Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment
NCT ID: NCT02341781
Last Updated: 2017-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2015-04-30
2016-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Relapsed,Progressed,Refractory or Intolerant to ibrutinib
MCL subjects who received lenalidomide after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Oliver Manzke, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Mayo Clinic Scottsdale
Phoenix, Arizona, United States
Innovative Clinical Research Institute
Whittier, California, United States
University of Miami and Sylvester Comprehensive Cancer
Miami, Florida, United States
University of Michigan Comprehensive Cancer Center Division of Hematology Oncology
Ann Arbor, Michigan, United States
Columbia Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Universitatsmedizin der Johannes Gutenberg- Universitat
Mainz, Rhineland-Palatinate, Germany
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, Italy
Derriford Hospital Plymouth Oncology Center Clinical
Plymouth, Devon, United Kingdom
Countries
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References
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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.
Other Identifiers
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CC-5013-MCL-004
Identifier Type: -
Identifier Source: org_study_id
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