide

Specified dose on specified days

Arms:

Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe

Other names:

Revlimid, L04AX04

Size

560

Primary endpoint

To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting.

Approximately 8.5 years

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 560, 'type': 'ESTIMATED'}}

Updated at

2022-10-21

1 organization

1 product

2 indications

Organization

Product

Indication

Indication