Clinical trial NCT02341781: Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Mantle-Cell
Keywords: MANTLE CELL LYMPHOMA
Multicenter
Observational
Lenalidomide (Revlimid®)
Relapsed or progressed
Ibrutinib
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mantle Cell Lymphoma (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.

Lenalidomide does not need to be the next subsequent treatment after ibrutinib.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Approximately 5.7 years
Secondary outcomes:
measure: Duration of response (DoR)
timeFrame: Approximately 5.7 years
measure: Adverse Events
timeFrame: Approximately 5.7 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Miami
country: United States
facility: University of Miami and Sylvester Comprehensive Cancer
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Division of Hematology Oncology
state: Michigan
city: Jefferson City
country: United States
facility: Columbia Comprehensive Cancer Care Clinic
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Froedtert and The Medical College of Wisconsin
state: Wisconsin
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg- Universitat
state: Rhineland-Palatinate
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
state: Emilia-Romagna
city: Plymouth
country: United Kingdom
facility: Derriford Hospital Plymouth Oncology Center Clinical
state: Devon
Study officials:
affiliation: Celgene Corporation
name: Oliver Manzke, MD
role: STUDY_DIRECTOR
References:
citation: Wang M, Schuster SJ, Phillips T, Lossos IS, Goy A, Rule S, Hamadani M, Ghosh N, Reeder CB, Barnett E, Bravo MC, Martin P. Observational study of lenalidomide in patients with mantle cell lymphoma who relapsed/progressed after or were refractory/intolerant to ibrutinib (MCL-004). J Hematol Oncol. 2017 Nov 2;10(1):171. doi: 10.1186/s13045-017-0537-5.