Clinical Trial: Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed Aft

Brief Summary:

The objective of this study is to determine the effectiveness of lenalidomide in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL subjects who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. It is therefore of benefit to have data on the outcomes of treatment options available in this patient population.

An observational study design was chosen to collect the clinical data already existing or being collected for MCL subjects being treated with lenalidomide.

MCL subjects who received lenalidomide either as monotherapy or as combination treatment after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.


Detailed Summary:
Sponsor: Celgene

Current Primary Outcome: Overall Response Rate (ORR) [ Time Frame: Approximately 5.7 years ]

Overall Response is defined as best response of Partial Remission (PR) or Complete Remission (CR) at any time during lenalidomide treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response (DoR) [ Time Frame: Approximately 5.7 years ]
    DoR is defined as the time from the date of the initial response of at least PR (PR or CR) to the date of progressive disease (PD) or relapse.
  • Adverse Events [ Time Frame: Approximately 5.7 years ]
    Number of participants with adverse events.


Original Secondary Outcome: Same as current

Information By: Celgene

Dates:
Date Received: January 14, 2015
Date Started: April 2015
Date Completion:
Last Updated: January 25, 2017
Last Verified: January 2017