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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-15

Study Completion Date

2020-07-15

Brief Summary

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This is a multicentric, observational and retrospective study of the use of lenalidomide in patients with relapsed or refractory mantle cell lymphoma that are included in the RRMCL spanish program.

The lenalidomide effectiveness and tolerability data will be retrospectely collected until the 30 of April 2018.

Detailed Description

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Conditions

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Mantle Cell Lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years old.
* 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

* ECOG \> 2.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Carlos García Pérez

Role: CONTACT

955 00 80 00

Facility Contacts

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Carlos García Pérez

Role: primary

955 00 80 00

Other Identifiers

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FIS-LEN-2018-01

Identifier Type: -

Identifier Source: org_study_id

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