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 (CC-5013-MCL-005)

Study identification

• EU PAS number:
  EUPAS23366
• Study ID:
  47194
• Official title and acronym:
  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 (CC-5013-MCL-005)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Greece

  Italy

  Netherlands

  Spain
• Study description:
  The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in patients with relapsed or refractory mantle cell lymphoma.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Celgene International

Study timelines

Date when funding contract was signed

Actual: 26/10/2017

Study start date

Planned: 28/02/2019

Actual: 20/07/2018

Data analysis start date

Planned: 31/12/2026

Date of final study report

Planned: 31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Celgene

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)