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Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment (MCL-004)

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ClinicalTrials.gov Identifier: NCT02341781
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

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.


Condition or disease
Lymphoma, Mantle-Cell

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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 Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Adverse Events [ Time Frame: Approximately 5.7 years ]
    Number of participants with adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341781


Locations
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United States, Arizona
Mayo Clinic Scottsdale
Phoenix, Arizona, United States, 85054
United States, California
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Florida
University of Miami and Sylvester Comprehensive Cancer
Miami, Florida, United States, 33136
United States, Michigan
University of Michigan Comprehensive Cancer Center Division of Hematology Oncology
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Columbia Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65101
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Germany
Universitatsmedizin der Johannes Gutenberg- Universitat
Mainz, Rhineland-Palatinate, Germany, 55131
Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, Italy, 40138
United Kingdom
Derriford Hospital Plymouth Oncology Center Clinical
Plymouth, Devon, United Kingdom, Pl68DH
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Oliver Manzke, MD Celgene Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02341781     History of Changes
Other Study ID Numbers: CC-5013-MCL-004
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Keywords provided by Celgene:
MANTLE CELL LYMPHOMA
Multicenter
Observational
Lenalidomide (Revlimid®)
Relapsed or progressed
Ibrutinib
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Lenalidomide
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents