Clinical trial NCT04109872: Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.
Official title: Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mantle Cell Lymphoma
Keywords: Lenalidomide
Mantle Cell Lymphoma
Relapsed
Refractory
RRMCL spanish program
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with mantle cell lymphoma that received lenalidomide through the RRMCL program as long as they meet all the inclusion criteria and none of the exclusion and independently from being dead or alive in the moment of data record.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Experience of real clinal practice lenalidomide use.
timeFrame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first
Secondary outcomes:
measure: Proportion of patients that achieve objective response.
timeFrame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first
measure: Duration of the response.
timeFrame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first
measure: Verify the disease free survival.
timeFrame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first
measure: Verify the disease overall survival.
timeFrame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first
measure: Evaluate the incidence of treatment adverse events.
timeFrame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Carlos García Pérez
role: STUDY_CHAIR
References: