Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Unknown

Conditions

Mantle Cell Lymphoma

Treatments

Drug: Lenalidomide

Study type

Observational

Funder types

Other

Identifiers

NCT04109872

FIS-LEN-2018-01

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.