Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.
NCT ID: NCT04109872
Last Updated: 2020-02-05
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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UNKNOWN
25 participants
OBSERVATIONAL
2018-09-15
2020-07-15
Brief Summary
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The lenalidomide effectiveness and tolerability data will be retrospectely collected until the 30 of April 2018.
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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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Mantle cell lymphoma treated with lenalidomide cohort
Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program.
Lenalidomide
Lenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018.
Interventions
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Lenalidomide
Lenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with relapsed or refractory mantle cell lymphoma verified by a tissue biopsy.
* Treated with monotherapy or combination of lenalidomide.
* Not candidate for any of the therapeutic options approved until that date for this disease.
* Not candidate or unable to be included in any clinical trial due to availability or geographical difficulty.
* Registered in the RRMCL spanish program.
Exclusion Criteria
* Patients with uncontrolled comorbidities.
* Blastoid variant.
* Central nervous system tumor infiltration.
* HIV, HBV and/or HCV active infection.
* Radiotherapy concomitant treatment or that have received radiotherapy in the previous 30 days to the beginning of the first cycle of lenalidomide.
* Diagnosed with other active solid tumor except for basal cell carcinoma skin cancer.
* Patients that haven´t completed at least one complete cycle of the treatment.
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Carlos García Pérez
Role: STUDY_CHAIR
Hospital Universitario Virgen Macarena
Locations
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Hospital Universitario Virgen Macarena
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FIS-LEN-2018-01
Identifier Type: -
Identifier Source: org_study_id
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