NCT02341781

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

A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed After Treatment With Ibrutinib or Are Refractory or Intolerant to Ibrutinib.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Mantle-Cell

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-01-19
• Last updated: 2017-01-26

Locations

14 sites across 4 countries: United States, Germany, Italy, United Kingdom