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

Lymphoma, Mantle-Cell Clinical Trial

— MCL-004  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341781
• Other study ID #: CC-5013-MCL-004
• Status: Completed
• Phase: N/A
• First received: January 14, 2015
• Last updated: January 25, 2017
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent document (ICD), if applicable, prior to any collection of study-related data.

2. Males or females = 18 years of age at the time of signing the ICD (if informed consent is applicable)

3. Diagnosis of Mantle Cell Lymphoma (MCL) as assessed by the investigator. A copy of a pathology report establishing the diagnosis of MCL must be available

4. Must have received at least one dose of ibrutinib and must have met at least one of the following criteria:

A. Relapse: Subjects with relapse following initial response of CR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib treatment at the time of relapse, and there is no upper limit on the time between the last dose of ibrutinib to time of relapse. B. Progressive disease (PD): Subjects with PD following initial response of PR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib at the time of progression, and there is no upper limit on the time between the last dose of ibrutinib to time of progression. C. Refractoriness: Subjects with i. Best response of stable disease (SD) during treatment with ibrutinib (or an ibrutinib-containing regimen), and then subsequently had PD, or ii. Best response of PD at anytime while on ibrutinib (or an ibrutinib-containing regimen) D. Intolerance: Subjects requiring premature discontinuation of ibrutinib for reasons other than PD prior to the planned end of treatment. Potential reasons for premature discontinuation may include Adverse Event (AE) attributed to ibrutinib or inability to continue ibrutinib for other reasons. Subjects responding to ibrutinib treatment must have documented PD/relapse following discontinuation of ibrutinib. The reason for the premature discontinuation of ibrutinib will be recorded.

Exclusion Criteria:

• no exclusion criteria.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Locations

Country	Name	City	State
Germany	Universitatsmedizin der Johannes Gutenberg- Universitat	Mainz	Rhineland-Palatinate
Italy	Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi	Bologna	Emilia-Romagna
United Kingdom	Derriford Hospital Plymouth Oncology Center Clinical	Plymouth	Devon
United States	University of Michigan Comprehensive Cancer Center Division of Hematology Oncology	Ann Arbor	Michigan
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Columbia Comprehensive Cancer Care Clinic	Jefferson City	Missouri
United States	University of Miami and Sylvester Comprehensive Cancer	Miami	Florida
United States	Froedtert and The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Weill Cornell Medical College	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Scottsdale	Phoenix	Arizona
United States	Innovative Clinical Research Institute	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	Overall Response is defined as best response of Partial Remission (PR) or Complete Remission (CR) at any time during lenalidomide treatment.	Approximately 5.7 years
Secondary	Duration of response (DoR)	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.	Approximately 5.7 years
Secondary	Adverse Events	Number of participants with adverse events.	Approximately 5.7 years