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

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)

Overall Status

Unknown status

CT.gov ID

NCT04109872

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma	Drug: Lenalidomide

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 15, 2018

Anticipated Primary Completion Date :

Jun 15, 2020

Anticipated Study Completion Date :

Jul 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Mantle cell lymphoma treated with lenalidomide cohort Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program.	Drug: Lenalidomide Lenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018.

Arm

Intervention/Treatment

Mantle cell lymphoma treated with lenalidomide cohort

Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program.

Drug: Lenalidomide

Lenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018.

Outcome Measures

Primary Outcome Measures

Experience of real clinal practice lenalidomide use. [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]
Results of the the usage in real clinical practice of the lenalidomide monotherapy or combination treatment in patients with relapsed or refractory mantle cell lymphoma that aren´t candidate to other alternative treatments inside the RRMCL spanish program.

Secondary Outcome Measures

Proportion of patients that achieve objective response. [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]
The objective response will be measured in terms of complete response, not confirmed complete response and partial response according to the 2007 International Working Group criteria after the 6º treatment cycle.
Duration of the response. [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]
Partial and complete response duration.
Verify the disease free survival. [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]
The disease free survival is defined as the time that passes from the inclusion in the record until a control is done or takes place a relapse (local or distant).
Verify the disease overall survival. [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]
The disease overall survival is defined as the time that passes from the inclusion in the record until a control is done or the patient´s death.
Evaluate the incidence of treatment adverse events. [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]
Number and description of adverse effects due to the lenalidomide treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.